A Phase 1/2, Open-label, Multi-center Study of the Safety... | NCT03829501 | Trialant
NCT03829501
Sponsor
Kymab Limited
Status
Terminated
Last Update Posted
Apr 2, 2025Actual
Enrollment
222Actual
Phase
Phase 1Phase 2
Conditions
Squamous Cell Carcinoma of Head and Neck
Non-small Cell Lung Cancer
Hepatocellular Carcinoma
Esophageal Cancer
Gastric Cancer
Melanoma
Renal Cell Carcinoma
Pancreatic Cancer
Cervical Cancer
Triple Negative Breast Cancer
Advanced Cancer
Metastatic Cancer
Interventions
Alomfilimab
Atezolizumab
Countries
United States
Hungary
Italy
Poland
Taiwan
United Kingdom
Protocol Section
Identification Module
NCT ID
NCT03829501
Obsolete or Duplicate NCT IDs
Not provided
Organization Study
KY1044-CT01
Secondary IDs
ID
Type
Description
Link
Sanofi Study ID
Other Identifier
TCD17370
2018-003172-12
EudraCT Number
U1111-1269-6777
Other Identifier
WHO ICTRP
Brief Title
A Phase 1/2, Open-label, Multi-center Study of the Safety and Efficacy of Alomfilimab (KY1044) as Single Agent and in Combination With Anti-PD-L1 (Atezolizumab) in Adult Patients With Selected Advanced Malignancies
Official Title
A Phase 1/2, Open-label, Multi-center Study of the Safety and Efficacy of KY1044 as Single Agent and in Combination With Anti-PD-L1 (Atezolizumab) in Adult Patients With Selected Advanced Malignancies
Acronym
Not provided
Organization
Kymab LimitedINDUSTRY
Status Module
Record Verification Date
Mar 2025
Overall Recruitment Status or Expanded Access Status
Terminated
Last Known Status
Not provided
Delayed Posting
Not provided
Why Stopped
Early discontinuation based on strategic sponsor decision not driven by any safety concerns.
Expanded Access Info
No
Start Date
Jan 28, 2019Actual
Primary Completion Date
Oct 3, 2024Actual
Completion Date
Oct 3, 2024Actual
First Submitted Date
Jan 17, 2019
First Submission Date that Met QC Criteria
Feb 1, 2019
First Posted Date
Feb 4, 2019Actual
Results Waived
Not provided
Results First Submitted Date
Jan 30, 2025
Results First Submitted that Met QC Criteria
Mar 13, 2025
Results First Posted Date
Apr 2, 2025Actual
Certification/Extension (aka Delayed Results) First Submitted Date
Not provided
Certification/Extension First Submitted that Passed QC Review
Not provided
Certification/Extension First Posted Date
Not provided
Last Update Submitted Date
Mar 13, 2025
Last Update Posted Date
Apr 2, 2025Actual
Sponsor/Collaborators Module
Responsible Party, by Official Title
Sponsor
Lead Sponsor
Kymab LimitedINDUSTRY
Collaborators
Name
Class
Sanofi
INDUSTRY
Oversight Module
Has Data Monitoring Committee (DMC)
Yes
Is FDA Regulated Drug
Yes
Is FDA Regulated Device
No
Is Unapproved Device
Not provided
Pediatric Postmarket Surveillance of a Device Product
Not provided
Product Exported from US
Not provided
FDAAA801 Violation
Not provided
Description Module
Brief Summary
A Phase 1/2, open label, multi-center study to evaluate the safety, efficacy and tolerability of alomfilimab as single agent and in combination with anti-PD-L1 (atezolizumab) in adult patients with selected advanced malignancies, who are ineligible for or there are no available therapies known to confer a clinical benefit for their disease, or they have exhausted all such available options in each indication and therefore will be patients for whom a clinical trial is appropriate.
Detailed Description
Not provided
Conditions Module
Conditions
Squamous Cell Carcinoma of Head and Neck
Non-small Cell Lung Cancer
Hepatocellular Carcinoma
Esophageal Cancer
Gastric Cancer
Melanoma
Renal Cell Carcinoma
Pancreatic Cancer
Cervical Cancer
Triple Negative Breast Cancer
Advanced Cancer
Metastatic Cancer
Keywords
Not provided
Design Module
Study Type
Interventional
Number of References to an Expanded Access Study
Not provided
Expanded Access Types
Not provided
Patient Registry
Not provided
Target Follow-Up Duration
Not provided
Phases
Phase 1Phase 2
Interventional Study Design
Allocation
Biospecimen
No data available
No data is available for this block.
Enrollment
222Actual
Arms/Interventions Module
Arm Groups
Label
Type
Description
Intervention Names
Phase 1: Alomfilimab Monotherapy
Experimental
Participants will receive alomfilimab 0.8 to 240 mg as a single agent via intravenous (IV) infusion every 3 weeks (Q3W).
Participants will receive alomfilimab 2.4 to 80 mg in combination with atezolizumab 1200 mg via IV infusion Q3W.
Drug: Alomfilimab
Drug: Atezolizumab
Phase 2: Alomfilimab + Atezolizumab in Anti-PD-(L)1 Naïve Participants
Experimental
Anti-PD-(L)1 naïve participants with pancreatic cancer, triple negative breast cancer (BC) or head and neck squamous cell carcinoma (HNSCC) will receive alomfilimab 2.4 to 24 mg in combination with atezolizumab 1200 mg via IV infusion Q3W.
Drug: Alomfilimab
Drug: Atezolizumab
Phase 2: Alomfilimab + Atezolizumab in Pre-treated Participants
Experimental
Pre-treated participants with pancreatic cancer, triple negative BC or HNSCC will receive alomfilimab 2.4 to 24 mg in combination with atezolizumab 1200 mg via IV infusion Q3W.
Phase 2: Alomfilimab + Atezolizumab in Anti-PD-(L)1 Naïve Participants
Outcomes Module
Primary Outcomes
Measure
Description
Time Frame
Phase 1: Number of Participants Experiencing Treatment-emergent Adverse Events (TEAEs)
An adverse event (AE) was any untoward medical occurrence in a participant administered a pharmaceutical product, which did not necessarily have a causal relationship with this treatment. An serious AE (SAE) was any AE that:
resulted in death;
was life-threatening;
resulted in inpatient hospitalization or prolongation of existing hospitalization;
resulted in a persistent or significant disability/incapacity;
resulted in congenital anomaly/birth defect in the offspring of a participant who received IMPs;
constituted an important medical event.
Clinically significant changes in laboratory parameters, vital signs and electrocardiogram results were reported as AEs. A TEAE was defined as an AE observed after starting administration of the specific treatment.
From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment; maximum duration of treatment exposure was up to approximately 212 weeks
Phase 1: Number of Participants Experiencing Dose Changes
Dose changes were defined as infusion interruption and dose reduction.
From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment; maximum duration of treatment exposure was up to approximately 212 weeks
Phase 1: Absolute Dose Intensity
Absolute dose intensity was calculated as cumulative dose received (mg) / study treatment duration (weeks).
From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment; maximum duration of treatment exposure was up to approximately 212 weeks
Phase 1: Relative Dose Intensity
Relative dose intensity was calculated as the cumulative dose received (mg) / initial planned cumulative dose (mg). Initial planned cumulative dose was calculated as the starting dose multiplied by the scheduled number of administrations within the study treatment duration.
Secondary Outcomes
Measure
Description
Time Frame
Best Overall Response (BOR) Per RECIST 1.1
BOR for each participant was defined as the best confirmed response per RECIST 1.1 among all responses recorded from start of treatment until PD, initiation of new anti-cancer therapy, death, or analysis cut-off date, whichever comes first, with responses of:
CR: disappearance of all target and non-target lesions. Any pathological lymph nodes (whether target or non-target) must have had a reduction in short axis to < 10 mm. All lymph nodes must have been non-pathological in size (< 10mm short axis).
PR: at least a 30% decrease in the sum of diameters of target lesions, taking as reference the Baseline sum diameters.
Stable disease (SD): neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD.
PD: at least a 20% increase in the sum of diameters of target lesions. The sum must also demonstrate an increase of at least 5mm. Unequivocal progression of existing non-target lesions.
Phase 1 and Phase 2 participants with advanced/metastatic malignancies who have measurable disease (non-measurable disease is allowed only in Phase 1) as determined by RECIST 1.1 will be eligible if, according to the National Comprehensive Cancer Network (NCCN) guidelines, there are no available therapies known to confer a clinical benefit for their disease, or they have exhausted all such available options. Additionally, the following specific tumor indications will be enrolled:
Phase 1: Participants with advanced/metastatic malignancies, and preferred indications (non-small cell lung cancer (NSCLC), head and neck squamous cell carcinoma (HNSCC), hepatocellular carcinoma (HCC), melanoma, cervical, esophageal, gastric, renal, pancreatic, and triple negative breast cancer)
Phase 2 Alomfilimab single agent: Participants with advanced/metastatic malignancies in indications in which signs of anti-tumor activity (Complete Response (CR), Partial Response (PR) or durable stable disease (SD) with tumor shrinkage that does not qualify for PR) were seen during the dose escalation of Alomfilimab as single agent
Phase 2 Alomfilimab in combination with atezolizumab: Participants with advanced/metastatic malignancies in the selected indications below, and/or indications which have shown promising activity in Phase 1:
NSCLC (anti-PD-(L)1 therapy naïve and pre-treated between 1 and 2 prior lines of systemic therapy for advanced disease)
Gastric (anti-PD-(L)1 therapy naïve and pre-treated)
Recurrent and/or metastatic HNSCC (anti-PD-(L)1 therapy naïve and pre-treated between 1 and 2 prior lines of systemic therapy for advanced disease)
Esophageal (anti-PD-(L)1 therapy naïve and pre-treated)
Cervical (anti-PD-(L)1 therapy naïve and pre-treated)
Indications, in which signs of anti-tumor activity has been observed in Phase 1 with Alomfilimab in combination with atezolizumab
Prior therapy with anti-PD-(L)1 inhibitors is allowed provided any toxicity attributed to prior anti-PD-(L)1-directed therapy did not lead to discontinuation of therapy
Eastern Cooperative Oncology Group (ECOG) Performance Status 0-1
Life expectancy longer than 12 weeks
Must have a site of disease amenable to biopsy, and be a candidate for tumor biopsy according to the treating institution's guidelines. Participants must be willing to undergo a new tumor biopsy at screening, and during therapy on the study
Exclusion Criteria:
Presence of symptomatic central nervous system (CNS) metastases, or CNS metastases that require local CNS-directed therapy, or increasing doses of corticosteroids within the prior 2 weeks of first dose of study treatment
History of severe hypersensitivity reactions to other monoclonal antibodies and/or their excipients
Known presence of neutralizing anti-atezolizumab antibodies (for patients previously treated with atezolizumab)
Having out of range laboratory values: creatinine, bilirubin, alanine aminotransferase (ALT), aspartate aminotransferase (AST), absolute neutrophil count (ANC), platelet count, hemoglobin
Impaired cardiac function or clinically significant cardiac disease, including any of the following:
Clinically significant and/or uncontrolled heart disease such as congestive heart failure requiring treatment (New York Heart Association [NYHA] Grade ≥2), uncontrolled hypertension or clinically significant arrhythmia
QTcF >470 msec on screening (electrocardiogram) ECG using Fridericia's formula (QTcF) or congenital long QT syndrome
Acute myocardial infarction or unstable angina pectoris
Known human immunodeficiency virus (HIV), active hepatitis B virus (HBV) or active hepatitis C virus (HCV) infection
Malignant disease, other than that being treated in this study
Any medical condition that would, in the Investigator's judgment, prevent participation in the clinical study due to safety concerns, compliance with clinical study procedures or interpretation of study results
Active autoimmune disease or a documented history of autoimmune disease
Participants previously exposed to anti-PD-(L)1 treatment who are not adequately treated for skin rash or had no replacement therapy for endocrinopathies should be excluded
Participants with a history of drug-induced pneumonitis or current pneumonitis
Systemic steroid therapy or any immunosuppressive therapy. Topical, inhaled, nasal, and ophthalmic steroids are not prohibited
Use of live attenuated vaccines against infectious diseases within 4 weeks of the first dose of study treatment. SARS-CoV-2 vaccines authorized for use by the competent local regulatory health authorities for active immunization to prevent COVID 19 are allowed (unless the vaccine is live or live attenuated) and must be given in accordance with the prevailing immunization guidelines.
Anti-CTLA4, anti-PD-(L)1 treatment within 4 weeks of the first dose of study treatment
Pre-treatment with anti-CTLA4 antibodies in combination with any other antibody or drug specifically targeting T-cell co-stimulation or checkpoint pathway
Presence of Common Terminology Criteria for Adverse Events version 5 (CTCAE v5) ≥Grade 2 toxicity (except alopecia, peripheral neuropathy and ototoxicity, which are excluded if CTCAE v5 ≥Grade 3) due to prior cancer therapy
Radiotherapy within 2 weeks of the first dose of study treatment, except for palliative radiotherapy to a limited field, such as for the treatment of bone pain or a focally painful tumor mass. To allow evaluation for response to treatment, participants enrolled in the Phase 2 part must have remaining measurable disease that has not been irradiated
Naing A, Lin CC, Patel MR, Curigliano G, Burris HA, Thistlethwaite F, De Braud F, Minchom A, Ascierto PA, Wake M, Nguyen MA, Abbadessa G, Sainson RCA, Palu CC, Quaratino S, Deantonio C. First-in-human, phase 1, open-label study of alomfilimab, an anti-ICOS antibody, as a single agent and in combination with anti-PD-L1 in advanced malignancies. J Immunother Cancer. 2026 Jun 8;14(6):e013540. doi: 10.1136/jitc-2025-013540.
See Also Links
Not provided
Available IPD Information
Not provided
IPD Sharing Statement Module
Plan to Share IPD
Yes
Description
Qualified researchers may request access to patient level data and related study documents including the clinical study report, study protocol with any amendments, blank case report form, statistical analysis plan, and dataset specifications. Patient level data will be anonymized and study documents will be redacted to protect the privacy of trial participants. Further details on Sanofi's data sharing criteria, eligible studies, and process for requesting access can be found at https://vivli.org
Types
Not provided
Time Frame
Not provided
Access Criteria
Not provided
URL
Not provided
Results Section
Participant Flow Module
Pre-assignment Details
Not provided
Recruitment Details
The study was conducted at 22 centers in 6 countries. A total of 222 participants, of which 0 were screen failures. Participants were enrolled from 28 January 2019 to 04 August 2023.
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
FG000
Alomfilimab 0.8 mg
Participants received alomfilimab 0.8 mg as a single agent via intravenous (IV) infusion every 3 weeks (Q3W). The participants continued treatment with alomfilimab within this clinical study, as long as they continued to derive benefit from treatment, until the participant experienced unacceptable toxicity or confirmed disease progression (PD) per immune-related (i) Response Evaluation Criteria in Solid Tumors (RECIST).
Periods
Title
Milestones
Reasons Not Completed
Overall Study
Type
Comment
Milestone Data
STARTED
Baseline Characteristics Module
Baseline Analysis Population Description
Outcome Measures Module
Outcome Measures
Adverse Events Module
Frequency Threshold
5
More Info Module
Limitations and Caveats
Not provided
Annotation Section
No data available
No data is available for this block.
Document Section
Large Document Module
Document Has No Statistical Analysis Plan (SAP)
Not provided
Uploaded Document Information
Type
Includes Protocol
Includes SAP
Includes ICF
Document Label
Document Date
Document Uploaded Date
Document File Name
Prot
Yes
No
No
Study Protocol
Nov 10, 2021
Jan 20, 2025
Derived Section
Miscellaneous Info Module
Version Holder
Jul 10, 2026
Removed Countries
Not provided
Submission Tracking
Estimated Results First Submitted Date
Not provided
Condition Browse Module
MeSH Terms
Intervention Browse Module
MeSH Terms
Non-Randomized
Intervention Model
Sequential Assignment
Intervention Model Description
Not provided
Primary Purpose
Treatment
Observational Model
Not provided
Time Perspective
Not provided
Masking Info
Masking
None (Open Label)
Masking Description
Not provided
Who Masked
Not provided
Phase 2: Alomfilimab + Atezolizumab in Pre-treated Participants
Phase 2: Alomfilimab + Atezolizumab in Anti-PD-(L)1 Naïve Participants
Phase 2: Alomfilimab + Atezolizumab in Pre-treated Participants
TECENTRIQ
From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment; maximum duration of treatment exposure was up to approximately 212 weeks
Phase 1: Number of Participants Experiencing Dose Limiting Toxicities (DLTs)
A DLT was defined as a clinically relevant AE or abnormal laboratory value of Common Terminology Criteria for Adverse Events Version 5.0 (CTCAE v5.0) ≥ Grade 3 assessed as unrelated to disease, PD, inter-current illness or concomitant medications, which occurs within the first cycle (21 days) of treatment with alomfilimab as single agent or in combination with atezolizumab during the dose escalation part of the study.
From first dose of study treatment (Day 1) up to 21 days
Phase 2: Overall Response Rate (ORR) Per RECIST 1.1
ORR was the percentage of participants with a measurable disease at baseline and with a confirmed response of complete response (CR) or partial response (PR) according to RECIST v1.1 as the best response. The response is confirmed by a later scan conducted at least 4 weeks after the initial response is observed. The 95% confidence interval (CI) was calculated using the exact binomial method (Clopper-Pearson).
CR: disappearance of all target and non-target lesions. Any pathological lymph nodes (whether target or non-target) must have had a reduction in short axis to < 10 mm. All lymph nodes must have been non-pathological in size (< 10mm short axis).
PR: at least a 30% decrease in the sum of diameters of target lesions, taking as reference the Baseline sum diameters.
From first dose of study treatment (Day 1) up to the end of the long term follow-up, approximately 162 weeks
From first dose of study treatment (Day 1) up to the end of the long term follow-up, approximately 236 and 162 weeks for Phase 1 and 2, respectively
Progression-free Survival (PFS) Per RECIST 1.1
PFS was calculated as (first documented PD or death due to any cause - first dose date of study drug +1)/30.4375. Participants who were not observed to have progressed or died were censored at the date of the last tumor assessment. Participants who missed two or more sequential assessments were censored at the date of the last tumor assessment before the missed assessments. Participants who started new anti-cancer therapy prior to documented PD were censored at the date of the last tumor assessment prior to the start of the new therapy. Participants who did not have any tumor assessments were censored with a duration of 1 day. PFS was obtained via Kaplan Meier estimation using the Brookmeyer-Crowley method.
PD: at least a 20% increase in the sum of diameters of target lesions. The sum must also demonstrate an increase of at least 5mm. Unequivocal progression of existing non-target lesions.
From first dose of study treatment (Day 1) up to the end of the long term follow-up, approximately 236 and 162 weeks for Phase 1 and 2, respectively
Duration of Response Per RECIST 1.1
Duration of response was calculated as (date of the first documentation of PD or to death due to any cause in the absence of PD - date of the first documentation of unconfirmed objective response [CR or PR] + 1]/30.4375. Participants who were not observed to have progressed or died were censored at the date of the last tumor assessment. Participants who missed two or more sequential assessments were censored at the date of the last tumor assessment before the missed assessments. Participants who started new anti-cancer therapy prior to documented PD were censored at the date of the last tumor assessment prior to the start of the new therapy. Participants with no disease assessment (or only had assessments with response = NE) after first study treatment or have baseline or post-baseline assessments where the RECIST criteria could not be applied had their duration of response time censored. Duration of response was obtained via Kaplan Meier estimation.
From first dose of study treatment (Day 1) up to the end of the long term follow-up, approximately 236 and 162 weeks for Phase 1 and 2, respectively
ORR Per iRECIST
RECIST 1.1 has been modified to take into consideration the unique response kinetics which have been observed with immunotherapy in some patients where responses to immune therapies may occur after progression has been assessed. ORR was the percentage of participants with a measurable disease at baseline and with a confirmed response of complete immune-response (iCR) or partial immune-response (iPR) according to iRECIST as the best response. The 95% CI was calculated using the exact binomial method (Clopper-Pearson).
iCR: disappearance of all target and non-target lesions. Any pathological lymph nodes (whether target or non-target) must have had a reduction in short axis to < 10 mm. All lymph nodes must have been non-pathological in size (< 10mm short axis).
iPR: at least a 30% decrease in the sum of diameters of target lesions, taking as reference the Baseline sum diameters.
From first dose of study treatment (Day 1) up to the end of the long term follow-up, approximately 236 and 162 weeks for Phase 1 and 2, respectively
PFS Per iRECIST
PFS was calculated as (first documented iPD or death due to any cause - first dose date of study drug +1)/30.4375. Participants who were not observed to have progressed or died were censored at the date of the last tumor assessment. Participants who missed two or more sequential assessments were censored at the date of the last tumor assessment before the missed assessments. Participants who started new anti-cancer therapy prior to documented PD were censored at the date of the last tumor assessment prior to the start of the new therapy. Participants who did not have any tumor assessments were censored with a duration of 1 day. PFS was obtained via Kaplan Meier estimation using the Brookmeyer-Crowley method.
iPD: at least a 20% increase in the sum of diameters of target lesions. The sum must also demonstrate an increase of at least 5mm. Unequivocal progression of existing non-target lesions.
From first dose of study treatment (Day 1) up to the end of the long term follow-up, approximately 236 and 162 weeks for Phase 1 and 2, respectively
Phase 1: ORR Per RECIST 1.1
ORR was the percentage of participants with a measurable disease at baseline and with a confirmed response of CR or PR according to RECIST v1.1 as the best response. The response is confirmed by a later scan conducted at least 4 weeks after the initial response is observed. The 95% CI was calculated using the exact binomial method (Clopper-Pearson).
CR: disappearance of all target and non-target lesions. Any pathological lymph nodes (whether target or non-target) must have had a reduction in short axis to < 10 mm. All lymph nodes must have been non-pathological in size (< 10mm short axis).
PR: at least a 30% decrease in the sum of diameters of target lesions, taking as reference the Baseline sum diameters.
From first dose of study treatment (Day 1) up to the end of the long term follow-up, approximately 236 weeks
Overall Survival Rate at 12 and 24 Months
Overall Survival rate was defined as the proportion of participants that had known survival status. Overall survival rate was obtained via Kaplan Meier estimation using the complimentary log-log transformation method.
Months 12 and 24
Phase 2: Number of Participants Experiencing TEAEs
An AE was any untoward medical occurrence in a participant administered a pharmaceutical product, which did not necessarily have a causal relationship with this treatment. An SAE was any AE that:
resulted in death;
was life-threatening;
resulted in inpatient hospitalization or prolongation of existing hospitalization;
resulted in a persistent or significant disability/incapacity;
resulted in congenital anomaly/birth defect in the offspring of a participant who received IMPs;
constituted an important medical event.
Clinically significant changes in laboratory parameters, vital signs and electrocardiogram results were reported as AEs. A TEAE was defined as an AE observed after starting administration of the specific treatment.
From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment; maximum duration of treatment exposure was up to approximately 86 weeks
Phase 2: Number of Participants Experiencing Dose Changes
Dose changes were defined as infusion interruption and dose reduction.
From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment; maximum duration of treatment exposure was up to approximately 86 weeks
Phase 2: Absolute Dose Intensity
Absolute dose intensity was calculated as cumulative dose received (mg) / study treatment duration (weeks).
From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment; maximum duration of treatment exposure was up to approximately 86 weeks
Phase 2: Relative Dose Intensity
Relative dose intensity was calculated as the cumulative dose received (mg) / initial planned cumulative dose (mg). Initial planned cumulative dose was calculated as the starting dose multiplied by the scheduled number of administrations within the study treatment duration.
From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment; maximum duration of treatment exposure was up to approximately 86 weeks
Phase 1: Maximum Concentration (Cmax) of Alomfilimab
The serum pharmacokinetics (PK) of alomfilimab were characterized using non-compartmental analysis (NCA). Nominal times of sample collections were used for the NCA. All below limit of quantification (BLQ) values were set to 0 units.
Cycles 1 and 3 Day 1 pre-infusion to 336 hours post-infusion start (21 day cycle length)
Phase 1: Half-life (t1/2) of Alomfilimab
The serum PK of alomfilimab were characterized using NCA. Nominal times of sample collections were used for the NCA. All BLQ values were set to 0 units.
Cycles 1 and 3 Day 1 pre-infusion to 336 hours post-infusion start (21 day cycle length)
Number of Participants Experiencing Anti-drug Antibodies (ADA) at Anytime
Detection of ADA was assessed from blood samples taken during the study using validated bioanalytical methods. The number of participants who developed detectable anti-alomfilimab or anti-atezolizumab antibodies during any cycle or the safety follow-up period (SFUP) was calculated.
Phase 1: pre-infusion at all cycles (up to 69 cycles) + 90 days SFUP; Phase 2: pre-infusion at all cycles (up to 28 cycles) + 90 day SFUP (21 day cycle length)
Change From Baseline in Tumor-infiltrating Lymphocytes Per mm^2 at Cycle 2 Day 8
Biological samples (e.g., archived and fresh tumor samples or blood samples) were collected for analysis of responsive biomarkers.
The summary of change in the following markers were calculated:
FOXP3-ICOS double-positive cells per mm^2 in the Tumor
CD8-positive cells per mm^2 in the tumor
CD8-positive cells per mm^2 in the invasive margin.
Baseline and Cycle 2 Day 8 (21 day cycle length)
New Haven
Connecticut
06510
United States
Kymab investigational site 1108
Orlando
Florida
32806
United States
Kymab investigational site 1104
Sarasota
Florida
34232
United States
Kymab investigational site 1103
Nashville
Tennessee
37203
United States
Kymab investigator site 1101
Houston
Texas
77030
United States
Kymab investigational site 3601
Nyíregyháza
Szabolcs-Szatmár-Bereg
4400
Hungary
Kymab investigational site 3602
Budapest
1122
Hungary
Kymab investigational site 3904
Meldola
Forlì-Cesena
47014
Italy
Kymab investigational site 3906
Candiolo
Torino
10060
Italy
Kymab investigational site 3901
Milan
Italy
Kymab investigational site 3903
Milan
Italy
Kymab investigational site 3902
Naples
Italy
Kymab investigational site 3910
Roma
Italy
Kymab investigational site 3908
Turin
10128
Italy
Kymab investigational site 4801
Siedlce
Masovian Voivodeship
04-141
Poland
Kymab investigational site 8806
Changhua
Changhwa
505
Taiwan
Kymab investigational site 8801
Taipei
Taiwan
Kymab investigational site 4405
London
United Kingdom
Kymab investigational site 4402
Manchester
United Kingdom
Kymab investigational site 4404
Oxford
United Kingdom
Kymab investigational site 4401
Sutton
United Kingdom
FG001
Alomfilimab 2.4 mg
Participants received alomfilimab 2.4 mg as a single agent via IV infusion Q3W. The participants continued treatment with alomfilimab within this clinical study, as long as they continued to derive benefit from treatment, until the participant experienced unacceptable toxicity or confirmed PD per iRECIST.
FG002
Alomfilimab 8 mg
Participants received alomfilimab 8 mg as a single agent via IV infusion Q3W. The participants continued treatment with alomfilimab within this clinical study, as long as they continued to derive benefit from treatment, until the participant experienced unacceptable toxicity or confirmed PD per iRECIST.
FG003
Alomfilimab 24 mg
Participants received alomfilimab 24 mg as a single agent via IV infusion Q3W. The participants continued treatment with alomfilimab within this clinical study, as long as they continued to derive benefit from treatment, until the participant experienced unacceptable toxicity or confirmed PD per iRECIST.
FG004
Alomfilimab 80 mg
Participants received alomfilimab 80 mg as a single agent via IV infusion Q3W. The participants continued treatment with alomfilimab within this clinical study, as long as they continued to derive benefit from treatment, until the participant experienced unacceptable toxicity or confirmed PD per iRECIST.
FG005
Alomfilimab 240 mg
Participants received alomfilimab 240 mg as a single agent via IV infusion Q3W. The participants continued treatment with alomfilimab within this clinical study, as long as they continued to derive benefit from treatment, until the participant experienced unacceptable toxicity or confirmed PD per iRECIST.
FG006
Alomfilimab 0.8 mg + Atezolizumab
Participants received alomfilimab 0.8 mg in combination with atezolizumab 1200 mg via IV infusion Q3W. The participants continued treatment with alomfilimab in combination with atezolizumab within this clinical study, as long as they continued to derive benefit from treatment, until the participant experienced unacceptable toxicity or confirmed PD per iRECIST.
FG007
Alomfilimab 2.4 mg + Atezolizumab
Participants received alomfilimab 2.4 mg in combination with atezolizumab 1200 mg via IV infusion Q3W. The participants continued treatment with alomfilimab in combination with atezolizumab within this clinical study, as long as they continued to derive benefit from treatment, until the participant experienced unacceptable toxicity or confirmed PD per iRECIST.
FG008
Alomfilimab 8 mg + Atezolizumab
Participants received alomfilimab 8 mg in combination with atezolizumab 1200 mg via IV infusion Q3W. The participants continued treatment with alomfilimab in combination with atezolizumab within this clinical study, as long as they continued to derive benefit from treatment, until the participant experienced unacceptable toxicity or confirmed PD per iRECIST.
FG009
Alomfilimab 24 mg + Atezolizumab
Participants received alomfilimab 24 mg in combination with atezolizumab 1200 mg via IV infusion Q3W. The participants continued treatment with alomfilimab in combination with atezolizumab within this clinical study, as long as they continued to derive benefit from treatment, until the participant experienced unacceptable toxicity or confirmed PD per iRECIST.
FG010
Alomfilimab 80 mg + Atezolizumab
Participants received alomfilimab 80 mg in combination with atezolizumab 1200 mg via IV infusion Q3W. The participants continued treatment with alomfilimab in combination with atezolizumab within this clinical study, as long as they continued to derive benefit from treatment, until the participant experienced unacceptable toxicity or confirmed PD per iRECIST.
FG011
Alomfilimab 2.4 mg + Atezolizumab in Anti-PD-(L)1 Naïve Pancreatic Cancer
Anti-PD-(L)1 naïve participants with pancreatic cancer received alomfilimab 2.4 mg in combination with atezolizumab 1200 mg via IV infusion Q3W. The participants continued treatment with alomfilimab in combination with atezolizumab within this clinical study, as long as they continued to derive benefit from treatment, until the participant experienced unacceptable toxicity or confirmed PD per iRECIST.
FG012
Alomfilimab 8 mg + Atezolizumab in Anti-PD-(L)1 Naïve Pancreatic Cancer
Anti-PD-(L)1 naïve participants with pancreatic cancer received alomfilimab 8 mg in combination with atezolizumab 1200 mg via IV infusion Q3W. The participants continued treatment with alomfilimab in combination with atezolizumab within this clinical study, as long as they continued to derive benefit from treatment, until the participant experienced unacceptable toxicity or confirmed PD per iRECIST.
FG013
Alomfilimab 2.4 mg + Atezolizumab in Anti-PD-(L)1 Naïve Triple Negative Breast Cancer (BC)
Anti-PD-(L)1 naïve participants with triple negative BC received alomfilimab 2.4 mg in combination with atezolizumab 1200 mg via IV infusion Q3W. The participants continued treatment with alomfilimab in combination with atezolizumab within this clinical study, as long as they continued to derive benefit from treatment, until the participant experienced unacceptable toxicity or confirmed PD per iRECIST.
FG014
Alomfilimab 8 mg + Atezolizumab in Anti-PD-(L)1 Naïve Triple Negative BC
Anti-PD-(L)1 naïve participants with triple negative BC received alomfilimab 8 mg in combination with atezolizumab 1200 mg via IV infusion Q3W. The participants continued treatment with alomfilimab in combination with atezolizumab within this clinical study, as long as they continued to derive benefit from treatment, until the participant experienced unacceptable toxicity or confirmed PD per iRECIST.
FG015
Alomfilimab 8 mg + Atezolizumab in Anti-PD-(L)1 Naïve Head and Neck Squamous Cell Carcinoma (HNSCC)
Anti-PD-(L)1 naïve participants with HNSCC received alomfilimab 8 mg in combination with atezolizumab 1200 mg via IV infusion Q3W. The participants continued treatment with alomfilimab in combination with atezolizumab within this clinical study, as long as they continued to derive benefit from treatment, until the participant experienced unacceptable toxicity or confirmed PD per iRECIST.
FG016
Alomfilimab 24 mg + Atezolizumab in Anti-PD-(L)1 Naïve HNSCC
Anti-PD-(L)1 naïve participants with HNSCC received alomfilimab 24 mg in combination with atezolizumab 1200 mg via IV infusion Q3W. The participants continued treatment with alomfilimab in combination with atezolizumab within this clinical study, as long as they continued to derive benefit from treatment, until the participant experienced unacceptable toxicity or confirmed PD per iRECIST.
FG017
Alomfilimab 2.4 mg + Atezolizumab in Anti-PD-(L)1 Pre-treated Pancreatic Cancer
Participants with pre-treated pancreatic cancer received alomfilimab 2.4 mg in combination with atezolizumab 1200 mg via IV infusion Q3W. The participants continued treatment with alomfilimab in combination with atezolizumab within this clinical study, as long as they continued to derive benefit from treatment, until the participant experienced unacceptable toxicity or confirmed PD per iRECIST.
FG018
Alomfilimab 8 mg + Atezolizumab in Anti-PD-(L)1 Pre-treated Pancreatic Cancer
Participants with pre-treated pancreatic cancer received alomfilimab 8 mg in combination with atezolizumab 1200 mg via IV infusion Q3W. The participants continued treatment with alomfilimab in combination with atezolizumab within this clinical study, as long as they continued to derive benefit from treatment, until the participant experienced unacceptable toxicity or confirmed PD per iRECIST.
FG019
Alomfilimab 2.4 mg + Atezolizumab in Anti-PD-(L)1 Pre-treated Triple Negative BC
Participants with pre-treated triple negative BC received alomfilimab 2.4 mg in combination with atezolizumab 1200 mg via IV infusion Q3W. The participants continued treatment with alomfilimab in combination with atezolizumab within this clinical study, as long as they continued to derive benefit from treatment, until the participant experienced unacceptable toxicity or confirmed PD per iRECIST.
FG020
Alomfilimab 8 mg + Atezolizumab in Anti-PD-(L)1 Pre-treated Triple Negative BC
Participants with pre-treated triple negative BC received alomfilimab 8 mg in combination with atezolizumab 1200 mg via IV infusion Q3W. The participants continued treatment with alomfilimab in combination with atezolizumab within this clinical study, as long as they continued to derive benefit from treatment, until the participant experienced unacceptable toxicity or confirmed PD per iRECIST.
FG021
Alomfilimab 8 mg + Atezolizumab in Anti-PD-(L)1 Pre-treated HNSCC
Participants with pre-treated HNSCC received alomfilimab 8 mg in combination with atezolizumab 1200 mg via IV infusion Q3W. The participants continued treatment with alomfilimab in combination with atezolizumab within this clinical study, as long as they continued to derive benefit from treatment, until the participant experienced unacceptable toxicity or confirmed PD per iRECIST.
FG022
Alomfilimab 24 mg + Atezolizumab in Anti-PD-(L)1 Pre-treated HNSCC
Participants with pre-treated HNSCC received alomfilimab 24 mg in combination with atezolizumab 1200 mg via IV infusion Q3W. The participants continued treatment with alomfilimab in combination with atezolizumab within this clinical study, as long as they continued to derive benefit from treatment, until the participant experienced unacceptable toxicity or confirmed PD per iRECIST.
FG0004 subjects
FG0015 subjects
FG0029 subjects
FG0038 subjects
FG0047 subjects
FG0055 subjects
FG0065 subjects
FG00743 subjects
FG00836 subjects
FG0099 subjects
FG0109 subjects
FG01115 subjects
FG01214 subjects
FG0137 subjects
FG01414 subjects
FG0155 subjects
FG0165 subjects
FG0172 subjects
FG0181 subjects
FG0191 subjects
FG0206 subjects
FG0213 subjects
FG0229 subjects
Treated
FG0004 subjects
FG0015 subjects
FG0029 subjects
FG0038 subjects
FG0047 subjects
FG0055 subjects
FG0065 subjects
FG00743 subjects
FG00836 subjects
FG0099 subjects
FG0109 subjects
FG01115 subjects
FG01214 subjects
FG0137 subjects
FG01414 subjects
FG0155 subjects
FG0165 subjects
FG0172 subjects
FG0181 subjects
FG0191 subjects
FG0206 subjects
FG0213 subjects
FG0228 subjects
Safety Analysis Set
FG0004 subjects
FG0015 subjects
FG00210 subjectsOne participant was planned to receive alomfilimab 8 mg + atezolizumab; however, the actual dose received was alomfilimab 8 mg. For the Safety Analysis Set, this participant was counted under actual dose received (alomfilimab 8 mg).
FG0038 subjects
FG0047 subjects
FG0055 subjects
FG0065 subjects
FG00743 subjects
FG00835 subjectsOne participant was planned to receive alomfilimab 8 mg + atezolizumab; however, the actual dose received was alomfilimab 8 mg. For the Safety Analysis Set, this participant was counted under actual dose received (alomfilimab 8 mg).
FG0099 subjects
FG0109 subjects
FG01115 subjects
FG01214 subjects
FG0137 subjects
FG01414 subjects
FG0155 subjects
FG0165 subjects
FG0172 subjects
FG0181 subjects
FG0191 subjects
FG0206 subjects
FG0213 subjects
FG0228 subjects
COMPLETED
FG0000 subjects
FG0011 subjects
FG0020 subjects
FG0030 subjects
FG0040 subjects
FG0050 subjects
FG0060 subjects
FG0073 subjects
FG0081 subjects
FG0090 subjects
FG0100 subjects
FG0110 subjects
FG0120 subjects
FG0131 subjects
FG0140 subjects
FG0150 subjects
FG0160 subjects
FG0170 subjects
FG0180 subjects
FG0190 subjects
FG0200 subjects
FG0211 subjects
FG0220 subjects
NOT COMPLETED
FG0004 subjects
FG0014 subjects
FG0029 subjects
FG0038 subjects
FG0047 subjects
FG0055 subjects
FG0065 subjects
FG00740 subjects
FG00835 subjects
FG0099 subjects
FG0109 subjects
FG01115 subjects
FG01214 subjects
FG0136 subjects
FG01414 subjects
FG0155 subjects
FG0165 subjects
FG0172 subjects
FG0181 subjects
FG0191 subjects
FG0206 subjects
FG0212 subjects
FG0229 subjects
Type
Comment
Reasons
Withdrawal of Consent
FG0002 subjects
FG0010 subjects
FG0023 subjects
FG0030 subjects
FG0041 subjects
FG0051 subjects
FG0060 subjects
FG00710 subjects
FG00810 subjects
FG0093 subjects
FG0104 subjects
FG0114 subjects
FG0124 subjects
FG0130 subjects
FG0143 subjects
FG0150 subjects
FG0161 subjects
FG0171 subjects
FG0180 subjects
FG0190 subjects
FG0203 subjects
FG0210 subjects
FG0221 subjects
PD
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0032 subjects
FG004
Study Terminated by Sponsor
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
Lost to Follow Up
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
Death
FG0002 subjects
FG0014 subjects
FG0025 subjects
FG0036 subjects
FG004
Miscellaneous
FG0000 subjects
FG0010 subjects
FG0021 subjects
FG0030 subjects
FG004
Full Analysis Set: all participants who were allocated to study drug, regardless of treatment ultimately received.
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
BG000
Alomfilimab 0.8 mg
Participants received alomfilimab 0.8 mg as a single agent via IV infusion Q3W. The participants continued treatment with alomfilimab within this clinical study, as long as they continued to derive benefit from treatment, until the participant experienced unacceptable toxicity or confirmed PD per iRECIST.
BG001
Alomfilimab 2.4 mg
Participants received alomfilimab 2.4 mg as a single agent via IV infusion Q3W. The participants continued treatment with alomfilimab within this clinical study, as long as they continued to derive benefit from treatment, until the participant experienced unacceptable toxicity or confirmed PD per iRECIST.
BG002
Alomfilimab 8 mg
Participants received alomfilimab 8 mg as a single agent via IV infusion Q3W. The participants continued treatment with alomfilimab within this clinical study, as long as they continued to derive benefit from treatment, until the participant experienced unacceptable toxicity or confirmed PD per iRECIST.
BG003
Alomfilimab 24 mg
Participants received alomfilimab 24 mg as a single agent via IV infusion Q3W. The participants continued treatment with alomfilimab within this clinical study, as long as they continued to derive benefit from treatment, until the participant experienced unacceptable toxicity or confirmed PD per iRECIST.
BG004
Alomfilimab 80 mg
Participants received alomfilimab 80 mg as a single agent via IV infusion Q3W. The participants continued treatment with alomfilimab within this clinical study, as long as they continued to derive benefit from treatment, until the participant experienced unacceptable toxicity or confirmed PD per iRECIST.
BG005
Alomfilimab 240 mg
Participants received alomfilimab 240 mg as a single agent via IV infusion Q3W. The participants continued treatment with alomfilimab within this clinical study, as long as they continued to derive benefit from treatment, until the participant experienced unacceptable toxicity or confirmed PD per iRECIST.
BG006
Alomfilimab 0.8 mg + Atezolizumab
Participants received alomfilimab 0.8 mg in combination with atezolizumab 1200 mg via IV infusion Q3W. The participants continued treatment with alomfilimab in combination with atezolizumab within this clinical study, as long as they continued to derive benefit from treatment, until the participant experienced unacceptable toxicity or confirmed PD per iRECIST.
BG007
Alomfilimab 2.4 mg + Atezolizumab
Participants received alomfilimab 2.4 mg in combination with atezolizumab 1200 mg via IV infusion Q3W. The participants continued treatment with alomfilimab in combination with atezolizumab within this clinical study, as long as they continued to derive benefit from treatment, until the participant experienced unacceptable toxicity or confirmed PD per iRECIST.
BG008
Alomfilimab 8 mg + Atezolizumab
Participants received alomfilimab 8 mg in combination with atezolizumab 1200 mg via IV infusion Q3W. The participants continued treatment with alomfilimab in combination with atezolizumab within this clinical study, as long as they continued to derive benefit from treatment, until the participant experienced unacceptable toxicity or confirmed PD per iRECIST.
BG009
Alomfilimab 24 mg + Atezolizumab
Participants received alomfilimab 24 mg in combination with atezolizumab 1200 mg via IV infusion Q3W. The participants continued treatment with alomfilimab in combination with atezolizumab within this clinical study, as long as they continued to derive benefit from treatment, until the participant experienced unacceptable toxicity or confirmed PD per iRECIST.
BG010
Alomfilimab 80 mg + Atezolizumab
Participants received alomfilimab 80 mg in combination with atezolizumab 1200 mg via IV infusion Q3W. The participants continued treatment with alomfilimab in combination with atezolizumab within this clinical study, as long as they continued to derive benefit from treatment, until the participant experienced unacceptable toxicity or confirmed PD per iRECIST.
BG011
Alomfilimab 2.4 mg + Atezolizumab in Anti-PD-(L)1 Naïve Pancreatic Cancer
Anti-PD-(L)1 naïve participants with pancreatic cancer received alomfilimab 2.4 mg in combination with atezolizumab 1200 mg via IV infusion Q3W. The participants continued treatment with alomfilimab in combination with atezolizumab within this clinical study, as long as they continued to derive benefit from treatment, until the participant experienced unacceptable toxicity or confirmed PD per iRECIST.
BG012
Alomfilimab 8 mg + Atezolizumab in Anti-PD-(L)1 Naïve Pancreatic Cancer
Anti-PD-(L)1 naïve participants with pancreatic cancer received alomfilimab 8 mg in combination with atezolizumab 1200 mg via IV infusion Q3W. The participants continued treatment with alomfilimab in combination with atezolizumab within this clinical study, as long as they continued to derive benefit from treatment, until the participant experienced unacceptable toxicity or confirmed PD per iRECIST.
BG013
Alomfilimab 2.4 mg + Atezolizumab in Anti-PD-(L)1 Naïve Triple Negative BC
Anti-PD-(L)1 naïve participants with triple negative BC received alomfilimab 2.4 mg in combination with atezolizumab 1200 mg via IV infusion Q3W. The participants continued treatment with alomfilimab in combination with atezolizumab within this clinical study, as long as they continued to derive benefit from treatment, until the participant experienced unacceptable toxicity or confirmed PD per iRECIST.
BG014
Alomfilimab 8 mg + Atezolizumab in Anti-PD-(L)1 Naïve Triple Negative BC
Anti-PD-(L)1 naïve participants with triple negative BC received alomfilimab 8 mg in combination with atezolizumab 1200 mg via IV infusion Q3W. The participants continued treatment with alomfilimab in combination with atezolizumab within this clinical study, as long as they continued to derive benefit from treatment, until the participant experienced unacceptable toxicity or confirmed PD per iRECIST.
BG015
Alomfilimab 8 mg + Atezolizumab in Anti-PD-(L)1 Naïve HNSCC
Anti-PD-(L)1 naïve participants with HNSCC received alomfilimab 8 mg in combination with atezolizumab 1200 mg via IV infusion Q3W. The participants continued treatment with alomfilimab in combination with atezolizumab within this clinical study, as long as they continued to derive benefit from treatment, until the participant experienced unacceptable toxicity or confirmed PD per iRECIST.
BG016
Alomfilimab 24 mg + Atezolizumab in Anti-PD-(L)1 Naïve HNSCC
Anti-PD-(L)1 naïve participants with HNSCC received alomfilimab 24 mg in combination with atezolizumab 1200 mg via IV infusion Q3W. The participants continued treatment with alomfilimab in combination with atezolizumab within this clinical study, as long as they continued to derive benefit from treatment, until the participant experienced unacceptable toxicity or confirmed PD per iRECIST.
BG017
Alomfilimab 2.4 mg + Atezolizumab in Anti-PD-(L)1 Pre-treated Pancreatic Cancer
Participants with pre-treated pancreatic cancer received alomfilimab 2.4 mg in combination with atezolizumab 1200 mg via IV infusion Q3W. The participants continued treatment with alomfilimab in combination with atezolizumab within this clinical study, as long as they continued to derive benefit from treatment, until the participant experienced unacceptable toxicity or confirmed PD per iRECIST.
BG018
Alomfilimab 8 mg + Atezolizumab in Anti-PD-(L)1 Pre-treated Pancreatic Cancer
Participants with pre-treated pancreatic cancer received alomfilimab 8 mg in combination with atezolizumab 1200 mg via IV infusion Q3W. The participants continued treatment with alomfilimab in combination with atezolizumab within this clinical study, as long as they continued to derive benefit from treatment, until the participant experienced unacceptable toxicity or confirmed PD per iRECIST.
BG019
Alomfilimab 2.4 mg + Atezolizumab in Anti-PD-(L)1 Pre-treated Triple Negative BC
Participants with pre-treated triple negative BC received alomfilimab 2.4 mg in combination with atezolizumab 1200 mg via IV infusion Q3W. The participants continued treatment with alomfilimab in combination with atezolizumab within this clinical study, as long as they continued to derive benefit from treatment, until the participant experienced unacceptable toxicity or confirmed PD per iRECIST.
BG020
Alomfilimab 8 mg + Atezolizumab in Anti-PD-(L)1 Pre-treated Triple Negative BC
Participants with pre-treated triple negative BC received alomfilimab 8 mg in combination with atezolizumab 1200 mg via IV infusion Q3W. The participants continued treatment with alomfilimab in combination with atezolizumab within this clinical study, as long as they continued to derive benefit from treatment, until the participant experienced unacceptable toxicity or confirmed PD per iRECIST.
BG021
Alomfilimab 8 mg + Atezolizumab in Anti-PD-(L)1 Pre-treated HNSCC
Participants with pre-treated HNSCC received alomfilimab 8 mg in combination with atezolizumab 1200 mg via IV infusion Q3W. The participants continued treatment with alomfilimab in combination with atezolizumab within this clinical study, as long as they continued to derive benefit from treatment, until the participant experienced unacceptable toxicity or confirmed PD per iRECIST.
BG022
Alomfilimab 24 mg + Atezolizumab in Anti-PD-(L)1 Pre-treated HNSCC
Participants with pre-treated HNSCC received alomfilimab 24 mg in combination with atezolizumab 1200 mg via IV infusion Q3W. The participants continued treatment with alomfilimab in combination with atezolizumab within this clinical study, as long as they continued to derive benefit from treatment, until the participant experienced unacceptable toxicity or confirmed PD per iRECIST.
BG023
Total
Total of all reporting groups
Denominators
Units
Counts
Participants
BG0004
BG0015
BG0029
BG0038
BG0047
BG0055
BG0065
BG00743
BG00836
BG0099
BG0109
BG01115
BG01214
BG0137
BG01414
BG0155
BG0165
BG0172
BG0181
BG0191
BG0206
BG0213
BG0229
BG023222
Baseline Measures
Title
Description
Population Description
Parameter Type
Dispersion Type
Unit of Measure
Calculate Percentage
Denominator Units Selected
Denominators
Classes
Age, Customized
Count of Participants
Participants
Title
Denominators
Categories
ParticipantsBG0004
ParticipantsBG0015
ParticipantsBG0029
ParticipantsBG003
Sex: Female, Male
Count of Participants
Participants
Title
Denominators
Categories
ParticipantsBG0004
ParticipantsBG0015
ParticipantsBG002
Race/Ethnicity, Customized
Count of Participants
Participants
Title
Denominators
Categories
ParticipantsBG0004
ParticipantsBG0015
ParticipantsBG002
Ethnicity Not Collected
Ethnicity was not collected from any participant.
Count of Participants
Participants
Title
Denominators
Categories
ParticipantsBG0000
ParticipantsBG0010
ParticipantsBG002
Type
Title
Description
Population Description
Reporting Status
Anticipated Posting Date
Parameter Type
Dispersion Type
Unit of Measure
Calculate Percentage
Time Frame
Units Analyzed
Denominator Units Selected
Arm/Group Information
Denominators
Classes
Analyses
Primary
Phase 1: Number of Participants Experiencing Treatment-emergent Adverse Events (TEAEs)
An adverse event (AE) was any untoward medical occurrence in a participant administered a pharmaceutical product, which did not necessarily have a causal relationship with this treatment. An serious AE (SAE) was any AE that:
resulted in death;
was life-threatening;
resulted in inpatient hospitalization or prolongation of existing hospitalization;
resulted in a persistent or significant disability/incapacity;
resulted in congenital anomaly/birth defect in the offspring of a participant who received IMPs;
constituted an important medical event.
Clinically significant changes in laboratory parameters, vital signs and electrocardiogram results were reported as AEs. A TEAE was defined as an AE observed after starting administration of the specific treatment.
Safety Analysis Set: all participants who took at least one dose of study drug within the relevant phase. Participants were grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length).
Posted
Count of Participants
Participants
From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment; maximum duration of treatment exposure was up to approximately 212 weeks
ID
Title
Description
OG000
Alomfilimab 0.8 mg
Participants received alomfilimab 0.8 mg as a single agent via IV infusion Q3W. The participants continued treatment with alomfilimab within this clinical study, as long as they continued to derive benefit from treatment, until the participant experienced unacceptable toxicity or confirmed PD per iRECIST.
OG001
Alomfilimab 2.4 mg
Participants received alomfilimab 2.4 mg as a single agent via IV infusion Q3W. The participants continued treatment with alomfilimab within this clinical study, as long as they continued to derive benefit from treatment, until the participant experienced unacceptable toxicity or confirmed PD per iRECIST.
OG002
Alomfilimab 8 mg
Participants received alomfilimab 8 mg as a single agent via IV infusion Q3W. The participants continued treatment with alomfilimab within this clinical study, as long as they continued to derive benefit from treatment, until the participant experienced unacceptable toxicity or confirmed PD per iRECIST.
OG003
Alomfilimab 24 mg
Participants received alomfilimab 24 mg as a single agent via IV infusion Q3W. The participants continued treatment with alomfilimab within this clinical study, as long as they continued to derive benefit from treatment, until the participant experienced unacceptable toxicity or confirmed PD per iRECIST.
OG004
Alomfilimab 80 mg
Participants received alomfilimab 80 mg as a single agent via IV infusion Q3W. The participants continued treatment with alomfilimab within this clinical study, as long as they continued to derive benefit from treatment, until the participant experienced unacceptable toxicity or confirmed PD per iRECIST.
OG005
Units
Counts
Participants
OG0004
OG0015
OG00210
OG003
Title
Denominators
Categories
Any TEAEs
Title
Measurements
OG0004
OG0014
OG0028
OG003
Primary
Phase 1: Number of Participants Experiencing Dose Changes
Dose changes were defined as infusion interruption and dose reduction.
Safety Analysis Set: all participants who took at least one dose of study drug within the relevant phase. Participants were grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length).
Posted
Count of Participants
Participants
From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment; maximum duration of treatment exposure was up to approximately 212 weeks
ID
Title
Description
OG000
Alomfilimab 0.8 mg
Participants received alomfilimab 0.8 mg as a single agent via IV infusion Q3W. The participants continued treatment with alomfilimab within this clinical study, as long as they continued to derive benefit from treatment, until the participant experienced unacceptable toxicity or confirmed PD per iRECIST.
OG001
Alomfilimab 2.4 mg
Participants received alomfilimab 2.4 mg as a single agent via IV infusion Q3W. The participants continued treatment with alomfilimab within this clinical study, as long as they continued to derive benefit from treatment, until the participant experienced unacceptable toxicity or confirmed PD per iRECIST.
OG002
Alomfilimab 8 mg
Primary
Phase 1: Absolute Dose Intensity
Absolute dose intensity was calculated as cumulative dose received (mg) / study treatment duration (weeks).
Safety Analysis Set: all participants who took at least one dose of study drug within the relevant phase. Participants were grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length).
Posted
Mean
Standard Deviation
mg/week
From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment; maximum duration of treatment exposure was up to approximately 212 weeks
ID
Title
Description
OG000
Alomfilimab 0.8 mg
Participants received alomfilimab 0.8 mg as a single agent via IV infusion Q3W. The participants continued treatment with alomfilimab within this clinical study, as long as they continued to derive benefit from treatment, until the participant experienced unacceptable toxicity or confirmed PD per iRECIST.
OG001
Alomfilimab 2.4 mg
Participants received alomfilimab 2.4 mg as a single agent via IV infusion Q3W. The participants continued treatment with alomfilimab within this clinical study, as long as they continued to derive benefit from treatment, until the participant experienced unacceptable toxicity or confirmed PD per iRECIST.
OG002
Alomfilimab 8 mg
Primary
Phase 1: Relative Dose Intensity
Relative dose intensity was calculated as the cumulative dose received (mg) / initial planned cumulative dose (mg). Initial planned cumulative dose was calculated as the starting dose multiplied by the scheduled number of administrations within the study treatment duration.
Safety Analysis Set: all participants who took at least one dose of study drug within the relevant phase. Participants were grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length).
Posted
Mean
Standard Deviation
ratio
From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment; maximum duration of treatment exposure was up to approximately 212 weeks
ID
Title
Description
OG000
Alomfilimab 0.8 mg
Participants received alomfilimab 0.8 mg as a single agent via IV infusion Q3W. The participants continued treatment with alomfilimab within this clinical study, as long as they continued to derive benefit from treatment, until the participant experienced unacceptable toxicity or confirmed PD per iRECIST.
OG001
Alomfilimab 2.4 mg
Participants received alomfilimab 2.4 mg as a single agent via IV infusion Q3W. The participants continued treatment with alomfilimab within this clinical study, as long as they continued to derive benefit from treatment, until the participant experienced unacceptable toxicity or confirmed PD per iRECIST.
Primary
Phase 1: Number of Participants Experiencing Dose Limiting Toxicities (DLTs)
A DLT was defined as a clinically relevant AE or abnormal laboratory value of Common Terminology Criteria for Adverse Events Version 5.0 (CTCAE v5.0) ≥ Grade 3 assessed as unrelated to disease, PD, inter-current illness or concomitant medications, which occurs within the first cycle (21 days) of treatment with alomfilimab as single agent or in combination with atezolizumab during the dose escalation part of the study.
Safety Analysis Set: all participants who took at least one dose of study drug within the relevant phase. Participants were grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length).
Posted
Count of Participants
Participants
From first dose of study treatment (Day 1) up to 21 days
ID
Title
Description
OG000
Alomfilimab 0.8 mg
Participants received alomfilimab 0.8 mg as a single agent via IV infusion Q3W. The participants continued treatment with alomfilimab within this clinical study, as long as they continued to derive benefit from treatment, until the participant experienced unacceptable toxicity or confirmed PD per iRECIST.
OG001
Alomfilimab 2.4 mg
Participants received alomfilimab 2.4 mg as a single agent via IV infusion Q3W. The participants continued treatment with alomfilimab within this clinical study, as long as they continued to derive benefit from treatment, until the participant experienced unacceptable toxicity or confirmed PD per iRECIST.
Primary
Phase 2: Overall Response Rate (ORR) Per RECIST 1.1
ORR was the percentage of participants with a measurable disease at baseline and with a confirmed response of complete response (CR) or partial response (PR) according to RECIST v1.1 as the best response. The response is confirmed by a later scan conducted at least 4 weeks after the initial response is observed. The 95% confidence interval (CI) was calculated using the exact binomial method (Clopper-Pearson).
CR: disappearance of all target and non-target lesions. Any pathological lymph nodes (whether target or non-target) must have had a reduction in short axis to < 10 mm. All lymph nodes must have been non-pathological in size (< 10mm short axis).
PR: at least a 30% decrease in the sum of diameters of target lesions, taking as reference the Baseline sum diameters.
Full Analysis Set: all participants who were allocated to study drug, regardless of treatment ultimately received. The number of participants analyzed is inclusive of those with measurable disease at baseline only for the purpose of evaluating ORR.
Posted
Number
95% Confidence Interval
percentage of participants
From first dose of study treatment (Day 1) up to the end of the long term follow-up, approximately 162 weeks
ID
Title
Description
OG000
Alomfilimab 2.4 mg + Atezolizumab in Anti-PD-(L)1 Naïve Pancreatic Cancer
Anti-PD-(L)1 naïve participants with pancreatic cancer received alomfilimab 2.4 mg in combination with atezolizumab 1200 mg via IV infusion Q3W. The participants continued treatment with alomfilimab in combination with atezolizumab within this clinical study, as long as they continued to derive benefit from treatment, until the participant experienced unacceptable toxicity or confirmed PD per iRECIST.
Secondary
Best Overall Response (BOR) Per RECIST 1.1
BOR for each participant was defined as the best confirmed response per RECIST 1.1 among all responses recorded from start of treatment until PD, initiation of new anti-cancer therapy, death, or analysis cut-off date, whichever comes first, with responses of:
CR: disappearance of all target and non-target lesions. Any pathological lymph nodes (whether target or non-target) must have had a reduction in short axis to < 10 mm. All lymph nodes must have been non-pathological in size (< 10mm short axis).
PR: at least a 30% decrease in the sum of diameters of target lesions, taking as reference the Baseline sum diameters.
Stable disease (SD): neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD.
PD: at least a 20% increase in the sum of diameters of target lesions. The sum must also demonstrate an increase of at least 5mm. Unequivocal progression of existing non-target lesions.
Not evaluable (NE).
Full Analysis Set: all participants who were allocated to study drug, regardless of treatment ultimately received.
Posted
Count of Participants
Participants
From first dose of study treatment (Day 1) up to the end of the long term follow-up, approximately 236 and 162 weeks for Phase 1 and 2, respectively
ID
Title
Description
OG000
Alomfilimab 0.8 mg
Participants received alomfilimab 0.8 mg as a single agent via IV infusion Q3W. The participants continued treatment with alomfilimab within this clinical study, as long as they continued to derive benefit from treatment, until the participant experienced unacceptable toxicity or confirmed PD per iRECIST.
Secondary
Progression-free Survival (PFS) Per RECIST 1.1
PFS was calculated as (first documented PD or death due to any cause - first dose date of study drug +1)/30.4375. Participants who were not observed to have progressed or died were censored at the date of the last tumor assessment. Participants who missed two or more sequential assessments were censored at the date of the last tumor assessment before the missed assessments. Participants who started new anti-cancer therapy prior to documented PD were censored at the date of the last tumor assessment prior to the start of the new therapy. Participants who did not have any tumor assessments were censored with a duration of 1 day. PFS was obtained via Kaplan Meier estimation using the Brookmeyer-Crowley method.
PD: at least a 20% increase in the sum of diameters of target lesions. The sum must also demonstrate an increase of at least 5mm. Unequivocal progression of existing non-target lesions.
Full Analysis Set: all participants who were allocated to study drug, regardless of treatment ultimately received. The number of participants analyzed is inclusive of those with observed events or participants that were censored for the purpose of evaluating PFS.
Posted
Median
95% Confidence Interval
months
From first dose of study treatment (Day 1) up to the end of the long term follow-up, approximately 236 and 162 weeks for Phase 1 and 2, respectively
ID
Title
Description
OG000
Alomfilimab 0.8 mg
Participants received alomfilimab 0.8 mg as a single agent via IV infusion Q3W. The participants continued treatment with alomfilimab within this clinical study, as long as they continued to derive benefit from treatment, until the participant experienced unacceptable toxicity or confirmed PD per iRECIST.
Secondary
Duration of Response Per RECIST 1.1
Duration of response was calculated as (date of the first documentation of PD or to death due to any cause in the absence of PD - date of the first documentation of unconfirmed objective response [CR or PR] + 1]/30.4375. Participants who were not observed to have progressed or died were censored at the date of the last tumor assessment. Participants who missed two or more sequential assessments were censored at the date of the last tumor assessment before the missed assessments. Participants who started new anti-cancer therapy prior to documented PD were censored at the date of the last tumor assessment prior to the start of the new therapy. Participants with no disease assessment (or only had assessments with response = NE) after first study treatment or have baseline or post-baseline assessments where the RECIST criteria could not be applied had their duration of response time censored. Duration of response was obtained via Kaplan Meier estimation.
Full Analysis Set: all participants who were allocated to study drug, regardless of treatment ultimately received. The number of participants analyzed is inclusive of those with observed events or participants that were censored for the purpose of evaluating duration of response.
Posted
Median
95% Confidence Interval
months
From first dose of study treatment (Day 1) up to the end of the long term follow-up, approximately 236 and 162 weeks for Phase 1 and 2, respectively
ID
Title
Description
OG000
Alomfilimab 0.8 mg
Participants received alomfilimab 0.8 mg as a single agent via IV infusion Q3W. The participants continued treatment with alomfilimab within this clinical study, as long as they continued to derive benefit from treatment, until the participant experienced unacceptable toxicity or confirmed PD per iRECIST.
Secondary
ORR Per iRECIST
RECIST 1.1 has been modified to take into consideration the unique response kinetics which have been observed with immunotherapy in some patients where responses to immune therapies may occur after progression has been assessed. ORR was the percentage of participants with a measurable disease at baseline and with a confirmed response of complete immune-response (iCR) or partial immune-response (iPR) according to iRECIST as the best response. The 95% CI was calculated using the exact binomial method (Clopper-Pearson).
iCR: disappearance of all target and non-target lesions. Any pathological lymph nodes (whether target or non-target) must have had a reduction in short axis to < 10 mm. All lymph nodes must have been non-pathological in size (< 10mm short axis).
iPR: at least a 30% decrease in the sum of diameters of target lesions, taking as reference the Baseline sum diameters.
Full Analysis Set: all participants who were allocated to study drug, regardless of treatment ultimately received. The number of participants analyzed is inclusive of those with measurable disease at baseline only for the purpose of evaluating ORR.
Posted
Number
95% Confidence Interval
percentage of participants
From first dose of study treatment (Day 1) up to the end of the long term follow-up, approximately 236 and 162 weeks for Phase 1 and 2, respectively
ID
Title
Description
OG000
Alomfilimab 0.8 mg
Participants received alomfilimab 0.8 mg as a single agent via IV infusion Q3W. The participants continued treatment with alomfilimab within this clinical study, as long as they continued to derive benefit from treatment, until the participant experienced unacceptable toxicity or confirmed PD per iRECIST.
Secondary
PFS Per iRECIST
PFS was calculated as (first documented iPD or death due to any cause - first dose date of study drug +1)/30.4375. Participants who were not observed to have progressed or died were censored at the date of the last tumor assessment. Participants who missed two or more sequential assessments were censored at the date of the last tumor assessment before the missed assessments. Participants who started new anti-cancer therapy prior to documented PD were censored at the date of the last tumor assessment prior to the start of the new therapy. Participants who did not have any tumor assessments were censored with a duration of 1 day. PFS was obtained via Kaplan Meier estimation using the Brookmeyer-Crowley method.
iPD: at least a 20% increase in the sum of diameters of target lesions. The sum must also demonstrate an increase of at least 5mm. Unequivocal progression of existing non-target lesions.
Full Analysis Set: all participants who were allocated to study drug, regardless of treatment ultimately received. The number of participants analyzed is inclusive of those with observed events or participants that were censored for the purpose of evaluating PFS.
Posted
Median
95% Confidence Interval
months
From first dose of study treatment (Day 1) up to the end of the long term follow-up, approximately 236 and 162 weeks for Phase 1 and 2, respectively
ID
Title
Description
OG000
Alomfilimab 0.8 mg
Participants received alomfilimab 0.8 mg as a single agent via IV infusion Q3W. The participants continued treatment with alomfilimab within this clinical study, as long as they continued to derive benefit from treatment, until the participant experienced unacceptable toxicity or confirmed PD per iRECIST.
Secondary
Phase 1: ORR Per RECIST 1.1
ORR was the percentage of participants with a measurable disease at baseline and with a confirmed response of CR or PR according to RECIST v1.1 as the best response. The response is confirmed by a later scan conducted at least 4 weeks after the initial response is observed. The 95% CI was calculated using the exact binomial method (Clopper-Pearson).
CR: disappearance of all target and non-target lesions. Any pathological lymph nodes (whether target or non-target) must have had a reduction in short axis to < 10 mm. All lymph nodes must have been non-pathological in size (< 10mm short axis).
PR: at least a 30% decrease in the sum of diameters of target lesions, taking as reference the Baseline sum diameters.
Full Analysis Set: all participants who were allocated to study drug, regardless of treatment ultimately received. Inclusive of participants with measurable disease at baseline only.
Posted
Number
95% Confidence Interval
percentage of participants
From first dose of study treatment (Day 1) up to the end of the long term follow-up, approximately 236 weeks
ID
Title
Description
OG000
Alomfilimab 0.8 mg
Participants received alomfilimab 0.8 mg as a single agent via IV infusion Q3W. The participants continued treatment with alomfilimab within this clinical study, as long as they continued to derive benefit from treatment, until the participant experienced unacceptable toxicity or confirmed PD per iRECIST.
OG001
Alomfilimab 2.4 mg
Secondary
Overall Survival Rate at 12 and 24 Months
Overall Survival rate was defined as the proportion of participants that had known survival status. Overall survival rate was obtained via Kaplan Meier estimation using the complimentary log-log transformation method.
Full Analysis Set: all participants who were allocated to study drug, regardless of treatment ultimately received.
Posted
Number
95% Confidence Interval
proportion of participants
Months 12 and 24
ID
Title
Description
OG000
Alomfilimab 0.8 mg
Participants received alomfilimab 0.8 mg as a single agent via IV infusion Q3W. The participants continued treatment with alomfilimab within this clinical study, as long as they continued to derive benefit from treatment, until the participant experienced unacceptable toxicity or confirmed PD per iRECIST.
OG001
Alomfilimab 2.4 mg
Participants received alomfilimab 2.4 mg as a single agent via IV infusion Q3W. The participants continued treatment with alomfilimab within this clinical study, as long as they continued to derive benefit from treatment, until the participant experienced unacceptable toxicity or confirmed PD per iRECIST.
OG002
Alomfilimab 8 mg
Participants received alomfilimab 8 mg as a single agent via IV infusion Q3W. The participants continued treatment with alomfilimab within this clinical study, as long as they continued to derive benefit from treatment, until the participant experienced unacceptable toxicity or confirmed PD per iRECIST.
Secondary
Phase 2: Number of Participants Experiencing TEAEs
An AE was any untoward medical occurrence in a participant administered a pharmaceutical product, which did not necessarily have a causal relationship with this treatment. An SAE was any AE that:
resulted in death;
was life-threatening;
resulted in inpatient hospitalization or prolongation of existing hospitalization;
resulted in a persistent or significant disability/incapacity;
resulted in congenital anomaly/birth defect in the offspring of a participant who received IMPs;
constituted an important medical event.
Clinically significant changes in laboratory parameters, vital signs and electrocardiogram results were reported as AEs. A TEAE was defined as an AE observed after starting administration of the specific treatment.
Safety Analysis Set: all participants who took at least one dose of study drug within the relevant phase. Participants were grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length).
Posted
Count of Participants
Participants
From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment; maximum duration of treatment exposure was up to approximately 86 weeks
ID
Title
Description
OG000
Alomfilimab 2.4 mg + Atezolizumab in Anti-PD-(L)1 Naïve Pancreatic Cancer
Anti-PD-(L)1 naïve participants with pancreatic cancer received alomfilimab 2.4 mg in combination with atezolizumab 1200 mg via IV infusion Q3W. The participants continued treatment with alomfilimab in combination with atezolizumab within this clinical study, as long as they continued to derive benefit from treatment, until the participant experienced unacceptable toxicity or confirmed PD per iRECIST.
Secondary
Phase 2: Number of Participants Experiencing Dose Changes
Dose changes were defined as infusion interruption and dose reduction.
Safety Analysis Set: all participants who took at least one dose of study drug within the relevant phase. Participants were grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length).
Posted
Count of Participants
Participants
From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment; maximum duration of treatment exposure was up to approximately 86 weeks
ID
Title
Description
OG000
Alomfilimab 2.4 mg + Atezolizumab in Anti-PD-(L)1 Naïve Pancreatic Cancer
Anti-PD-(L)1 naïve participants with pancreatic cancer received alomfilimab 2.4 mg in combination with atezolizumab 1200 mg via IV infusion Q3W. The participants continued treatment with alomfilimab in combination with atezolizumab within this clinical study, as long as they continued to derive benefit from treatment, until the participant experienced unacceptable toxicity or confirmed PD per iRECIST.
OG001
Alomfilimab 8 mg + Atezolizumab in Anti-PD-(L)1 Naïve Pancreatic Cancer
Anti-PD-(L)1 naïve participants with pancreatic cancer received alomfilimab 8 mg in combination with atezolizumab 1200 mg via IV infusion Q3W. The participants continued treatment with alomfilimab in combination with atezolizumab within this clinical study, as long as they continued to derive benefit from treatment, until the participant experienced unacceptable toxicity or confirmed PD per iRECIST.
Secondary
Phase 2: Absolute Dose Intensity
Absolute dose intensity was calculated as cumulative dose received (mg) / study treatment duration (weeks).
Safety Analysis Set: all participants who took at least one dose of study drug within the relevant phase. Participants were grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length).
Posted
Mean
Standard Deviation
mg/week
From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment; maximum duration of treatment exposure was up to approximately 86 weeks
ID
Title
Description
OG000
Alomfilimab 2.4 mg + Atezolizumab in Anti-PD-(L)1 Naïve Pancreatic Cancer
Anti-PD-(L)1 naïve participants with pancreatic cancer received alomfilimab 2.4 mg in combination with atezolizumab 1200 mg via IV infusion Q3W. The participants continued treatment with alomfilimab in combination with atezolizumab within this clinical study, as long as they continued to derive benefit from treatment, until the participant experienced unacceptable toxicity or confirmed PD per iRECIST.
OG001
Alomfilimab 8 mg + Atezolizumab in Anti-PD-(L)1 Naïve Pancreatic Cancer
Anti-PD-(L)1 naïve participants with pancreatic cancer received alomfilimab 8 mg in combination with atezolizumab 1200 mg via IV infusion Q3W. The participants continued treatment with alomfilimab in combination with atezolizumab within this clinical study, as long as they continued to derive benefit from treatment, until the participant experienced unacceptable toxicity or confirmed PD per iRECIST.
Secondary
Phase 2: Relative Dose Intensity
Relative dose intensity was calculated as the cumulative dose received (mg) / initial planned cumulative dose (mg). Initial planned cumulative dose was calculated as the starting dose multiplied by the scheduled number of administrations within the study treatment duration.
Safety Analysis Set: all participants who took at least one dose of study drug within the relevant phase. Participants were grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length).
Posted
Mean
Standard Deviation
ratio
From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment; maximum duration of treatment exposure was up to approximately 86 weeks
ID
Title
Description
OG000
Alomfilimab 2.4 mg + Atezolizumab in Anti-PD-(L)1 Naïve Pancreatic Cancer
Anti-PD-(L)1 naïve participants with pancreatic cancer received alomfilimab 2.4 mg in combination with atezolizumab 1200 mg via IV infusion Q3W. The participants continued treatment with alomfilimab in combination with atezolizumab within this clinical study, as long as they continued to derive benefit from treatment, until the participant experienced unacceptable toxicity or confirmed PD per iRECIST.
OG001
Alomfilimab 8 mg + Atezolizumab in Anti-PD-(L)1 Naïve Pancreatic Cancer
Anti-PD-(L)1 naïve participants with pancreatic cancer received alomfilimab 8 mg in combination with atezolizumab 1200 mg via IV infusion Q3W. The participants continued treatment with alomfilimab in combination with atezolizumab within this clinical study, as long as they continued to derive benefit from treatment, until the participant experienced unacceptable toxicity or confirmed PD per iRECIST.
Secondary
Phase 1: Maximum Concentration (Cmax) of Alomfilimab
The serum pharmacokinetics (PK) of alomfilimab were characterized using non-compartmental analysis (NCA). Nominal times of sample collections were used for the NCA. All below limit of quantification (BLQ) values were set to 0 units.
PK Evaluable Set: consisted of all participants who had sufficient concentration-time data within the relevant phase to permit calculation of PK parameters for alomfilimab.
Posted
Mean
Standard Deviation
ug/mL
Cycles 1 and 3 Day 1 pre-infusion to 336 hours post-infusion start (21 day cycle length)
ID
Title
Description
OG000
Alomfilimab 0.8 mg
Participants received alomfilimab 0.8 mg as a single agent via IV infusion Q3W. The participants continued treatment with alomfilimab within this clinical study, as long as they continued to derive benefit from treatment, until the participant experienced unacceptable toxicity or confirmed PD per iRECIST.
OG001
Alomfilimab 2.4 mg
Participants received alomfilimab 2.4 mg as a single agent via IV infusion Q3W. The participants continued treatment with alomfilimab within this clinical study, as long as they continued to derive benefit from treatment, until the participant experienced unacceptable toxicity or confirmed PD per iRECIST.
OG002
Alomfilimab 8 mg
Secondary
Phase 1: Half-life (t1/2) of Alomfilimab
The serum PK of alomfilimab were characterized using NCA. Nominal times of sample collections were used for the NCA. All BLQ values were set to 0 units.
PK Evaluable Set: consisted of all participants who had sufficient concentration-time data within the relevant phase to permit calculation of PK parameters for alomfilimab.
Posted
Mean
Standard Deviation
hours
Cycles 1 and 3 Day 1 pre-infusion to 336 hours post-infusion start (21 day cycle length)
ID
Title
Description
OG000
Alomfilimab 0.8 mg
Participants received alomfilimab 0.8 mg as a single agent via IV infusion Q3W. The participants continued treatment with alomfilimab within this clinical study, as long as they continued to derive benefit from treatment, until the participant experienced unacceptable toxicity or confirmed PD per iRECIST.
OG001
Alomfilimab 2.4 mg
Participants received alomfilimab 2.4 mg as a single agent via IV infusion Q3W. The participants continued treatment with alomfilimab within this clinical study, as long as they continued to derive benefit from treatment, until the participant experienced unacceptable toxicity or confirmed PD per iRECIST.
OG002
Alomfilimab 8 mg
Secondary
Number of Participants Experiencing Anti-drug Antibodies (ADA) at Anytime
Detection of ADA was assessed from blood samples taken during the study using validated bioanalytical methods. The number of participants who developed detectable anti-alomfilimab or anti-atezolizumab antibodies during any cycle or the safety follow-up period (SFUP) was calculated.
Anti-drug Antibody Evaluable Set: consisted of all participants who received at least one dose of alomfilimab or atezolizumab and had ADA results available for analysis within the relevant phase.
Posted
Count of Participants
Participants
Phase 1: pre-infusion at all cycles (up to 69 cycles) + 90 days SFUP; Phase 2: pre-infusion at all cycles (up to 28 cycles) + 90 day SFUP (21 day cycle length)
ID
Title
Description
OG000
Alomfilimab 0.8 mg
Participants received alomfilimab 0.8 mg as a single agent via IV infusion Q3W. The participants continued treatment with alomfilimab within this clinical study, as long as they continued to derive benefit from treatment, until the participant experienced unacceptable toxicity or confirmed PD per iRECIST.
OG001
Alomfilimab 2.4 mg
Participants received alomfilimab 2.4 mg as a single agent via IV infusion Q3W. The participants continued treatment with alomfilimab within this clinical study, as long as they continued to derive benefit from treatment, until the participant experienced unacceptable toxicity or confirmed PD per iRECIST.
Secondary
Change From Baseline in Tumor-infiltrating Lymphocytes Per mm^2 at Cycle 2 Day 8
Biological samples (e.g., archived and fresh tumor samples or blood samples) were collected for analysis of responsive biomarkers.
The summary of change in the following markers were calculated:
FOXP3-ICOS double-positive cells per mm^2 in the Tumor
CD8-positive cells per mm^2 in the tumor
CD8-positive cells per mm^2 in the invasive margin.
Biomarker Evaluable Set: consisted of all participants who received at least one dose of study drug and had at least one of ICOS, FOXP3 and CD8 cells results available for analysis within the relevant phase.
Posted
Mean
Standard Deviation
cells per mm^2
Baseline and Cycle 2 Day 8 (21 day cycle length)
ID
Title
Description
OG000
Alomfilimab 0.8 mg
Participants received alomfilimab 0.8 mg as a single agent via IV infusion Q3W. The participants continued treatment with alomfilimab within this clinical study, as long as they continued to derive benefit from treatment, until the participant experienced unacceptable toxicity or confirmed PD per iRECIST.
OG001
Alomfilimab 2.4 mg
Participants received alomfilimab 2.4 mg as a single agent via IV infusion Q3W. The participants continued treatment with alomfilimab within this clinical study, as long as they continued to derive benefit from treatment, until the participant experienced unacceptable toxicity or confirmed PD per iRECIST.
Time Frame
AEs: up to 30 days post last dose of study treatment, a maximum of approximately 216 and 90 weeks for Phase 1 and 2, respectively; All-cause mortality: up to the end of the long term follow-up, a maximum of approximately 236 and 162 weeks for Phase 1 and 2, respectively
Description
AEs are presented per the Safety Analysis Set with participants grouped according to the study drug received at Cycle 1 Day 1 (21-day cycle length). All-cause mortality is presented per the Full Analysis Set.
All-Cause Mortality Comment
Not provided
Arm/Groups
ID
Title
Description
Deaths (Affected)
Deaths (At Risk)
Serious Events (Affected)
Serious Events (At Risk)
Other Events (Affected)
Other Events (At Risk)
EG000
Alomfilimab 0.8 mg
Participants received alomfilimab 0.8 mg as a single agent via IV infusion Q3W. The participants continued treatment with alomfilimab within this clinical study, as long as they continued to derive benefit from treatment, until the participant experienced unacceptable toxicity or confirmed PD per iRECIST.
2
4
1
4
4
4
EG001
Alomfilimab 2.4 mg
Participants received alomfilimab 2.4 mg as a single agent via IV infusion Q3W. The participants continued treatment with alomfilimab within this clinical study, as long as they continued to derive benefit from treatment, until the participant experienced unacceptable toxicity or confirmed PD per iRECIST.
4
5
1
5
4
5
EG002
Alomfilimab 8 mg
Participants received alomfilimab 8 mg as a single agent via IV infusion Q3W. The participants continued treatment with alomfilimab within this clinical study, as long as they continued to derive benefit from treatment, until the participant experienced unacceptable toxicity or confirmed PD per iRECIST.
5
9
3
10
7
10
EG003
Alomfilimab 24 mg
Participants received alomfilimab 24 mg as a single agent via IV infusion Q3W. The participants continued treatment with alomfilimab within this clinical study, as long as they continued to derive benefit from treatment, until the participant experienced unacceptable toxicity or confirmed PD per iRECIST.
7
8
2
8
7
8
EG004
Alomfilimab 80 mg
Participants received alomfilimab 80 mg as a single agent via IV infusion Q3W. The participants continued treatment with alomfilimab within this clinical study, as long as they continued to derive benefit from treatment, until the participant experienced unacceptable toxicity or confirmed PD per iRECIST.
5
7
3
7
7
7
EG005
Alomfilimab 240 mg
Participants received alomfilimab 240 mg as a single agent via IV infusion Q3W. The participants continued treatment with alomfilimab within this clinical study, as long as they continued to derive benefit from treatment, until the participant experienced unacceptable toxicity or confirmed PD per iRECIST.
4
5
2
5
5
5
EG006
Alomfilimab 0.8 mg + Atezolizumab
Participants received alomfilimab 0.8 mg in combination with atezolizumab 1200 mg via IV infusion Q3W. The participants continued treatment with alomfilimab in combination with atezolizumab within this clinical study, as long as they continued to derive benefit from treatment, until the participant experienced unacceptable toxicity or confirmed PD per iRECIST.
5
5
2
5
4
5
EG007
Alomfilimab 2.4 mg + Atezolizumab
Participants received alomfilimab 2.4 mg in combination with atezolizumab 1200 mg via IV infusion Q3W. The participants continued treatment with alomfilimab in combination with atezolizumab within this clinical study, as long as they continued to derive benefit from treatment, until the participant experienced unacceptable toxicity or confirmed PD per iRECIST.
24
43
17
43
39
43
EG008
Alomfilimab 8 mg + Atezolizumab
Participants received alomfilimab 8 mg in combination with atezolizumab 1200 mg via IV infusion Q3W. The participants continued treatment with alomfilimab in combination with atezolizumab within this clinical study, as long as they continued to derive benefit from treatment, until the participant experienced unacceptable toxicity or confirmed PD per iRECIST.
22
36
11
35
34
35
EG009
Alomfilimab 24 mg + Atezolizumab
Participants received alomfilimab 24 mg in combination with atezolizumab 1200 mg via IV infusion Q3W. The participants continued treatment with alomfilimab in combination with atezolizumab within this clinical study, as long as they continued to derive benefit from treatment, until the participant experienced unacceptable toxicity or confirmed PD per iRECIST.
6
9
4
9
9
9
EG010
Alomfilimab 80 mg + Atezolizumab
Participants received alomfilimab 80 mg in combination with atezolizumab 1200 mg via IV infusion Q3W. The participants continued treatment with alomfilimab in combination with atezolizumab within this clinical study, as long as they continued to derive benefit from treatment, until the participant experienced unacceptable toxicity or confirmed PD per iRECIST.
3
9
3
9
9
9
EG011
Alomfilimab 2.4 mg + Atezolizumab in Anti-PD-(L)1 Naïve Pancreatic Cancer
Anti-PD-(L)1 naïve participants with pancreatic cancer received alomfilimab 2.4 mg in combination with atezolizumab 1200 mg via IV infusion Q3W. The participants continued treatment with alomfilimab in combination with atezolizumab within this clinical study, as long as they continued to derive benefit from treatment, until the participant experienced unacceptable toxicity or confirmed PD per iRECIST.
10
15
6
15
15
15
EG012
Alomfilimab 8 mg + Atezolizumab in Anti-PD-(L)1 Naïve Pancreatic Cancer
Anti-PD-(L)1 naïve participants with pancreatic cancer received alomfilimab 8 mg in combination with atezolizumab 1200 mg via IV infusion Q3W. The participants continued treatment with alomfilimab in combination with atezolizumab within this clinical study, as long as they continued to derive benefit from treatment, until the participant experienced unacceptable toxicity or confirmed PD per iRECIST.
10
14
2
14
13
14
EG013
Alomfilimab 2.4 mg + Atezolizumab in Anti-PD-(L)1 Naïve Triple Negative BC
Anti-PD-(L)1 naïve participants with triple negative BC received alomfilimab 2.4 mg in combination with atezolizumab 1200 mg via IV infusion Q3W. The participants continued treatment with alomfilimab in combination with atezolizumab within this clinical study, as long as they continued to derive benefit from treatment, until the participant experienced unacceptable toxicity or confirmed PD per iRECIST.
5
7
1
7
7
7
EG014
Alomfilimab 8 mg + Atezolizumab in Anti-PD-(L)1 Naïve Triple Negative BC
Anti-PD-(L)1 naïve participants with triple negative BC received alomfilimab 8 mg in combination with atezolizumab 1200 mg via IV infusion Q3W. The participants continued treatment with alomfilimab in combination with atezolizumab within this clinical study, as long as they continued to derive benefit from treatment, until the participant experienced unacceptable toxicity or confirmed PD per iRECIST.
7
14
2
14
14
14
EG015
Alomfilimab 8 mg + Atezolizumab in Anti-PD-(L)1 Naïve HNSCC
Anti-PD-(L)1 naïve participants with HNSCC received alomfilimab 8 mg in combination with atezolizumab 1200 mg via IV infusion Q3W. The participants continued treatment with alomfilimab in combination with atezolizumab within this clinical study, as long as they continued to derive benefit from treatment, until the participant experienced unacceptable toxicity or confirmed PD per iRECIST.
3
5
1
5
5
5
EG016
Alomfilimab 24 mg + Atezolizumab in Anti-PD-(L)1 Naïve HNSCC
Anti-PD-(L)1 naïve participants with HNSCC received alomfilimab 24 mg in combination with atezolizumab 1200 mg via IV infusion Q3W. The participants continued treatment with alomfilimab in combination with atezolizumab within this clinical study, as long as they continued to derive benefit from treatment, until the participant experienced unacceptable toxicity or confirmed PD per iRECIST.
2
5
1
5
5
5
EG017
Alomfilimab 2.4 mg + Atezolizumab in Anti-PD-(L)1 Pre-treated Pancreatic Cancer
Participants with pre-treated pancreatic cancer received alomfilimab 2.4 mg in combination with atezolizumab 1200 mg via IV infusion Q3W. The participants continued treatment with alomfilimab in combination with atezolizumab within this clinical study, as long as they continued to derive benefit from treatment, until the participant experienced unacceptable toxicity or confirmed PD per iRECIST.
1
2
1
2
2
2
EG018
Alomfilimab 8 mg + Atezolizumab in Anti-PD-(L)1 Pre-treated Pancreatic Cancer
Participants with pre-treated pancreatic cancer received alomfilimab 8 mg in combination with atezolizumab 1200 mg via IV infusion Q3W. The participants continued treatment with alomfilimab in combination with atezolizumab within this clinical study, as long as they continued to derive benefit from treatment, until the participant experienced unacceptable toxicity or confirmed PD per iRECIST.
1
1
0
1
1
1
EG019
Alomfilimab 2.4 mg + Atezolizumab in Anti-PD-(L)1 Pre-treated Triple Negative BC
Participants with pre-treated triple negative BC received alomfilimab 2.4 mg in combination with atezolizumab 1200 mg via IV infusion Q3W. The participants continued treatment with alomfilimab in combination with atezolizumab within this clinical study, as long as they continued to derive benefit from treatment, until the participant experienced unacceptable toxicity or confirmed PD per iRECIST.
1
1
0
1
1
1
EG020
Alomfilimab 8 mg + Atezolizumab in Anti-PD-(L)1 Pre-treated Triple Negative BC
Participants with pre-treated triple negative BC received alomfilimab 8 mg in combination with atezolizumab 1200 mg via IV infusion Q3W. The participants continued treatment with alomfilimab in combination with atezolizumab within this clinical study, as long as they continued to derive benefit from treatment, until the participant experienced unacceptable toxicity or confirmed PD per iRECIST.
1
6
2
6
6
6
EG021
Alomfilimab 8 mg + Atezolizumab in Anti-PD-(L)1 Pre-treated HNSCC
Participants with pre-treated HNSCC received alomfilimab 8 mg in combination with atezolizumab 1200 mg via IV infusion Q3W. The participants continued treatment with alomfilimab in combination with atezolizumab within this clinical study, as long as they continued to derive benefit from treatment, until the participant experienced unacceptable toxicity or confirmed PD per iRECIST.
2
3
1
3
2
3
EG022
Alomfilimab 24 mg + Atezolizumab in Anti-PD-(L)1 Pre-treated HNSCC
Participants with pre-treated HNSCC received alomfilimab 24 mg in combination with atezolizumab 1200 mg via IV infusion Q3W. The participants continued treatment with alomfilimab in combination with atezolizumab within this clinical study, as long as they continued to derive benefit from treatment, until the participant experienced unacceptable toxicity or confirmed PD per iRECIST.
4
9
4
8
8
8
Serious Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Anaemia
Blood and lymphatic system disorders
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected10 at risk
EG0030 events0 affected8 at risk
EG0040 events0 affected7 at risk
EG0050 events0 affected5 at risk
EG0060 events0 affected5 at risk
EG0070 events0 affected43 at risk
EG0080 events0 affected35 at risk
EG0090 events0 affected9 at risk
EG0100 events0 affected9 at risk
EG0110 events0 affected15 at risk
EG0120 events0 affected14 at risk
EG0130 events0 affected7 at risk
EG0140 events0 affected14 at risk
EG0150 events0 affected5 at risk
EG0161 events1 affected5 at risk
EG0170 events0 affected2 at risk
EG0180 events0 affected1 at risk
EG0190 events0 affected1 at risk
EG0200 events0 affected6 at risk
EG0210 events0 affected3 at risk
EG0220 events0 affected8 at risk
Atrial fibrillation
Cardiac disorders
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected10 at risk
EG003
Inappropriate antidiuretic hormone secretion
Endocrine disorders
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected10 at risk
EG003
Abdominal pain
Gastrointestinal disorders
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected4 at risk
EG0011 events1 affected5 at risk
EG0022 events2 affected10 at risk
EG003
Ascites
Gastrointestinal disorders
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected10 at risk
EG003
Dysphagia
Gastrointestinal disorders
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected10 at risk
EG003
Mouth haemorrhage
Gastrointestinal disorders
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected10 at risk
EG003
Nausea
Gastrointestinal disorders
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected10 at risk
EG003
Obstruction gastric
Gastrointestinal disorders
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected10 at risk
EG003
Odynophagia
Gastrointestinal disorders
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected10 at risk
EG003
Oesophageal haemorrhage
Gastrointestinal disorders
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected10 at risk
EG003
Oesophageal stenosis
Gastrointestinal disorders
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected10 at risk
EG003
Small intestinal obstruction
Gastrointestinal disorders
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected10 at risk
EG003
Upper gastrointestinal haemorrhage
Gastrointestinal disorders
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected10 at risk
EG003
Vomiting
Gastrointestinal disorders
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected10 at risk
EG003
Chest pain
General disorders
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected10 at risk
EG003
Chills
General disorders
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected5 at risk
EG0021 events1 affected10 at risk
EG003
Death
General disorders
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected10 at risk
EG003
Face oedema
General disorders
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected10 at risk
EG003
Fatigue
General disorders
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected10 at risk
EG003
Medical device discomfort
General disorders
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected10 at risk
EG003
Pain
General disorders
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected10 at risk
EG003
Pyrexia
General disorders
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected5 at risk
EG0021 events1 affected10 at risk
EG003
Cholangitis
Hepatobiliary disorders
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected10 at risk
EG003
Hepatic failure
Hepatobiliary disorders
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected10 at risk
EG003
Hepatic haemorrhage
Hepatobiliary disorders
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected10 at risk
EG003
Jaundice cholestatic
Hepatobiliary disorders
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected10 at risk
EG003
Appendicitis
Infections and infestations
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected10 at risk
EG003
Atypical pneumonia
Infections and infestations
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected10 at risk
EG003
Bacterial sepsis
Infections and infestations
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected10 at risk
EG003
COVID-19 pneumonia
Infections and infestations
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected10 at risk
EG003
Cellulitis
Infections and infestations
MedDRA 27.0
Systematic Assessment
EG0001 events1 affected4 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected10 at risk
EG003
Clostridium difficile infection
Infections and infestations
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected10 at risk
EG003
Escherichia bacteraemia
Infections and infestations
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected10 at risk
EG003
Infective exacerbation of chronic obstructive airways disease
Infections and infestations
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected10 at risk
EG003
Lower respiratory tract infection
Infections and infestations
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected10 at risk
EG003
Pneumonia
Infections and infestations
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected10 at risk
EG003
Pneumonia mycoplasmal
Infections and infestations
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected10 at risk
EG003
Rhinovirus infection
Infections and infestations
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected10 at risk
EG003
Sepsis
Infections and infestations
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected10 at risk
EG003
Skin infection
Infections and infestations
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected10 at risk
EG003
Soft tissue infection
Infections and infestations
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected10 at risk
EG003
Urinary tract infection
Infections and infestations
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected10 at risk
EG003
Infusion related reaction
Injury, poisoning and procedural complications
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected5 at risk
EG0021 events1 affected10 at risk
EG003
Post procedural haemorrhage
Injury, poisoning and procedural complications
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected10 at risk
EG003
Procedural pain
Injury, poisoning and procedural complications
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected10 at risk
EG003
Wound complication
Injury, poisoning and procedural complications
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected10 at risk
EG003
Blood bilirubin increased
Investigations
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected10 at risk
EG003
Dehydration
Metabolism and nutrition disorders
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected10 at risk
EG003
Hypercalcaemia
Metabolism and nutrition disorders
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected5 at risk
EG0021 events1 affected10 at risk
EG003
Hyponatraemia
Metabolism and nutrition disorders
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected10 at risk
EG003
Arthralgia
Musculoskeletal and connective tissue disorders
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected10 at risk
EG003
Back pain
Musculoskeletal and connective tissue disorders
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected5 at risk
EG0021 events1 affected10 at risk
EG003
Immune-mediated myositis
Musculoskeletal and connective tissue disorders
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected10 at risk
EG003
Neck pain
Musculoskeletal and connective tissue disorders
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected10 at risk
EG003
Colon cancer
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected10 at risk
EG003
Oesophageal carcinoma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected10 at risk
EG003
Tumour associated fever
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected10 at risk
EG003
Tumour haemorrhage
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected10 at risk
EG003
Tumour pain
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected10 at risk
EG003
Brain oedema
Nervous system disorders
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected10 at risk
EG003
Cerebrovascular accident
Nervous system disorders
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected10 at risk
EG003
Dizziness
Nervous system disorders
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected10 at risk
EG003
Hemiplegia
Nervous system disorders
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected10 at risk
EG003
Seizure
Nervous system disorders
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected10 at risk
EG003
Spinal cord compression
Nervous system disorders
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected10 at risk
EG003
Syncope
Nervous system disorders
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected10 at risk
EG003
Completed suicide
Psychiatric disorders
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected10 at risk
EG003
Urinary incontinence
Renal and urinary disorders
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected10 at risk
EG003
Urinary tract obstruction
Renal and urinary disorders
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected10 at risk
EG003
Bronchial obstruction
Respiratory, thoracic and mediastinal disorders
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected10 at risk
EG003
Dyspnoea
Respiratory, thoracic and mediastinal disorders
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected10 at risk
EG003
Pleural effusion
Respiratory, thoracic and mediastinal disorders
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected10 at risk
EG003
Stridor
Respiratory, thoracic and mediastinal disorders
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected10 at risk
EG003
Embolism
Vascular disorders
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected10 at risk
EG003
Hypotension
Vascular disorders
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected10 at risk
EG003
Superior vena cava syndrome
Vascular disorders
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected10 at risk
EG003
Other Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Anaemia
Blood and lymphatic system disorders
MedDRA 27.0
Systematic Assessment
EG0001 events1 affected4 at risk
EG0011 events1 affected5 at risk
EG0022 events2 affected10 at risk
EG0033 events3 affected8 at risk
EG0044 events1 affected7 at risk
EG0053 events2 affected5 at risk
EG0060 events0 affected5 at risk
EG00715 events9 affected43 at risk
EG00820 events11 affected35 at risk
EG0093 events3 affected9 at risk
EG0105 events3 affected9 at risk
EG0118 events5 affected15 at risk
EG0122 events1 affected14 at risk
EG0130 events0 affected7 at risk
EG0146 events3 affected14 at risk
EG0152 events1 affected5 at risk
EG0162 events2 affected5 at risk
EG0172 events1 affected2 at risk
EG0180 events0 affected1 at risk
EG0190 events0 affected1 at risk
EG0201 events1 affected6 at risk
EG0212 events1 affected3 at risk
EG0220 events0 affected8 at risk
Eosinophilia
Blood and lymphatic system disorders
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected10 at risk
EG003
Iron deficiency anaemia
Blood and lymphatic system disorders
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected10 at risk
EG003
Leukocytosis
Blood and lymphatic system disorders
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected10 at risk
EG003
Leukopenia
Blood and lymphatic system disorders
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected10 at risk
EG003
Lymph node pain
Blood and lymphatic system disorders
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected10 at risk
EG003
Lymphopenia
Blood and lymphatic system disorders
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected10 at risk
EG003
Neutropenia
Blood and lymphatic system disorders
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected10 at risk
EG003
Neutrophilia
Blood and lymphatic system disorders
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected10 at risk
EG003
Atrial fibrillation
Cardiac disorders
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected10 at risk
EG003
Palpitations
Cardiac disorders
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected10 at risk
EG003
Sinus tachycardia
Cardiac disorders
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected10 at risk
EG003
Hypoacusis
Ear and labyrinth disorders
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected10 at risk
EG003
Tinnitus
Ear and labyrinth disorders
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected10 at risk
EG003
Vertigo
Ear and labyrinth disorders
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected10 at risk
EG003
Adrenal insufficiency
Endocrine disorders
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected10 at risk
EG003
Hypothyroidism
Endocrine disorders
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected10 at risk
EG003
Immune-mediated hypothyroidism
Endocrine disorders
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected10 at risk
EG003
Dry eye
Eye disorders
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected10 at risk
EG003
Periorbital oedema
Eye disorders
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected10 at risk
EG003
Periorbital pain
Eye disorders
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected10 at risk
EG003
Vision blurred
Eye disorders
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected10 at risk
EG003
Abdominal discomfort
Gastrointestinal disorders
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected10 at risk
EG003
Abdominal distension
Gastrointestinal disorders
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected4 at risk
EG0011 events1 affected5 at risk
EG0020 events0 affected10 at risk
EG003
Abdominal pain
Gastrointestinal disorders
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected4 at risk
EG0011 events1 affected5 at risk
EG0021 events1 affected10 at risk
EG003
Abdominal pain upper
Gastrointestinal disorders
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected10 at risk
EG003
Abdominal tenderness
Gastrointestinal disorders
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected10 at risk
EG003
Aphthous ulcer
Gastrointestinal disorders
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected10 at risk
EG003
Ascites
Gastrointestinal disorders
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected10 at risk
EG003
Constipation
Gastrointestinal disorders
MedDRA 27.0
Systematic Assessment
EG0001 events1 affected4 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected10 at risk
EG003
Diarrhoea
Gastrointestinal disorders
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected10 at risk
EG003
Dry mouth
Gastrointestinal disorders
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected5 at risk
EG0021 events1 affected10 at risk
EG003
Dyspepsia
Gastrointestinal disorders
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected10 at risk
EG003
Dysphagia
Gastrointestinal disorders
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected10 at risk
EG003
Eructation
Gastrointestinal disorders
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected10 at risk
EG003
Flatulence
Gastrointestinal disorders
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected10 at risk
EG003
Gastrooesophageal reflux disease
Gastrointestinal disorders
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected10 at risk
EG003
Intestinal obstruction
Gastrointestinal disorders
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected10 at risk
EG003
Melaena
Gastrointestinal disorders
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected10 at risk
EG003
Mouth haemorrhage
Gastrointestinal disorders
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected10 at risk
EG003
Mouth ulceration
Gastrointestinal disorders
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected10 at risk
EG003
Nausea
Gastrointestinal disorders
MedDRA 27.0
Systematic Assessment
EG0001 events1 affected4 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected10 at risk
EG003
Odynophagia
Gastrointestinal disorders
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected10 at risk
EG003
Stomatitis
Gastrointestinal disorders
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected10 at risk
EG003
Toothache
Gastrointestinal disorders
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected10 at risk
EG003
Vomiting
Gastrointestinal disorders
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected10 at risk
EG003
Asthenia
General disorders
MedDRA 27.0
Systematic Assessment
EG0001 events1 affected4 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected10 at risk
EG003
Chest pain
General disorders
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected10 at risk
EG003
Chills
General disorders
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected10 at risk
EG003
Fatigue
General disorders
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected4 at risk
EG0011 events1 affected5 at risk
EG0021 events1 affected10 at risk
EG003
Influenza like illness
General disorders
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected10 at risk
EG003
Malaise
General disorders
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected4 at risk
EG0011 events1 affected5 at risk
EG0020 events0 affected10 at risk
EG003
Mucosal inflammation
General disorders
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected10 at risk
EG003
Non-cardiac chest pain
General disorders
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected10 at risk
EG003
Oedema peripheral
General disorders
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected10 at risk
EG003
Pain
General disorders
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected10 at risk
EG003
Peripheral swelling
General disorders
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected10 at risk
EG003
Pyrexia
General disorders
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected10 at risk
EG003
Swelling
General disorders
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected10 at risk
EG003
Hyperbilirubinaemia
Hepatobiliary disorders
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected10 at risk
EG003
Asymptomatic bacteriuria
Infections and infestations
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected10 at risk
EG003
Bacteriuria
Infections and infestations
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected10 at risk
EG003
COVID-19
Infections and infestations
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected10 at risk
EG003
Candida infection
Infections and infestations
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected10 at risk
EG003
Catheter site infection
Infections and infestations
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected10 at risk
EG003
Cystitis
Infections and infestations
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected10 at risk
EG003
Eye infection
Infections and infestations
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected10 at risk
EG003
Folliculitis
Infections and infestations
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected10 at risk
EG003
Herpes zoster
Infections and infestations
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected10 at risk
EG003
Herpes zoster reactivation
Infections and infestations
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected10 at risk
EG003
Hordeolum
Infections and infestations
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected10 at risk
EG003
Lower respiratory tract infection
Infections and infestations
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected10 at risk
EG003
Mucosal infection
Infections and infestations
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected10 at risk
EG003
Nasopharyngitis
Infections and infestations
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected5 at risk
EG0021 events1 affected10 at risk
EG003
Ophthalmic herpes zoster
Infections and infestations
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected10 at risk
EG003
Oral candidiasis
Infections and infestations
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected10 at risk
EG003
Oral herpes
Infections and infestations
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected10 at risk
EG003
Pneumonia
Infections and infestations
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected10 at risk
EG003
Respiratory tract infection
Infections and infestations
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected10 at risk
EG003
Rhinitis
Infections and infestations
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected10 at risk
EG003
Sepsis
Infections and infestations
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected10 at risk
EG003
Sinusitis
Infections and infestations
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected10 at risk
EG003
Skin infection
Infections and infestations
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected10 at risk
EG003
Soft tissue infection
Infections and infestations
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected10 at risk
EG003
Tinea pedis
Infections and infestations
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected10 at risk
EG003
Tooth abscess
Infections and infestations
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected10 at risk
EG003
Tooth infection
Infections and infestations
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected10 at risk
EG003
Upper respiratory tract infection
Infections and infestations
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected10 at risk
EG003
Urinary tract infection
Infections and infestations
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected4 at risk
EG0011 events1 affected5 at risk
EG0021 events1 affected10 at risk
EG003
Vaginal infection
Infections and infestations
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected10 at risk
EG003
Fall
Injury, poisoning and procedural complications
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected10 at risk
EG003
Infusion related reaction
Injury, poisoning and procedural complications
MedDRA 27.0
Systematic Assessment
EG0001 events1 affected4 at risk
EG0010 events0 affected5 at risk
EG0021 events1 affected10 at risk
EG003
Lumbar vertebral fracture
Injury, poisoning and procedural complications
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected10 at risk
EG003
Post procedural haemorrhage
Injury, poisoning and procedural complications
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected10 at risk
EG003
Post-traumatic pain
Injury, poisoning and procedural complications
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected10 at risk
EG003
Procedural pain
Injury, poisoning and procedural complications
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected10 at risk
EG003
Procedural pneumothorax
Injury, poisoning and procedural complications
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected5 at risk
EG0021 events1 affected10 at risk
EG003
Spinal fracture
Injury, poisoning and procedural complications
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected10 at risk
EG003
Stoma site inflammation
Injury, poisoning and procedural complications
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected10 at risk
EG003
Tooth fracture
Injury, poisoning and procedural complications
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected10 at risk
EG003
Vascular access complication
Injury, poisoning and procedural complications
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected10 at risk
EG003
Activated partial thromboplastin time prolonged
Investigations
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected10 at risk
EG003
Alanine aminotransferase increased
Investigations
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected10 at risk
EG003
Amylase increased
Investigations
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected10 at risk
EG003
Aspartate aminotransferase increased
Investigations
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected10 at risk
EG003
Blood alkaline phosphatase increased
Investigations
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected10 at risk
EG003
Blood bilirubin increased
Investigations
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected10 at risk
EG003
Blood cholesterol increased
Investigations
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected10 at risk
EG003
Blood creatine phosphokinase increased
Investigations
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected10 at risk
EG003
Blood creatinine increased
Investigations
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected10 at risk
EG003
Blood lactate dehydrogenase increased
Investigations
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected10 at risk
EG003
Blood pressure increased
Investigations
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected10 at risk
EG003
Blood thyroid stimulating hormone increased
Investigations
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected10 at risk
EG003
Body temperature decreased
Investigations
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected10 at risk
EG003
Cardiac murmur
Investigations
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected10 at risk
EG003
Fibrin D dimer increased
Investigations
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected10 at risk
EG003
Gamma-glutamyltransferase
Investigations
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected10 at risk
EG003
Gamma-glutamyltransferase increased
Investigations
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected10 at risk
EG003
International normalised ratio increased
Investigations
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected10 at risk
EG003
Lipase decreased
Investigations
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected10 at risk
EG003
Lipase increased
Investigations
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected10 at risk
EG003
Lymphocyte count decreased
Investigations
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected5 at risk
EG0021 events1 affected10 at risk
EG003
Platelet count decreased
Investigations
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected10 at risk
EG003
Weight decreased
Investigations
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected10 at risk
EG003
White blood cell count decreased
Investigations
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected10 at risk
EG003
Cachexia
Metabolism and nutrition disorders
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected10 at risk
EG003
Decreased appetite
Metabolism and nutrition disorders
MedDRA 27.0
Systematic Assessment
EG0001 events1 affected4 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected10 at risk
EG003
Dehydration
Metabolism and nutrition disorders
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected10 at risk
EG003
Hyperamylasaemia
Metabolism and nutrition disorders
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected10 at risk
EG003
Hypercalcaemia
Metabolism and nutrition disorders
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected10 at risk
EG003
Hypercholesterolaemia
Metabolism and nutrition disorders
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected10 at risk
EG003
Hyperglycaemia
Metabolism and nutrition disorders
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected10 at risk
EG003
Hyperkalaemia
Metabolism and nutrition disorders
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected5 at risk
EG0021 events1 affected10 at risk
EG003
Hyperlipasaemia
Metabolism and nutrition disorders
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected10 at risk
EG003
Hypoalbuminaemia
Metabolism and nutrition disorders
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected10 at risk
EG003
Hypocalcaemia
Metabolism and nutrition disorders
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected5 at risk
EG0021 events1 affected10 at risk
EG003
Hypokalaemia
Metabolism and nutrition disorders
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected5 at risk
EG0022 events1 affected10 at risk
EG003
Hypomagnesaemia
Metabolism and nutrition disorders
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected10 at risk
EG003
Hyponatraemia
Metabolism and nutrition disorders
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected10 at risk
EG003
Iron deficiency
Metabolism and nutrition disorders
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected10 at risk
EG003
Arthralgia
Musculoskeletal and connective tissue disorders
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected10 at risk
EG003
Back pain
Musculoskeletal and connective tissue disorders
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected10 at risk
EG003
Bone pain
Musculoskeletal and connective tissue disorders
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected10 at risk
EG003
Flank pain
Musculoskeletal and connective tissue disorders
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected10 at risk
EG003
Groin pain
Musculoskeletal and connective tissue disorders
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected10 at risk
EG003
Muscle spasms
Musculoskeletal and connective tissue disorders
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected10 at risk
EG003
Muscle tightness
Musculoskeletal and connective tissue disorders
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected10 at risk
EG003
Muscular weakness
Musculoskeletal and connective tissue disorders
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected10 at risk
EG003
Musculoskeletal chest pain
Musculoskeletal and connective tissue disorders
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected10 at risk
EG003
Musculoskeletal discomfort
Musculoskeletal and connective tissue disorders
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected10 at risk
EG003
Musculoskeletal pain
Musculoskeletal and connective tissue disorders
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected10 at risk
EG003
Myalgia
Musculoskeletal and connective tissue disorders
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected10 at risk
EG003
Neck pain
Musculoskeletal and connective tissue disorders
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected10 at risk
EG003
Osteoporosis
Musculoskeletal and connective tissue disorders
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected10 at risk
EG003
Pain in extremity
Musculoskeletal and connective tissue disorders
MedDRA 27.0
Systematic Assessment
EG0001 events1 affected4 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected10 at risk
EG003
Pain in jaw
Musculoskeletal and connective tissue disorders
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected10 at risk
EG003
Rhabdomyolysis
Musculoskeletal and connective tissue disorders
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected10 at risk
EG003
Rotator cuff syndrome
Musculoskeletal and connective tissue disorders
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected10 at risk
EG003
Trismus
Musculoskeletal and connective tissue disorders
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected10 at risk
EG003
Cancer pain
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected10 at risk
EG003
Infected neoplasm
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected10 at risk
EG003
Tumour associated fever
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected10 at risk
EG003
Tumour cavitation
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected10 at risk
EG003
Tumour ulceration
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected10 at risk
EG003
Uterine leiomyoma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected10 at risk
EG003
Aphasia
Nervous system disorders
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected10 at risk
EG003
Coordination abnormal
Nervous system disorders
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected10 at risk
EG003
Dizziness
Nervous system disorders
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected10 at risk
EG003
Dysgeusia
Nervous system disorders
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected10 at risk
EG003
Dysmetria
Nervous system disorders
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected10 at risk
EG003
Headache
Nervous system disorders
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected5 at risk
EG0021 events1 affected10 at risk
EG003
Hemianopia
Nervous system disorders
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected10 at risk
EG003
Hemianopia homonymous
Nervous system disorders
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected10 at risk
EG003
Hypersomnia
Nervous system disorders
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected10 at risk
EG003
Hypoaesthesia
Nervous system disorders
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected10 at risk
EG003
Migraine
Nervous system disorders
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected10 at risk
EG003
Neuralgia
Nervous system disorders
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected10 at risk
EG003
Paraesthesia
Nervous system disorders
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected10 at risk
EG003
Peripheral motor neuropathy
Nervous system disorders
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected10 at risk
EG003
Peripheral sensory neuropathy
Nervous system disorders
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected10 at risk
EG003
Presyncope
Nervous system disorders
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected10 at risk
EG003
Sinus headache
Nervous system disorders
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected10 at risk
EG003
Somnolence
Nervous system disorders
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected10 at risk
EG003
Tremor
Nervous system disorders
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected10 at risk
EG003
Anxiety
Psychiatric disorders
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected10 at risk
EG003
Confusional state
Psychiatric disorders
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected10 at risk
EG003
Depression
Psychiatric disorders
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected10 at risk
EG003
Hallucination
Psychiatric disorders
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected10 at risk
EG003
Insomnia
Psychiatric disorders
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected4 at risk
EG0011 events1 affected5 at risk
EG0020 events0 affected10 at risk
EG003
Terminal insomnia
Psychiatric disorders
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected10 at risk
EG003
Chromaturia
Renal and urinary disorders
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected10 at risk
EG003
Dysuria
Renal and urinary disorders
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected10 at risk
EG003
Haematuria
Renal and urinary disorders
MedDRA 27.0
Systematic Assessment
EG0001 events1 affected4 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected10 at risk
EG003
Hydronephrosis
Renal and urinary disorders
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected10 at risk
EG003
Urinary hesitation
Renal and urinary disorders
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected10 at risk
EG003
Erectile dysfunction
Reproductive system and breast disorders
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected10 at risk
EG003
Pelvic pain
Reproductive system and breast disorders
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected4 at risk
EG0011 events1 affected5 at risk
EG0020 events0 affected10 at risk
EG003
Vaginal haemorrhage
Reproductive system and breast disorders
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected4 at risk
EG0012 events1 affected5 at risk
EG0020 events0 affected10 at risk
EG003
Cough
Respiratory, thoracic and mediastinal disorders
MedDRA 27.0
Systematic Assessment
EG0001 events1 affected4 at risk
EG0010 events0 affected5 at risk
EG0022 events2 affected10 at risk
EG003
Dysphonia
Respiratory, thoracic and mediastinal disorders
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected10 at risk
EG003
Dyspnoea
Respiratory, thoracic and mediastinal disorders
MedDRA 27.0
Systematic Assessment
EG0001 events1 affected4 at risk
EG0010 events0 affected5 at risk
EG0022 events2 affected10 at risk
EG003
Dyspnoea exertional
Respiratory, thoracic and mediastinal disorders
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected10 at risk
EG003
Epistaxis
Respiratory, thoracic and mediastinal disorders
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected10 at risk
EG003
Haemoptysis
Respiratory, thoracic and mediastinal disorders
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected5 at risk
EG0022 events1 affected10 at risk
EG003
Immune-mediated lung disease
Respiratory, thoracic and mediastinal disorders
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected10 at risk
EG003
Oropharyngeal pain
Respiratory, thoracic and mediastinal disorders
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected10 at risk
EG003
Paranasal sinus haemorrhage
Respiratory, thoracic and mediastinal disorders
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected10 at risk
EG003
Pleural effusion
Respiratory, thoracic and mediastinal disorders
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected10 at risk
EG003
Pneumothorax
Respiratory, thoracic and mediastinal disorders
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected10 at risk
EG003
Pulmonary embolism
Respiratory, thoracic and mediastinal disorders
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected10 at risk
EG003
Rhinorrhoea
Respiratory, thoracic and mediastinal disorders
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected10 at risk
EG003
Sinus congestion
Respiratory, thoracic and mediastinal disorders
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected4 at risk
EG0011 events1 affected5 at risk
EG0020 events0 affected10 at risk
EG003
Alopecia
Skin and subcutaneous tissue disorders
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected10 at risk
EG003
Dermatitis
Skin and subcutaneous tissue disorders
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected10 at risk
EG003
Dry skin
Skin and subcutaneous tissue disorders
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected10 at risk
EG003
Eczema
Skin and subcutaneous tissue disorders
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected10 at risk
EG003
Erythema
Skin and subcutaneous tissue disorders
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected10 at risk
EG003
Hyperhidrosis
Skin and subcutaneous tissue disorders
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected10 at risk
EG003
Pruritus
Skin and subcutaneous tissue disorders
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected10 at risk
EG003
Rash
Skin and subcutaneous tissue disorders
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected10 at risk
EG003
Rash maculo-papular
Skin and subcutaneous tissue disorders
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected4 at risk
EG0011 events1 affected5 at risk
EG0021 events1 affected10 at risk
EG003
Rash papular
Skin and subcutaneous tissue disorders
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected10 at risk
EG003
Rash pruritic
Skin and subcutaneous tissue disorders
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected10 at risk
EG003
Rash vesicular
Skin and subcutaneous tissue disorders
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected10 at risk
EG003
Skin plaque
Skin and subcutaneous tissue disorders
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected10 at risk
EG003
Skin ulcer
Skin and subcutaneous tissue disorders
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected10 at risk
EG003
Embolism
Vascular disorders
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected10 at risk
EG003
Hypertension
Vascular disorders
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected10 at risk
EG003
Hypotension
Vascular disorders
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected10 at risk
EG003
Jugular vein thrombosis
Vascular disorders
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected10 at risk
EG003
Lymphoedema
Vascular disorders
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected10 at risk
EG003
Superficial vein thrombosis
Vascular disorders
MedDRA 27.0
Systematic Assessment
EG0001 events1 affected4 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected10 at risk
EG003
Certain Agreements
Are all PI(s) employees of the sponsor?
No
Restriction Type
OTHER
Results Disclosure Restriction on PI(s)?
Yes
Other Details
The Sponsor supports publication of clinical trial results but may request that investigators temporarily delay or alter publications in order to protect proprietary information. The Sponsor may also require that the results of multicenter studies be published only in their entirety and not as individual site data.
Female Urogenital Diseases and Pregnancy Complications
D000091642
Urogenital Diseases
D007674
Kidney Diseases
D014570
Urologic Diseases
D052801
Male Urogenital Diseases
D004701
Endocrine Gland Neoplasms
D010182
Pancreatic Diseases
D004700
Endocrine System Diseases
D014594
Uterine Neoplasms
D005833
Genital Neoplasms, Female
D002577
Uterine Cervical Diseases
D014591
Uterine Diseases
D005831
Genital Diseases, Female
D000091662
Genital Diseases
D001943
Breast Neoplasms
D001941
Breast Diseases
D009385
Neoplastic Processes
D010335
Pathologic Processes
D013568
Pathological Conditions, Signs and Symptoms
Browse Leaves
Not provided
Browse Branches
Not provided
ID
Term
C000594389
atezolizumab
Ancestor Terms
Not provided
Browse Leaves
Not provided
Browse Branches
Not provided
0 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
FG0080 subjects
FG0090 subjects
FG0100 subjects
FG0110 subjects
FG0120 subjects
FG0130 subjects
FG0140 subjects
FG0151 subjects
FG0160 subjects
FG0170 subjects
FG0180 subjects
FG0190 subjects
FG0201 subjects
FG0210 subjects
FG0220 subjects
0 subjects
FG0050 subjects
FG0060 subjects
FG0073 subjects
FG0081 subjects
FG0090 subjects
FG0100 subjects
FG0110 subjects
FG0120 subjects
FG0130 subjects
FG0143 subjects
FG0152 subjects
FG0162 subjects
FG0170 subjects
FG0180 subjects
FG0190 subjects
FG0201 subjects
FG0210 subjects
FG0223 subjects
1 subjects
FG0050 subjects
FG0060 subjects
FG0072 subjects
FG0082 subjects
FG0090 subjects
FG0102 subjects
FG0111 subjects
FG0120 subjects
FG0131 subjects
FG0141 subjects
FG0150 subjects
FG0160 subjects
FG0170 subjects
FG0180 subjects
FG0190 subjects
FG0200 subjects
FG0210 subjects
FG0221 subjects
5 subjects
FG0054 subjects
FG0065 subjects
FG00724 subjects
FG00822 subjects
FG0096 subjects
FG0103 subjects
FG01110 subjects
FG01210 subjects
FG0135 subjects
FG0147 subjects
FG0152 subjects
FG0162 subjects
FG0171 subjects
FG0181 subjects
FG0191 subjects
FG0201 subjects
FG0212 subjects
FG0223 subjects
0 subjects
FG0050 subjects
FG0060 subjects
FG0071 subjects
FG0080 subjects
FG0090 subjects
FG0100 subjects
FG0110 subjects
FG0120 subjects
FG0130 subjects
FG0140 subjects
FG0150 subjects
FG0160 subjects
FG0170 subjects
FG0180 subjects
FG0190 subjects
FG0200 subjects
FG0210 subjects
FG0221 subjects
8
ParticipantsBG0047
ParticipantsBG0055
ParticipantsBG0065
ParticipantsBG00743
ParticipantsBG00836
ParticipantsBG0099
ParticipantsBG0109
ParticipantsBG01115
ParticipantsBG01214
ParticipantsBG0137
ParticipantsBG01414
ParticipantsBG0155
ParticipantsBG0165
ParticipantsBG0172
ParticipantsBG0181
ParticipantsBG0191
ParticipantsBG0206
ParticipantsBG0213
ParticipantsBG0229
ParticipantsBG023222
Title
Measurements
>= 18 - 64 years
BG0002
BG0012
BG0026
BG0032
BG0044
BG0053
BG0062
BG00727
BG00827
BG0095
BG0105
BG0118
BG0125
BG0136
BG01410
BG0153
BG0164
BG0171
BG0180
BG0191
BG0204
BG0213
BG0223
BG023133
>= 65 to 84 years
BG0002
BG0013
BG0023
BG0036
BG004
>= 85 years
BG0000
BG0010
BG0020
BG0030
BG004
9
ParticipantsBG0038
ParticipantsBG0047
ParticipantsBG0055
ParticipantsBG0065
ParticipantsBG00743
ParticipantsBG00836
ParticipantsBG0099
ParticipantsBG0109
ParticipantsBG01115
ParticipantsBG01214
ParticipantsBG0137
ParticipantsBG01414
ParticipantsBG0155
ParticipantsBG0165
ParticipantsBG0172
ParticipantsBG0181
ParticipantsBG0191
ParticipantsBG0206
ParticipantsBG0213
ParticipantsBG0229
ParticipantsBG023222
Title
Measurements
Female
BG0003
BG0013
BG0022
BG0036
BG0043
BG0053
BG0063
BG00720
BG00820
BG0095
BG0104
BG0116
BG0126
BG0137
BG01414
BG0150
BG0161
BG0170
BG0180
BG0191
BG0206
BG0211
BG0224
BG023118
Male
BG0001
BG0012
BG0027
BG0032
BG004
9
ParticipantsBG0038
ParticipantsBG0047
ParticipantsBG0055
ParticipantsBG0065
ParticipantsBG00743
ParticipantsBG00836
ParticipantsBG0099
ParticipantsBG0109
ParticipantsBG01115
ParticipantsBG01214
ParticipantsBG0137
ParticipantsBG01414
ParticipantsBG0155
ParticipantsBG0165
ParticipantsBG0172
ParticipantsBG0181
ParticipantsBG0191
ParticipantsBG0206
ParticipantsBG0213
ParticipantsBG0229
ParticipantsBG023222
Title
Measurements
American Indian or Alaska Native
BG0000
BG0010
BG0020
BG0030
BG0040
BG0050
BG0060
BG0070
BG0080
BG0090
BG0100
BG0110
BG0120
BG0130
BG0140
BG0150
BG0160
BG0170
BG0180
BG0190
BG0200
BG0210
BG0220
BG0230
Asian
BG0000
BG0010
BG0021
BG0030
BG004
Black or African American
BG0000
BG0010
BG0020
BG0030
BG004
Native Hawaiian or other Pacific Islander
BG0000
BG0010
BG0020
BG0030
BG004
White
BG0004
BG0015
BG0028
BG0038
BG004
Other
BG0000
BG0010
BG0020
BG0030
BG004
Missing
BG0000
BG0010
BG0020
BG0030
BG004
0
ParticipantsBG0030
ParticipantsBG0040
ParticipantsBG0050
ParticipantsBG0060
ParticipantsBG0070
ParticipantsBG0080
ParticipantsBG0090
ParticipantsBG0100
ParticipantsBG0110
ParticipantsBG0120
ParticipantsBG0130
ParticipantsBG0140
ParticipantsBG0150
ParticipantsBG0160
ParticipantsBG0170
ParticipantsBG0180
ParticipantsBG0190
ParticipantsBG0200
ParticipantsBG0210
ParticipantsBG0220
ParticipantsBG0230
Title
Measurements
BG0230
Alomfilimab 240 mg
Participants received alomfilimab 240 mg as a single agent via IV infusion Q3W. The participants continued treatment with alomfilimab within this clinical study, as long as they continued to derive benefit from treatment, until the participant experienced unacceptable toxicity or confirmed PD per iRECIST.
OG006
Alomfilimab 0.8 mg + Atezolizumab
Participants received alomfilimab 0.8 mg in combination with atezolizumab 1200 mg via IV infusion Q3W. The participants continued treatment with alomfilimab in combination with atezolizumab within this clinical study, as long as they continued to derive benefit from treatment, until the participant experienced unacceptable toxicity or confirmed PD per iRECIST.
OG007
Alomfilimab 2.4 mg + Atezolizumab
Participants received alomfilimab 2.4 mg in combination with atezolizumab 1200 mg via IV infusion Q3W. The participants continued treatment with alomfilimab in combination with atezolizumab within this clinical study, as long as they continued to derive benefit from treatment, until the participant experienced unacceptable toxicity or confirmed PD per iRECIST.
OG008
Alomfilimab 8 mg + Atezolizumab
Participants received alomfilimab 8 mg in combination with atezolizumab 1200 mg via IV infusion Q3W. The participants continued treatment with alomfilimab in combination with atezolizumab within this clinical study, as long as they continued to derive benefit from treatment, until the participant experienced unacceptable toxicity or confirmed PD per iRECIST.
OG009
Alomfilimab 24 mg + Atezolizumab
Participants received alomfilimab 24 mg in combination with atezolizumab 1200 mg via IV infusion Q3W. The participants continued treatment with alomfilimab in combination with atezolizumab within this clinical study, as long as they continued to derive benefit from treatment, until the participant experienced unacceptable toxicity or confirmed PD per iRECIST.
OG010
Alomfilimab 80 mg + Atezolizumab
Participants received alomfilimab 80 mg in combination with atezolizumab 1200 mg via IV infusion Q3W. The participants continued treatment with alomfilimab in combination with atezolizumab within this clinical study, as long as they continued to derive benefit from treatment, until the participant experienced unacceptable toxicity or confirmed PD per iRECIST.
8
OG0047
OG0055
OG0065
OG00743
OG00835
OG0099
OG0109
7
OG0047
OG0055
OG0064
OG00743
OG00834
OG0099
OG0109
Any Serious TEAEs
Title
Measurements
OG0001
OG0011
OG0023
OG0032
OG0043
OG0052
OG0062
OG00717
OG00811
OG0094
OG0103
Participants received alomfilimab 8 mg as a single agent via IV infusion Q3W. The participants continued treatment with alomfilimab within this clinical study, as long as they continued to derive benefit from treatment, until the participant experienced unacceptable toxicity or confirmed PD per iRECIST.
OG003
Alomfilimab 24 mg
Participants received alomfilimab 24 mg as a single agent via IV infusion Q3W. The participants continued treatment with alomfilimab within this clinical study, as long as they continued to derive benefit from treatment, until the participant experienced unacceptable toxicity or confirmed PD per iRECIST.
OG004
Alomfilimab 80 mg
Participants received alomfilimab 80 mg as a single agent via IV infusion Q3W. The participants continued treatment with alomfilimab within this clinical study, as long as they continued to derive benefit from treatment, until the participant experienced unacceptable toxicity or confirmed PD per iRECIST.
OG005
Alomfilimab 240 mg
Participants received alomfilimab 240 mg as a single agent via IV infusion Q3W. The participants continued treatment with alomfilimab within this clinical study, as long as they continued to derive benefit from treatment, until the participant experienced unacceptable toxicity or confirmed PD per iRECIST.
OG006
Alomfilimab 0.8 mg + Atezolizumab
Participants received alomfilimab 0.8 mg in combination with atezolizumab 1200 mg via IV infusion Q3W. The participants continued treatment with alomfilimab in combination with atezolizumab within this clinical study, as long as they continued to derive benefit from treatment, until the participant experienced unacceptable toxicity or confirmed PD per iRECIST.
OG007
Alomfilimab 2.4 mg + Atezolizumab
Participants received alomfilimab 2.4 mg in combination with atezolizumab 1200 mg via IV infusion Q3W. The participants continued treatment with alomfilimab in combination with atezolizumab within this clinical study, as long as they continued to derive benefit from treatment, until the participant experienced unacceptable toxicity or confirmed PD per iRECIST.
OG008
Alomfilimab 8 mg + Atezolizumab
Participants received alomfilimab 8 mg in combination with atezolizumab 1200 mg via IV infusion Q3W. The participants continued treatment with alomfilimab in combination with atezolizumab within this clinical study, as long as they continued to derive benefit from treatment, until the participant experienced unacceptable toxicity or confirmed PD per iRECIST.
OG009
Alomfilimab 24 mg + Atezolizumab
Participants received alomfilimab 24 mg in combination with atezolizumab 1200 mg via IV infusion Q3W. The participants continued treatment with alomfilimab in combination with atezolizumab within this clinical study, as long as they continued to derive benefit from treatment, until the participant experienced unacceptable toxicity or confirmed PD per iRECIST.
OG010
Alomfilimab 80 mg + Atezolizumab
Participants received alomfilimab 80 mg in combination with atezolizumab 1200 mg via IV infusion Q3W. The participants continued treatment with alomfilimab in combination with atezolizumab within this clinical study, as long as they continued to derive benefit from treatment, until the participant experienced unacceptable toxicity or confirmed PD per iRECIST.
Units
Counts
Participants
OG0004
OG0015
OG00210
OG0038
OG0047
OG0055
OG0065
OG00743
OG00835
OG0099
OG0109
Title
Denominators
Categories
Infusion Interruption
Title
Measurements
OG0001
OG0010
OG0020
OG0031
OG0041
OG0050
OG0060
OG0072
OG0080
OG0090
OG0102
Dose Reduction
Title
Measurements
OG0000
OG0010
OG0020
OG003
Participants received alomfilimab 8 mg as a single agent via IV infusion Q3W. The participants continued treatment with alomfilimab within this clinical study, as long as they continued to derive benefit from treatment, until the participant experienced unacceptable toxicity or confirmed PD per iRECIST.
OG003
Alomfilimab 24 mg
Participants received alomfilimab 24 mg as a single agent via IV infusion Q3W. The participants continued treatment with alomfilimab within this clinical study, as long as they continued to derive benefit from treatment, until the participant experienced unacceptable toxicity or confirmed PD per iRECIST.
OG004
Alomfilimab 80 mg
Participants received alomfilimab 80 mg as a single agent via IV infusion Q3W. The participants continued treatment with alomfilimab within this clinical study, as long as they continued to derive benefit from treatment, until the participant experienced unacceptable toxicity or confirmed PD per iRECIST.
OG005
Alomfilimab 240 mg
Participants received alomfilimab 240 mg as a single agent via IV infusion Q3W. The participants continued treatment with alomfilimab within this clinical study, as long as they continued to derive benefit from treatment, until the participant experienced unacceptable toxicity or confirmed PD per iRECIST.
OG006
Alomfilimab 0.8 mg + Atezolizumab
Participants received alomfilimab 0.8 mg in combination with atezolizumab 1200 mg via IV infusion Q3W. The participants continued treatment with alomfilimab in combination with atezolizumab within this clinical study, as long as they continued to derive benefit from treatment, until the participant experienced unacceptable toxicity or confirmed PD per iRECIST.
OG007
Alomfilimab 2.4 mg + Atezolizumab
Participants received alomfilimab 2.4 mg in combination with atezolizumab 1200 mg via IV infusion Q3W. The participants continued treatment with alomfilimab in combination with atezolizumab within this clinical study, as long as they continued to derive benefit from treatment, until the participant experienced unacceptable toxicity or confirmed PD per iRECIST.
OG008
Alomfilimab 8 mg + Atezolizumab
Participants received alomfilimab 8 mg in combination with atezolizumab 1200 mg via IV infusion Q3W. The participants continued treatment with alomfilimab in combination with atezolizumab within this clinical study, as long as they continued to derive benefit from treatment, until the participant experienced unacceptable toxicity or confirmed PD per iRECIST.
OG009
Alomfilimab 24 mg + Atezolizumab
Participants received alomfilimab 24 mg in combination with atezolizumab 1200 mg via IV infusion Q3W. The participants continued treatment with alomfilimab in combination with atezolizumab within this clinical study, as long as they continued to derive benefit from treatment, until the participant experienced unacceptable toxicity or confirmed PD per iRECIST.
OG010
Alomfilimab 80 mg + Atezolizumab
Participants received alomfilimab 80 mg in combination with atezolizumab 1200 mg via IV infusion Q3W. The participants continued treatment with alomfilimab in combination with atezolizumab within this clinical study, as long as they continued to derive benefit from treatment, until the participant experienced unacceptable toxicity or confirmed PD per iRECIST.
Units
Counts
Participants
OG0004
OG0015
OG00210
OG0038
OG0047
OG0055
OG0065
OG00743
OG00835
OG0099
OG0109
Title
Denominators
Categories
Title
Measurements
OG0000.260± 0.0000
OG0010.778± 0.0179
OG0022.616± 0.0427
OG0037.799± 0.2694
OG00426.174± 0.1952
OG00576.650± 4.8260
OG0060.236± 0.0288
OG0070.780± 0.0176
OG0082.573± 0.1159
OG0097.418± 1.1455
OG01025.774± 0.9037
OG002
Alomfilimab 8 mg
Participants received alomfilimab 8 mg as a single agent via IV infusion Q3W. The participants continued treatment with alomfilimab within this clinical study, as long as they continued to derive benefit from treatment, until the participant experienced unacceptable toxicity or confirmed PD per iRECIST.
OG003
Alomfilimab 24 mg
Participants received alomfilimab 24 mg as a single agent via IV infusion Q3W. The participants continued treatment with alomfilimab within this clinical study, as long as they continued to derive benefit from treatment, until the participant experienced unacceptable toxicity or confirmed PD per iRECIST.
OG004
Alomfilimab 80 mg
Participants received alomfilimab 80 mg as a single agent via IV infusion Q3W. The participants continued treatment with alomfilimab within this clinical study, as long as they continued to derive benefit from treatment, until the participant experienced unacceptable toxicity or confirmed PD per iRECIST.
OG005
Alomfilimab 240 mg
Participants received alomfilimab 240 mg as a single agent via IV infusion Q3W. The participants continued treatment with alomfilimab within this clinical study, as long as they continued to derive benefit from treatment, until the participant experienced unacceptable toxicity or confirmed PD per iRECIST.
OG006
Alomfilimab 0.8 mg + Atezolizumab
Participants received alomfilimab 0.8 mg in combination with atezolizumab 1200 mg via IV infusion Q3W. The participants continued treatment with alomfilimab in combination with atezolizumab within this clinical study, as long as they continued to derive benefit from treatment, until the participant experienced unacceptable toxicity or confirmed PD per iRECIST.
OG007
Alomfilimab 2.4 mg + Atezolizumab
Participants received alomfilimab 2.4 mg in combination with atezolizumab 1200 mg via IV infusion Q3W. The participants continued treatment with alomfilimab in combination with atezolizumab within this clinical study, as long as they continued to derive benefit from treatment, until the participant experienced unacceptable toxicity or confirmed PD per iRECIST.
OG008
Alomfilimab 8 mg + Atezolizumab
Participants received alomfilimab 8 mg in combination with atezolizumab 1200 mg via IV infusion Q3W. The participants continued treatment with alomfilimab in combination with atezolizumab within this clinical study, as long as they continued to derive benefit from treatment, until the participant experienced unacceptable toxicity or confirmed PD per iRECIST.
OG009
Alomfilimab 24 mg + Atezolizumab
Participants received alomfilimab 24 mg in combination with atezolizumab 1200 mg via IV infusion Q3W. The participants continued treatment with alomfilimab in combination with atezolizumab within this clinical study, as long as they continued to derive benefit from treatment, until the participant experienced unacceptable toxicity or confirmed PD per iRECIST.
OG010
Alomfilimab 80 mg + Atezolizumab
Participants received alomfilimab 80 mg in combination with atezolizumab 1200 mg via IV infusion Q3W. The participants continued treatment with alomfilimab in combination with atezolizumab within this clinical study, as long as they continued to derive benefit from treatment, until the participant experienced unacceptable toxicity or confirmed PD per iRECIST.
Units
Counts
Participants
OG0004
OG0015
OG00210
OG0038
OG0047
OG0055
OG0065
OG00743
OG00835
OG0099
OG0109
Title
Denominators
Categories
Title
Measurements
OG0000.988± 0.0189
OG0010.978± 0.0179
OG0020.979± 0.0179
OG0031.015± 0.0835
OG0040.980± 0.0058
OG0050.958± 0.0610
OG0060.884± 0.1071
OG0070.978± 0.0202
OG0080.963± 0.0432
OG0090.928± 0.1422
OG0100.967± 0.0316
OG002
Alomfilimab 8 mg
Participants received alomfilimab 8 mg as a single agent via IV infusion Q3W. The participants continued treatment with alomfilimab within this clinical study, as long as they continued to derive benefit from treatment, until the participant experienced unacceptable toxicity or confirmed PD per iRECIST.
OG003
Alomfilimab 24 mg
Participants received alomfilimab 24 mg as a single agent via IV infusion Q3W. The participants continued treatment with alomfilimab within this clinical study, as long as they continued to derive benefit from treatment, until the participant experienced unacceptable toxicity or confirmed PD per iRECIST.
OG004
Alomfilimab 80 mg
Participants received alomfilimab 80 mg as a single agent via IV infusion Q3W. The participants continued treatment with alomfilimab within this clinical study, as long as they continued to derive benefit from treatment, until the participant experienced unacceptable toxicity or confirmed PD per iRECIST.
OG005
Alomfilimab 240 mg
Participants received alomfilimab 240 mg as a single agent via IV infusion Q3W. The participants continued treatment with alomfilimab within this clinical study, as long as they continued to derive benefit from treatment, until the participant experienced unacceptable toxicity or confirmed PD per iRECIST.
OG006
Alomfilimab 0.8 mg + Atezolizumab
Participants received alomfilimab 0.8 mg in combination with atezolizumab 1200 mg via IV infusion Q3W. The participants continued treatment with alomfilimab in combination with atezolizumab within this clinical study, as long as they continued to derive benefit from treatment, until the participant experienced unacceptable toxicity or confirmed PD per iRECIST.
OG007
Alomfilimab 2.4 mg + Atezolizumab
Participants received alomfilimab 2.4 mg in combination with atezolizumab 1200 mg via IV infusion Q3W. The participants continued treatment with alomfilimab in combination with atezolizumab within this clinical study, as long as they continued to derive benefit from treatment, until the participant experienced unacceptable toxicity or confirmed PD per iRECIST.
OG008
Alomfilimab 8 mg + Atezolizumab
Participants received alomfilimab 8 mg in combination with atezolizumab 1200 mg via IV infusion Q3W. The participants continued treatment with alomfilimab in combination with atezolizumab within this clinical study, as long as they continued to derive benefit from treatment, until the participant experienced unacceptable toxicity or confirmed PD per iRECIST.
OG009
Alomfilimab 24 mg + Atezolizumab
Participants received alomfilimab 24 mg in combination with atezolizumab 1200 mg via IV infusion Q3W. The participants continued treatment with alomfilimab in combination with atezolizumab within this clinical study, as long as they continued to derive benefit from treatment, until the participant experienced unacceptable toxicity or confirmed PD per iRECIST.
OG010
Alomfilimab 80 mg + Atezolizumab
Participants received alomfilimab 80 mg in combination with atezolizumab 1200 mg via IV infusion Q3W. The participants continued treatment with alomfilimab in combination with atezolizumab within this clinical study, as long as they continued to derive benefit from treatment, until the participant experienced unacceptable toxicity or confirmed PD per iRECIST.
Units
Counts
Participants
OG0004
OG0015
OG00210
OG0038
OG0047
OG0055
OG0065
OG00743
OG00835
OG0099
OG0109
Title
Denominators
Categories
Title
Measurements
OG0000
OG0010
OG0020
OG0030
OG0040
OG0050
OG0060
OG0070
OG0080
OG0090
OG0100
OG001
Alomfilimab 8 mg + Atezolizumab in Anti-PD-(L)1 Naïve Pancreatic Cancer
Anti-PD-(L)1 naïve participants with pancreatic cancer received alomfilimab 8 mg in combination with atezolizumab 1200 mg via IV infusion Q3W. The participants continued treatment with alomfilimab in combination with atezolizumab within this clinical study, as long as they continued to derive benefit from treatment, until the participant experienced unacceptable toxicity or confirmed PD per iRECIST.
OG002
Alomfilimab 2.4 mg + Atezolizumab in Anti-PD-(L)1 Naïve Triple Negative BC
Anti-PD-(L)1 naïve participants with triple negative BC received alomfilimab 2.4 mg in combination with atezolizumab 1200 mg via IV infusion Q3W. The participants continued treatment with alomfilimab in combination with atezolizumab within this clinical study, as long as they continued to derive benefit from treatment, until the participant experienced unacceptable toxicity or confirmed PD per iRECIST.
OG003
Alomfilimab 8 mg + Atezolizumab in Anti-PD-(L)1 Naïve Triple Negative BC
Anti-PD-(L)1 naïve participants with triple negative BC received alomfilimab 8 mg in combination with atezolizumab 1200 mg via IV infusion Q3W. The participants continued treatment with alomfilimab in combination with atezolizumab within this clinical study, as long as they continued to derive benefit from treatment, until the participant experienced unacceptable toxicity or confirmed PD per iRECIST.
OG004
Alomfilimab 8 mg + Atezolizumab in Anti-PD-(L)1 Naïve HNSCC
Anti-PD-(L)1 naïve participants with HNSCC received alomfilimab 8 mg in combination with atezolizumab 1200 mg via IV infusion Q3W. The participants continued treatment with alomfilimab in combination with atezolizumab within this clinical study, as long as they continued to derive benefit from treatment, until the participant experienced unacceptable toxicity or confirmed PD per iRECIST.
OG005
Alomfilimab 24 mg + Atezolizumab in Anti-PD-(L)1 Naïve HNSCC
Anti-PD-(L)1 naïve participants with HNSCC received alomfilimab 24 mg in combination with atezolizumab 1200 mg via IV infusion Q3W. The participants continued treatment with alomfilimab in combination with atezolizumab within this clinical study, as long as they continued to derive benefit from treatment, until the participant experienced unacceptable toxicity or confirmed PD per iRECIST.
OG006
Alomfilimab 2.4 mg + Atezolizumab in Anti-PD-(L)1 Pre-treated Pancreatic Cancer
Participants with pre-treated pancreatic cancer received alomfilimab 2.4 mg in combination with atezolizumab 1200 mg via IV infusion Q3W. The participants continued treatment with alomfilimab in combination with atezolizumab within this clinical study, as long as they continued to derive benefit from treatment, until the participant experienced unacceptable toxicity or confirmed PD per iRECIST.
OG007
Alomfilimab 8 mg + Atezolizumab in Anti-PD-(L)1 Pre-treated Pancreatic Cancer
Participants with pre-treated pancreatic cancer received alomfilimab 8 mg in combination with atezolizumab 1200 mg via IV infusion Q3W. The participants continued treatment with alomfilimab in combination with atezolizumab within this clinical study, as long as they continued to derive benefit from treatment, until the participant experienced unacceptable toxicity or confirmed PD per iRECIST.
OG008
Alomfilimab 2.4 mg + Atezolizumab in Anti-PD-(L)1 Pre-treated Triple Negative BC
Participants with pre-treated triple negative BC received alomfilimab 2.4 mg in combination with atezolizumab 1200 mg via IV infusion Q3W. The participants continued treatment with alomfilimab in combination with atezolizumab within this clinical study, as long as they continued to derive benefit from treatment, until the participant experienced unacceptable toxicity or confirmed PD per iRECIST.
OG009
Alomfilimab 8 mg + Atezolizumab in Anti-PD-(L)1 Pre-treated Triple Negative BC
Participants with pre-treated triple negative BC received alomfilimab 8 mg in combination with atezolizumab 1200 mg via IV infusion Q3W. The participants continued treatment with alomfilimab in combination with atezolizumab within this clinical study, as long as they continued to derive benefit from treatment, until the participant experienced unacceptable toxicity or confirmed PD per iRECIST.
OG010
Alomfilimab 8 mg + Atezolizumab in Anti-PD-(L)1 Pre-treated HNSCC
Participants with pre-treated HNSCC received alomfilimab 8 mg in combination with atezolizumab 1200 mg via IV infusion Q3W. The participants continued treatment with alomfilimab in combination with atezolizumab within this clinical study, as long as they continued to derive benefit from treatment, until the participant experienced unacceptable toxicity or confirmed PD per iRECIST.
OG011
Alomfilimab 24 mg + Atezolizumab in Anti-PD-(L)1 Pre-treated HNSCC
Participants with pre-treated HNSCC received alomfilimab 24 mg in combination with atezolizumab 1200 mg via IV infusion Q3W. The participants continued treatment with alomfilimab in combination with atezolizumab within this clinical study, as long as they continued to derive benefit from treatment, until the participant experienced unacceptable toxicity or confirmed PD per iRECIST.
Units
Counts
Participants
OG00015
OG00114
OG0027
OG00314
OG0045
OG0055
OG0062
OG0071
OG0081
OG0096
OG0103
OG0118
Title
Denominators
Categories
Title
Measurements
OG0000(0.0 to 21.8)
OG0010(0.0 to 28.5)
OG0020(0.0 to 45.9)
OG0037.1(0.2 to 36.0)
OG0040(0.0 to 60.2)
OG0050(0.0 to 70.8)
OG0060(0.0 to 97.5)
OG0070(0.0 to 97.5)
OG0080(0.0 to 97.5)
OG0090(0.0 to 52.2)
OG01033.3(0.8 to 90.6)
OG0110(0.0 to 41.0)
OG001
Alomfilimab 2.4 mg
Participants received alomfilimab 2.4 mg as a single agent via IV infusion Q3W. The participants continued treatment with alomfilimab within this clinical study, as long as they continued to derive benefit from treatment, until the participant experienced unacceptable toxicity or confirmed PD per iRECIST.
OG002
Alomfilimab 8 mg
Participants received alomfilimab 8 mg as a single agent via IV infusion Q3W. The participants continued treatment with alomfilimab within this clinical study, as long as they continued to derive benefit from treatment, until the participant experienced unacceptable toxicity or confirmed PD per iRECIST.
OG003
Alomfilimab 24 mg
Participants received alomfilimab 24 mg as a single agent via IV infusion Q3W. The participants continued treatment with alomfilimab within this clinical study, as long as they continued to derive benefit from treatment, until the participant experienced unacceptable toxicity or confirmed PD per iRECIST.
OG004
Alomfilimab 80 mg
Participants received alomfilimab 80 mg as a single agent via IV infusion Q3W. The participants continued treatment with alomfilimab within this clinical study, as long as they continued to derive benefit from treatment, until the participant experienced unacceptable toxicity or confirmed PD per iRECIST.
OG005
Alomfilimab 240 mg
Participants received alomfilimab 240 mg as a single agent via IV infusion Q3W. The participants continued treatment with alomfilimab within this clinical study, as long as they continued to derive benefit from treatment, until the participant experienced unacceptable toxicity or confirmed PD per iRECIST.
OG006
Alomfilimab 0.8 mg + Atezolizumab
Participants received alomfilimab 0.8 mg in combination with atezolizumab 1200 mg via IV infusion Q3W. The participants continued treatment with alomfilimab in combination with atezolizumab within this clinical study, as long as they continued to derive benefit from treatment, until the participant experienced unacceptable toxicity or confirmed PD per iRECIST.
OG007
Alomfilimab 2.4 mg + Atezolizumab
Participants received alomfilimab 2.4 mg in combination with atezolizumab 1200 mg via IV infusion Q3W. The participants continued treatment with alomfilimab in combination with atezolizumab within this clinical study, as long as they continued to derive benefit from treatment, until the participant experienced unacceptable toxicity or confirmed PD per iRECIST.
OG008
Alomfilimab 8 mg + Atezolizumab
Participants received alomfilimab 8 mg in combination with atezolizumab 1200 mg via IV infusion Q3W. The participants continued treatment with alomfilimab in combination with atezolizumab within this clinical study, as long as they continued to derive benefit from treatment, until the participant experienced unacceptable toxicity or confirmed PD per iRECIST.
OG009
Alomfilimab 24 mg + Atezolizumab
Participants received alomfilimab 24 mg in combination with atezolizumab 1200 mg via IV infusion Q3W. The participants continued treatment with alomfilimab in combination with atezolizumab within this clinical study, as long as they continued to derive benefit from treatment, until the participant experienced unacceptable toxicity or confirmed PD per iRECIST.
OG010
Alomfilimab 80 mg + Atezolizumab
Participants received alomfilimab 80 mg in combination with atezolizumab 1200 mg via IV infusion Q3W. The participants continued treatment with alomfilimab in combination with atezolizumab within this clinical study, as long as they continued to derive benefit from treatment, until the participant experienced unacceptable toxicity or confirmed PD per iRECIST.
OG011
Alomfilimab 2.4 mg + Atezolizumab in Anti-PD-(L)1 Naïve Pancreatic Cancer
Anti-PD-(L)1 naïve participants with pancreatic cancer received alomfilimab 2.4 mg in combination with atezolizumab 1200 mg via IV infusion Q3W. The participants continued treatment with alomfilimab in combination with atezolizumab within this clinical study, as long as they continued to derive benefit from treatment, until the participant experienced unacceptable toxicity or confirmed PD per iRECIST.
OG012
Alomfilimab 8 mg + Atezolizumab in Anti-PD-(L)1 Naïve Pancreatic Cancer
Anti-PD-(L)1 naïve participants with pancreatic cancer received alomfilimab 8 mg in combination with atezolizumab 1200 mg via IV infusion Q3W. The participants continued treatment with alomfilimab in combination with atezolizumab within this clinical study, as long as they continued to derive benefit from treatment, until the participant experienced unacceptable toxicity or confirmed PD per iRECIST.
OG013
Alomfilimab 2.4 mg + Atezolizumab in Anti-PD-(L)1 Naïve Triple Negative BC
Anti-PD-(L)1 naïve participants with triple negative BC received alomfilimab 2.4 mg in combination with atezolizumab 1200 mg via IV infusion Q3W. The participants continued treatment with alomfilimab in combination with atezolizumab within this clinical study, as long as they continued to derive benefit from treatment, until the participant experienced unacceptable toxicity or confirmed PD per iRECIST.
OG014
Alomfilimab 8 mg + Atezolizumab in Anti-PD-(L)1 Naïve Triple Negative BC
Anti-PD-(L)1 naïve participants with triple negative BC received alomfilimab 8 mg in combination with atezolizumab 1200 mg via IV infusion Q3W. The participants continued treatment with alomfilimab in combination with atezolizumab within this clinical study, as long as they continued to derive benefit from treatment, until the participant experienced unacceptable toxicity or confirmed PD per iRECIST.
OG015
Alomfilimab 8 mg + Atezolizumab in Anti-PD-(L)1 Naïve HNSCC
Anti-PD-(L)1 naïve participants with HNSCC received alomfilimab 8 mg in combination with atezolizumab 1200 mg via IV infusion Q3W. The participants continued treatment with alomfilimab in combination with atezolizumab within this clinical study, as long as they continued to derive benefit from treatment, until the participant experienced unacceptable toxicity or confirmed PD per iRECIST.
OG016
Alomfilimab 24 mg + Atezolizumab in Anti-PD-(L)1 Naïve HNSCC
Anti-PD-(L)1 naïve participants with HNSCC received alomfilimab 24 mg in combination with atezolizumab 1200 mg via IV infusion Q3W. The participants continued treatment with alomfilimab in combination with atezolizumab within this clinical study, as long as they continued to derive benefit from treatment, until the participant experienced unacceptable toxicity or confirmed PD per iRECIST.
OG017
Alomfilimab 2.4 mg + Atezolizumab in Anti-PD-(L)1 Pre-treated Pancreatic Cancer
Participants with pre-treated pancreatic cancer received alomfilimab 2.4 mg in combination with atezolizumab 1200 mg via IV infusion Q3W. The participants continued treatment with alomfilimab in combination with atezolizumab within this clinical study, as long as they continued to derive benefit from treatment, until the participant experienced unacceptable toxicity or confirmed PD per iRECIST.
OG018
Alomfilimab 8 mg + Atezolizumab in Anti-PD-(L)1 Pre-treated Pancreatic Cancer
Participants with pre-treated pancreatic cancer received alomfilimab 8 mg in combination with atezolizumab 1200 mg via IV infusion Q3W. The participants continued treatment with alomfilimab in combination with atezolizumab within this clinical study, as long as they continued to derive benefit from treatment, until the participant experienced unacceptable toxicity or confirmed PD per iRECIST.
OG019
Alomfilimab 2.4 mg + Atezolizumab in Anti-PD-(L)1 Pre-treated Triple Negative BC
Participants with pre-treated triple negative BC received alomfilimab 2.4 mg in combination with atezolizumab 1200 mg via IV infusion Q3W. The participants continued treatment with alomfilimab in combination with atezolizumab within this clinical study, as long as they continued to derive benefit from treatment, until the participant experienced unacceptable toxicity or confirmed PD per iRECIST.
OG020
Alomfilimab 8 mg + Atezolizumab in Anti-PD-(L)1 Pre-treated Triple Negative BC
Participants with pre-treated triple negative BC received alomfilimab 8 mg in combination with atezolizumab 1200 mg via IV infusion Q3W. The participants continued treatment with alomfilimab in combination with atezolizumab within this clinical study, as long as they continued to derive benefit from treatment, until the participant experienced unacceptable toxicity or confirmed PD per iRECIST.
OG021
Alomfilimab 8 mg + Atezolizumab in Anti-PD-(L)1 Pre-treated HNSCC
Participants with pre-treated HNSCC received alomfilimab 8 mg in combination with atezolizumab 1200 mg via IV infusion Q3W. The participants continued treatment with alomfilimab in combination with atezolizumab within this clinical study, as long as they continued to derive benefit from treatment, until the participant experienced unacceptable toxicity or confirmed PD per iRECIST.
OG022
Alomfilimab 24 mg + Atezolizumab in Anti-PD-(L)1 Pre-treated HNSCC
Participants with pre-treated HNSCC received alomfilimab 24 mg in combination with atezolizumab 1200 mg via IV infusion Q3W. The participants continued treatment with alomfilimab in combination with atezolizumab within this clinical study, as long as they continued to derive benefit from treatment, until the participant experienced unacceptable toxicity or confirmed PD per iRECIST.
Units
Counts
Participants
OG0004
OG0015
OG0029
OG0038
OG0047
OG0055
OG0065
OG00743
OG00836
OG0099
OG0109
OG01115
OG01214
OG0137
OG01414
OG0155
OG0165
OG0172
OG0181
OG0191
OG0206
OG0213
OG0229
Title
Denominators
Categories
Title
Measurements
CR
OG0000
OG0010
OG0020
OG0030
OG0040
OG0050
OG0060
OG0071
OG0080
OG0090
OG0100
OG0110
OG0120
OG0130
OG0140
OG0150
OG0160
OG0170
OG0180
OG0190
OG0200
OG0210
OG0220
PR
OG0000
OG0010
OG0020
OG0030
OG004
SD
OG0001
OG0010
OG0022
OG0032
OG004
PD
OG0003
OG0013
OG0027
OG0033
OG004
NE
OG0000
OG0012
OG0020
OG0033
OG004
OG001
Alomfilimab 2.4 mg
Participants received alomfilimab 2.4 mg as a single agent via IV infusion Q3W. The participants continued treatment with alomfilimab within this clinical study, as long as they continued to derive benefit from treatment, until the participant experienced unacceptable toxicity or confirmed PD per iRECIST.
OG002
Alomfilimab 8 mg
Participants received alomfilimab 8 mg as a single agent via IV infusion Q3W. The participants continued treatment with alomfilimab within this clinical study, as long as they continued to derive benefit from treatment, until the participant experienced unacceptable toxicity or confirmed PD per iRECIST.
OG003
Alomfilimab 24 mg
Participants received alomfilimab 24 mg as a single agent via IV infusion Q3W. The participants continued treatment with alomfilimab within this clinical study, as long as they continued to derive benefit from treatment, until the participant experienced unacceptable toxicity or confirmed PD per iRECIST.
OG004
Alomfilimab 80 mg
Participants received alomfilimab 80 mg as a single agent via IV infusion Q3W. The participants continued treatment with alomfilimab within this clinical study, as long as they continued to derive benefit from treatment, until the participant experienced unacceptable toxicity or confirmed PD per iRECIST.
OG005
Alomfilimab 240 mg
Participants received alomfilimab 240 mg as a single agent via IV infusion Q3W. The participants continued treatment with alomfilimab within this clinical study, as long as they continued to derive benefit from treatment, until the participant experienced unacceptable toxicity or confirmed PD per iRECIST.
OG006
Alomfilimab 0.8 mg + Atezolizumab
Participants received alomfilimab 0.8 mg in combination with atezolizumab 1200 mg via IV infusion Q3W. The participants continued treatment with alomfilimab in combination with atezolizumab within this clinical study, as long as they continued to derive benefit from treatment, until the participant experienced unacceptable toxicity or confirmed PD per iRECIST.
OG007
Alomfilimab 2.4 mg + Atezolizumab
Participants received alomfilimab 2.4 mg in combination with atezolizumab 1200 mg via IV infusion Q3W. The participants continued treatment with alomfilimab in combination with atezolizumab within this clinical study, as long as they continued to derive benefit from treatment, until the participant experienced unacceptable toxicity or confirmed PD per iRECIST.
OG008
Alomfilimab 8 mg + Atezolizumab
Participants received alomfilimab 8 mg in combination with atezolizumab 1200 mg via IV infusion Q3W. The participants continued treatment with alomfilimab in combination with atezolizumab within this clinical study, as long as they continued to derive benefit from treatment, until the participant experienced unacceptable toxicity or confirmed PD per iRECIST.
OG009
Alomfilimab 24 mg + Atezolizumab
Participants received alomfilimab 24 mg in combination with atezolizumab 1200 mg via IV infusion Q3W. The participants continued treatment with alomfilimab in combination with atezolizumab within this clinical study, as long as they continued to derive benefit from treatment, until the participant experienced unacceptable toxicity or confirmed PD per iRECIST.
OG010
Alomfilimab 80 mg + Atezolizumab
Participants received alomfilimab 80 mg in combination with atezolizumab 1200 mg via IV infusion Q3W. The participants continued treatment with alomfilimab in combination with atezolizumab within this clinical study, as long as they continued to derive benefit from treatment, until the participant experienced unacceptable toxicity or confirmed PD per iRECIST.
OG011
Alomfilimab 2.4 mg + Atezolizumab in Anti-PD-(L)1 Naïve Pancreatic Cancer
Anti-PD-(L)1 naïve participants with pancreatic cancer received alomfilimab 2.4 mg in combination with atezolizumab 1200 mg via IV infusion Q3W. The participants continued treatment with alomfilimab in combination with atezolizumab within this clinical study, as long as they continued to derive benefit from treatment, until the participant experienced unacceptable toxicity or confirmed PD per iRECIST.
OG012
Alomfilimab 8 mg + Atezolizumab in Anti-PD-(L)1 Naïve Pancreatic Cancer
Anti-PD-(L)1 naïve participants with pancreatic cancer received alomfilimab 8 mg in combination with atezolizumab 1200 mg via IV infusion Q3W. The participants continued treatment with alomfilimab in combination with atezolizumab within this clinical study, as long as they continued to derive benefit from treatment, until the participant experienced unacceptable toxicity or confirmed PD per iRECIST.
OG013
Alomfilimab 2.4 mg + Atezolizumab in Anti-PD-(L)1 Naïve Triple Negative BC
Anti-PD-(L)1 naïve participants with triple negative BC received alomfilimab 2.4 mg in combination with atezolizumab 1200 mg via IV infusion Q3W. The participants continued treatment with alomfilimab in combination with atezolizumab within this clinical study, as long as they continued to derive benefit from treatment, until the participant experienced unacceptable toxicity or confirmed PD per iRECIST.
OG014
Alomfilimab 8 mg + Atezolizumab in Anti-PD-(L)1 Naïve Triple Negative BC
Anti-PD-(L)1 naïve participants with triple negative BC received alomfilimab 8 mg in combination with atezolizumab 1200 mg via IV infusion Q3W. The participants continued treatment with alomfilimab in combination with atezolizumab within this clinical study, as long as they continued to derive benefit from treatment, until the participant experienced unacceptable toxicity or confirmed PD per iRECIST.
OG015
Alomfilimab 8 mg + Atezolizumab in Anti-PD-(L)1 Naïve HNSCC
Anti-PD-(L)1 naïve participants with HNSCC received alomfilimab 8 mg in combination with atezolizumab 1200 mg via IV infusion Q3W. The participants continued treatment with alomfilimab in combination with atezolizumab within this clinical study, as long as they continued to derive benefit from treatment, until the participant experienced unacceptable toxicity or confirmed PD per iRECIST.
OG016
Alomfilimab 24 mg + Atezolizumab in Anti-PD-(L)1 Naïve HNSCC
Anti-PD-(L)1 naïve participants with HNSCC received alomfilimab 24 mg in combination with atezolizumab 1200 mg via IV infusion Q3W. The participants continued treatment with alomfilimab in combination with atezolizumab within this clinical study, as long as they continued to derive benefit from treatment, until the participant experienced unacceptable toxicity or confirmed PD per iRECIST.
OG017
Alomfilimab 2.4 mg + Atezolizumab in Anti-PD-(L)1 Pre-treated Pancreatic Cancer
Participants with pre-treated pancreatic cancer received alomfilimab 2.4 mg in combination with atezolizumab 1200 mg via IV infusion Q3W. The participants continued treatment with alomfilimab in combination with atezolizumab within this clinical study, as long as they continued to derive benefit from treatment, until the participant experienced unacceptable toxicity or confirmed PD per iRECIST.
OG018
Alomfilimab 8 mg + Atezolizumab in Anti-PD-(L)1 Pre-treated Pancreatic Cancer
Participants with pre-treated pancreatic cancer received alomfilimab 8 mg in combination with atezolizumab 1200 mg via IV infusion Q3W. The participants continued treatment with alomfilimab in combination with atezolizumab within this clinical study, as long as they continued to derive benefit from treatment, until the participant experienced unacceptable toxicity or confirmed PD per iRECIST.
OG019
Alomfilimab 2.4 mg + Atezolizumab in Anti-PD-(L)1 Pre-treated Triple Negative BC
Participants with pre-treated triple negative BC received alomfilimab 2.4 mg in combination with atezolizumab 1200 mg via IV infusion Q3W. The participants continued treatment with alomfilimab in combination with atezolizumab within this clinical study, as long as they continued to derive benefit from treatment, until the participant experienced unacceptable toxicity or confirmed PD per iRECIST.
OG020
Alomfilimab 8 mg + Atezolizumab in Anti-PD-(L)1 Pre-treated Triple Negative BC
Participants with pre-treated triple negative BC received alomfilimab 8 mg in combination with atezolizumab 1200 mg via IV infusion Q3W. The participants continued treatment with alomfilimab in combination with atezolizumab within this clinical study, as long as they continued to derive benefit from treatment, until the participant experienced unacceptable toxicity or confirmed PD per iRECIST.
OG021
Alomfilimab 8 mg + Atezolizumab in Anti-PD-(L)1 Pre-treated HNSCC
Participants with pre-treated HNSCC received alomfilimab 8 mg in combination with atezolizumab 1200 mg via IV infusion Q3W. The participants continued treatment with alomfilimab in combination with atezolizumab within this clinical study, as long as they continued to derive benefit from treatment, until the participant experienced unacceptable toxicity or confirmed PD per iRECIST.
OG022
Alomfilimab 24 mg + Atezolizumab in Anti-PD-(L)1 Pre-treated HNSCC
Participants with pre-treated HNSCC received alomfilimab 24 mg in combination with atezolizumab 1200 mg via IV infusion Q3W. The participants continued treatment with alomfilimab in combination with atezolizumab within this clinical study, as long as they continued to derive benefit from treatment, until the participant experienced unacceptable toxicity or confirmed PD per iRECIST.
Units
Counts
Participants
OG0004
OG0015
OG0029
OG0038
OG0047
OG0055
OG0065
OG00743
OG00836
OG0099
OG0109
OG01115
OG01214
OG0137
OG01414
OG0155
OG0165
OG0172
OG0181
OG0191
OG0206
OG0213
OG0228
Title
Denominators
Categories
Title
Measurements
OG0002(2 to NA)Upper confidence interval was not calculable due to insufficient event data occurring above the median.
OG0012(1 to NA)Upper confidence interval was not calculable due to insufficient event data occurring above the median.
OG0022(1 to 6)
OG0033(1 to NA)Upper confidence interval was not calculable due to insufficient event data occurring above the median.
OG0042(1 to NA)Upper confidence interval was not calculable due to insufficient event data occurring above the median.
OG0051(1 to NA)Upper confidence interval was not calculable due to insufficient event data occurring above the median.
OG0063(2 to NA)Upper confidence interval was not calculable due to insufficient event data occurring above the median.
OG0072(2 to 4)
OG0082(2 to 2)
OG0092(1 to 4)
OG0104(2 to NA)Upper confidence interval was not calculable due to insufficient event data occurring above the median.
OG0112(1 to 4)
OG0122(2 to 2)
OG0132(1 to NA)Upper confidence interval was not calculable due to insufficient event data occurring above the median.
OG0142(1 to 4)
OG0154(2 to NA)Upper confidence interval was not calculable due to insufficient event data occurring above the median.
OG0162(1 to NA)Upper confidence interval was not calculable due to insufficient event data occurring above the median.
OG0172(NA to NA)Confidence intervals were not calculable due to insufficient event data occurring near the median.
OG0183(NA to NA)Confidence intervals were not calculable due to insufficient event data occurring near the median.
OG0192(NA to NA)Confidence intervals were not calculable due to insufficient event data occurring near the median.
OG0204(2 to NA)Upper confidence interval was not calculable due to insufficient event data occurring above the median.
OG0212(2 to NA)Upper confidence interval was not calculable due to insufficient event data occurring above the median.
OG0223(2 to 4)
OG001
Alomfilimab 2.4 mg
Participants received alomfilimab 2.4 mg as a single agent via IV infusion Q3W. The participants continued treatment with alomfilimab within this clinical study, as long as they continued to derive benefit from treatment, until the participant experienced unacceptable toxicity or confirmed PD per iRECIST.
OG002
Alomfilimab 8 mg
Participants received alomfilimab 8 mg as a single agent via IV infusion Q3W. The participants continued treatment with alomfilimab within this clinical study, as long as they continued to derive benefit from treatment, until the participant experienced unacceptable toxicity or confirmed PD per iRECIST.
OG003
Alomfilimab 24 mg
Participants received alomfilimab 24 mg as a single agent via IV infusion Q3W. The participants continued treatment with alomfilimab within this clinical study, as long as they continued to derive benefit from treatment, until the participant experienced unacceptable toxicity or confirmed PD per iRECIST.
OG004
Alomfilimab 80 mg
Participants received alomfilimab 80 mg as a single agent via IV infusion Q3W. The participants continued treatment with alomfilimab within this clinical study, as long as they continued to derive benefit from treatment, until the participant experienced unacceptable toxicity or confirmed PD per iRECIST.
OG005
Alomfilimab 240 mg
Participants received alomfilimab 240 mg as a single agent via IV infusion Q3W. The participants continued treatment with alomfilimab within this clinical study, as long as they continued to derive benefit from treatment, until the participant experienced unacceptable toxicity or confirmed PD per iRECIST.
OG006
Alomfilimab 0.8 mg + Atezolizumab
Participants received alomfilimab 0.8 mg in combination with atezolizumab 1200 mg via IV infusion Q3W. The participants continued treatment with alomfilimab in combination with atezolizumab within this clinical study, as long as they continued to derive benefit from treatment, until the participant experienced unacceptable toxicity or confirmed PD per iRECIST.
OG007
Alomfilimab 2.4 mg + Atezolizumab
Participants received alomfilimab 2.4 mg in combination with atezolizumab 1200 mg via IV infusion Q3W. The participants continued treatment with alomfilimab in combination with atezolizumab within this clinical study, as long as they continued to derive benefit from treatment, until the participant experienced unacceptable toxicity or confirmed PD per iRECIST.
OG008
Alomfilimab 8 mg + Atezolizumab
Participants received alomfilimab 8 mg in combination with atezolizumab 1200 mg via IV infusion Q3W. The participants continued treatment with alomfilimab in combination with atezolizumab within this clinical study, as long as they continued to derive benefit from treatment, until the participant experienced unacceptable toxicity or confirmed PD per iRECIST.
OG009
Alomfilimab 24 mg + Atezolizumab
Participants received alomfilimab 24 mg in combination with atezolizumab 1200 mg via IV infusion Q3W. The participants continued treatment with alomfilimab in combination with atezolizumab within this clinical study, as long as they continued to derive benefit from treatment, until the participant experienced unacceptable toxicity or confirmed PD per iRECIST.
OG010
Alomfilimab 80 mg + Atezolizumab
Participants received alomfilimab 80 mg in combination with atezolizumab 1200 mg via IV infusion Q3W. The participants continued treatment with alomfilimab in combination with atezolizumab within this clinical study, as long as they continued to derive benefit from treatment, until the participant experienced unacceptable toxicity or confirmed PD per iRECIST.
OG011
Alomfilimab 2.4 mg + Atezolizumab in Anti-PD-(L)1 Naïve Pancreatic Cancer
Anti-PD-(L)1 naïve participants with pancreatic cancer received alomfilimab 2.4 mg in combination with atezolizumab 1200 mg via IV infusion Q3W. The participants continued treatment with alomfilimab in combination with atezolizumab within this clinical study, as long as they continued to derive benefit from treatment, until the participant experienced unacceptable toxicity or confirmed PD per iRECIST.
OG012
Alomfilimab 8 mg + Atezolizumab in Anti-PD-(L)1 Naïve Pancreatic Cancer
Anti-PD-(L)1 naïve participants with pancreatic cancer received alomfilimab 8 mg in combination with atezolizumab 1200 mg via IV infusion Q3W. The participants continued treatment with alomfilimab in combination with atezolizumab within this clinical study, as long as they continued to derive benefit from treatment, until the participant experienced unacceptable toxicity or confirmed PD per iRECIST.
OG013
Alomfilimab 2.4 mg + Atezolizumab in Anti-PD-(L)1 Naïve Triple Negative BC
Anti-PD-(L)1 naïve participants with triple negative BC received alomfilimab 2.4 mg in combination with atezolizumab 1200 mg via IV infusion Q3W. The participants continued treatment with alomfilimab in combination with atezolizumab within this clinical study, as long as they continued to derive benefit from treatment, until the participant experienced unacceptable toxicity or confirmed PD per iRECIST.
OG014
Alomfilimab 8 mg + Atezolizumab in Anti-PD-(L)1 Naïve Triple Negative BC
Anti-PD-(L)1 naïve participants with triple negative BC received alomfilimab 8 mg in combination with atezolizumab 1200 mg via IV infusion Q3W. The participants continued treatment with alomfilimab in combination with atezolizumab within this clinical study, as long as they continued to derive benefit from treatment, until the participant experienced unacceptable toxicity or confirmed PD per iRECIST.
OG015
Alomfilimab 8 mg + Atezolizumab in Anti-PD-(L)1 Naïve HNSCC
Anti-PD-(L)1 naïve participants with HNSCC received alomfilimab 8 mg in combination with atezolizumab 1200 mg via IV infusion Q3W. The participants continued treatment with alomfilimab in combination with atezolizumab within this clinical study, as long as they continued to derive benefit from treatment, until the participant experienced unacceptable toxicity or confirmed PD per iRECIST.
OG016
Alomfilimab 24 mg + Atezolizumab in Anti-PD-(L)1 Naïve HNSCC
Anti-PD-(L)1 naïve participants with HNSCC received alomfilimab 24 mg in combination with atezolizumab 1200 mg via IV infusion Q3W. The participants continued treatment with alomfilimab in combination with atezolizumab within this clinical study, as long as they continued to derive benefit from treatment, until the participant experienced unacceptable toxicity or confirmed PD per iRECIST.
OG017
Alomfilimab 2.4 mg + Atezolizumab in Anti-PD-(L)1 Pre-treated Pancreatic Cancer
Participants with pre-treated pancreatic cancer received alomfilimab 2.4 mg in combination with atezolizumab 1200 mg via IV infusion Q3W. The participants continued treatment with alomfilimab in combination with atezolizumab within this clinical study, as long as they continued to derive benefit from treatment, until the participant experienced unacceptable toxicity or confirmed PD per iRECIST.
OG018
Alomfilimab 8 mg + Atezolizumab in Anti-PD-(L)1 Pre-treated Pancreatic Cancer
Participants with pre-treated pancreatic cancer received alomfilimab 8 mg in combination with atezolizumab 1200 mg via IV infusion Q3W. The participants continued treatment with alomfilimab in combination with atezolizumab within this clinical study, as long as they continued to derive benefit from treatment, until the participant experienced unacceptable toxicity or confirmed PD per iRECIST.
OG019
Alomfilimab 2.4 mg + Atezolizumab in Anti-PD-(L)1 Pre-treated Triple Negative BC
Participants with pre-treated triple negative BC received alomfilimab 2.4 mg in combination with atezolizumab 1200 mg via IV infusion Q3W. The participants continued treatment with alomfilimab in combination with atezolizumab within this clinical study, as long as they continued to derive benefit from treatment, until the participant experienced unacceptable toxicity or confirmed PD per iRECIST.
OG020
Alomfilimab 8 mg + Atezolizumab in Anti-PD-(L)1 Pre-treated Triple Negative BC
Participants with pre-treated triple negative BC received alomfilimab 8 mg in combination with atezolizumab 1200 mg via IV infusion Q3W. The participants continued treatment with alomfilimab in combination with atezolizumab within this clinical study, as long as they continued to derive benefit from treatment, until the participant experienced unacceptable toxicity or confirmed PD per iRECIST.
OG021
Alomfilimab 8 mg + Atezolizumab in Anti-PD-(L)1 Pre-treated HNSCC
Participants with pre-treated HNSCC received alomfilimab 8 mg in combination with atezolizumab 1200 mg via IV infusion Q3W. The participants continued treatment with alomfilimab in combination with atezolizumab within this clinical study, as long as they continued to derive benefit from treatment, until the participant experienced unacceptable toxicity or confirmed PD per iRECIST.
OG022
Alomfilimab 24 mg + Atezolizumab in Anti-PD-(L)1 Pre-treated HNSCC
Participants with pre-treated HNSCC received alomfilimab 24 mg in combination with atezolizumab 1200 mg via IV infusion Q3W. The participants continued treatment with alomfilimab in combination with atezolizumab within this clinical study, as long as they continued to derive benefit from treatment, until the participant experienced unacceptable toxicity or confirmed PD per iRECIST.
Units
Counts
Participants
OG0000
OG0010
OG0020
OG0030
OG0040
OG0050
OG0061
OG0075
OG0082
OG0091
OG0100
OG0111
OG0120
OG0130
OG0141
OG0150
OG0160
OG0170
OG0180
OG0190
OG0200
OG0211
OG0220
Title
Denominators
Categories
Title
Measurements
OG00611(NA to NA)Confidence intervals could not be calculated as a single participant was analyzed.
OG0076(2.1 to NA)Upper confidence interval was not calculable due to insufficient event data occurring above the median.
OG008NA(13.9 to NA)Median and upper confidence intervals were not calculable due to fewer than 50% events.
OG00911(NA to NA)Confidence intervals could not be calculated as a single participant was analyzed.
OG0112(NA to NA)Confidence intervals could not be calculated as a single participant was analyzed.
OG01413(NA to NA)Confidence intervals could not be calculated as a single participant was analyzed.
OG021NA(NA to NA)Median and confidence intervals could not be calculated as a single participant was censored.
OG001
Alomfilimab 2.4 mg
Participants received alomfilimab 2.4 mg as a single agent via IV infusion Q3W. The participants continued treatment with alomfilimab within this clinical study, as long as they continued to derive benefit from treatment, until the participant experienced unacceptable toxicity or confirmed PD per iRECIST.
OG002
Alomfilimab 8 mg
Participants received alomfilimab 8 mg as a single agent via IV infusion Q3W. The participants continued treatment with alomfilimab within this clinical study, as long as they continued to derive benefit from treatment, until the participant experienced unacceptable toxicity or confirmed PD per iRECIST.
OG003
Alomfilimab 24 mg
Participants received alomfilimab 24 mg as a single agent via IV infusion Q3W. The participants continued treatment with alomfilimab within this clinical study, as long as they continued to derive benefit from treatment, until the participant experienced unacceptable toxicity or confirmed PD per iRECIST.
OG004
Alomfilimab 80 mg
Participants received alomfilimab 80 mg as a single agent via IV infusion Q3W. The participants continued treatment with alomfilimab within this clinical study, as long as they continued to derive benefit from treatment, until the participant experienced unacceptable toxicity or confirmed PD per iRECIST.
OG005
Alomfilimab 240 mg
Participants received alomfilimab 240 mg as a single agent via IV infusion Q3W. The participants continued treatment with alomfilimab within this clinical study, as long as they continued to derive benefit from treatment, until the participant experienced unacceptable toxicity or confirmed PD per iRECIST.
OG006
Alomfilimab 0.8 mg + Atezolizumab
Participants received alomfilimab 0.8 mg in combination with atezolizumab 1200 mg via IV infusion Q3W. The participants continued treatment with alomfilimab in combination with atezolizumab within this clinical study, as long as they continued to derive benefit from treatment, until the participant experienced unacceptable toxicity or confirmed PD per iRECIST.
OG007
Alomfilimab 2.4 mg + Atezolizumab
Participants received alomfilimab 2.4 mg in combination with atezolizumab 1200 mg via IV infusion Q3W. The participants continued treatment with alomfilimab in combination with atezolizumab within this clinical study, as long as they continued to derive benefit from treatment, until the participant experienced unacceptable toxicity or confirmed PD per iRECIST.
OG008
Alomfilimab 8 mg + Atezolizumab
Participants received alomfilimab 8 mg in combination with atezolizumab 1200 mg via IV infusion Q3W. The participants continued treatment with alomfilimab in combination with atezolizumab within this clinical study, as long as they continued to derive benefit from treatment, until the participant experienced unacceptable toxicity or confirmed PD per iRECIST.
OG009
Alomfilimab 24 mg + Atezolizumab
Participants received alomfilimab 24 mg in combination with atezolizumab 1200 mg via IV infusion Q3W. The participants continued treatment with alomfilimab in combination with atezolizumab within this clinical study, as long as they continued to derive benefit from treatment, until the participant experienced unacceptable toxicity or confirmed PD per iRECIST.
OG010
Alomfilimab 80 mg + Atezolizumab
Participants received alomfilimab 80 mg in combination with atezolizumab 1200 mg via IV infusion Q3W. The participants continued treatment with alomfilimab in combination with atezolizumab within this clinical study, as long as they continued to derive benefit from treatment, until the participant experienced unacceptable toxicity or confirmed PD per iRECIST.
OG011
Alomfilimab 2.4 mg + Atezolizumab in Anti-PD-(L)1 Naïve Pancreatic Cancer
Anti-PD-(L)1 naïve participants with pancreatic cancer received alomfilimab 2.4 mg in combination with atezolizumab 1200 mg via IV infusion Q3W. The participants continued treatment with alomfilimab in combination with atezolizumab within this clinical study, as long as they continued to derive benefit from treatment, until the participant experienced unacceptable toxicity or confirmed PD per iRECIST.
OG012
Alomfilimab 8 mg + Atezolizumab in Anti-PD-(L)1 Naïve Pancreatic Cancer
Anti-PD-(L)1 naïve participants with pancreatic cancer received alomfilimab 8 mg in combination with atezolizumab 1200 mg via IV infusion Q3W. The participants continued treatment with alomfilimab in combination with atezolizumab within this clinical study, as long as they continued to derive benefit from treatment, until the participant experienced unacceptable toxicity or confirmed PD per iRECIST.
OG013
Alomfilimab 2.4 mg + Atezolizumab in Anti-PD-(L)1 Naïve Triple Negative BC
Anti-PD-(L)1 naïve participants with triple negative BC received alomfilimab 2.4 mg in combination with atezolizumab 1200 mg via IV infusion Q3W. The participants continued treatment with alomfilimab in combination with atezolizumab within this clinical study, as long as they continued to derive benefit from treatment, until the participant experienced unacceptable toxicity or confirmed PD per iRECIST.
OG014
Alomfilimab 8 mg + Atezolizumab in Anti-PD-(L)1 Naïve Triple Negative BC
Anti-PD-(L)1 naïve participants with triple negative BC received alomfilimab 8 mg in combination with atezolizumab 1200 mg via IV infusion Q3W. The participants continued treatment with alomfilimab in combination with atezolizumab within this clinical study, as long as they continued to derive benefit from treatment, until the participant experienced unacceptable toxicity or confirmed PD per iRECIST.
OG015
Alomfilimab 8 mg + Atezolizumab in Anti-PD-(L)1 Naïve HNSCC
Anti-PD-(L)1 naïve participants with HNSCC received alomfilimab 8 mg in combination with atezolizumab 1200 mg via IV infusion Q3W. The participants continued treatment with alomfilimab in combination with atezolizumab within this clinical study, as long as they continued to derive benefit from treatment, until the participant experienced unacceptable toxicity or confirmed PD per iRECIST.
OG016
Alomfilimab 24 mg + Atezolizumab in Anti-PD-(L)1 Naïve HNSCC
Anti-PD-(L)1 naïve participants with HNSCC received alomfilimab 24 mg in combination with atezolizumab 1200 mg via IV infusion Q3W. The participants continued treatment with alomfilimab in combination with atezolizumab within this clinical study, as long as they continued to derive benefit from treatment, until the participant experienced unacceptable toxicity or confirmed PD per iRECIST.
OG017
Alomfilimab 2.4 mg + Atezolizumab in Anti-PD-(L)1 Pre-treated Pancreatic Cancer
Participants with pre-treated pancreatic cancer received alomfilimab 2.4 mg in combination with atezolizumab 1200 mg via IV infusion Q3W. The participants continued treatment with alomfilimab in combination with atezolizumab within this clinical study, as long as they continued to derive benefit from treatment, until the participant experienced unacceptable toxicity or confirmed PD per iRECIST.
OG018
Alomfilimab 8 mg + Atezolizumab in Anti-PD-(L)1 Pre-treated Pancreatic Cancer
Participants with pre-treated pancreatic cancer received alomfilimab 8 mg in combination with atezolizumab 1200 mg via IV infusion Q3W. The participants continued treatment with alomfilimab in combination with atezolizumab within this clinical study, as long as they continued to derive benefit from treatment, until the participant experienced unacceptable toxicity or confirmed PD per iRECIST.
OG019
Alomfilimab 2.4 mg + Atezolizumab in Anti-PD-(L)1 Pre-treated Triple Negative BC
Participants with pre-treated triple negative BC received alomfilimab 2.4 mg in combination with atezolizumab 1200 mg via IV infusion Q3W. The participants continued treatment with alomfilimab in combination with atezolizumab within this clinical study, as long as they continued to derive benefit from treatment, until the participant experienced unacceptable toxicity or confirmed PD per iRECIST.
OG020
Alomfilimab 8 mg + Atezolizumab in Anti-PD-(L)1 Pre-treated Triple Negative BC
Participants with pre-treated triple negative BC received alomfilimab 8 mg in combination with atezolizumab 1200 mg via IV infusion Q3W. The participants continued treatment with alomfilimab in combination with atezolizumab within this clinical study, as long as they continued to derive benefit from treatment, until the participant experienced unacceptable toxicity or confirmed PD per iRECIST.
OG021
Alomfilimab 8 mg + Atezolizumab in Anti-PD-(L)1 Pre-treated HNSCC
Participants with pre-treated HNSCC received alomfilimab 8 mg in combination with atezolizumab 1200 mg via IV infusion Q3W. The participants continued treatment with alomfilimab in combination with atezolizumab within this clinical study, as long as they continued to derive benefit from treatment, until the participant experienced unacceptable toxicity or confirmed PD per iRECIST.
OG022
Alomfilimab 24 mg + Atezolizumab in Anti-PD-(L)1 Pre-treated HNSCC
Participants with pre-treated HNSCC received alomfilimab 24 mg in combination with atezolizumab 1200 mg via IV infusion Q3W. The participants continued treatment with alomfilimab in combination with atezolizumab within this clinical study, as long as they continued to derive benefit from treatment, until the participant experienced unacceptable toxicity or confirmed PD per iRECIST.
Units
Counts
Participants
OG0004
OG0015
OG0028
OG0038
OG0047
OG0055
OG0064
OG00741
OG00836
OG0099
OG0109
OG01115
OG01214
OG0137
OG01414
OG0155
OG0165
OG0172
OG0181
OG0191
OG0206
OG0213
OG0228
Title
Denominators
Categories
Title
Measurements
OG0000(0.0 to 60.2)
OG0010(0.0 to 70.8)
OG0020(0.0 to 33.6)
OG0030(0.0 to 52.2)
OG0040(0.0 to 45.9)
OG0050(0.0 to 52.2)
OG0060(0.0 to 60.2)
OG0079.3(3.1 to 26.1)
OG0085.6(0.8 to 21.4)
OG00911.1(0.3 to 48.2)
OG0100(0.0 to 45.9)
OG0110(0.0 to 23.2)
OG0120(0.0 to 30.8)
OG0130(0.0 to 45.9)
OG0147.1(0.2 to 38.5)
OG0150(0.0 to 60.2)
OG0160(0.0 to 70.8)
OG0170(0.0 to 97.5)
OG0180(0.0 to 97.5)
OG0190(0.0 to 97.5)
OG0200(0.0 to 52.2)
OG02133.3(2.5 to 100.0)
OG0220(0.0 to 41.0)
OG001
Alomfilimab 2.4 mg
Participants received alomfilimab 2.4 mg as a single agent via IV infusion Q3W. The participants continued treatment with alomfilimab within this clinical study, as long as they continued to derive benefit from treatment, until the participant experienced unacceptable toxicity or confirmed PD per iRECIST.
OG002
Alomfilimab 8 mg
Participants received alomfilimab 8 mg as a single agent via IV infusion Q3W. The participants continued treatment with alomfilimab within this clinical study, as long as they continued to derive benefit from treatment, until the participant experienced unacceptable toxicity or confirmed PD per iRECIST.
OG003
Alomfilimab 24 mg
Participants received alomfilimab 24 mg as a single agent via IV infusion Q3W. The participants continued treatment with alomfilimab within this clinical study, as long as they continued to derive benefit from treatment, until the participant experienced unacceptable toxicity or confirmed PD per iRECIST.
OG004
Alomfilimab 80 mg
Participants received alomfilimab 80 mg as a single agent via IV infusion Q3W. The participants continued treatment with alomfilimab within this clinical study, as long as they continued to derive benefit from treatment, until the participant experienced unacceptable toxicity or confirmed PD per iRECIST.
OG005
Alomfilimab 240 mg
Participants received alomfilimab 240 mg as a single agent via IV infusion Q3W. The participants continued treatment with alomfilimab within this clinical study, as long as they continued to derive benefit from treatment, until the participant experienced unacceptable toxicity or confirmed PD per iRECIST.
OG006
Alomfilimab 0.8 mg + Atezolizumab
Participants received alomfilimab 0.8 mg in combination with atezolizumab 1200 mg via IV infusion Q3W. The participants continued treatment with alomfilimab in combination with atezolizumab within this clinical study, as long as they continued to derive benefit from treatment, until the participant experienced unacceptable toxicity or confirmed PD per iRECIST.
OG007
Alomfilimab 2.4 mg + Atezolizumab
Participants received alomfilimab 2.4 mg in combination with atezolizumab 1200 mg via IV infusion Q3W. The participants continued treatment with alomfilimab in combination with atezolizumab within this clinical study, as long as they continued to derive benefit from treatment, until the participant experienced unacceptable toxicity or confirmed PD per iRECIST.
OG008
Alomfilimab 8 mg + Atezolizumab
Participants received alomfilimab 8 mg in combination with atezolizumab 1200 mg via IV infusion Q3W. The participants continued treatment with alomfilimab in combination with atezolizumab within this clinical study, as long as they continued to derive benefit from treatment, until the participant experienced unacceptable toxicity or confirmed PD per iRECIST.
OG009
Alomfilimab 24 mg + Atezolizumab
Participants received alomfilimab 24 mg in combination with atezolizumab 1200 mg via IV infusion Q3W. The participants continued treatment with alomfilimab in combination with atezolizumab within this clinical study, as long as they continued to derive benefit from treatment, until the participant experienced unacceptable toxicity or confirmed PD per iRECIST.
OG010
Alomfilimab 80 mg + Atezolizumab
Participants received alomfilimab 80 mg in combination with atezolizumab 1200 mg via IV infusion Q3W. The participants continued treatment with alomfilimab in combination with atezolizumab within this clinical study, as long as they continued to derive benefit from treatment, until the participant experienced unacceptable toxicity or confirmed PD per iRECIST.
OG011
Alomfilimab 2.4 mg + Atezolizumab in Anti-PD-(L)1 Naïve Pancreatic Cancer
Anti-PD-(L)1 naïve participants with pancreatic cancer received alomfilimab 2.4 mg in combination with atezolizumab 1200 mg via IV infusion Q3W. The participants continued treatment with alomfilimab in combination with atezolizumab within this clinical study, as long as they continued to derive benefit from treatment, until the participant experienced unacceptable toxicity or confirmed PD per iRECIST.
OG012
Alomfilimab 8 mg + Atezolizumab in Anti-PD-(L)1 Naïve Pancreatic Cancer
Anti-PD-(L)1 naïve participants with pancreatic cancer received alomfilimab 8 mg in combination with atezolizumab 1200 mg via IV infusion Q3W. The participants continued treatment with alomfilimab in combination with atezolizumab within this clinical study, as long as they continued to derive benefit from treatment, until the participant experienced unacceptable toxicity or confirmed PD per iRECIST.
OG013
Alomfilimab 2.4 mg + Atezolizumab in Anti-PD-(L)1 Naïve Triple Negative BC
Anti-PD-(L)1 naïve participants with triple negative BC received alomfilimab 2.4 mg in combination with atezolizumab 1200 mg via IV infusion Q3W. The participants continued treatment with alomfilimab in combination with atezolizumab within this clinical study, as long as they continued to derive benefit from treatment, until the participant experienced unacceptable toxicity or confirmed PD per iRECIST.
OG014
Alomfilimab 8 mg + Atezolizumab in Anti-PD-(L)1 Naïve Triple Negative BC
Anti-PD-(L)1 naïve participants with triple negative BC received alomfilimab 8 mg in combination with atezolizumab 1200 mg via IV infusion Q3W. The participants continued treatment with alomfilimab in combination with atezolizumab within this clinical study, as long as they continued to derive benefit from treatment, until the participant experienced unacceptable toxicity or confirmed PD per iRECIST.
OG015
Alomfilimab 8 mg + Atezolizumab in Anti-PD-(L)1 Naïve HNSCC
Anti-PD-(L)1 naïve participants with HNSCC received alomfilimab 8 mg in combination with atezolizumab 1200 mg via IV infusion Q3W. The participants continued treatment with alomfilimab in combination with atezolizumab within this clinical study, as long as they continued to derive benefit from treatment, until the participant experienced unacceptable toxicity or confirmed PD per iRECIST.
OG016
Alomfilimab 24 mg + Atezolizumab in Anti-PD-(L)1 Naïve HNSCC
Anti-PD-(L)1 naïve participants with HNSCC received alomfilimab 24 mg in combination with atezolizumab 1200 mg via IV infusion Q3W. The participants continued treatment with alomfilimab in combination with atezolizumab within this clinical study, as long as they continued to derive benefit from treatment, until the participant experienced unacceptable toxicity or confirmed PD per iRECIST.
OG017
Alomfilimab 2.4 mg + Atezolizumab in Anti-PD-(L)1 Pre-treated Pancreatic Cancer
Participants with pre-treated pancreatic cancer received alomfilimab 2.4 mg in combination with atezolizumab 1200 mg via IV infusion Q3W. The participants continued treatment with alomfilimab in combination with atezolizumab within this clinical study, as long as they continued to derive benefit from treatment, until the participant experienced unacceptable toxicity or confirmed PD per iRECIST.
OG018
Alomfilimab 8 mg + Atezolizumab in Anti-PD-(L)1 Pre-treated Pancreatic Cancer
Participants with pre-treated pancreatic cancer received alomfilimab 8 mg in combination with atezolizumab 1200 mg via IV infusion Q3W. The participants continued treatment with alomfilimab in combination with atezolizumab within this clinical study, as long as they continued to derive benefit from treatment, until the participant experienced unacceptable toxicity or confirmed PD per iRECIST.
OG019
Alomfilimab 2.4 mg + Atezolizumab in Anti-PD-(L)1 Pre-treated Triple Negative BC
Participants with pre-treated triple negative BC received alomfilimab 2.4 mg in combination with atezolizumab 1200 mg via IV infusion Q3W. The participants continued treatment with alomfilimab in combination with atezolizumab within this clinical study, as long as they continued to derive benefit from treatment, until the participant experienced unacceptable toxicity or confirmed PD per iRECIST.
OG020
Alomfilimab 8 mg + Atezolizumab in Anti-PD-(L)1 Pre-treated Triple Negative BC
Participants with pre-treated triple negative BC received alomfilimab 8 mg in combination with atezolizumab 1200 mg via IV infusion Q3W. The participants continued treatment with alomfilimab in combination with atezolizumab within this clinical study, as long as they continued to derive benefit from treatment, until the participant experienced unacceptable toxicity or confirmed PD per iRECIST.
OG021
Alomfilimab 8 mg + Atezolizumab in Anti-PD-(L)1 Pre-treated HNSCC
Participants with pre-treated HNSCC received alomfilimab 8 mg in combination with atezolizumab 1200 mg via IV infusion Q3W. The participants continued treatment with alomfilimab in combination with atezolizumab within this clinical study, as long as they continued to derive benefit from treatment, until the participant experienced unacceptable toxicity or confirmed PD per iRECIST.
OG022
Alomfilimab 24 mg + Atezolizumab in Anti-PD-(L)1 Pre-treated HNSCC
Participants with pre-treated HNSCC received alomfilimab 24 mg in combination with atezolizumab 1200 mg via IV infusion Q3W. The participants continued treatment with alomfilimab in combination with atezolizumab within this clinical study, as long as they continued to derive benefit from treatment, until the participant experienced unacceptable toxicity or confirmed PD per iRECIST.
Units
Counts
Participants
OG0004
OG0015
OG0029
OG0038
OG0047
OG0055
OG0065
OG00743
OG00836
OG0099
OG0109
OG01115
OG01214
OG0137
OG01414
OG0155
OG0165
OG0172
OG0181
OG0191
OG0206
OG0213
OG0228
Title
Denominators
Categories
Title
Measurements
OG0007(NA to NA)Confidence intervals could not be calculated as a single participant had observed events.
OG00110(4.2 to NA)Upper confidence interval was not calculable due to insufficient event data occurring above the median.
OG00210(3.4 to NA)Upper confidence interval was not calculable due to insufficient event data occurring above the median.
OG0036(3.3 to NA)Upper confidence interval was not calculable due to insufficient event data occurring above the median.
OG0046(2.7 to NA)Upper confidence interval was not calculable due to insufficient event data occurring above the median.
OG0056(3.4 to NA)Upper confidence interval was not calculable due to insufficient event data occurring above the median.
OG0064(2.5 to NA)Upper confidence interval was not calculable due to insufficient event data occurring above the median.
OG0077(5.5 to 10.0)
OG0085(2.8 to 9.9)
OG0093(1.8 to 4.0)
OG0105(4.6 to NA)Upper confidence interval was not calculable due to insufficient event data occurring above the median.
OG0115(2.5 to NA)Upper confidence interval was not calculable due to insufficient event data occurring above the median.
OG0125(2.7 to NA)Upper confidence interval was not calculable due to insufficient event data occurring above the median.
OG0134(2.6 to NA)Upper confidence interval was not calculable due to insufficient event data occurring above the median.
OG01410(1.7 to NA)Upper confidence interval was not calculable due to insufficient event data occurring above the median.
OG0155(5.0 to NA)Upper confidence interval was not calculable due to insufficient event data occurring above the median.
OG0164(1.5 to NA)Upper confidence interval was not calculable due to insufficient event data occurring above the median.
OG017NA(NA to NA)Median and confidence intervals could not be calculated as two participants were censored.
OG01810(NA to NA)Confidence intervals could not be calculated as a single participant had observed events.
OG01917(NA to NA)Confidence intervals could not be calculated as a single participant had observed events.
OG02012(NA to NA)Confidence intervals could not be calculated as a single participant had observed events.
OG021NA(NA to NA)Median and confidence intervals could not be calculated as three participants were censored.
OG0226(2.6 to NA)Upper confidence interval was not calculable due to insufficient event data occurring above the median.
Participants received alomfilimab 2.4 mg as a single agent via IV infusion Q3W. The participants continued treatment with alomfilimab within this clinical study, as long as they continued to derive benefit from treatment, until the participant experienced unacceptable toxicity or confirmed PD per iRECIST.
OG002
Alomfilimab 8 mg
Participants received alomfilimab 8 mg as a single agent via IV infusion Q3W. The participants continued treatment with alomfilimab within this clinical study, as long as they continued to derive benefit from treatment, until the participant experienced unacceptable toxicity or confirmed PD per iRECIST.
OG003
Alomfilimab 24 mg
Participants received alomfilimab 24 mg as a single agent via IV infusion Q3W. The participants continued treatment with alomfilimab within this clinical study, as long as they continued to derive benefit from treatment, until the participant experienced unacceptable toxicity or confirmed PD per iRECIST.
OG004
Alomfilimab 80 mg
Participants received alomfilimab 80 mg as a single agent via IV infusion Q3W. The participants continued treatment with alomfilimab within this clinical study, as long as they continued to derive benefit from treatment, until the participant experienced unacceptable toxicity or confirmed PD per iRECIST.
OG005
Alomfilimab 240 mg
Participants received alomfilimab 240 mg as a single agent via IV infusion Q3W. The participants continued treatment with alomfilimab within this clinical study, as long as they continued to derive benefit from treatment, until the participant experienced unacceptable toxicity or confirmed PD per iRECIST.
OG006
Alomfilimab 0.8 mg + Atezolizumab
Participants received alomfilimab 0.8 mg in combination with atezolizumab 1200 mg via IV infusion Q3W. The participants continued treatment with alomfilimab in combination with atezolizumab within this clinical study, as long as they continued to derive benefit from treatment, until the participant experienced unacceptable toxicity or confirmed PD per iRECIST.
OG007
Alomfilimab 2.4 mg + Atezolizumab
Participants received alomfilimab 2.4 mg in combination with atezolizumab 1200 mg via IV infusion Q3W. The participants continued treatment with alomfilimab in combination with atezolizumab within this clinical study, as long as they continued to derive benefit from treatment, until the participant experienced unacceptable toxicity or confirmed PD per iRECIST.
OG008
Alomfilimab 8 mg + Atezolizumab
Participants received alomfilimab 8 mg in combination with atezolizumab 1200 mg via IV infusion Q3W. The participants continued treatment with alomfilimab in combination with atezolizumab within this clinical study, as long as they continued to derive benefit from treatment, until the participant experienced unacceptable toxicity or confirmed PD per iRECIST.
OG009
Alomfilimab 24 mg + Atezolizumab
Participants received alomfilimab 24 mg in combination with atezolizumab 1200 mg via IV infusion Q3W. The participants continued treatment with alomfilimab in combination with atezolizumab within this clinical study, as long as they continued to derive benefit from treatment, until the participant experienced unacceptable toxicity or confirmed PD per iRECIST.
OG010
Alomfilimab 80 mg + Atezolizumab
Participants received alomfilimab 80 mg in combination with atezolizumab 1200 mg via IV infusion Q3W. The participants continued treatment with alomfilimab in combination with atezolizumab within this clinical study, as long as they continued to derive benefit from treatment, until the participant experienced unacceptable toxicity or confirmed PD per iRECIST.
Units
Counts
Participants
OG0004
OG0015
OG0028
OG0038
OG0047
OG0055
OG0064
OG00741
OG00836
OG0099
OG0109
Title
Denominators
Categories
Title
Measurements
OG0000(0.0 to 60.2)
OG0010(0.0 to 70.8)
OG0020(0.0 to 33.6)
OG0030(0.0 to 52.2)
OG0040(0.0 to 45.9)
OG0050(0.0 to 52.2)
OG0060(0.0 to 60.2)
OG0079.3(3.1 to 26.1)
OG0085.6(0.8 to 20.8)
OG00911.1(0.3 to 48.2)
OG0100(0.0 to 45.9)
OG003
Alomfilimab 24 mg
Participants received alomfilimab 24 mg as a single agent via IV infusion Q3W. The participants continued treatment with alomfilimab within this clinical study, as long as they continued to derive benefit from treatment, until the participant experienced unacceptable toxicity or confirmed PD per iRECIST.
OG004
Alomfilimab 80 mg
Participants received alomfilimab 80 mg as a single agent via IV infusion Q3W. The participants continued treatment with alomfilimab within this clinical study, as long as they continued to derive benefit from treatment, until the participant experienced unacceptable toxicity or confirmed PD per iRECIST.
OG005
Alomfilimab 240 mg
Participants received alomfilimab 240 mg as a single agent via IV infusion Q3W. The participants continued treatment with alomfilimab within this clinical study, as long as they continued to derive benefit from treatment, until the participant experienced unacceptable toxicity or confirmed PD per iRECIST.
OG006
Alomfilimab 0.8 mg + Atezolizumab
Participants received alomfilimab 0.8 mg in combination with atezolizumab 1200 mg via IV infusion Q3W. The participants continued treatment with alomfilimab in combination with atezolizumab within this clinical study, as long as they continued to derive benefit from treatment, until the participant experienced unacceptable toxicity or confirmed PD per iRECIST.
OG007
Alomfilimab 2.4 mg + Atezolizumab
Participants received alomfilimab 2.4 mg in combination with atezolizumab 1200 mg via IV infusion Q3W. The participants continued treatment with alomfilimab in combination with atezolizumab within this clinical study, as long as they continued to derive benefit from treatment, until the participant experienced unacceptable toxicity or confirmed PD per iRECIST.
OG008
Alomfilimab 8 mg + Atezolizumab
Participants received alomfilimab 8 mg in combination with atezolizumab 1200 mg via IV infusion Q3W. The participants continued treatment with alomfilimab in combination with atezolizumab within this clinical study, as long as they continued to derive benefit from treatment, until the participant experienced unacceptable toxicity or confirmed PD per iRECIST.
OG009
Alomfilimab 24 mg + Atezolizumab
Participants received alomfilimab 24 mg in combination with atezolizumab 1200 mg via IV infusion Q3W. The participants continued treatment with alomfilimab in combination with atezolizumab within this clinical study, as long as they continued to derive benefit from treatment, until the participant experienced unacceptable toxicity or confirmed PD per iRECIST.
OG010
Alomfilimab 80 mg + Atezolizumab
Participants received alomfilimab 80 mg in combination with atezolizumab 1200 mg via IV infusion Q3W. The participants continued treatment with alomfilimab in combination with atezolizumab within this clinical study, as long as they continued to derive benefit from treatment, until the participant experienced unacceptable toxicity or confirmed PD per iRECIST.
OG011
Alomfilimab 2.4 mg + Atezolizumab in Anti-PD-(L)1 Naïve Pancreatic Cancer
Anti-PD-(L)1 naïve participants with pancreatic cancer received alomfilimab 2.4 mg in combination with atezolizumab 1200 mg via IV infusion Q3W. The participants continued treatment with alomfilimab in combination with atezolizumab within this clinical study, as long as they continued to derive benefit from treatment, until the participant experienced unacceptable toxicity or confirmed PD per iRECIST.
OG012
Alomfilimab 8 mg + Atezolizumab in Anti-PD-(L)1 Naïve Pancreatic Cancer
Anti-PD-(L)1 naïve participants with pancreatic cancer received alomfilimab 8 mg in combination with atezolizumab 1200 mg via IV infusion Q3W. The participants continued treatment with alomfilimab in combination with atezolizumab within this clinical study, as long as they continued to derive benefit from treatment, until the participant experienced unacceptable toxicity or confirmed PD per iRECIST.
OG013
Alomfilimab 2.4 mg + Atezolizumab in Anti-PD-(L)1 Naïve Triple Negative BC
Anti-PD-(L)1 naïve participants with triple negative BC received alomfilimab 2.4 mg in combination with atezolizumab 1200 mg via IV infusion Q3W. The participants continued treatment with alomfilimab in combination with atezolizumab within this clinical study, as long as they continued to derive benefit from treatment, until the participant experienced unacceptable toxicity or confirmed PD per iRECIST.
OG014
Alomfilimab 8 mg + Atezolizumab in Anti-PD-(L)1 Naïve Triple Negative BC
Anti-PD-(L)1 naïve participants with triple negative BC received alomfilimab 8 mg in combination with atezolizumab 1200 mg via IV infusion Q3W. The participants continued treatment with alomfilimab in combination with atezolizumab within this clinical study, as long as they continued to derive benefit from treatment, until the participant experienced unacceptable toxicity or confirmed PD per iRECIST.
OG015
Alomfilimab 8 mg + Atezolizumab in Anti-PD-(L)1 Naïve HNSCC
Anti-PD-(L)1 naïve participants with HNSCC received alomfilimab 8 mg in combination with atezolizumab 1200 mg via IV infusion Q3W. The participants continued treatment with alomfilimab in combination with atezolizumab within this clinical study, as long as they continued to derive benefit from treatment, until the participant experienced unacceptable toxicity or confirmed PD per iRECIST.
OG016
Alomfilimab 24 mg + Atezolizumab in Anti-PD-(L)1 Naïve HNSCC
Anti-PD-(L)1 naïve participants with HNSCC received alomfilimab 24 mg in combination with atezolizumab 1200 mg via IV infusion Q3W. The participants continued treatment with alomfilimab in combination with atezolizumab within this clinical study, as long as they continued to derive benefit from treatment, until the participant experienced unacceptable toxicity or confirmed PD per iRECIST.
OG017
Alomfilimab 2.4 mg + Atezolizumab in Anti-PD-(L)1 Pre-treated Pancreatic Cancer
Participants with pre-treated pancreatic cancer received alomfilimab 2.4 mg in combination with atezolizumab 1200 mg via IV infusion Q3W. The participants continued treatment with alomfilimab in combination with atezolizumab within this clinical study, as long as they continued to derive benefit from treatment, until the participant experienced unacceptable toxicity or confirmed PD per iRECIST.
OG018
Alomfilimab 8 mg + Atezolizumab in Anti-PD-(L)1 Pre-treated Pancreatic Cancer
Participants with pre-treated pancreatic cancer received alomfilimab 8 mg in combination with atezolizumab 1200 mg via IV infusion Q3W. The participants continued treatment with alomfilimab in combination with atezolizumab within this clinical study, as long as they continued to derive benefit from treatment, until the participant experienced unacceptable toxicity or confirmed PD per iRECIST.
OG019
Alomfilimab 2.4 mg + Atezolizumab in Anti-PD-(L)1 Pre-treated Triple Negative BC
Participants with pre-treated triple negative BC received alomfilimab 2.4 mg in combination with atezolizumab 1200 mg via IV infusion Q3W. The participants continued treatment with alomfilimab in combination with atezolizumab within this clinical study, as long as they continued to derive benefit from treatment, until the participant experienced unacceptable toxicity or confirmed PD per iRECIST.
OG020
Alomfilimab 8 mg + Atezolizumab in Anti-PD-(L)1 Pre-treated Triple Negative BC
Participants with pre-treated triple negative BC received alomfilimab 8 mg in combination with atezolizumab 1200 mg via IV infusion Q3W. The participants continued treatment with alomfilimab in combination with atezolizumab within this clinical study, as long as they continued to derive benefit from treatment, until the participant experienced unacceptable toxicity or confirmed PD per iRECIST.
OG021
Alomfilimab 8 mg + Atezolizumab in Anti-PD-(L)1 Pre-treated HNSCC
Participants with pre-treated HNSCC received alomfilimab 8 mg in combination with atezolizumab 1200 mg via IV infusion Q3W. The participants continued treatment with alomfilimab in combination with atezolizumab within this clinical study, as long as they continued to derive benefit from treatment, until the participant experienced unacceptable toxicity or confirmed PD per iRECIST.
OG022
Alomfilimab 24 mg + Atezolizumab in Anti-PD-(L)1 Pre-treated HNSCC
Participants with pre-treated HNSCC received alomfilimab 24 mg in combination with atezolizumab 1200 mg via IV infusion Q3W. The participants continued treatment with alomfilimab in combination with atezolizumab within this clinical study, as long as they continued to derive benefit from treatment, until the participant experienced unacceptable toxicity or confirmed PD per iRECIST.
Units
Counts
Participants
OG0004
OG0015
OG0029
OG0038
OG0047
OG0055
OG0065
OG00743
OG00836
OG0099
OG0109
OG01115
OG01214
OG0137
OG01414
OG0155
OG0165
OG0172
OG0181
OG0191
OG0206
OG0213
OG0229
Title
Denominators
Categories
12 months
Title
Measurements
OG0000.0(NA to NA)Confidence intervals could not be calculated as no participants had known survival status at 12 months.
OG0010.2(0.01 to 0.58)
OG0020.4(0.10 to 0.73)
OG0030.3(0.04 to 0.56)
OG0040.4(0.10 to 0.73)
OG0050.0(NA to NA)Confidence intervals could not be calculated as no participants had known survival status at 12 months.
OG0060.4(0.05 to 0.75)
OG0070.4(0.27 to 0.60)
OG0080.4(0.22 to 0.57)
OG0090.2(0.01 to 0.64)
OG0100.5(0.12 to 0.82)
OG0110.2(0.03 to 0.47)
OG0120.0(NA to NA)Confidence intervals could not be calculated as no participants had known survival status at 12 months.
OG0130.6(0.17 to 0.84)
OG0140.7(0.38 to 0.88)
OG015NA(NA to NA)Number and confidence intervals could not be calculated as all participants were not alive or survival status was unknown at this timepoint.
OG016NA(NA to NA)Number and confidence intervals could not be calculated as all participants were not alive or survival status was unknown at this timepoint.
OG017NA(NA to NA)Number and confidence intervals could not be calculated as all participants were not alive or survival status was unknown at this timepoint.
OG0180.0(NA to NA)Confidence intervals could not be calculated as no participants had known survival status at 12 months.
OG019NA(NA to NA)Number and confidence intervals could not be calculated as all participants were not alive or survival status was unknown at this timepoint.
OG020NA(NA to NA)Number and confidence intervals could not be calculated as all participants were not alive or survival status was unknown at this timepoint.
OG0210.3(0.01 to 0.77)
OG022NA(NA to NA)Number and confidence intervals could not be calculated as all participants were not alive or survival status was unknown at this timepoint.
24 months
Title
Measurements
OG0000.0(NA to NA)Confidence intervals could not be calculated as no participants had known survival status at 24 months.
OG0010.2(0.01 to 0.58)
OG0020.3(0.04 to 0.61)
OG003
OG001
Alomfilimab 8 mg + Atezolizumab in Anti-PD-(L)1 Naïve Pancreatic Cancer
Anti-PD-(L)1 naïve participants with pancreatic cancer received alomfilimab 8 mg in combination with atezolizumab 1200 mg via IV infusion Q3W. The participants continued treatment with alomfilimab in combination with atezolizumab within this clinical study, as long as they continued to derive benefit from treatment, until the participant experienced unacceptable toxicity or confirmed PD per iRECIST.
OG002
Alomfilimab 2.4 mg + Atezolizumab in Anti-PD-(L)1 Naïve Triple Negative BC
Anti-PD-(L)1 naïve participants with triple negative BC received alomfilimab 2.4 mg in combination with atezolizumab 1200 mg via IV infusion Q3W. The participants continued treatment with alomfilimab in combination with atezolizumab within this clinical study, as long as they continued to derive benefit from treatment, until the participant experienced unacceptable toxicity or confirmed PD per iRECIST.
OG003
Alomfilimab 8 mg + Atezolizumab in Anti-PD-(L)1 Naïve Triple Negative BC
Anti-PD-(L)1 naïve participants with triple negative BC received alomfilimab 8 mg in combination with atezolizumab 1200 mg via IV infusion Q3W. The participants continued treatment with alomfilimab in combination with atezolizumab within this clinical study, as long as they continued to derive benefit from treatment, until the participant experienced unacceptable toxicity or confirmed PD per iRECIST.
OG004
Alomfilimab 8 mg + Atezolizumab in Anti-PD-(L)1 Naïve HNSCC
Anti-PD-(L)1 naïve participants with HNSCC received alomfilimab 8 mg in combination with atezolizumab 1200 mg via IV infusion Q3W. The participants continued treatment with alomfilimab in combination with atezolizumab within this clinical study, as long as they continued to derive benefit from treatment, until the participant experienced unacceptable toxicity or confirmed PD per iRECIST.
OG005
Alomfilimab 24 mg + Atezolizumab in Anti-PD-(L)1 Naïve HNSCC
Anti-PD-(L)1 naïve participants with HNSCC received alomfilimab 24 mg in combination with atezolizumab 1200 mg via IV infusion Q3W. The participants continued treatment with alomfilimab in combination with atezolizumab within this clinical study, as long as they continued to derive benefit from treatment, until the participant experienced unacceptable toxicity or confirmed PD per iRECIST.
OG006
Alomfilimab 2.4 mg + Atezolizumab in Anti-PD-(L)1 Pre-treated Pancreatic Cancer
Participants with pre-treated pancreatic cancer received alomfilimab 2.4 mg in combination with atezolizumab 1200 mg via IV infusion Q3W. The participants continued treatment with alomfilimab in combination with atezolizumab within this clinical study, as long as they continued to derive benefit from treatment, until the participant experienced unacceptable toxicity or confirmed PD per iRECIST.
OG007
Alomfilimab 8 mg + Atezolizumab in Anti-PD-(L)1 Pre-treated Pancreatic Cancer
Participants with pre-treated pancreatic cancer received alomfilimab 8 mg in combination with atezolizumab 1200 mg via IV infusion Q3W. The participants continued treatment with alomfilimab in combination with atezolizumab within this clinical study, as long as they continued to derive benefit from treatment, until the participant experienced unacceptable toxicity or confirmed PD per iRECIST.
OG008
Alomfilimab 2.4 mg + Atezolizumab in Anti-PD-(L)1 Pre-treated Triple Negative BC
Participants with pre-treated triple negative BC received alomfilimab 2.4 mg in combination with atezolizumab 1200 mg via IV infusion Q3W. The participants continued treatment with alomfilimab in combination with atezolizumab within this clinical study, as long as they continued to derive benefit from treatment, until the participant experienced unacceptable toxicity or confirmed PD per iRECIST.
OG009
Alomfilimab 8 mg + Atezolizumab in Anti-PD-(L)1 Pre-treated Triple Negative BC
Participants with pre-treated triple negative BC received alomfilimab 8 mg in combination with atezolizumab 1200 mg via IV infusion Q3W. The participants continued treatment with alomfilimab in combination with atezolizumab within this clinical study, as long as they continued to derive benefit from treatment, until the participant experienced unacceptable toxicity or confirmed PD per iRECIST.
OG010
Alomfilimab 8 mg + Atezolizumab in Anti-PD-(L)1 Pre-treated HNSCC
Participants with pre-treated HNSCC received alomfilimab 8 mg in combination with atezolizumab 1200 mg via IV infusion Q3W. The participants continued treatment with alomfilimab in combination with atezolizumab within this clinical study, as long as they continued to derive benefit from treatment, until the participant experienced unacceptable toxicity or confirmed PD per iRECIST.
OG011
Alomfilimab 24 mg + Atezolizumab in Anti-PD-(L)1 Pre-treated HNSCC
Participants with pre-treated HNSCC received alomfilimab 24 mg in combination with atezolizumab 1200 mg via IV infusion Q3W. The participants continued treatment with alomfilimab in combination with atezolizumab within this clinical study, as long as they continued to derive benefit from treatment, until the participant experienced unacceptable toxicity or confirmed PD per iRECIST.
Units
Counts
Participants
OG00015
OG00114
OG0027
OG00314
OG0045
OG0055
OG0062
OG0071
OG0081
OG0096
OG0103
OG0118
Title
Denominators
Categories
Any TEAEs
Title
Measurements
OG00015
OG00113
OG0027
OG00314
OG0045
OG0055
OG0062
OG0071
OG0081
OG0096
OG0103
OG0118
Any Serious TEAEs
Title
Measurements
OG0006
OG0012
OG0021
OG003
OG002
Alomfilimab 2.4 mg + Atezolizumab in Anti-PD-(L)1 Naïve Triple Negative BC
Anti-PD-(L)1 naïve participants with triple negative BC received alomfilimab 2.4 mg in combination with atezolizumab 1200 mg via IV infusion Q3W. The participants continued treatment with alomfilimab in combination with atezolizumab within this clinical study, as long as they continued to derive benefit from treatment, until the participant experienced unacceptable toxicity or confirmed PD per iRECIST.
OG003
Alomfilimab 8 mg + Atezolizumab in Anti-PD-(L)1 Naïve Triple Negative BC
Anti-PD-(L)1 naïve participants with triple negative BC received alomfilimab 8 mg in combination with atezolizumab 1200 mg via IV infusion Q3W. The participants continued treatment with alomfilimab in combination with atezolizumab within this clinical study, as long as they continued to derive benefit from treatment, until the participant experienced unacceptable toxicity or confirmed PD per iRECIST.
OG004
Alomfilimab 8 mg + Atezolizumab in Anti-PD-(L)1 Naïve HNSCC
Anti-PD-(L)1 naïve participants with HNSCC received alomfilimab 8 mg in combination with atezolizumab 1200 mg via IV infusion Q3W. The participants continued treatment with alomfilimab in combination with atezolizumab within this clinical study, as long as they continued to derive benefit from treatment, until the participant experienced unacceptable toxicity or confirmed PD per iRECIST.
OG005
Alomfilimab 24 mg + Atezolizumab in Anti-PD-(L)1 Naïve HNSCC
Anti-PD-(L)1 naïve participants with HNSCC received alomfilimab 24 mg in combination with atezolizumab 1200 mg via IV infusion Q3W. The participants continued treatment with alomfilimab in combination with atezolizumab within this clinical study, as long as they continued to derive benefit from treatment, until the participant experienced unacceptable toxicity or confirmed PD per iRECIST.
OG006
Alomfilimab 2.4 mg + Atezolizumab in Anti-PD-(L)1 Pre-treated Pancreatic Cancer
Participants with pre-treated pancreatic cancer received alomfilimab 2.4 mg in combination with atezolizumab 1200 mg via IV infusion Q3W. The participants continued treatment with alomfilimab in combination with atezolizumab within this clinical study, as long as they continued to derive benefit from treatment, until the participant experienced unacceptable toxicity or confirmed PD per iRECIST.
OG007
Alomfilimab 8 mg + Atezolizumab in Anti-PD-(L)1 Pre-treated Pancreatic Cancer
Participants with pre-treated pancreatic cancer received alomfilimab 8 mg in combination with atezolizumab 1200 mg via IV infusion Q3W. The participants continued treatment with alomfilimab in combination with atezolizumab within this clinical study, as long as they continued to derive benefit from treatment, until the participant experienced unacceptable toxicity or confirmed PD per iRECIST.
OG008
Alomfilimab 2.4 mg + Atezolizumab in Anti-PD-(L)1 Pre-treated Triple Negative BC
Participants with pre-treated triple negative BC received alomfilimab 2.4 mg in combination with atezolizumab 1200 mg via IV infusion Q3W. The participants continued treatment with alomfilimab in combination with atezolizumab within this clinical study, as long as they continued to derive benefit from treatment, until the participant experienced unacceptable toxicity or confirmed PD per iRECIST.
OG009
Alomfilimab 8 mg + Atezolizumab in Anti-PD-(L)1 Pre-treated Triple Negative BC
Participants with pre-treated triple negative BC received alomfilimab 8 mg in combination with atezolizumab 1200 mg via IV infusion Q3W. The participants continued treatment with alomfilimab in combination with atezolizumab within this clinical study, as long as they continued to derive benefit from treatment, until the participant experienced unacceptable toxicity or confirmed PD per iRECIST.
OG010
Alomfilimab 8 mg + Atezolizumab in Anti-PD-(L)1 Pre-treated HNSCC
Participants with pre-treated HNSCC received alomfilimab 8 mg in combination with atezolizumab 1200 mg via IV infusion Q3W. The participants continued treatment with alomfilimab in combination with atezolizumab within this clinical study, as long as they continued to derive benefit from treatment, until the participant experienced unacceptable toxicity or confirmed PD per iRECIST.
OG011
Alomfilimab 24 mg + Atezolizumab in Anti-PD-(L)1 Pre-treated HNSCC
Participants with pre-treated HNSCC received alomfilimab 24 mg in combination with atezolizumab 1200 mg via IV infusion Q3W. The participants continued treatment with alomfilimab in combination with atezolizumab within this clinical study, as long as they continued to derive benefit from treatment, until the participant experienced unacceptable toxicity or confirmed PD per iRECIST.
Units
Counts
Participants
OG00015
OG00114
OG0027
OG00314
OG0045
OG0055
OG0062
OG0071
OG0081
OG0096
OG0103
OG0118
Title
Denominators
Categories
Infusion Interruption
Title
Measurements
OG0000
OG0010
OG0020
OG0030
OG0041
OG0050
OG0060
OG0070
OG0080
OG0091
OG0101
OG0110
Dose Reduction
Title
Measurements
OG0000
OG0010
OG0020
OG003
OG002
Alomfilimab 2.4 mg + Atezolizumab in Anti-PD-(L)1 Naïve Triple Negative BC
Anti-PD-(L)1 naïve participants with triple negative BC received alomfilimab 2.4 mg in combination with atezolizumab 1200 mg via IV infusion Q3W. The participants continued treatment with alomfilimab in combination with atezolizumab within this clinical study, as long as they continued to derive benefit from treatment, until the participant experienced unacceptable toxicity or confirmed PD per iRECIST.
OG003
Alomfilimab 8 mg + Atezolizumab in Anti-PD-(L)1 Naïve Triple Negative BC
Anti-PD-(L)1 naïve participants with triple negative BC received alomfilimab 8 mg in combination with atezolizumab 1200 mg via IV infusion Q3W. The participants continued treatment with alomfilimab in combination with atezolizumab within this clinical study, as long as they continued to derive benefit from treatment, until the participant experienced unacceptable toxicity or confirmed PD per iRECIST.
OG004
Alomfilimab 8 mg + Atezolizumab in Anti-PD-(L)1 Naïve HNSCC
Anti-PD-(L)1 naïve participants with HNSCC received alomfilimab 8 mg in combination with atezolizumab 1200 mg via IV infusion Q3W. The participants continued treatment with alomfilimab in combination with atezolizumab within this clinical study, as long as they continued to derive benefit from treatment, until the participant experienced unacceptable toxicity or confirmed PD per iRECIST.
OG005
Alomfilimab 24 mg + Atezolizumab in Anti-PD-(L)1 Naïve HNSCC
Anti-PD-(L)1 naïve participants with HNSCC received alomfilimab 24 mg in combination with atezolizumab 1200 mg via IV infusion Q3W. The participants continued treatment with alomfilimab in combination with atezolizumab within this clinical study, as long as they continued to derive benefit from treatment, until the participant experienced unacceptable toxicity or confirmed PD per iRECIST.
OG006
Alomfilimab 2.4 mg + Atezolizumab in Anti-PD-(L)1 Pre-treated Pancreatic Cancer
Participants with pre-treated pancreatic cancer received alomfilimab 2.4 mg in combination with atezolizumab 1200 mg via IV infusion Q3W. The participants continued treatment with alomfilimab in combination with atezolizumab within this clinical study, as long as they continued to derive benefit from treatment, until the participant experienced unacceptable toxicity or confirmed PD per iRECIST.
OG007
Alomfilimab 8 mg + Atezolizumab in Anti-PD-(L)1 Pre-treated Pancreatic Cancer
Participants with pre-treated pancreatic cancer received alomfilimab 8 mg in combination with atezolizumab 1200 mg via IV infusion Q3W. The participants continued treatment with alomfilimab in combination with atezolizumab within this clinical study, as long as they continued to derive benefit from treatment, until the participant experienced unacceptable toxicity or confirmed PD per iRECIST.
OG008
Alomfilimab 2.4 mg + Atezolizumab in Anti-PD-(L)1 Pre-treated Triple Negative BC
Participants with pre-treated triple negative BC received alomfilimab 2.4 mg in combination with atezolizumab 1200 mg via IV infusion Q3W. The participants continued treatment with alomfilimab in combination with atezolizumab within this clinical study, as long as they continued to derive benefit from treatment, until the participant experienced unacceptable toxicity or confirmed PD per iRECIST.
OG009
Alomfilimab 8 mg + Atezolizumab in Anti-PD-(L)1 Pre-treated Triple Negative BC
Participants with pre-treated triple negative BC received alomfilimab 8 mg in combination with atezolizumab 1200 mg via IV infusion Q3W. The participants continued treatment with alomfilimab in combination with atezolizumab within this clinical study, as long as they continued to derive benefit from treatment, until the participant experienced unacceptable toxicity or confirmed PD per iRECIST.
OG010
Alomfilimab 8 mg + Atezolizumab in Anti-PD-(L)1 Pre-treated HNSCC
Participants with pre-treated HNSCC received alomfilimab 8 mg in combination with atezolizumab 1200 mg via IV infusion Q3W. The participants continued treatment with alomfilimab in combination with atezolizumab within this clinical study, as long as they continued to derive benefit from treatment, until the participant experienced unacceptable toxicity or confirmed PD per iRECIST.
OG011
Alomfilimab 24 mg + Atezolizumab in Anti-PD-(L)1 Pre-treated HNSCC
Participants with pre-treated HNSCC received alomfilimab 24 mg in combination with atezolizumab 1200 mg via IV infusion Q3W. The participants continued treatment with alomfilimab in combination with atezolizumab within this clinical study, as long as they continued to derive benefit from treatment, until the participant experienced unacceptable toxicity or confirmed PD per iRECIST.
Units
Counts
Participants
OG00015
OG00114
OG0027
OG00314
OG0045
OG0055
OG0062
OG0071
OG0081
OG0096
OG0103
OG0118
Title
Denominators
Categories
Title
Measurements
OG0000.778± 0.0540
OG0012.559± 0.1712
OG0020.777± 0.0111
OG0032.536± 0.1628
OG0042.366± 0.3577
OG0056.818± 2.3926
OG0060.775± 0.0212
OG0072.640± NAStandard deviation could not be calculated as a single participant was analyzed.
OG0080.760± NAStandard deviation could not be calculated as a single participant was analyzed.
OG0092.607± 0.0841
OG0102.613± 0.0551
OG0117.794± 0.1676
OG002
Alomfilimab 2.4 mg + Atezolizumab in Anti-PD-(L)1 Naïve Triple Negative BC
Anti-PD-(L)1 naïve participants with triple negative BC received alomfilimab 2.4 mg in combination with atezolizumab 1200 mg via IV infusion Q3W. The participants continued treatment with alomfilimab in combination with atezolizumab within this clinical study, as long as they continued to derive benefit from treatment, until the participant experienced unacceptable toxicity or confirmed PD per iRECIST.
OG003
Alomfilimab 8 mg + Atezolizumab in Anti-PD-(L)1 Naïve Triple Negative BC
Anti-PD-(L)1 naïve participants with triple negative BC received alomfilimab 8 mg in combination with atezolizumab 1200 mg via IV infusion Q3W. The participants continued treatment with alomfilimab in combination with atezolizumab within this clinical study, as long as they continued to derive benefit from treatment, until the participant experienced unacceptable toxicity or confirmed PD per iRECIST.
OG004
Alomfilimab 8 mg + Atezolizumab in Anti-PD-(L)1 Naïve HNSCC
Anti-PD-(L)1 naïve participants with HNSCC received alomfilimab 8 mg in combination with atezolizumab 1200 mg via IV infusion Q3W. The participants continued treatment with alomfilimab in combination with atezolizumab within this clinical study, as long as they continued to derive benefit from treatment, until the participant experienced unacceptable toxicity or confirmed PD per iRECIST.
OG005
Alomfilimab 24 mg + Atezolizumab in Anti-PD-(L)1 Naïve HNSCC
Anti-PD-(L)1 naïve participants with HNSCC received alomfilimab 24 mg in combination with atezolizumab 1200 mg via IV infusion Q3W. The participants continued treatment with alomfilimab in combination with atezolizumab within this clinical study, as long as they continued to derive benefit from treatment, until the participant experienced unacceptable toxicity or confirmed PD per iRECIST.
OG006
Alomfilimab 2.4 mg + Atezolizumab in Anti-PD-(L)1 Pre-treated Pancreatic Cancer
Participants with pre-treated pancreatic cancer received alomfilimab 2.4 mg in combination with atezolizumab 1200 mg via IV infusion Q3W. The participants continued treatment with alomfilimab in combination with atezolizumab within this clinical study, as long as they continued to derive benefit from treatment, until the participant experienced unacceptable toxicity or confirmed PD per iRECIST.
OG007
Alomfilimab 8 mg + Atezolizumab in Anti-PD-(L)1 Pre-treated Pancreatic Cancer
Participants with pre-treated pancreatic cancer received alomfilimab 8 mg in combination with atezolizumab 1200 mg via IV infusion Q3W. The participants continued treatment with alomfilimab in combination with atezolizumab within this clinical study, as long as they continued to derive benefit from treatment, until the participant experienced unacceptable toxicity or confirmed PD per iRECIST.
OG008
Alomfilimab 2.4 mg + Atezolizumab in Anti-PD-(L)1 Pre-treated Triple Negative BC
Participants with pre-treated triple negative BC received alomfilimab 2.4 mg in combination with atezolizumab 1200 mg via IV infusion Q3W. The participants continued treatment with alomfilimab in combination with atezolizumab within this clinical study, as long as they continued to derive benefit from treatment, until the participant experienced unacceptable toxicity or confirmed PD per iRECIST.
OG009
Alomfilimab 8 mg + Atezolizumab in Anti-PD-(L)1 Pre-treated Triple Negative BC
Participants with pre-treated triple negative BC received alomfilimab 8 mg in combination with atezolizumab 1200 mg via IV infusion Q3W. The participants continued treatment with alomfilimab in combination with atezolizumab within this clinical study, as long as they continued to derive benefit from treatment, until the participant experienced unacceptable toxicity or confirmed PD per iRECIST.
OG010
Alomfilimab 8 mg + Atezolizumab in Anti-PD-(L)1 Pre-treated HNSCC
Participants with pre-treated HNSCC received alomfilimab 8 mg in combination with atezolizumab 1200 mg via IV infusion Q3W. The participants continued treatment with alomfilimab in combination with atezolizumab within this clinical study, as long as they continued to derive benefit from treatment, until the participant experienced unacceptable toxicity or confirmed PD per iRECIST.
OG011
Alomfilimab 24 mg + Atezolizumab in Anti-PD-(L)1 Pre-treated HNSCC
Participants with pre-treated HNSCC received alomfilimab 24 mg in combination with atezolizumab 1200 mg via IV infusion Q3W. The participants continued treatment with alomfilimab in combination with atezolizumab within this clinical study, as long as they continued to derive benefit from treatment, until the participant experienced unacceptable toxicity or confirmed PD per iRECIST.
Units
Counts
Participants
OG00015
OG00114
OG0027
OG00314
OG0045
OG0055
OG0062
OG0071
OG0081
OG0096
OG0103
OG0118
Title
Denominators
Categories
Title
Measurements
OG0000.973± 0.0660
OG0010.956± 0.0638
OG0020.976± 0.0113
OG0031.014± 0.1256
OG0040.886± 0.1316
OG0050.980± 0.0274
OG0060.975± 0.0212
OG0070.990± NAStandard deviation could not be calculated as a single participant was analyzed.
OG0080.960± NAStandard deviation could not be calculated as a single participant was analyzed.
OG0090.977± 0.0333
OG0100.980± 0.0200
OG0110.973± 0.0191
Participants received alomfilimab 8 mg as a single agent via IV infusion Q3W. The participants continued treatment with alomfilimab within this clinical study, as long as they continued to derive benefit from treatment, until the participant experienced unacceptable toxicity or confirmed PD per iRECIST.
OG003
Alomfilimab 24 mg
Participants received alomfilimab 24 mg as a single agent via IV infusion Q3W. The participants continued treatment with alomfilimab within this clinical study, as long as they continued to derive benefit from treatment, until the participant experienced unacceptable toxicity or confirmed PD per iRECIST.
OG004
Alomfilimab 80 mg
Participants received alomfilimab 80 mg as a single agent via IV infusion Q3W. The participants continued treatment with alomfilimab within this clinical study, as long as they continued to derive benefit from treatment, until the participant experienced unacceptable toxicity or confirmed PD per iRECIST.
OG005
Alomfilimab 240 mg
Participants received alomfilimab 240 mg as a single agent via IV infusion Q3W. The participants continued treatment with alomfilimab within this clinical study, as long as they continued to derive benefit from treatment, until the participant experienced unacceptable toxicity or confirmed PD per iRECIST.
OG006
Alomfilimab 0.8 mg + Atezolizumab
Participants received alomfilimab 0.8 mg in combination with atezolizumab 1200 mg via IV infusion Q3W. The participants continued treatment with alomfilimab in combination with atezolizumab within this clinical study, as long as they continued to derive benefit from treatment, until the participant experienced unacceptable toxicity or confirmed PD per iRECIST.
OG007
Alomfilimab 2.4 mg + Atezolizumab
Participants received alomfilimab 2.4 mg in combination with atezolizumab 1200 mg via IV infusion Q3W. The participants continued treatment with alomfilimab in combination with atezolizumab within this clinical study, as long as they continued to derive benefit from treatment, until the participant experienced unacceptable toxicity or confirmed PD per iRECIST.
OG008
Alomfilimab 8 mg + Atezolizumab
Participants received alomfilimab 8 mg in combination with atezolizumab 1200 mg via IV infusion Q3W. The participants continued treatment with alomfilimab in combination with atezolizumab within this clinical study, as long as they continued to derive benefit from treatment, until the participant experienced unacceptable toxicity or confirmed PD per iRECIST.
OG009
Alomfilimab 24 mg + Atezolizumab
Participants received alomfilimab 24 mg in combination with atezolizumab 1200 mg via IV infusion Q3W. The participants continued treatment with alomfilimab in combination with atezolizumab within this clinical study, as long as they continued to derive benefit from treatment, until the participant experienced unacceptable toxicity or confirmed PD per iRECIST.
OG010
Alomfilimab 80 mg + Atezolizumab
Participants received alomfilimab 80 mg in combination with atezolizumab 1200 mg via IV infusion Q3W. The participants continued treatment with alomfilimab in combination with atezolizumab within this clinical study, as long as they continued to derive benefit from treatment, until the participant experienced unacceptable toxicity or confirmed PD per iRECIST.
Units
Counts
Participants
OG0004
OG0015
OG0029
OG0037
OG0047
OG0055
OG0065
OG00735
OG00829
OG0098
OG0109
Title
Denominators
Categories
Cycle 1
ParticipantsOG0004
ParticipantsOG0015
ParticipantsOG0029
ParticipantsOG0037
ParticipantsOG0047
ParticipantsOG0055
ParticipantsOG0065
ParticipantsOG00735
ParticipantsOG00829
ParticipantsOG0098
ParticipantsOG0109
Title
Measurements
OG0000.3022± 0.12476
OG0010.9773± 0.29919
OG0023.3327± 0.95752
OG003
Cycle 3
ParticipantsOG0003
ParticipantsOG0012
ParticipantsOG0027
ParticipantsOG0033
Participants received alomfilimab 8 mg as a single agent via IV infusion Q3W. The participants continued treatment with alomfilimab within this clinical study, as long as they continued to derive benefit from treatment, until the participant experienced unacceptable toxicity or confirmed PD per iRECIST.
OG003
Alomfilimab 24 mg
Participants received alomfilimab 24 mg as a single agent via IV infusion Q3W. The participants continued treatment with alomfilimab within this clinical study, as long as they continued to derive benefit from treatment, until the participant experienced unacceptable toxicity or confirmed PD per iRECIST.
OG004
Alomfilimab 80 mg
Participants received alomfilimab 80 mg as a single agent via IV infusion Q3W. The participants continued treatment with alomfilimab within this clinical study, as long as they continued to derive benefit from treatment, until the participant experienced unacceptable toxicity or confirmed PD per iRECIST.
OG005
Alomfilimab 240 mg
Participants received alomfilimab 240 mg as a single agent via IV infusion Q3W. The participants continued treatment with alomfilimab within this clinical study, as long as they continued to derive benefit from treatment, until the participant experienced unacceptable toxicity or confirmed PD per iRECIST.
OG006
Alomfilimab 0.8 mg + Atezolizumab
Participants received alomfilimab 0.8 mg in combination with atezolizumab 1200 mg via IV infusion Q3W. The participants continued treatment with alomfilimab in combination with atezolizumab within this clinical study, as long as they continued to derive benefit from treatment, until the participant experienced unacceptable toxicity or confirmed PD per iRECIST.
OG007
Alomfilimab 2.4 mg + Atezolizumab
Participants received alomfilimab 2.4 mg in combination with atezolizumab 1200 mg via IV infusion Q3W. The participants continued treatment with alomfilimab in combination with atezolizumab within this clinical study, as long as they continued to derive benefit from treatment, until the participant experienced unacceptable toxicity or confirmed PD per iRECIST.
OG008
Alomfilimab 8 mg + Atezolizumab
Participants received alomfilimab 8 mg in combination with atezolizumab 1200 mg via IV infusion Q3W. The participants continued treatment with alomfilimab in combination with atezolizumab within this clinical study, as long as they continued to derive benefit from treatment, until the participant experienced unacceptable toxicity or confirmed PD per iRECIST.
OG009
Alomfilimab 24 mg + Atezolizumab
Participants received alomfilimab 24 mg in combination with atezolizumab 1200 mg via IV infusion Q3W. The participants continued treatment with alomfilimab in combination with atezolizumab within this clinical study, as long as they continued to derive benefit from treatment, until the participant experienced unacceptable toxicity or confirmed PD per iRECIST.
OG010
Alomfilimab 80 mg + Atezolizumab
Participants received alomfilimab 80 mg in combination with atezolizumab 1200 mg via IV infusion Q3W. The participants continued treatment with alomfilimab in combination with atezolizumab within this clinical study, as long as they continued to derive benefit from treatment, until the participant experienced unacceptable toxicity or confirmed PD per iRECIST.
Units
Counts
Participants
OG0004
OG0015
OG0029
OG0038
OG0047
OG0055
OG0064
OG00736
OG00830
OG0098
OG0109
Title
Denominators
Categories
Cycle 1
ParticipantsOG0004
ParticipantsOG0015
ParticipantsOG0029
ParticipantsOG0038
ParticipantsOG0047
ParticipantsOG0055
ParticipantsOG0064
ParticipantsOG00736
ParticipantsOG00830
ParticipantsOG0098
ParticipantsOG0109
Title
Measurements
OG00042.7633± 20.84762
OG00172.2276± 9.56084
OG002149.0872± 55.14152
OG003
Cycle 3
ParticipantsOG0000
ParticipantsOG0011
ParticipantsOG0025
ParticipantsOG0032
OG002
Alomfilimab 8 mg
Participants received alomfilimab 8 mg as a single agent via IV infusion Q3W. The participants continued treatment with alomfilimab within this clinical study, as long as they continued to derive benefit from treatment, until the participant experienced unacceptable toxicity or confirmed PD per iRECIST.
OG003
Alomfilimab 24 mg
Participants received alomfilimab 24 mg as a single agent via IV infusion Q3W. The participants continued treatment with alomfilimab within this clinical study, as long as they continued to derive benefit from treatment, until the participant experienced unacceptable toxicity or confirmed PD per iRECIST.
OG004
Alomfilimab 80 mg
Participants received alomfilimab 80 mg as a single agent via IV infusion Q3W. The participants continued treatment with alomfilimab within this clinical study, as long as they continued to derive benefit from treatment, until the participant experienced unacceptable toxicity or confirmed PD per iRECIST.
OG005
Alomfilimab 240 mg
Participants received alomfilimab 240 mg as a single agent via IV infusion Q3W. The participants continued treatment with alomfilimab within this clinical study, as long as they continued to derive benefit from treatment, until the participant experienced unacceptable toxicity or confirmed PD per iRECIST.
OG006
Alomfilimab 0.8 mg + Atezolizumab
Participants received alomfilimab 0.8 mg in combination with atezolizumab 1200 mg via IV infusion Q3W. The participants continued treatment with alomfilimab in combination with atezolizumab within this clinical study, as long as they continued to derive benefit from treatment, until the participant experienced unacceptable toxicity or confirmed PD per iRECIST.
OG007
Alomfilimab 2.4 mg + Atezolizumab
Participants received alomfilimab 2.4 mg in combination with atezolizumab 1200 mg via IV infusion Q3W. The participants continued treatment with alomfilimab in combination with atezolizumab within this clinical study, as long as they continued to derive benefit from treatment, until the participant experienced unacceptable toxicity or confirmed PD per iRECIST.
OG008
Alomfilimab 8 mg + Atezolizumab
Participants received alomfilimab 8 mg in combination with atezolizumab 1200 mg via IV infusion Q3W. The participants continued treatment with alomfilimab in combination with atezolizumab within this clinical study, as long as they continued to derive benefit from treatment, until the participant experienced unacceptable toxicity or confirmed PD per iRECIST.
OG009
Alomfilimab 24 mg + Atezolizumab
Participants received alomfilimab 24 mg in combination with atezolizumab 1200 mg via IV infusion Q3W. The participants continued treatment with alomfilimab in combination with atezolizumab within this clinical study, as long as they continued to derive benefit from treatment, until the participant experienced unacceptable toxicity or confirmed PD per iRECIST.
OG010
Alomfilimab 80 mg + Atezolizumab
Participants received alomfilimab 80 mg in combination with atezolizumab 1200 mg via IV infusion Q3W. The participants continued treatment with alomfilimab in combination with atezolizumab within this clinical study, as long as they continued to derive benefit from treatment, until the participant experienced unacceptable toxicity or confirmed PD per iRECIST.
OG011
Alomfilimab 2.4 mg + Atezolizumab in Anti-PD-(L)1 Naïve Pancreatic Cancer
Anti-PD-(L)1 naïve participants with pancreatic cancer received alomfilimab 2.4 mg in combination with atezolizumab 1200 mg via IV infusion Q3W. The participants continued treatment with alomfilimab in combination with atezolizumab within this clinical study, as long as they continued to derive benefit from treatment, until the participant experienced unacceptable toxicity or confirmed PD per iRECIST.
OG012
Alomfilimab 8 mg + Atezolizumab in Anti-PD-(L)1 Naïve Pancreatic Cancer
Anti-PD-(L)1 naïve participants with pancreatic cancer received alomfilimab 8 mg in combination with atezolizumab 1200 mg via IV infusion Q3W. The participants continued treatment with alomfilimab in combination with atezolizumab within this clinical study, as long as they continued to derive benefit from treatment, until the participant experienced unacceptable toxicity or confirmed PD per iRECIST.
OG013
Alomfilimab 2.4 mg + Atezolizumab in Anti-PD-(L)1 Naïve Triple Negative BC
Anti-PD-(L)1 naïve participants with triple negative BC received alomfilimab 2.4 mg in combination with atezolizumab 1200 mg via IV infusion Q3W. The participants continued treatment with alomfilimab in combination with atezolizumab within this clinical study, as long as they continued to derive benefit from treatment, until the participant experienced unacceptable toxicity or confirmed PD per iRECIST.
OG014
Alomfilimab 8 mg + Atezolizumab in Anti-PD-(L)1 Naïve Triple Negative BC
Anti-PD-(L)1 naïve participants with triple negative BC received alomfilimab 8 mg in combination with atezolizumab 1200 mg via IV infusion Q3W. The participants continued treatment with alomfilimab in combination with atezolizumab within this clinical study, as long as they continued to derive benefit from treatment, until the participant experienced unacceptable toxicity or confirmed PD per iRECIST.
OG015
Alomfilimab 8 mg + Atezolizumab in Anti-PD-(L)1 Naïve HNSCC
Anti-PD-(L)1 naïve participants with HNSCC received alomfilimab 8 mg in combination with atezolizumab 1200 mg via IV infusion Q3W. The participants continued treatment with alomfilimab in combination with atezolizumab within this clinical study, as long as they continued to derive benefit from treatment, until the participant experienced unacceptable toxicity or confirmed PD per iRECIST.
OG016
Alomfilimab 24 mg + Atezolizumab in Anti-PD-(L)1 Naïve HNSCC
Anti-PD-(L)1 naïve participants with HNSCC received alomfilimab 24 mg in combination with atezolizumab 1200 mg via IV infusion Q3W. The participants continued treatment with alomfilimab in combination with atezolizumab within this clinical study, as long as they continued to derive benefit from treatment, until the participant experienced unacceptable toxicity or confirmed PD per iRECIST.
OG017
Alomfilimab 2.4 mg + Atezolizumab in Anti-PD-(L)1 Pre-treated Pancreatic Cancer
Participants with pre-treated pancreatic cancer received alomfilimab 2.4 mg in combination with atezolizumab 1200 mg via IV infusion Q3W. The participants continued treatment with alomfilimab in combination with atezolizumab within this clinical study, as long as they continued to derive benefit from treatment, until the participant experienced unacceptable toxicity or confirmed PD per iRECIST.
OG018
Alomfilimab 8 mg + Atezolizumab in Anti-PD-(L)1 Pre-treated Pancreatic Cancer
Participants with pre-treated pancreatic cancer received alomfilimab 8 mg in combination with atezolizumab 1200 mg via IV infusion Q3W. The participants continued treatment with alomfilimab in combination with atezolizumab within this clinical study, as long as they continued to derive benefit from treatment, until the participant experienced unacceptable toxicity or confirmed PD per iRECIST.
OG019
Alomfilimab 2.4 mg + Atezolizumab in Anti-PD-(L)1 Pre-treated Triple Negative BC
Participants with pre-treated triple negative BC received alomfilimab 2.4 mg in combination with atezolizumab 1200 mg via IV infusion Q3W. The participants continued treatment with alomfilimab in combination with atezolizumab within this clinical study, as long as they continued to derive benefit from treatment, until the participant experienced unacceptable toxicity or confirmed PD per iRECIST.
OG020
Alomfilimab 8 mg + Atezolizumab in Anti-PD-(L)1 Pre-treated Triple Negative BC
Participants with pre-treated triple negative BC received alomfilimab 8 mg in combination with atezolizumab 1200 mg via IV infusion Q3W. The participants continued treatment with alomfilimab in combination with atezolizumab within this clinical study, as long as they continued to derive benefit from treatment, until the participant experienced unacceptable toxicity or confirmed PD per iRECIST.
OG021
Alomfilimab 8 mg + Atezolizumab in Anti-PD-(L)1 Pre-treated HNSCC
Participants with pre-treated HNSCC received alomfilimab 8 mg in combination with atezolizumab 1200 mg via IV infusion Q3W. The participants continued treatment with alomfilimab in combination with atezolizumab within this clinical study, as long as they continued to derive benefit from treatment, until the participant experienced unacceptable toxicity or confirmed PD per iRECIST.
OG022
Alomfilimab 24 mg + Atezolizumab in Anti-PD-(L)1 Pre-treated HNSCC
Participants with pre-treated HNSCC received alomfilimab 24 mg in combination with atezolizumab 1200 mg via IV infusion Q3W. The participants continued treatment with alomfilimab in combination with atezolizumab within this clinical study, as long as they continued to derive benefit from treatment, until the participant experienced unacceptable toxicity or confirmed PD per iRECIST.
Units
Counts
Participants
OG0004
OG0013
OG0028
OG0038
OG0047
OG0055
OG0065
OG00736
OG00834
OG0098
OG0106
OG01113
OG01211
OG0136
OG01412
OG0155
OG0163
OG0171
OG0181
OG0190
OG0206
OG0213
OG0227
Title
Denominators
Categories
≥ 1 Positive Anti-alomfilimab Antibodies Result
ParticipantsOG0004
ParticipantsOG0013
ParticipantsOG0028
ParticipantsOG0038
ParticipantsOG0047
ParticipantsOG0055
ParticipantsOG0065
ParticipantsOG00736
ParticipantsOG00834
ParticipantsOG0098
ParticipantsOG0106
ParticipantsOG01113
ParticipantsOG01211
ParticipantsOG0136
ParticipantsOG01412
ParticipantsOG0154
ParticipantsOG0160
ParticipantsOG0171
ParticipantsOG0181
ParticipantsOG0190
ParticipantsOG0206
ParticipantsOG0213
ParticipantsOG0220
Title
Measurements
OG0001
OG0010
OG0022
OG003
≥ 1 Positive Anti-atezolizumab Antibodies Result
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0030
OG002
Alomfilimab 8 mg
Participants received alomfilimab 8 mg as a single agent via IV infusion Q3W. The participants continued treatment with alomfilimab within this clinical study, as long as they continued to derive benefit from treatment, until the participant experienced unacceptable toxicity or confirmed PD per iRECIST.
OG003
Alomfilimab 24 mg
Participants received alomfilimab 24 mg as a single agent via IV infusion Q3W. The participants continued treatment with alomfilimab within this clinical study, as long as they continued to derive benefit from treatment, until the participant experienced unacceptable toxicity or confirmed PD per iRECIST.
OG004
Alomfilimab 80 mg
Participants received alomfilimab 80 mg as a single agent via IV infusion Q3W. The participants continued treatment with alomfilimab within this clinical study, as long as they continued to derive benefit from treatment, until the participant experienced unacceptable toxicity or confirmed PD per iRECIST.
OG005
Alomfilimab 240 mg
Participants received alomfilimab 240 mg as a single agent via IV infusion Q3W. The participants continued treatment with alomfilimab within this clinical study, as long as they continued to derive benefit from treatment, until the participant experienced unacceptable toxicity or confirmed PD per iRECIST.
OG006
Alomfilimab 0.8 mg + Atezolizumab
Participants received alomfilimab 0.8 mg in combination with atezolizumab 1200 mg via IV infusion Q3W. The participants continued treatment with alomfilimab in combination with atezolizumab within this clinical study, as long as they continued to derive benefit from treatment, until the participant experienced unacceptable toxicity or confirmed PD per iRECIST.
OG007
Alomfilimab 2.4 mg + Atezolizumab
Participants received alomfilimab 2.4 mg in combination with atezolizumab 1200 mg via IV infusion Q3W. The participants continued treatment with alomfilimab in combination with atezolizumab within this clinical study, as long as they continued to derive benefit from treatment, until the participant experienced unacceptable toxicity or confirmed PD per iRECIST.
OG008
Alomfilimab 8 mg + Atezolizumab
Participants received alomfilimab 8 mg in combination with atezolizumab 1200 mg via IV infusion Q3W. The participants continued treatment with alomfilimab in combination with atezolizumab within this clinical study, as long as they continued to derive benefit from treatment, until the participant experienced unacceptable toxicity or confirmed PD per iRECIST.
OG009
Alomfilimab 24 mg + Atezolizumab
Participants received alomfilimab 24 mg in combination with atezolizumab 1200 mg via IV infusion Q3W. The participants continued treatment with alomfilimab in combination with atezolizumab within this clinical study, as long as they continued to derive benefit from treatment, until the participant experienced unacceptable toxicity or confirmed PD per iRECIST.
OG010
Alomfilimab 80 mg + Atezolizumab
Participants received alomfilimab 80 mg in combination with atezolizumab 1200 mg via IV infusion Q3W. The participants continued treatment with alomfilimab in combination with atezolizumab within this clinical study, as long as they continued to derive benefit from treatment, until the participant experienced unacceptable toxicity or confirmed PD per iRECIST.
OG011
Alomfilimab 2.4 mg + Atezolizumab in Anti-PD-(L)1 Naïve Pancreatic Cancer
Anti-PD-(L)1 naïve participants with pancreatic cancer received alomfilimab 2.4 mg in combination with atezolizumab 1200 mg via IV infusion Q3W. The participants continued treatment with alomfilimab in combination with atezolizumab within this clinical study, as long as they continued to derive benefit from treatment, until the participant experienced unacceptable toxicity or confirmed PD per iRECIST.
OG012
Alomfilimab 8 mg + Atezolizumab in Anti-PD-(L)1 Naïve Pancreatic Cancer
Anti-PD-(L)1 naïve participants with pancreatic cancer received alomfilimab 8 mg in combination with atezolizumab 1200 mg via IV infusion Q3W. The participants continued treatment with alomfilimab in combination with atezolizumab within this clinical study, as long as they continued to derive benefit from treatment, until the participant experienced unacceptable toxicity or confirmed PD per iRECIST.
OG013
Alomfilimab 2.4 mg + Atezolizumab in Anti-PD-(L)1 Naïve Triple Negative BC
Anti-PD-(L)1 naïve participants with triple negative BC received alomfilimab 2.4 mg in combination with atezolizumab 1200 mg via IV infusion Q3W. The participants continued treatment with alomfilimab in combination with atezolizumab within this clinical study, as long as they continued to derive benefit from treatment, until the participant experienced unacceptable toxicity or confirmed PD per iRECIST.
OG014
Alomfilimab 8 mg + Atezolizumab in Anti-PD-(L)1 Naïve Triple Negative BC
Anti-PD-(L)1 naïve participants with triple negative BC received alomfilimab 8 mg in combination with atezolizumab 1200 mg via IV infusion Q3W. The participants continued treatment with alomfilimab in combination with atezolizumab within this clinical study, as long as they continued to derive benefit from treatment, until the participant experienced unacceptable toxicity or confirmed PD per iRECIST.
OG015
Alomfilimab 8 mg + Atezolizumab in Anti-PD-(L)1 Naïve HNSCC
Anti-PD-(L)1 naïve participants with HNSCC received alomfilimab 8 mg in combination with atezolizumab 1200 mg via IV infusion Q3W. The participants continued treatment with alomfilimab in combination with atezolizumab within this clinical study, as long as they continued to derive benefit from treatment, until the participant experienced unacceptable toxicity or confirmed PD per iRECIST.
OG016
Alomfilimab 24 mg + Atezolizumab in Anti-PD-(L)1 Naïve HNSCC
Anti-PD-(L)1 naïve participants with HNSCC received alomfilimab 24 mg in combination with atezolizumab 1200 mg via IV infusion Q3W. The participants continued treatment with alomfilimab in combination with atezolizumab within this clinical study, as long as they continued to derive benefit from treatment, until the participant experienced unacceptable toxicity or confirmed PD per iRECIST.
OG017
Alomfilimab 2.4 mg + Atezolizumab in Anti-PD-(L)1 Pre-treated Pancreatic Cancer
Participants with pre-treated pancreatic cancer received alomfilimab 2.4 mg in combination with atezolizumab 1200 mg via IV infusion Q3W. The participants continued treatment with alomfilimab in combination with atezolizumab within this clinical study, as long as they continued to derive benefit from treatment, until the participant experienced unacceptable toxicity or confirmed PD per iRECIST.
OG018
Alomfilimab 8 mg + Atezolizumab in Anti-PD-(L)1 Pre-treated Pancreatic Cancer
Participants with pre-treated pancreatic cancer received alomfilimab 8 mg in combination with atezolizumab 1200 mg via IV infusion Q3W. The participants continued treatment with alomfilimab in combination with atezolizumab within this clinical study, as long as they continued to derive benefit from treatment, until the participant experienced unacceptable toxicity or confirmed PD per iRECIST.
OG019
Alomfilimab 2.4 mg + Atezolizumab in Anti-PD-(L)1 Pre-treated Triple Negative BC
Participants with pre-treated triple negative BC received alomfilimab 2.4 mg in combination with atezolizumab 1200 mg via IV infusion Q3W. The participants continued treatment with alomfilimab in combination with atezolizumab within this clinical study, as long as they continued to derive benefit from treatment, until the participant experienced unacceptable toxicity or confirmed PD per iRECIST.
OG020
Alomfilimab 8 mg + Atezolizumab in Anti-PD-(L)1 Pre-treated Triple Negative BC
Participants with pre-treated triple negative BC received alomfilimab 8 mg in combination with atezolizumab 1200 mg via IV infusion Q3W. The participants continued treatment with alomfilimab in combination with atezolizumab within this clinical study, as long as they continued to derive benefit from treatment, until the participant experienced unacceptable toxicity or confirmed PD per iRECIST.
OG021
Alomfilimab 8 mg + Atezolizumab in Anti-PD-(L)1 Pre-treated HNSCC
Participants with pre-treated HNSCC received alomfilimab 8 mg in combination with atezolizumab 1200 mg via IV infusion Q3W. The participants continued treatment with alomfilimab in combination with atezolizumab within this clinical study, as long as they continued to derive benefit from treatment, until the participant experienced unacceptable toxicity or confirmed PD per iRECIST.
OG022
Alomfilimab 24 mg + Atezolizumab in Anti-PD-(L)1 Pre-treated HNSCC
Participants with pre-treated HNSCC received alomfilimab 24 mg in combination with atezolizumab 1200 mg via IV infusion Q3W. The participants continued treatment with alomfilimab in combination with atezolizumab within this clinical study, as long as they continued to derive benefit from treatment, until the participant experienced unacceptable toxicity or confirmed PD per iRECIST.
Units
Counts
Participants
OG0002
OG0013
OG0027
OG0033
OG0045
OG0053
OG0063
OG00716
OG00816
OG0093
OG0103
OG0118
OG0125
OG0134
OG0148
OG0151
OG0162
OG0170
OG0181
OG0190
OG0202
OG0211
OG0223
Title
Denominators
Categories
FOXP3-ICOS double-positive cells per mm^2 in the tumor
ParticipantsOG0002
ParticipantsOG0012
ParticipantsOG0026
ParticipantsOG0033
ParticipantsOG0045
ParticipantsOG0053
ParticipantsOG0063
ParticipantsOG00716
ParticipantsOG00814
ParticipantsOG0093
ParticipantsOG0103
ParticipantsOG0116
ParticipantsOG0125
ParticipantsOG0134
ParticipantsOG0148
ParticipantsOG0151
ParticipantsOG0162
ParticipantsOG0170
ParticipantsOG0181
ParticipantsOG0190
ParticipantsOG0202
ParticipantsOG0211
ParticipantsOG0223
Title
Measurements
OG0000.275± 5.5649
OG00121.905± 30.1015
OG002-50.323± 42.9514
OG003
CD8-positive cells per mm^2 in the tumor
ParticipantsOG0001
ParticipantsOG0013
ParticipantsOG0027
ParticipantsOG0033
CD8-positive cells per mm^2 in the invasive margin
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0022
ParticipantsOG003
0 events
0 affected
8 at risk
EG0040 events0 affected7 at risk
EG0050 events0 affected5 at risk
EG0060 events0 affected5 at risk
EG0070 events0 affected43 at risk
EG0080 events0 affected35 at risk
EG0090 events0 affected9 at risk
EG0101 events1 affected9 at risk
EG0110 events0 affected15 at risk
EG0120 events0 affected14 at risk
EG0130 events0 affected7 at risk
EG0140 events0 affected14 at risk
EG0150 events0 affected5 at risk
EG0160 events0 affected5 at risk
EG0170 events0 affected2 at risk
EG0180 events0 affected1 at risk
EG0190 events0 affected1 at risk
EG0200 events0 affected6 at risk
EG0210 events0 affected3 at risk
EG0220 events0 affected8 at risk
0 events
0 affected
8 at risk
EG0040 events0 affected7 at risk
EG0050 events0 affected5 at risk
EG0060 events0 affected5 at risk
EG0070 events0 affected43 at risk
EG0080 events0 affected35 at risk
EG0090 events0 affected9 at risk
EG0100 events0 affected9 at risk
EG0110 events0 affected15 at risk
EG0120 events0 affected14 at risk
EG0130 events0 affected7 at risk
EG0140 events0 affected14 at risk
EG0151 events1 affected5 at risk
EG0160 events0 affected5 at risk
EG0170 events0 affected2 at risk
EG0180 events0 affected1 at risk
EG0190 events0 affected1 at risk
EG0200 events0 affected6 at risk
EG0210 events0 affected3 at risk
EG0220 events0 affected8 at risk
0 events
0 affected
8 at risk
EG0041 events1 affected7 at risk
EG0051 events1 affected5 at risk
EG0060 events0 affected5 at risk
EG0072 events2 affected43 at risk
EG0080 events0 affected35 at risk
EG0090 events0 affected9 at risk
EG0100 events0 affected9 at risk
EG0110 events0 affected15 at risk
EG0121 events1 affected14 at risk
EG0130 events0 affected7 at risk
EG0140 events0 affected14 at risk
EG0150 events0 affected5 at risk
EG0160 events0 affected5 at risk
EG0170 events0 affected2 at risk
EG0180 events0 affected1 at risk
EG0190 events0 affected1 at risk
EG0200 events0 affected6 at risk
EG0210 events0 affected3 at risk
EG0220 events0 affected8 at risk
0 events
0 affected
8 at risk
EG0040 events0 affected7 at risk
EG0050 events0 affected5 at risk
EG0060 events0 affected5 at risk
EG0070 events0 affected43 at risk
EG0080 events0 affected35 at risk
EG0090 events0 affected9 at risk
EG0100 events0 affected9 at risk
EG0111 events1 affected15 at risk
EG0120 events0 affected14 at risk
EG0130 events0 affected7 at risk
EG0140 events0 affected14 at risk
EG0150 events0 affected5 at risk
EG0160 events0 affected5 at risk
EG0170 events0 affected2 at risk
EG0180 events0 affected1 at risk
EG0190 events0 affected1 at risk
EG0200 events0 affected6 at risk
EG0210 events0 affected3 at risk
EG0220 events0 affected8 at risk
0 events
0 affected
8 at risk
EG0041 events1 affected7 at risk
EG0050 events0 affected5 at risk
EG0060 events0 affected5 at risk
EG0070 events0 affected43 at risk
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BG0190
BG0200
BG0210
BG0220
BG0231
4
BG0052
BG0062
BG00723
BG00816
BG0094
BG0105
BG0119
BG0128
BG0130
BG0140
BG0155
BG0164
BG0172
BG0181
BG0190
BG0200
BG0212
BG0225
BG023104
1
BG0050
BG0060
BG0079
BG0086
BG0092
BG0103
BG0110
BG0120
BG0130
BG0141
BG0151
BG0161
BG0170
BG0180
BG0190
BG0202
BG0210
BG0221
BG02328
1
BG0050
BG0060
BG0071
BG0081
BG0091
BG0100
BG0110
BG0120
BG0130
BG0140
BG0150
BG0161
BG0170
BG0180
BG0190
BG0201
BG0212
BG0220
BG0238
0
BG0050
BG0060
BG0070
BG0080
BG0090
BG0100
BG0110
BG0120
BG0130
BG0140
BG0150
BG0160
BG0170
BG0180
BG0190
BG0200
BG0210
BG0220
BG0230
5
BG0055
BG0065
BG00730
BG00828
BG0096
BG0106
BG01114
BG01214
BG0137
BG01413
BG0154
BG0163
BG0172
BG0181
BG0191
BG0203
BG0211
BG0228
BG023181
0
BG0050
BG0060
BG0072
BG0081
BG0090
BG0100
BG0111
BG0120
BG0130
BG0140
BG0150
BG0160
BG0170
BG0180
BG0190
BG0200
BG0210
BG0220
BG0234
0
BG0050
BG0060
BG0071
BG0080
BG0090
BG0100
BG0110
BG0120
BG0130
BG0140
BG0150
BG0160
BG0170
BG0180
BG0190
BG0200
BG0210
BG0220
BG0231
0
OG0040
OG0050
OG0060
OG0070
OG0080
OG0090
OG0100
0
OG0050
OG0060
OG0073
OG0082
OG0091
OG0100
OG0110
OG0120
OG0130
OG0141
OG0150
OG0160
OG0170
OG0180
OG0190
OG0200
OG0211
OG0220
2
OG0051
OG0063
OG00712
OG0088
OG0091
OG0104
OG0116
OG0120
OG0131
OG0144
OG0152
OG0161
OG0170
OG0181
OG0190
OG0202
OG0210
OG0223
4
OG0054
OG0061
OG00720
OG00822
OG0097
OG0102
OG0119
OG01211
OG0135
OG0148
OG0152
OG0162
OG0171
OG0180
OG0191
OG0203
OG0212
OG0224
1
OG0050
OG0061
OG0077
OG0084
OG0090
OG0103
OG0110
OG0123
OG0131
OG0141
OG0151
OG0162
OG0171
OG0180
OG0190
OG0201
OG0210
OG0222
NA
(NA to NA)
Number and confidence intervals could not be calculated as all participants were not alive or survival status was unknown at this timepoint.
OG0040.0(NA to NA)Confidence intervals could not be calculated as no participants had known survival status at 24 months.
OG0050.0(NA to NA)Confidence intervals could not be calculated as no participants had known survival status at 24 months.
OG0060.0(NA to NA)Confidence intervals could not be calculated as no participants had known survival status at 24 months.
OG0070.3(0.13 to 0.43)
OG0080.3(0.11 to 0.44)
OG0090.0(NA to NA)Confidence intervals could not be calculated as no participants had known survival status at 24 months.
OG010NA(NA to NA)Number and confidence intervals could not be calculated as all participants were not alive or survival status was unknown at this timepoint.
OG0110.0(NA to NA)Confidence intervals could not be calculated as no participants had known survival status at 24 months.
OG0120.0(NA to NA)Confidence intervals could not be calculated as no participants had known survival status at 24 months.
OG0130.2(0.01 to 0.56)
OG0140.4(0.13 to 0.66)
OG015NA(NA to NA)Number and confidence intervals could not be calculated as all participants were not alive or survival status was unknown at this timepoint.
OG016NA(NA to NA)Number and confidence intervals could not be calculated as all participants were not alive or survival status was unknown at this timepoint.
OG017NA(NA to NA)Number and confidence intervals could not be calculated as all participants were not alive or survival status was unknown at this timepoint.
OG0180.0(NA to NA)Confidence intervals could not be calculated as no participants had known survival status at 24 months.
OG0190.0(NA to NA)Confidence intervals could not be calculated as no participants had known survival status at 24 months.
OG020NA(NA to NA)Number and confidence intervals could not be calculated as all participants were not alive or survival status was unknown at this timepoint.
OG021NA(NA to NA)Number and confidence intervals could not be calculated as all participants were not alive or survival status was unknown at this timepoint.
OG022NA(NA to NA)Number and confidence intervals could not be calculated as all participants were not alive or survival status was unknown at this timepoint.
2
OG0041
OG0051
OG0061
OG0070
OG0080
OG0092
OG0101
OG0114
2
OG0040
OG0051
OG0060
OG0070
OG0080
OG0090
OG0100
OG0110
8.7301
± 2.84671
OG00433.7844± 12.98646
OG005124.4294± 79.79754
OG0060.3339± 0.17905
OG0071.1201± 0.66885
OG0083.3476± 1.23416
OG0098.2597± 2.75396
OG01031.4793± 10.38008
Participants
OG004
5
ParticipantsOG0052
ParticipantsOG0063
ParticipantsOG00725
ParticipantsOG00821
ParticipantsOG0095
ParticipantsOG0106
Title
Measurements
OG0000.2671± 0.06805
OG0011.2029± 0.24583
OG0023.7461± 0.86853
OG00330.5647± 39.72256
OG00443.8045± 14.07259
OG005141.8131± 62.54794
OG0060.2840± 0.24914
OG0071.6449± 3.01380
OG0089.5099± 28.23379
OG00910.2883± 3.86029
OG01051.6622± 41.65071
226.2922
± 75.20291
OG004377.5444± 126.28273
OG005356.4297± 109.96450
OG00637.4777± 3.96733
OG00793.0339± 33.82676
OG008165.8783± 89.07566
OG009174.9685± 79.39134
OG010300.0089± 113.49910
Participants
OG004
5
ParticipantsOG0051
ParticipantsOG0060
ParticipantsOG00715
ParticipantsOG00814
ParticipantsOG0092
ParticipantsOG0105
Title
Measurements
OG00180.3268± NAStandard deviation could not be calculated as a single participant was analyzed.
OG002215.6472± 98.90118
OG003358.6064± 143.16181
OG004342.6067± 193.81667
OG005273.6673± NAStandard deviation could not be calculated as a single participant was analyzed.
OG007116.0599± 42.16269
OG008202.0099± 78.48781
OG009230.5514± 103.13822
OG010440.0235± 236.99886
1
OG0041
OG0050
OG0062
OG0079
OG0088
OG0090
OG0100
OG0111
OG0122
OG0131
OG0140
OG0153
OG0171
OG0180
OG0200
OG0211
ParticipantsOG0040
ParticipantsOG0050
ParticipantsOG0065
ParticipantsOG00736
ParticipantsOG00834
ParticipantsOG0098
ParticipantsOG0106
ParticipantsOG01113
ParticipantsOG01211
ParticipantsOG0136
ParticipantsOG01412
ParticipantsOG0155
ParticipantsOG0163
ParticipantsOG0171
ParticipantsOG0181
ParticipantsOG0190
ParticipantsOG0206
ParticipantsOG0213
ParticipantsOG0227
Title
Measurements
OG0061
OG0078
OG0088
OG0094
OG0101
OG0115
OG0122
OG0131
OG0140
OG0151
OG0160
OG0170
OG0180
OG0200
OG0211
OG0221
-42.210
± 26.6714
OG004-29.318± 28.0896
OG005-67.160± 59.7524
OG006-18.860± 33.2369
OG007-129.334± 118.3340
OG008-90.589± 115.9495
OG009-117.610± 174.4591
OG010-3.653± 6.5269
OG011-58.865± 65.7823
OG012-45.618± 34.5880
OG013-51.293± 56.8048
OG014-76.331± 63.0946
OG015-437.660± NAStandard deviation could not be calculated as a single participant was analyzed.
OG016-518.975± 668.5624
OG018-31.120± NAStandard deviation could not be calculated as a single participant was analyzed.
OG020-149.445± 137.0019
OG021-197.940± NAStandard deviation could not be calculated as a single participant was analyzed.
OG022-397.437± 307.3676
ParticipantsOG0045
ParticipantsOG0053
ParticipantsOG0063
ParticipantsOG00714
ParticipantsOG00816
ParticipantsOG0093
ParticipantsOG0102
ParticipantsOG0118
ParticipantsOG0125
ParticipantsOG0133
ParticipantsOG0148
ParticipantsOG0151
ParticipantsOG0161
ParticipantsOG0170
ParticipantsOG0181
ParticipantsOG0190
ParticipantsOG0202
ParticipantsOG0211
ParticipantsOG0223
Title
Measurements
OG000-449.920± NAStandard deviation could not be calculated as a single participant was analyzed.
OG001448.833± 443.5399
OG00247.126± 294.7947
OG003-105.110± 190.2826
OG004-11.532± 169.8503
OG005-371.857± 884.7449
OG006-218.017± 282.9603
OG007111.154± 939.3540
OG008174.339± 693.8745
OG009300.433± 325.6656
OG01021.925± 56.3211
OG011202.501± 588.9525
OG012-63.528± 65.5904
OG013318.470± 385.7782
OG014320.923± 685.1093
OG015-116.950± NAStandard deviation could not be calculated as a single participant was analyzed.
OG016-1009.800± NAStandard deviation could not be calculated as a single participant was analyzed.
OG018-34.840± NAStandard deviation could not be calculated as a single participant was analyzed.
OG020181.120± 147.3752
OG021-39.600± NAStandard deviation could not be calculated as a single participant was analyzed.
OG022171.170± 293.3937
0
ParticipantsOG0041
ParticipantsOG0050
ParticipantsOG0061
ParticipantsOG0070
ParticipantsOG0080
ParticipantsOG0091
ParticipantsOG0100
ParticipantsOG0110
ParticipantsOG0120
ParticipantsOG0130
ParticipantsOG0140
ParticipantsOG0150
ParticipantsOG0160
ParticipantsOG0170
ParticipantsOG0180
ParticipantsOG0190
ParticipantsOG0200
ParticipantsOG0210
ParticipantsOG0220
Title
Measurements
OG002-229.600± 114.8200
OG004336.140± NAStandard deviation could not be calculated as a single participant was analyzed.
OG006-422.680± NAStandard deviation could not be calculated as a single participant was analyzed.
OG009-163.910± NAStandard deviation could not be calculated as a single participant was analyzed.