A Study of Gebasaxturev (V937) in Combination With Pembro... | NCT04521621 | Trialant
NCT04521621
Sponsor
Merck Sharp & Dohme LLC
Status
Terminated
Last Update Posted
Oct 1, 2024Actual
Enrollment
76Actual
Phase
Phase 1Phase 2
Conditions
Neoplasm Metastasis
Interventions
Gebasaxturev
Pembrolizumab
Countries
United States
Canada
France
Germany
Hungary
Israel
Italy
Japan
Norway
Peru
Poland
Portugal
Spain
Taiwan
Protocol Section
Identification Module
NCT ID
NCT04521621
Obsolete or Duplicate NCT IDs
Not provided
Organization Study
V937-013
Secondary IDs
ID
Type
Description
Link
V937-013
Other Identifier
MSD
jRCT2033200191
Registry Identifier
jRCT
2020-001908-42
EudraCT Number
Brief Title
A Study of Gebasaxturev (V937) in Combination With Pembrolizumab (MK-3475) in Participants With Advanced/Metastatic Solid Tumors (V937-013)
Official Title
A Phase 1b/2 Clinical Study of Intratumoral Administration of V937 in Combination With Pembrolizumab (MK-3475) in Participants With Advanced/Metastatic Solid Tumors
Acronym
Not provided
Organization
Merck Sharp & Dohme LLCINDUSTRY
Status Module
Record Verification Date
Sep 2024
Overall Recruitment Status or Expanded Access Status
Terminated
Last Known Status
Not provided
Delayed Posting
Not provided
Why Stopped
Business Reasons
Expanded Access Info
No
Start Date
Oct 28, 2020Actual
Primary Completion Date
Jul 25, 2023Actual
Completion Date
Jul 25, 2023Actual
First Submitted Date
Aug 17, 2020
First Submission Date that Met QC Criteria
Aug 17, 2020
First Posted Date
Aug 20, 2020Actual
Results Waived
Not provided
Results First Submitted Date
Jul 12, 2024
Results First Submitted that Met QC Criteria
Jul 12, 2024
Results First Posted Date
Aug 7, 2024Actual
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
Sep 4, 2024
Last Update Posted Date
Oct 1, 2024Actual
Sponsor/Collaborators Module
Responsible Party, by Official Title
Sponsor
Lead Sponsor
Merck Sharp & Dohme LLCINDUSTRY
Collaborators
Not provided
Oversight Module
Has Data Monitoring Committee (DMC)
No
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
The purpose of this study is to evaluate the safety, tolerability, and efficacy in participants with advanced/metastatic or recurrent malignancies who receive gebasaxturev (V937) in combination with pembrolizumab (MK-3475). The primary objective for Part 1 is to evaluate the objective response rate, and the primary objective for Part 2 is to determine the safety and tolerability of gebasaxturev administered in combination with pembrolizumab. With Amendment 4, this study will be terminated once all participants who have completed or discontinued gebasaxturev treatment and are only receiving pembrolizumab may be enrolled in a pembrolizumab extension study, if available, to continue pembrolizumab monotherapy for up to 35 cycles from first pembrolizumab dose on V937-013.
Detailed Description
Not provided
Conditions Module
Conditions
Neoplasm Metastasis
Keywords
Programmed Cell Death-1 (PD1, PD-1)
Programmed Death-Ligand 1 (PDL1, PD-L1)
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
76Actual
Arms/Interventions Module
Arm Groups
Label
Type
Description
Intervention Names
Part 1, Cohort A: Triple-Negative Breast Cancer
Experimental
This arm will enroll participants with triple-negative breast cancer (TNBC) solid tumors. Participants receive 3 X 10^8 50% tissue culture infectious dose (TCID50) of gebasaxturev intratumorally for 8 cycles, and pembrolizumab intravenously for a maximum of 35 cycles. Cycle 1 is 28 days, and cycles 2-35 are 21 days.
Biological: Gebasaxturev
Drug: Pembrolizumab
Part 1, Cohort B: Head and Neck Squamous Cell Carcinoma
Experimental
This arm will enroll participants with head and neck squamous cell carcinoma (HNSCC) solid tumors. Participants receive 3 X 10^8 TCID50 of gebasaxturev intratumorally for 8 cycles, and pembrolizumab intravenously for a maximum of 35 cycles. Cycle 1 is 28 days, and cycles 2-35 are 21 days.
Biological: Gebasaxturev
Drug: Pembrolizumab
Part 1, Cohort C: Cutaneous Squamous Cell Carcinoma
Experimental
This arm will enroll participants with cutaneous squamous cell carcinoma (cSCC) solid tumors. Participants receive 3 X 10^8 TCID50 of gebasaxturev intratumorally for 8 cycles, and pembrolizumab intravenously for a maximum of 35 cycles. Cycle 1 is 28 days, and cycles 2-35 are 21 days.
Biological: Gebasaxturev
Drug: Pembrolizumab
Part 2 Dose Level 1, Solid Tumors + Liver Metastases
Experimental
This arm will enroll participants with solid tumors with liver metastases. Participants receive 3 X 10^7 TCID50 of gebasaxturev intratumorally for 8 cycles, and pembrolizumab intravenously for a maximum of 35 cycles. Cycle 1 is 28 days, and cycles 2-35 are 21 days.
Interventions
Name
Type
Description
Arm Group Labels
Other Names
Gebasaxturev
Biological
Participants receive gebasaxturev intratumorally for 1 28-day cycle followed by 7 21-day cycles.
Part 1, Cohort A: Triple-Negative Breast Cancer
Outcomes Module
Primary Outcomes
Measure
Description
Time Frame
Part 1: Objective Response Rate (ORR) Per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 as Assessed by Investigator
ORR was defined as the percentage of participants in the analysis population who had a Complete Response (CR: Disappearance of all target lesions and no new lesions) or a Partial Response (PR: ≥30% decrease in the sum of diameters of target lesions) per RECIST 1.1 as assessed by investigator. For this study, RECIST 1.1 has been modified to follow a maximum of 10 target lesions and a maximum of 5 target lesions per organ, and to specify that intratumoral injection does not render a lesion non-evaluable. Per protocol, only participants in Part 1 were analyzed in this outcome measure.
Up to approximately 30 months
Number of Participants Who Experienced a Dose-Limiting Toxicity (DLT)
The following toxicities during DLT evaluation period were considered a DLT, if assessed by investigator to be possibly, probably, or definitely related to treatment: Grade (Gr) 4 nonhematologic toxicity; Gr 4 hematologic toxicity lasting ≥7 days, except Gr 3 thrombocytopenia (if associated with clinically significant bleeding) or any grade febrile neutropenia; nonhematologic adverse event (AE) ≥ Gr 3 (with exceptions); Gr 3 or 4 nonhematologic lab abnormality (if medical intervention is required, leads to hospitalization, or persists for >1 week); drug-related toxicity that causes a >2 week delay in Cycle 2 initiation; drug-related toxicity that causes treatment discontinuation or missed dosage of gebasaxturev; or Gr 5 toxicity. Per protocol, only the participants in Part 2 were analyzed in this outcome measure.
Cycle 1 (28-day cycle)
Part 2: Number of Participants Who Experienced One or More Adverse Events (AEs)
An AE is defined as any unfavorable and unintended sign, symptom, disease, or worsening of preexisting condition temporally associated with study treatment and irrespective of causality to study treatment. Per protocol, only participants in Part 2 were analyzed in this outcome measure.
Up to approximately 29 months
Part 2: Number of Participants Who Discontinued Study Intervention Due to an AE
Secondary Outcomes
Measure
Description
Time Frame
Part 1: Number of Participants Who Experienced One or More AEs
An AE was defined as any unfavorable and unintended sign, symptom, disease, or worsening of preexisting condition temporally associated with study treatment and irrespective of causality to study treatment. Per protocol, only participants in Part 1 were analyzed in this outcome measure.
Up to approximately 30 months
Other Outcomes
Not provided
Eligibility Module
Eligibility Criteria
Inclusion Criteria:
Locally-advanced disease that is not amenable to surgery or radiation, or Stage IV advanced/metastatic solid tumor malignancies
Histologically- or cytologically-confirmed diagnosis of an advanced/metastatic solid tumor.
Measurable disease by RECIST 1.1 criteria as assessed by investigator. Target lesions in a previously irradiated area will be considered measurable if progression has been demonstrated in such lesions
Submitted a baseline tumor sample for analysis. Participants enrolling in Part 2 Cohorts D-F may enroll without submitting a tumor sample if all other enrollment criteria are met.
Performance status of 0 or 1 on the Eastern Cooperative Oncology Group (ECOG) Performance Scale obtained within 72 hours prior to the first dose of study intervention
If participant has known human immunodeficiency virus (HIV)-positive disease, participant must have well-controlled HIV on antiretroviral therapy (ART), per study criteria.
Adequate organ function
Male participants are eligible to participate if they agree to the following during the intervention period and for at least 120 days: Be abstinent from heterosexual intercourse as their preferred and usual lifestyle and agree to remain abstinent, OR must agree to use contraception unless confirmed to be azoospermic.
Female participants are eligible to participate if not pregnant or breastfeeding, and at least one of the following conditions applies:
Is not a woman of childbearing potential (WOCBP)
Is a WOCBP and using a contraceptive method that is highly effective, or be abstinent from heterosexual intercourse as their preferred and usual lifestyle (abstinent on a long term and persistent basis), during the intervention period and for at least 120 days after the last dose of study intervention.
Contraceptive use by women should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies.
Part 1, All Cohorts: participants must have at least one injectable lesion amenable to injection and/or biopsy.
Part 1, Cohort A:
Locally recurrent, inoperable OR metastatic breast cancer treated with at least 1 prior line of therapy in the metastatic setting with skin involvement and/or subcutaneous lesions or accessible lymph nodes amenable to local injection. An exception would be allowed for participants who are not eligible to receive chemotherapy.
Diagnosis of triple-negative breast cancer (estrogen receptor, progesterone receptor, and HER2-receptor negative status)
Part 1, Cohort B:
Histologically confirmed advanced or metastatic head and neck squamous cell carcinoma (HNSCC) of the oral cavity, oropharynx, hypopharynx, and/or larynx considered incurable and/or treated with no more than 1 previous line of therapy
Tumors must be PD-L1+
Documentation of HPV status for oropharyngeal cancers. Other HNSCC subtypes may submit HPV testing, but is not required.
Part 1, Cohort C:
Histologically confirmed cutaneous squamous cell carcinoma (cSCC) as the primary site of malignancy
Recurrent/metastatic disease only: Has metastatic disease defined as disseminated disease distant from the initial/primary site of diagnosis and/or with a history of locally-recurrent disease previously treated with surgery and/or radiotherapy, which is now incurable
Locally-advanced disease only: Must be ineligible for surgical resection per study criteria, and must have received prior radiation therapy to the index site or deemed ineligible for radiation therapy
Part 2, Solid Tumors+Liver Metastases Dose Level 1-3 arms:
Histologically-confirmed advanced/metastatic solid tumor that has progressed on all treatment known to confer clinical benefit
Metastatic liver lesion(s) not exceeding one-third of the total liver volume AND a minimum of one injectable liver lesion
Part 2, Cohort D:
Advanced hepatocellular carcinoma (HCC) following progression on, or intolerance to, sorafenib or lenvatinib with no curative options
Diagnosis of HCC confirmed by radiology, histology, or cytology
Child-Pugh Class A score
If a participant has a history of hepatitis C virus (HCV) infection, then the participant must have been successfully treated for this condition
Controlled (treated) hepatitis B participants will be allowed if they meet protocol-specified criteria
Participants who are anti-hepatitis B core (HBc) positive, negative for hepatitis B surface antigen (HBsAg), negative or positive for anti-hepatitis B surface (HBs), and who have an HBV viral load under 100 IU/mL, do not require HBV anti-viral prophylaxis
Part 2, Cohort E:
Histologically- or cytologically-confirmed diagnosis of locally advanced, unresectable or metastatic gastric or gastroesophageal junction (GEJ) adenocarcinoma
Received at least one prior line of therapy that includes a platinum/fluoropyrimidine doublet or triplet regimen
Had proven clinical progression 6 months following (or during) last dose of adjuvant or neo-adjuvant therapy
Human epidermal growth factor receptor 2 (HER2) negative status; or, those with HER2 positive status AND documented disease progression on a prior regimen containing trastuzumab
Exclusion Criteria:
Chemotherapy, definitive radiation, or biological cancer therapy within 4 weeks (2 weeks for palliative radiation) prior to first dose of study intervention, or has not recovered to Common Terminology Criteria for Adverse Events (CTCAE) Grade 1 or better
If major or minor surgery was performed at/near the area being considered for injection, participant must be recovered from toxicity and/or complications of intervention
If participant has had injection or radiation therapy, participant must be recovered from toxicity and/or complications of intervention
History of second malignancy, unless potentially curative treatment has been completed with no further evidence of disease for ≥5 years.
Known active central nervous system (CNS) metastases and/or carcinomatous meningitis. Participants with treated brain metastases may participate if lesions are radiologically stable.
Active infection requiring therapy, except HIV criteria as stated above, and HBV and HCV criteria for HCC cohort as stated above
History of interstitial lung disease
History of noninfectious pneumonitis requiring active steroid therapy or ongoing pneumonitis
Active autoimmune disease that required systemic treatment in the past 2 years except vitiligo or resolved childhood asthma/atopy
Known Hepatitis B or C infections or known to be positive for HBsAg/HBV deoxyribonucleic acid (DNA) or Hepatitis C Antibody or ribonucleic acid (RNA)
History of Kaposi's sarcoma and/or Multicentric Castleman's Disease
Known hypersensitivity to gebasaxturev and/or pembrolizumab or any of their excipients
Received prior therapy with anti-programmed cell death protein-1 (anti-PD-1), anti-programmed cell death-ligand 1 (anti-PD-L1) agents, Talimogene Laherparepvec (T-VEC), or any other oncolytic virus therapies
Received a live or live-attenuated vaccine within 30 days prior to first dose of study intervention. Administration of killed vaccines is allowed.
Pregnant or breastfeeding or expecting to conceive or father children within the projected duration of the study, starting with the screening visit through 120 days after the last dose of study intervention
Part 2, Cohort D:
Has had esophageal or gastric variceal bleeding within the last 6 months
Has had clinically diagnosed hepatic encephalopathy in the 6 months prior to initiation of study intervention
Deng JZ, Rustandi RR, Barbacci D, Swartz AR, Gulasarian A, Loughney JW. Reverse-Phase Ultra-Performance Chromatography Method for Oncolytic Coxsackievirus Viral Protein Separation and Empty to Full Capsid Quantification. Hum Gene Ther. 2022 Jul;33(13-14):765-775. doi: 10.1089/hum.2022.013. Epub 2022 Jun 1.
76 participants were allocated and 75 participants received study intervention. The study was terminated before any participants were enrolled into Cohorts D and E.
Recruitment Details
Not provided
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
FG000
Part 1, Cohort A: Triple-Negative Breast Cancer
Participants with triple-negative breast cancer (TNBC) solid tumors received 3 X 10^8 50% tissue culture infectious dose (TCID50) of gebasaxturev intratumorally for 8 cycles, and pembrolizumab intravenously for a maximum of 35 cycles. Cycle 1 was 28 days, and cycles 2-35 were 21 days.
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_SAP
Yes
Yes
No
Study Protocol and Statistical Analysis Plan
Oct 25, 2022
Derived Section
Miscellaneous Info Module
Version Holder
Jul 10, 2026
Removed Countries
Not provided
Submission Tracking
No data available
No data is available for this block.
Condition Browse Module
MeSH Terms
Intervention Browse Module
MeSH Terms
Non-Randomized
Intervention Model
Parallel 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
Biological: Gebasaxturev
Drug: Pembrolizumab
Part 2 Dose Level 2, Solid Tumors + Liver Metastases
Experimental
This arm will enroll participants with solid tumors with liver metastases. Participants receive 1 X 10^8 TCID50 of gebasaxturev intratumorally for 8 cycles, and pembrolizumab intravenously for a maximum of 35 cycles. Cycle 1 is 28 days, and cycles 2-35 are 21 days.
Biological: Gebasaxturev
Drug: Pembrolizumab
Part 2 Dose Level 3, Solid Tumors + Liver Metastases
Experimental
This arm will enroll participants with solid tumors with liver metastases. Participants receive 3 X 10^8 TCID50 of gebasaxturev intratumorally for 8 cycles, and pembrolizumab intravenously for a maximum of 35 cycles. Cycle 1 is 28 days, and cycles 2-35 are 21 days.
Biological: Gebasaxturev
Drug: Pembrolizumab
Part 2, Cohort D: Hepatocellular Carcinoma (HCC)
Experimental
This arm will enroll participants with hepatocellular carcinoma (HCC) solid tumors. Participants receive the gebasaxturev recommended phase 2 dose (RP2D) intratumorally for 8 cycles, and pembrolizumab intravenously for a maximum of 35 cycles. Cycle 1 is 28 days, and cycles 2-35 are 21 days.
Biological: Gebasaxturev
Drug: Pembrolizumab
Part 2, Cohort E: Gastric Carcinoma
Experimental
This arm will enroll participants with gastric carcinoma solid tumors. Participants receive the gebasaxturev recommended phase 2 dose (RP2D) intratumorally for 8 cycles, and pembrolizumab intravenously for a maximum of 35 cycles. Cycle 1 is 28 days, and cycles 2-35 are 21 days.
Biological: Gebasaxturev
Drug: Pembrolizumab
Part 1, Cohort B: Head and Neck Squamous Cell Carcinoma
Part 1, Cohort C: Cutaneous Squamous Cell Carcinoma
Part 2 Dose Level 1, Solid Tumors + Liver Metastases
Part 2 Dose Level 2, Solid Tumors + Liver Metastases
Part 2 Dose Level 3, Solid Tumors + Liver Metastases
Part 2, Cohort D: Hepatocellular Carcinoma (HCC)
Part 2, Cohort E: Gastric Carcinoma
Coxsackievirus A21 (CVA21)
Formerly known as CAVATAK®
CAV21
V937
Pembrolizumab
Drug
Participants receive pembrolizumab intravenously for 1 28-day cycle followed by 34 21-day cycles.
Part 1, Cohort A: Triple-Negative Breast Cancer
Part 1, Cohort B: Head and Neck Squamous Cell Carcinoma
Part 1, Cohort C: Cutaneous Squamous Cell Carcinoma
Part 2 Dose Level 1, Solid Tumors + Liver Metastases
Part 2 Dose Level 2, Solid Tumors + Liver Metastases
Part 2 Dose Level 3, Solid Tumors + Liver Metastases
Part 2, Cohort D: Hepatocellular Carcinoma (HCC)
Part 2, Cohort E: Gastric Carcinoma
MK-3475
KEYTRUDA®
An AE was defined as any unfavorable and unintended sign, symptom, disease, or worsening of preexisting condition temporally associated with study treatment and irrespective of causality to study treatment. Per protocol, only participants in Part 2 were analyzed in this outcome measure.
Up to approximately 10 months
Part 1: Number of Participants Who Discontinued Study Intervention Due to an AE
An AE was defined as any unfavorable and unintended sign, symptom, disease, or worsening of preexisting condition temporally associated with study treatment and irrespective of causality to study treatment. Per protocol, only participants in Part 1 were analyzed in this outcome measure.
Up to approximately 23 months
Progression-Free Survival (PFS) Per RECIST 1.1 as Assessed by Investigator
PFS was defined as the time from first dose of study treatment to the first documented progressive disease (PD) or death due to any cause, whichever occurs first as assessed by investigator. Per RECIST 1.1, PD is defined as ≥20% increase in the sum of diameters of target lesions. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of ≥5 mm. The appearance of one or more new lesions is also considered PD. For this study, RECIST 1.1 has been modified to follow a maximum of 10 target lesions and a maximum of 5 target lesions per organ, and to specify that intratumoral injection does not render a lesion non-evaluable. Per protocol, only participants in Part 1 were analyzed in this outcome measure.
Up to approximately 30 months
Duration of Response (DOR) Per RECIST 1.1 as Assessed by Investigator
For participants who demonstrated a confirmed Complete Response (CR: Disappearance of all target lesions) or a Partial Response (PR: ≥30% decrease in the sum of diameters of target lesions) per RECIST 1.1 as assessed by investigator, DOR was defined as the time from first documented evidence of CR or PR until disease progression or death, whichever occurs first. For this study, RECIST 1.1 was modified to follow a maximum of 10 target lesions and a maximum of 5 target lesions per organ, and to specify that intratumoral injection did not render a lesion non-evaluable. Per protocol, only participants in Part 1 were analyzed in this outcome measure.
Up to approximately 30 months
PFS Per Response Evaluation Criteria in Solid Tumors 1.1 for Immune-Based Therapeutics (iRECIST) as Assessed by Investigator
PFS was defined as the time from first dose of study treatment to the first documented immune-based confirmed progressive disease (iCPD) or death due to any cause, whichever occurs first as assessed by investigator. Per iRECIST, iCPD was defined as worsening of any existing cause of progression, or the appearance of any other cause of progression, relative to the initial appearance of progressive disease by RECIST 1.1. Per protocol, only participants in Part 1 were analyzed in this outcome measure.
Up to approximately 30 months
DOR Per iRECIST as Assessed by Investigator
For participants who demonstrated confirmed CR (disappearance of all target lesions and non-target lesions) or PR (≥30% decrease in the sum of diameters of target lesions) per RECIST 1.1 or immune-based Complete Response (iCR: Disappearance of all target lesions) or immune-based Partial Response (iPR: ≥30% decrease in the sum of diameters of target lesions) after a single PD per iRECIST, DOR was defined as the time from the first documented CR or PR, or iCR or an iPR, as assessed by investigator, until progressive disease or death, whichever occurs first. For this study, RECIST 1.1 was modified to follow a maximum of 10 target lesions and a maximum of 5 target lesions per organ, and to specify that intratumoral injection did not render a lesion non-evaluable. Per protocol, only participants in Part 1 were analyzed in this outcome measure.
Up to approximately 30 months
ORR Per iRECIST as Assessed by Investigator
ORR was defined as the percentage of participants who had confirmed responses assessed using RECIST 1.1 before PD or an immune-based Complete Response (iCR: Disappearance of all target lesions) or an immune-based Partial Response (iPR: ≥30% decrease in the sum of diameters of target lesions) after a single PD per iRECIST as assessed by investigator.
Up to approximately 30 months
Overall Survival (OS)
OS was defined as the time from first dose of study intervention to death due to any cause. Per protocol, only participants in Part 1 were analyzed in this outcome measure.
Up to approximately 30 months
Part 2: ORR Per RECIST 1.1 as Assessed by Investigator
ORR was defined as the percentage of participants in the analysis population who had a Complete Response (CR: Disappearance of all target lesions and no new lesions) or a Partial Response (PR: ≥30% decrease in the sum of diameters of target lesions) per RECIST 1.1 as assessed by investigator. For this study, RECIST 1.1 was modified to follow a maximum of 10 target lesions and a maximum of 5 target lesions per organ, and to specify that intratumoral injection does not render a lesion non-evaluable. Per protocol, only participants in Part 2 were analyzed for this outcome measure.
Up to approximately 29 months
Portland
Oregon
97213
United States
Princess Margaret Cancer Centre ( Site 0031)
Toronto
Ontario
M5G 2M9
Canada
Centre Hospitalier de l Universite de Montreal - CHUM ( Site 0032)
Universitaetsklinikum Heidelberg-Nationales Centrum für Tumorerkrankungen ( Site 0172)
Heidelberg
Baden-Wurttemberg
69120
Germany
Universitaetsklinikum Tuebingen ( Site 0171)
Tübingen
Baden-Wurttemberg
72076
Germany
Orszagos Onkologiai Intezet ( Site 0070)
Budapest
1122
Hungary
HaEmek Medical Center ( Site 0071)
Afula
1834111
Israel
Hadassah Medical Center. Ein Kerem ( Site 0072)
Jerusalem
9112001
Israel
Sourasky Medical Center ( Site 0073)
Tel Aviv
6423906
Israel
Istituto Europeo di Oncologia IRCCS-Divisione di Sviluppo di Nuovi Farmaci per Terapie Innovative (
Milan
20141
Italy
National Cancer Center Hospital East ( Site 0166)
Kashiwa
Chiba
277-8577
Japan
Helse Bergen HF - Haukeland Universitetssykehus ( Site 0162)
Bergen
Hordaland
5021
Norway
Oslo Universitetssykehus Radiumhospitalet ( Site 0161)
Oslo
0379
Norway
Clinica San Gabriel ( Site 0097)
Lima
15087
Peru
Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie - P-Oddzial Badan Wczesnych Faz ( Site 0181
Warsaw
Masovian Voivodeship
02-781
Poland
Centro Hospitalar Universitário Lisboa Norte, E.P.E. - Hospital de Santa Maria ( Site 0192)
Lisbon
Lisbon District
1649-035
Portugal
Instituto Português de Oncologia do Porto Francisco Gentil, EPE ( Site 0191)
Porto
4200-072
Portugal
Hospital Universitari Vall d Hebron ( Site 0121)
Barcelona
08035
Spain
Clinica Universitaria de Navarra ( Site 0122)
Madrid
28027
Spain
Chang Gung Medical Foundation - Kaohsiung ( Site 0145)
Kaohsiung City
833
Taiwan
China Medical University Hospital ( Site 0144)
Taichung
40447
Taiwan
National Cheng Kung University Hospital ( Site 0142)
Tainan
704
Taiwan
National Taiwan University Hospital ( Site 0141)
Taipei
10002
Taiwan
Mackay Memorial Hospital ( Site 0143)
Taipei
10449
Taiwan
Chang Gung Memorial Hospital - Linkou Branch ( Site 0146)
Taoyuan
333
Taiwan
FG001
Part 1, Cohort B: Head and Neck Squamous Cell Carcinoma
Participants with head and neck squamous cell carcinoma (HNSCC) solid tumors received 3 X 10^8 TCID50 of gebasaxturev intratumorally for 8 cycles, and pembrolizumab intravenously for a maximum of 35 cycles. Cycle 1 was 28 days, and cycles 2-35 were 21 days.
FG002
Part 1, Cohort C: Cutaneous Squamous Cell Carcinoma
Participants with cutaneous squamous cell carcinoma (cSCC) solid tumors received 3 X 10^8 TCID50 of gebasaxturev intratumorally for 8 cycles, and pembrolizumab intravenously for a maximum of 35 cycles. Cycle 1 was 28 days, and cycles 2-35 were 21 days.
FG003
Part 2 Dose Level 1, Solid Tumors + Liver Metastases
Participants with solid tumors with liver metastases received 3 X 10^7 TCID50 of gebasaxturev intratumorally for 8 cycles, and pembrolizumab intravenously for a maximum of 35 cycles. Cycle 1 was 28 days, and cycles 2-35 were 21 days.
FG004
Part 2 Dose Level 2, Solid Tumors + Liver Metastases
Participants with solid tumors with liver metastases received 1 X 10^8 TCID50 of gebasaxturev intratumorally for 8 cycles, and pembrolizumab intravenously for a maximum of 35 cycles. Cycle 1 was 28 days, and cycles 2-35 were 21 days.
FG005
Part 2 Dose Level 3, Solid Tumors + Liver Metastases
Participants with solid tumors with liver metastases received 3 X 10^8 TCID50 of gebasaxturev intratumorally for 8 cycles, and pembrolizumab intravenously for a maximum of 35 cycles. Cycle 1 was 28 days, and cycles 2-35 were 21 days.
FG006
Part 2, Cohort D: Hepatocellular Carcinoma (HCC)
Participants with hepatocellular carcinoma (HCC) solid tumors received the gebasaxturev recommended phase 2 dose (RP2D) intratumorally for 8 cycles, and pembrolizumab intravenously for a maximum of 35 cycles. Cycle 1 was 28 days, and cycles 2-35 were 21 days. No participants were enrolled into this arm.
FG007
Part 2, Cohort E: Gastric Carcinoma
Participants with gastric carcinoma solid tumors received the gebasaxturev recommended phase 2 dose (RP2D) intratumorally for 8 cycles, and pembrolizumab intravenously for a maximum of 35 cycles. Cycle 1 was 28 days, and cycles 2-35 were 21 days. No participants were enrolled into this arm.
FG00022 subjects
FG00114 subjects
FG00217 subjects
FG0036 subjects
FG0043 subjects
FG00514 subjects
FG0060 subjects
FG0070 subjects
Treated
FG00021 subjects
FG00114 subjects
FG00217 subjects
FG0036 subjects
FG0043 subjects
FG00514 subjects
FG0060 subjects
FG0070 subjects
COMPLETED
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG0040 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
NOT COMPLETED
FG00022 subjects
FG00114 subjects
FG00217 subjects
FG0036 subjects
FG0043 subjects
FG00514 subjects
FG0060 subjects
FG0070 subjects
Type
Comment
Reasons
Death
FG00017 subjects
FG0018 subjects
FG0028 subjects
FG0035 subjects
FG0042 subjects
FG0057 subjects
FG0060 subjects
FG0070 subjects
Study Terminated by Sponsor
FG0004 subjects
FG0016 subjects
FG0028 subjects
FG0030 subjects
FG004
Withdrawal by Subject
FG0000 subjects
FG0010 subjects
FG0021 subjects
FG0031 subjects
FG004
Allocated in error without study intervention
FG0001 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
No participants were enrolled in Part 2 Cohort D or Part 2 Cohort E arms due to early study termination.
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
BG000
Part 1, Cohort A: Triple-Negative Breast Cancer
Participants with triple-negative breast cancer (TNBC) solid tumors received 3 X 10^8 50% tissue culture infectious dose (TCID50) of gebasaxturev intratumorally for 8 cycles, and pembrolizumab intravenously for a maximum of 35 cycles. Cycle 1 was 28 days, and cycles 2-35 were 21 days.
BG001
Part 1, Cohort B: Head and Neck Squamous Cell Carcinoma
Participants with head and neck squamous cell carcinoma (HNSCC) solid tumors received 3 X 10^8 TCID50 of gebasaxturev intratumorally for 8 cycles, and pembrolizumab intravenously for a maximum of 35 cycles. Cycle 1 was 28 days, and cycles 2-35 were 21 days.
BG002
Part 1, Cohort C: Cutaneous Squamous Cell Carcinoma
Participants with cutaneous squamous cell carcinoma (cSCC) solid tumors received 3 X 10^8 TCID50 of gebasaxturev intratumorally for 8 cycles, and pembrolizumab intravenously for a maximum of 35 cycles. Cycle 1 was 28 days, and cycles 2-35 were 21 days.
BG003
Part 2 Dose Level 1, Solid Tumors + Liver Metastases
Participants with solid tumors with liver metastases received 3 X 10^7 TCID50 of gebasaxturev intratumorally for 8 cycles, and pembrolizumab intravenously for a maximum of 35 cycles. Cycle 1 was 28 days, and cycles 2-35 were 21 days.
BG004
Part 2 Dose Level 2, Solid Tumors + Liver Metastases
Participants with solid tumors with liver metastases received 1 X 10^8 TCID50 of gebasaxturev intratumorally for 8 cycles, and pembrolizumab intravenously for a maximum of 35 cycles. Cycle 1 was 28 days, and cycles 2-35 were 21 days.
BG005
Part 2 Dose Level 3, Solid Tumors + Liver Metastases
Participants with solid tumors with liver metastases received 3 X 10^8 TCID50 of gebasaxturev intratumorally for 8 cycles, and pembrolizumab intravenously for a maximum of 35 cycles. Cycle 1 was 28 days, and cycles 2-35 were 21 days.
BG006
Total
Total of all reporting groups
Denominators
Units
Counts
Participants
BG00022
BG00114
BG00217
BG0036
BG0043
BG00514
BG00676
Baseline Measures
Title
Description
Population Description
Parameter Type
Dispersion Type
Unit of Measure
Calculate Percentage
Denominator Units Selected
Denominators
Classes
Age, Continuous
Mean
Standard Deviation
years
Title
Denominators
Categories
Title
Measurements
BG00055.5± 11.5
BG00159.7± 13.1
BG00280.6± 12.8
BG003
Sex: Female, Male
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
Female
BG00022
BG0012
BG002
Ethnicity (NIH/OMB)
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
Hispanic or Latino
BG0004
BG0010
BG002
Race (NIH/OMB)
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
American Indian or Alaska Native
BG0000
BG0010
BG002
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
Part 1: Objective Response Rate (ORR) Per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 as Assessed by Investigator
ORR was defined as the percentage of participants in the analysis population who had a Complete Response (CR: Disappearance of all target lesions and no new lesions) or a Partial Response (PR: ≥30% decrease in the sum of diameters of target lesions) per RECIST 1.1 as assessed by investigator. For this study, RECIST 1.1 has been modified to follow a maximum of 10 target lesions and a maximum of 5 target lesions per organ, and to specify that intratumoral injection does not render a lesion non-evaluable. Per protocol, only participants in Part 1 were analyzed in this outcome measure.
The analysis population consisted of all allocated participants in Part 1 with a baseline scan that demonstrated measurable disease and who received at least 1 dose of study intervention. Cohorts D and E in Part 2 did not enroll any participants.
Posted
Number
95% Confidence Interval
Percentage of Participants
Up to approximately 30 months
ID
Title
Description
OG000
Part 1, Cohort A: Triple-Negative Breast Cancer
Participants with triple-negative breast cancer (TNBC) solid tumors received 3 X 10^8 50% tissue culture infectious dose (TCID50) of gebasaxturev intratumorally for 8 cycles, and pembrolizumab intravenously for a maximum of 35 cycles. Cycle 1 was 28 days, and cycles 2-35 were 21 days.
OG001
Part 1, Cohort B: Head and Neck Squamous Cell Carcinoma
Participants with head and neck squamous cell carcinoma (HNSCC) solid tumors received 3 X 10^8 TCID50 of gebasaxturev intratumorally for 8 cycles, and pembrolizumab intravenously for a maximum of 35 cycles. Cycle 1 was 28 days, and cycles 2-35 were 21 days.
OG002
Part 1, Cohort C: Cutaneous Squamous Cell Carcinoma
Participants with cutaneous squamous cell carcinoma (cSCC) solid tumors received 3 X 10^8 TCID50 of gebasaxturev intratumorally for 8 cycles, and pembrolizumab intravenously for a maximum of 35 cycles. Cycle 1 was 28 days, and cycles 2-35 were 21 days.
OG003
Part 2 Dose Level 1, Solid Tumors + Liver Metastases
Participants with solid tumors with liver metastases received 3 X 10^7 TCID50 of gebasaxturev intratumorally for 8 cycles, and pembrolizumab intravenously for a maximum of 35 cycles. Cycle 1 was 28 days, and cycles 2-35 were 21 days.
OG004
Part 2 Dose Level 2, Solid Tumors + Liver Metastases
Participants with solid tumors with liver metastases received 1 X 10^8 TCID50 of gebasaxturev intratumorally for 8 cycles, and pembrolizumab intravenously for a maximum of 35 cycles. Cycle 1 was 28 days, and cycles 2-35 were 21 days.
OG005
Part 2 Dose Level 3, Solid Tumors + Liver Metastases
Participants with solid tumors with liver metastases received 3 X 10^8 TCID50 of gebasaxturev intratumorally for 8 cycles, and pembrolizumab intravenously for a maximum of 35 cycles. Cycle 1 was 28 days, and cycles 2-35 were 21 days.
Units
Counts
Participants
OG00021
OG00114
OG00217
OG003
Title
Denominators
Categories
Title
Measurements
OG0000.0(0.0 to 16.1)
OG00135.7(12.8 to 64.9)
OG00264.7(38.3 to 85.8)
Primary
Number of Participants Who Experienced a Dose-Limiting Toxicity (DLT)
The following toxicities during DLT evaluation period were considered a DLT, if assessed by investigator to be possibly, probably, or definitely related to treatment: Grade (Gr) 4 nonhematologic toxicity; Gr 4 hematologic toxicity lasting ≥7 days, except Gr 3 thrombocytopenia (if associated with clinically significant bleeding) or any grade febrile neutropenia; nonhematologic adverse event (AE) ≥ Gr 3 (with exceptions); Gr 3 or 4 nonhematologic lab abnormality (if medical intervention is required, leads to hospitalization, or persists for >1 week); drug-related toxicity that causes a >2 week delay in Cycle 2 initiation; drug-related toxicity that causes treatment discontinuation or missed dosage of gebasaxturev; or Gr 5 toxicity. Per protocol, only the participants in Part 2 were analyzed in this outcome measure.
The analysis population included all allocated participants in Part 2 who received at least 1 dose of study treatment who met the criteria for DLT evaluability (e.g. finished Cycle 1 without a DLT or experienced a DLT in Cycle 1). Cohorts D and E in Part 2 did not enroll any participants.
Posted
Count of Participants
Participants
Cycle 1 (28-day cycle)
ID
Title
Description
OG000
Part 1, Cohort A: Triple-Negative Breast Cancer
Participants with triple-negative breast cancer (TNBC) solid tumors. Participants received 3 X 10^8 50% tissue culture infectious dose (TCID50) of gebasaxturev intratumorally for 8 cycles, and pembrolizumab intravenously for a maximum of 35 cycles. Cycle 1 was 28 days, and cycles 2-35 were 21 days.
Primary
Part 2: Number of Participants Who Experienced One or More Adverse Events (AEs)
An AE is defined as any unfavorable and unintended sign, symptom, disease, or worsening of preexisting condition temporally associated with study treatment and irrespective of causality to study treatment. Per protocol, only participants in Part 2 were analyzed in this outcome measure.
The analysis population included all allocated participants in Part 2 who received study intervention. Cohorts D and E in Part 2 did not enroll any participants.
Posted
Count of Participants
Participants
Up to approximately 29 months
ID
Title
Description
OG000
Part 1, Cohort A: Triple-Negative Breast Cancer
Participants with triple-negative breast cancer (TNBC) solid tumors. Participants received 3 X 10^8 50% tissue culture infectious dose (TCID50) of gebasaxturev intratumorally for 8 cycles, and pembrolizumab intravenously for a maximum of 35 cycles. Cycle 1 was 28 days, and cycles 2-35 were 21 days.
OG001
Part 1, Cohort B: Head and Neck Squamous Cell Carcinoma
Participants with head and neck squamous cell carcinoma (HNSCC) solid tumors received 3 X 10^8 TCID50 of gebasaxturev intratumorally for 8 cycles, and pembrolizumab intravenously for a maximum of 35 cycles. Cycle 1 was 28 days, and cycles 2-35 were 21 days.
OG002
Primary
Part 2: Number of Participants Who Discontinued Study Intervention Due to an AE
An AE was defined as any unfavorable and unintended sign, symptom, disease, or worsening of preexisting condition temporally associated with study treatment and irrespective of causality to study treatment. Per protocol, only participants in Part 2 were analyzed in this outcome measure.
The analysis population included all allocated participants in Part 2 who received study intervention. Cohorts D and E in Part 2 did not enroll any participants.
Posted
Count of Participants
Participants
Up to approximately 10 months
ID
Title
Description
OG000
Part 1, Cohort A: Triple-Negative Breast Cancer
Participants with triple-negative breast cancer (TNBC) solid tumors. Participants received 3 X 10^8 50% tissue culture infectious dose (TCID50) of gebasaxturev intratumorally for 8 cycles, and pembrolizumab intravenously for a maximum of 35 cycles. Cycle 1 was 28 days, and cycles 2-35 were 21 days.
OG001
Part 1, Cohort B: Head and Neck Squamous Cell Carcinoma
Participants with head and neck squamous cell carcinoma (HNSCC) solid tumors received 3 X 10^8 TCID50 of gebasaxturev intratumorally for 8 cycles, and pembrolizumab intravenously for a maximum of 35 cycles. Cycle 1 was 28 days, and cycles 2-35 were 21 days.
OG002
Secondary
Part 1: Number of Participants Who Experienced One or More AEs
An AE was defined as any unfavorable and unintended sign, symptom, disease, or worsening of preexisting condition temporally associated with study treatment and irrespective of causality to study treatment. Per protocol, only participants in Part 1 were analyzed in this outcome measure.
The analysis population included all allocated participants in Part 1 who received study intervention. Cohorts D and E in Part 2 did not enroll any participants.
Posted
Count of Participants
Participants
Up to approximately 30 months
ID
Title
Description
OG000
Part 1, Cohort A: Triple-Negative Breast Cancer
Participants with triple-negative breast cancer (TNBC) solid tumors. Participants received 3 X 10^8 50% tissue culture infectious dose (TCID50) of gebasaxturev intratumorally for 8 cycles, and pembrolizumab intravenously for a maximum of 35 cycles. Cycle 1 was 28 days, and cycles 2-35 were 21 days.
OG001
Part 1, Cohort B: Head and Neck Squamous Cell Carcinoma
Participants with head and neck squamous cell carcinoma (HNSCC) solid tumors received 3 X 10^8 TCID50 of gebasaxturev intratumorally for 8 cycles, and pembrolizumab intravenously for a maximum of 35 cycles. Cycle 1 was 28 days, and cycles 2-35 were 21 days.
OG002
Part 1, Cohort C: Cutaneous Squamous Cell Carcinoma
Secondary
Part 1: Number of Participants Who Discontinued Study Intervention Due to an AE
An AE was defined as any unfavorable and unintended sign, symptom, disease, or worsening of preexisting condition temporally associated with study treatment and irrespective of causality to study treatment. Per protocol, only participants in Part 1 were analyzed in this outcome measure.
The analysis population included all allocated participants in Part 1 who received study intervention. Cohorts D and E in Part 2 did not enroll any participants.
Posted
Count of Participants
Participants
Up to approximately 23 months
ID
Title
Description
OG000
Part 1, Cohort A: Triple-Negative Breast Cancer
Participants with triple-negative breast cancer (TNBC) solid tumors. Participants received 3 X 10^8 50% tissue culture infectious dose (TCID50) of gebasaxturev intratumorally for 8 cycles, and pembrolizumab intravenously for a maximum of 35 cycles. Cycle 1 was 28 days, and cycles 2-35 were 21 days.
OG001
Part 1, Cohort B: Head and Neck Squamous Cell Carcinoma
Participants with head and neck squamous cell carcinoma (HNSCC) solid tumors received 3 X 10^8 TCID50 of gebasaxturev intratumorally for 8 cycles, and pembrolizumab intravenously for a maximum of 35 cycles. Cycle 1 was 28 days, and cycles 2-35 were 21 days.
OG002
Secondary
Progression-Free Survival (PFS) Per RECIST 1.1 as Assessed by Investigator
PFS was defined as the time from first dose of study treatment to the first documented progressive disease (PD) or death due to any cause, whichever occurs first as assessed by investigator. Per RECIST 1.1, PD is defined as ≥20% increase in the sum of diameters of target lesions. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of ≥5 mm. The appearance of one or more new lesions is also considered PD. For this study, RECIST 1.1 has been modified to follow a maximum of 10 target lesions and a maximum of 5 target lesions per organ, and to specify that intratumoral injection does not render a lesion non-evaluable. Per protocol, only participants in Part 1 were analyzed in this outcome measure.
The analysis population consisted of all allocated participants in Part 1 with a baseline scan that demonstrated measurable disease and who received at least 1 dose of study intervention. Cohorts D and E in Part 2 did not enroll any participants.
Posted
Median
95% Confidence Interval
Months
Up to approximately 30 months
ID
Title
Description
OG000
Part 1, Cohort A: Triple-Negative Breast Cancer
Participants with triple-negative breast cancer (TNBC) solid tumors. Participants received 3 X 10^8 50% tissue culture infectious dose (TCID50) of gebasaxturev intratumorally for 8 cycles, and pembrolizumab intravenously for a maximum of 35 cycles. Cycle 1 was 28 days, and cycles 2-35 were 21 days.
OG001
Part 1, Cohort B: Head and Neck Squamous Cell Carcinoma
Secondary
Duration of Response (DOR) Per RECIST 1.1 as Assessed by Investigator
For participants who demonstrated a confirmed Complete Response (CR: Disappearance of all target lesions) or a Partial Response (PR: ≥30% decrease in the sum of diameters of target lesions) per RECIST 1.1 as assessed by investigator, DOR was defined as the time from first documented evidence of CR or PR until disease progression or death, whichever occurs first. For this study, RECIST 1.1 was modified to follow a maximum of 10 target lesions and a maximum of 5 target lesions per organ, and to specify that intratumoral injection did not render a lesion non-evaluable. Per protocol, only participants in Part 1 were analyzed in this outcome measure.
The analysis population consisted of all allocated participants in Part 1 who experienced a confirmed CR or PR with a baseline scan that demonstrated measurable disease and who received at least 1 dose of study intervention. No participants in Part 1, Cohort A were eligible for analysis. Cohorts D and E in Part 2 did not enroll any participants.
Posted
Median
95% Confidence Interval
Months
Up to approximately 30 months
ID
Title
Description
OG000
Part 1, Cohort A: Triple-Negative Breast Cancer
Participants with triple-negative breast cancer (TNBC) solid tumors. Participants received 3 X 10^8 50% tissue culture infectious dose (TCID50) of gebasaxturev intratumorally for 8 cycles, and pembrolizumab intravenously for a maximum of 35 cycles. Cycle 1 was 28 days, and cycles 2-35 were 21 days.
OG001
Part 1, Cohort B: Head and Neck Squamous Cell Carcinoma
Secondary
PFS Per Response Evaluation Criteria in Solid Tumors 1.1 for Immune-Based Therapeutics (iRECIST) as Assessed by Investigator
PFS was defined as the time from first dose of study treatment to the first documented immune-based confirmed progressive disease (iCPD) or death due to any cause, whichever occurs first as assessed by investigator. Per iRECIST, iCPD was defined as worsening of any existing cause of progression, or the appearance of any other cause of progression, relative to the initial appearance of progressive disease by RECIST 1.1. Per protocol, only participants in Part 1 were analyzed in this outcome measure.
The analysis population consisted of all allocated participants in Part 1 with a baseline scan that demonstrated measurable disease and who received at least 1 dose of study intervention. Cohorts D and E in Part 2 did not enroll any participants.
Posted
Median
95% Confidence Interval
Months
Up to approximately 30 months
ID
Title
Description
OG000
Part 1, Cohort A: Triple-Negative Breast Cancer
Participants with triple-negative breast cancer (TNBC) solid tumors. Participants received 3 X 10^8 50% tissue culture infectious dose (TCID50) of gebasaxturev intratumorally for 8 cycles, and pembrolizumab intravenously for a maximum of 35 cycles. Cycle 1 was 28 days, and cycles 2-35 were 21 days.
OG001
Part 1, Cohort B: Head and Neck Squamous Cell Carcinoma
Participants with head and neck squamous cell carcinoma (HNSCC) solid tumors received 3 X 10^8 TCID50 of gebasaxturev intratumorally for 8 cycles, and pembrolizumab intravenously for a maximum of 35 cycles. Cycle 1 was 28 days, and cycles 2-35 were 21 days.
Secondary
DOR Per iRECIST as Assessed by Investigator
For participants who demonstrated confirmed CR (disappearance of all target lesions and non-target lesions) or PR (≥30% decrease in the sum of diameters of target lesions) per RECIST 1.1 or immune-based Complete Response (iCR: Disappearance of all target lesions) or immune-based Partial Response (iPR: ≥30% decrease in the sum of diameters of target lesions) after a single PD per iRECIST, DOR was defined as the time from the first documented CR or PR, or iCR or an iPR, as assessed by investigator, until progressive disease or death, whichever occurs first. For this study, RECIST 1.1 was modified to follow a maximum of 10 target lesions and a maximum of 5 target lesions per organ, and to specify that intratumoral injection did not render a lesion non-evaluable. Per protocol, only participants in Part 1 were analyzed in this outcome measure.
The analysis population consisted of all allocated participants in Part 1 who experienced a confirmed response (CR, PR, iCR or iPR) with a baseline scan that demonstrated measurable disease and who received at least 1 dose of study intervention. No participants in Part 1, Cohort A were eligible for analysis. Cohorts D and E in Part 2 did not enroll any participants.
Posted
Median
95% Confidence Interval
Months
Up to approximately 30 months
ID
Title
Description
OG000
Part 1, Cohort A: Triple-Negative Breast Cancer
Participants with triple-negative breast cancer (TNBC) solid tumors. Participants received 3 X 10^8 50% tissue culture infectious dose (TCID50) of gebasaxturev intratumorally for 8 cycles, and pembrolizumab intravenously for a maximum of 35 cycles. Cycle 1 was 28 days, and cycles 2-35 were 21 days.
Secondary
ORR Per iRECIST as Assessed by Investigator
ORR was defined as the percentage of participants who had confirmed responses assessed using RECIST 1.1 before PD or an immune-based Complete Response (iCR: Disappearance of all target lesions) or an immune-based Partial Response (iPR: ≥30% decrease in the sum of diameters of target lesions) after a single PD per iRECIST as assessed by investigator.
The analysis population consisted of all participants with a baseline scan that demonstrated measurable disease and who were administered at least one dose of study intervention. Cohorts D and E in Part 2 did not enroll any participants.
Posted
Number
95% Confidence Interval
Percentage of Participants
Up to approximately 30 months
ID
Title
Description
OG000
Part 1, Cohort A: Triple-Negative Breast Cancer
Participants with triple-negative breast cancer (TNBC) solid tumors. Participants received 3 X 10^8 50% tissue culture infectious dose (TCID50) of gebasaxturev intratumorally for 8 cycles, and pembrolizumab intravenously for a maximum of 35 cycles. Cycle 1 was 28 days, and cycles 2-35 were 21 days.
OG001
Part 1, Cohort B: Head and Neck Squamous Cell Carcinoma
Participants with head and neck squamous cell carcinoma (HNSCC) solid tumors received 3 X 10^8 TCID50 of gebasaxturev intratumorally for 8 cycles, and pembrolizumab intravenously for a maximum of 35 cycles. Cycle 1 was 28 days, and cycles 2-35 were 21 days.
Secondary
Overall Survival (OS)
OS was defined as the time from first dose of study intervention to death due to any cause. Per protocol, only participants in Part 1 were analyzed in this outcome measure.
The analysis population consisted of all allocated participants in Part 1 with a baseline scan that demonstrated measurable disease and who received at least 1 dose of study intervention. Cohorts D and E in Part 2 did not enroll any participants.
Posted
Median
95% Confidence Interval
Months
Up to approximately 30 months
ID
Title
Description
OG000
Part 1, Cohort A: Triple-Negative Breast Cancer
Participants with triple-negative breast cancer (TNBC) solid tumors. Participants received 3 X 10^8 50% tissue culture infectious dose (TCID50) of gebasaxturev intratumorally for 8 cycles, and pembrolizumab intravenously for a maximum of 35 cycles. Cycle 1 was 28 days, and cycles 2-35 were 21 days.
OG001
Part 1, Cohort B: Head and Neck Squamous Cell Carcinoma
Participants with head and neck squamous cell carcinoma (HNSCC) solid tumors received 3 X 10^8 TCID50 of gebasaxturev intratumorally for 8 cycles, and pembrolizumab intravenously for a maximum of 35 cycles. Cycle 1 was 28 days, and cycles 2-35 were 21 days.
OG002
Part 1, Cohort C: Cutaneous Squamous Cell Carcinoma
Secondary
Part 2: ORR Per RECIST 1.1 as Assessed by Investigator
ORR was defined as the percentage of participants in the analysis population who had a Complete Response (CR: Disappearance of all target lesions and no new lesions) or a Partial Response (PR: ≥30% decrease in the sum of diameters of target lesions) per RECIST 1.1 as assessed by investigator. For this study, RECIST 1.1 was modified to follow a maximum of 10 target lesions and a maximum of 5 target lesions per organ, and to specify that intratumoral injection does not render a lesion non-evaluable. Per protocol, only participants in Part 2 were analyzed for this outcome measure.
The analysis population consisted of all allocated participants in Part 2 with a baseline scan that demonstrated measurable disease and who received at least 1 dose of study intervention. Cohorts D and E in Part 2 did not enroll any participants
Posted
Number
95% Confidence Interval
Percentage of Participants
Up to approximately 29 months
ID
Title
Description
OG000
Part 1, Cohort A: Triple-Negative Breast Cancer
Participants with triple-negative breast cancer (TNBC) solid tumors. Participants received 3 X 10^8 50% tissue culture infectious dose (TCID50) of gebasaxturev intratumorally for 8 cycles, and pembrolizumab intravenously for a maximum of 35 cycles. Cycle 1 was 28 days, and cycles 2-35 were 21 days.
OG001
Part 1, Cohort B: Head and Neck Squamous Cell Carcinoma
Participants with head and neck squamous cell carcinoma (HNSCC) solid tumors received 3 X 10^8 TCID50 of gebasaxturev intratumorally for 8 cycles, and pembrolizumab intravenously for a maximum of 35 cycles. Cycle 1 was 28 days, and cycles 2-35 were 21 days.
Time Frame
Up to approximately 30 months
Description
Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" & "Disease progression" not related to study treatment are excluded as AEs. No participants were allocated to Cohort D or E.
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
Part 1, Cohort A: Triple-Negative Breast Cancer
Participants with triple-negative breast cancer (TNBC) solid tumors received 3 X 10^8 50% tissue culture infectious dose (TCID50) of gebasaxturev intratumorally for 8 cycles, and pembrolizumab intravenously for a maximum of 35 cycles. Cycle 1 was 28 days, and cycles 2-35 were 21 days.
18
22
4
21
18
21
EG001
Part 1, Cohort B: Head and Neck Squamous Cell Carcinoma
Participants with head and neck squamous cell carcinoma (HNSCC) solid tumors received 3 X 10^8 TCID50 of gebasaxturev intratumorally for 8 cycles, and pembrolizumab intravenously for a maximum of 35 cycles. Cycle 1 was 28 days, and cycles 2-35 were 21 days.
8
14
8
14
14
14
EG002
Part 1, Cohort C: Cutaneous Squamous Cell Carcinoma
Participants with cutaneous squamous cell carcinoma (cSCC) solid tumors received 3 X 10^8 TCID50 of gebasaxturev intratumorally for 8 cycles, and pembrolizumab intravenously for a maximum of 35 cycles. Cycle 1 was 28 days, and cycles 2-35 were 21 days.
8
17
6
17
17
17
EG003
Part 2 Dose Level 1, Solid Tumors + Liver Metastases
Participants with solid tumors with liver metastases received 3 X 10^7 TCID50 of gebasaxturev intratumorally for 8 cycles, and pembrolizumab intravenously for a maximum of 35 cycles. Cycle 1 was 28 days, and cycles 2-35 were 21 days.
5
6
4
6
6
6
EG004
Part 2 Dose Level 2, Solid Tumors + Liver Metastases
Participants with solid tumors with liver metastases received 1 X 10^8 TCID50 of gebasaxturev intratumorally for 8 cycles, and pembrolizumab intravenously for a maximum of 35 cycles. Cycle 1 was 28 days, and cycles 2-35 were 21 days.
2
3
1
3
2
3
EG005
Part 2 Dose Level 3, Solid Tumors + Liver Metastases
Participants with solid tumors with liver metastases received 3 X 10^8 TCID50 of gebasaxturev intratumorally for 8 cycles, and pembrolizumab intravenously for a maximum of 35 cycles. Cycle 1 was 28 days, and cycles 2-35 were 21 days.
7
14
3
14
14
14
Serious Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Cardiac arrest
Cardiac disorders
MedDRA 26.0
Systematic Assessment
EG0000 events0 affected21 at risk
EG0010 events0 affected14 at risk
EG0021 events1 affected17 at risk
EG0030 events0 affected6 at risk
EG0040 events0 affected3 at risk
EG0050 events0 affected14 at risk
Cardiac failure congestive
Cardiac disorders
MedDRA 26.0
Systematic Assessment
EG0000 events0 affected21 at risk
EG0010 events0 affected14 at risk
EG0021 events1 affected17 at risk
EG003
Abdominal pain
Gastrointestinal disorders
MedDRA 26.0
Systematic Assessment
EG0000 events0 affected21 at risk
EG0010 events0 affected14 at risk
EG0020 events0 affected17 at risk
EG003
Haematemesis
Gastrointestinal disorders
MedDRA 26.0
Systematic Assessment
EG0000 events0 affected21 at risk
EG0010 events0 affected14 at risk
EG0020 events0 affected17 at risk
EG003
Vomiting
Gastrointestinal disorders
MedDRA 26.0
Systematic Assessment
EG0000 events0 affected21 at risk
EG0010 events0 affected14 at risk
EG0020 events0 affected17 at risk
EG003
General physical health deterioration
General disorders
MedDRA 26.0
Systematic Assessment
EG0000 events0 affected21 at risk
EG0011 events1 affected14 at risk
EG0021 events1 affected17 at risk
EG003
Pain
General disorders
MedDRA 26.0
Systematic Assessment
EG0000 events0 affected21 at risk
EG0010 events0 affected14 at risk
EG0020 events0 affected17 at risk
EG003
Pyrexia
General disorders
MedDRA 26.0
Systematic Assessment
EG0000 events0 affected21 at risk
EG0011 events1 affected14 at risk
EG0020 events0 affected17 at risk
EG003
Cholestasis
Hepatobiliary disorders
MedDRA 26.0
Systematic Assessment
EG0000 events0 affected21 at risk
EG0010 events0 affected14 at risk
EG0020 events0 affected17 at risk
EG003
COVID-19 pneumonia
Infections and infestations
MedDRA 26.0
Systematic Assessment
EG0000 events0 affected21 at risk
EG0011 events1 affected14 at risk
EG0020 events0 affected17 at risk
EG003
Cellulitis
Infections and infestations
MedDRA 26.0
Systematic Assessment
EG0001 events1 affected21 at risk
EG0010 events0 affected14 at risk
EG0020 events0 affected17 at risk
EG003
Diverticulitis
Infections and infestations
MedDRA 26.0
Systematic Assessment
EG0000 events0 affected21 at risk
EG0010 events0 affected14 at risk
EG0021 events1 affected17 at risk
EG003
Liver abscess
Infections and infestations
MedDRA 26.0
Systematic Assessment
EG0000 events0 affected21 at risk
EG0010 events0 affected14 at risk
EG0020 events0 affected17 at risk
EG003
Pneumonia
Infections and infestations
MedDRA 26.0
Systematic Assessment
EG0000 events0 affected21 at risk
EG0011 events1 affected14 at risk
EG0021 events1 affected17 at risk
EG003
Pneumonia aspiration
Infections and infestations
MedDRA 26.0
Systematic Assessment
EG0000 events0 affected21 at risk
EG0012 events2 affected14 at risk
EG0020 events0 affected17 at risk
EG003
Septic shock
Infections and infestations
MedDRA 26.0
Systematic Assessment
EG0000 events0 affected21 at risk
EG0010 events0 affected14 at risk
EG0021 events1 affected17 at risk
EG003
Cervical vertebral fracture
Injury, poisoning and procedural complications
MedDRA 26.0
Systematic Assessment
EG0000 events0 affected21 at risk
EG0010 events0 affected14 at risk
EG0020 events0 affected17 at risk
EG003
Head injury
Injury, poisoning and procedural complications
MedDRA 26.0
Systematic Assessment
EG0000 events0 affected21 at risk
EG0010 events0 affected14 at risk
EG0021 events1 affected17 at risk
EG003
Hepatic seroma
Injury, poisoning and procedural complications
MedDRA 26.0
Systematic Assessment
EG0000 events0 affected21 at risk
EG0010 events0 affected14 at risk
EG0020 events0 affected17 at risk
EG003
Humerus fracture
Injury, poisoning and procedural complications
MedDRA 26.0
Systematic Assessment
EG0000 events0 affected21 at risk
EG0011 events1 affected14 at risk
EG0020 events0 affected17 at risk
EG003
Troponin increased
Investigations
MedDRA 26.0
Systematic Assessment
EG0001 events1 affected21 at risk
EG0010 events0 affected14 at risk
EG0020 events0 affected17 at risk
EG003
Hyponatraemia
Metabolism and nutrition disorders
MedDRA 26.0
Systematic Assessment
EG0000 events0 affected21 at risk
EG0010 events0 affected14 at risk
EG0020 events0 affected17 at risk
EG003
Infected neoplasm
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 26.0
Systematic Assessment
EG0000 events0 affected21 at risk
EG0011 events1 affected14 at risk
EG0020 events0 affected17 at risk
EG003
Malignant melanoma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 26.0
Systematic Assessment
EG0000 events0 affected21 at risk
EG0011 events1 affected14 at risk
EG0020 events0 affected17 at risk
EG003
Tumour haemorrhage
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 26.0
Systematic Assessment
EG0000 events0 affected21 at risk
EG0011 events1 affected14 at risk
EG0020 events0 affected17 at risk
EG003
Encephalopathy
Nervous system disorders
MedDRA 26.0
Systematic Assessment
EG0000 events0 affected21 at risk
EG0011 events1 affected14 at risk
EG0020 events0 affected17 at risk
EG003
Polyneuropathy
Nervous system disorders
MedDRA 26.0
Systematic Assessment
EG0000 events0 affected21 at risk
EG0010 events0 affected14 at risk
EG0020 events0 affected17 at risk
EG003
Chronic obstructive pulmonary disease
Respiratory, thoracic and mediastinal disorders
MedDRA 26.0
Systematic Assessment
EG0000 events0 affected21 at risk
EG0012 events2 affected14 at risk
EG0020 events0 affected17 at risk
EG003
Pleural effusion
Respiratory, thoracic and mediastinal disorders
MedDRA 26.0
Systematic Assessment
EG0002 events2 affected21 at risk
EG0010 events0 affected14 at risk
EG0020 events0 affected17 at risk
EG003
Pneumothorax
Respiratory, thoracic and mediastinal disorders
MedDRA 26.0
Systematic Assessment
EG0000 events0 affected21 at risk
EG0011 events1 affected14 at risk
EG0020 events0 affected17 at risk
EG003
Respiratory tract haemorrhage
Respiratory, thoracic and mediastinal disorders
MedDRA 26.0
Systematic Assessment
EG0000 events0 affected21 at risk
EG0011 events1 affected14 at risk
EG0020 events0 affected17 at risk
EG003
Lichenoid keratosis
Skin and subcutaneous tissue disorders
MedDRA 26.0
Systematic Assessment
EG0000 events0 affected21 at risk
EG0010 events0 affected14 at risk
EG0021 events1 affected17 at risk
EG003
Stevens-Johnson syndrome
Skin and subcutaneous tissue disorders
MedDRA 26.0
Systematic Assessment
EG0000 events0 affected21 at risk
EG0011 events1 affected14 at risk
EG0020 events0 affected17 at risk
EG003
Other Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Anaemia
Blood and lymphatic system disorders
MedDRA 26.0
Systematic Assessment
EG0005 events5 affected21 at risk
EG0010 events0 affected14 at risk
EG0021 events1 affected17 at risk
EG0031 events1 affected6 at risk
EG0040 events0 affected3 at risk
EG0053 events2 affected14 at risk
Hyperleukocytosis
Blood and lymphatic system disorders
MedDRA 26.0
Systematic Assessment
EG0000 events0 affected21 at risk
EG0010 events0 affected14 at risk
EG0021 events1 affected17 at risk
EG003
Iron deficiency anaemia
Blood and lymphatic system disorders
MedDRA 26.0
Systematic Assessment
EG0000 events0 affected21 at risk
EG0010 events0 affected14 at risk
EG0021 events1 affected17 at risk
EG003
Lymphopenia
Blood and lymphatic system disorders
MedDRA 26.0
Systematic Assessment
EG0000 events0 affected21 at risk
EG0010 events0 affected14 at risk
EG0021 events1 affected17 at risk
EG003
Thrombocytopenia
Blood and lymphatic system disorders
MedDRA 26.0
Systematic Assessment
EG0000 events0 affected21 at risk
EG0010 events0 affected14 at risk
EG0021 events1 affected17 at risk
EG003
Angina pectoris
Cardiac disorders
MedDRA 26.0
Systematic Assessment
EG0000 events0 affected21 at risk
EG0010 events0 affected14 at risk
EG0021 events1 affected17 at risk
EG003
Atrial fibrillation
Cardiac disorders
MedDRA 26.0
Systematic Assessment
EG0001 events1 affected21 at risk
EG0010 events0 affected14 at risk
EG0021 events1 affected17 at risk
EG003
Bradycardia
Cardiac disorders
MedDRA 26.0
Systematic Assessment
EG0001 events1 affected21 at risk
EG0010 events0 affected14 at risk
EG0021 events1 affected17 at risk
EG003
Sinus tachycardia
Cardiac disorders
MedDRA 26.0
Systematic Assessment
EG0000 events0 affected21 at risk
EG0011 events1 affected14 at risk
EG0020 events0 affected17 at risk
EG003
Tachycardia
Cardiac disorders
MedDRA 26.0
Systematic Assessment
EG0000 events0 affected21 at risk
EG0011 events1 affected14 at risk
EG0020 events0 affected17 at risk
EG003
Deafness
Ear and labyrinth disorders
MedDRA 26.0
Systematic Assessment
EG0000 events0 affected21 at risk
EG0010 events0 affected14 at risk
EG0021 events1 affected17 at risk
EG003
Ear discomfort
Ear and labyrinth disorders
MedDRA 26.0
Systematic Assessment
EG0000 events0 affected21 at risk
EG0010 events0 affected14 at risk
EG0021 events1 affected17 at risk
EG003
Adrenal insufficiency
Endocrine disorders
MedDRA 26.0
Systematic Assessment
EG0000 events0 affected21 at risk
EG0011 events1 affected14 at risk
EG0020 events0 affected17 at risk
EG003
Hyperthyroidism
Endocrine disorders
MedDRA 26.0
Systematic Assessment
EG0005 events5 affected21 at risk
EG0011 events1 affected14 at risk
EG0021 events1 affected17 at risk
EG003
Hypothyroidism
Endocrine disorders
MedDRA 26.0
Systematic Assessment
EG0004 events4 affected21 at risk
EG0016 events6 affected14 at risk
EG0020 events0 affected17 at risk
EG003
Thyroiditis
Endocrine disorders
MedDRA 26.0
Systematic Assessment
EG0000 events0 affected21 at risk
EG0011 events1 affected14 at risk
EG0020 events0 affected17 at risk
EG003
Dry eye
Eye disorders
MedDRA 26.0
Systematic Assessment
EG0002 events2 affected21 at risk
EG0010 events0 affected14 at risk
EG0020 events0 affected17 at risk
EG003
Exophthalmos
Eye disorders
MedDRA 26.0
Systematic Assessment
EG0000 events0 affected21 at risk
EG0011 events1 affected14 at risk
EG0020 events0 affected17 at risk
EG003
Lacrimation increased
Eye disorders
MedDRA 26.0
Systematic Assessment
EG0000 events0 affected21 at risk
EG0010 events0 affected14 at risk
EG0021 events1 affected17 at risk
EG003
Vision blurred
Eye disorders
MedDRA 26.0
Systematic Assessment
EG0000 events0 affected21 at risk
EG0010 events0 affected14 at risk
EG0020 events0 affected17 at risk
EG003
Abdominal pain
Gastrointestinal disorders
MedDRA 26.0
Systematic Assessment
EG0002 events1 affected21 at risk
EG0011 events1 affected14 at risk
EG0020 events0 affected17 at risk
EG003
Abdominal pain lower
Gastrointestinal disorders
MedDRA 26.0
Systematic Assessment
EG0000 events0 affected21 at risk
EG0010 events0 affected14 at risk
EG0020 events0 affected17 at risk
EG003
Abdominal pain upper
Gastrointestinal disorders
MedDRA 26.0
Systematic Assessment
EG0000 events0 affected21 at risk
EG0010 events0 affected14 at risk
EG0021 events1 affected17 at risk
EG003
Anorectal discomfort
Gastrointestinal disorders
MedDRA 26.0
Systematic Assessment
EG0000 events0 affected21 at risk
EG0010 events0 affected14 at risk
EG0020 events0 affected17 at risk
EG003
Ascites
Gastrointestinal disorders
MedDRA 26.0
Systematic Assessment
EG0000 events0 affected21 at risk
EG0010 events0 affected14 at risk
EG0020 events0 affected17 at risk
EG003
Constipation
Gastrointestinal disorders
MedDRA 26.0
Systematic Assessment
EG0000 events0 affected21 at risk
EG0011 events1 affected14 at risk
EG0020 events0 affected17 at risk
EG003
Diarrhoea
Gastrointestinal disorders
MedDRA 26.0
Systematic Assessment
EG0000 events0 affected21 at risk
EG0012 events1 affected14 at risk
EG00212 events4 affected17 at risk
EG003
Dry mouth
Gastrointestinal disorders
MedDRA 26.0
Systematic Assessment
EG0002 events2 affected21 at risk
EG0011 events1 affected14 at risk
EG0020 events0 affected17 at risk
EG003
Dysphagia
Gastrointestinal disorders
MedDRA 26.0
Systematic Assessment
EG0000 events0 affected21 at risk
EG0010 events0 affected14 at risk
EG0021 events1 affected17 at risk
EG003
Epigastric discomfort
Gastrointestinal disorders
MedDRA 26.0
Systematic Assessment
EG0000 events0 affected21 at risk
EG0011 events1 affected14 at risk
EG0020 events0 affected17 at risk
EG003
Eructation
Gastrointestinal disorders
MedDRA 26.0
Systematic Assessment
EG0000 events0 affected21 at risk
EG0010 events0 affected14 at risk
EG0020 events0 affected17 at risk
EG003
Gastrooesophageal reflux disease
Gastrointestinal disorders
MedDRA 26.0
Systematic Assessment
EG0001 events1 affected21 at risk
EG0010 events0 affected14 at risk
EG0021 events1 affected17 at risk
EG003
Nausea
Gastrointestinal disorders
MedDRA 26.0
Systematic Assessment
EG0008 events5 affected21 at risk
EG0012 events2 affected14 at risk
EG0020 events0 affected17 at risk
EG003
Odynophagia
Gastrointestinal disorders
MedDRA 26.0
Systematic Assessment
EG0000 events0 affected21 at risk
EG0011 events1 affected14 at risk
EG0020 events0 affected17 at risk
EG003
Oral pain
Gastrointestinal disorders
MedDRA 26.0
Systematic Assessment
EG0000 events0 affected21 at risk
EG0010 events0 affected14 at risk
EG0021 events1 affected17 at risk
EG003
Salivary gland pain
Gastrointestinal disorders
MedDRA 26.0
Systematic Assessment
EG0000 events0 affected21 at risk
EG0010 events0 affected14 at risk
EG0021 events1 affected17 at risk
EG003
Stomatitis
Gastrointestinal disorders
MedDRA 26.0
Systematic Assessment
EG0000 events0 affected21 at risk
EG0010 events0 affected14 at risk
EG0021 events1 affected17 at risk
EG003
Tongue geographic
Gastrointestinal disorders
MedDRA 26.0
Systematic Assessment
EG0000 events0 affected21 at risk
EG0010 events0 affected14 at risk
EG0020 events0 affected17 at risk
EG003
Toothache
Gastrointestinal disorders
MedDRA 26.0
Systematic Assessment
EG0000 events0 affected21 at risk
EG0011 events1 affected14 at risk
EG0020 events0 affected17 at risk
EG003
Vomiting
Gastrointestinal disorders
MedDRA 26.0
Systematic Assessment
EG0003 events3 affected21 at risk
EG0010 events0 affected14 at risk
EG0021 events1 affected17 at risk
EG003
Asthenia
General disorders
MedDRA 26.0
Systematic Assessment
EG0002 events2 affected21 at risk
EG0011 events1 affected14 at risk
EG0024 events4 affected17 at risk
EG003
Chills
General disorders
MedDRA 26.0
Systematic Assessment
EG0006 events4 affected21 at risk
EG0011 events1 affected14 at risk
EG0021 events1 affected17 at risk
EG003
Discomfort
General disorders
MedDRA 26.0
Systematic Assessment
EG0000 events0 affected21 at risk
EG0010 events0 affected14 at risk
EG0021 events1 affected17 at risk
EG003
Face oedema
General disorders
MedDRA 26.0
Systematic Assessment
EG0000 events0 affected21 at risk
EG0011 events1 affected14 at risk
EG0020 events0 affected17 at risk
EG003
Facial pain
General disorders
MedDRA 26.0
Systematic Assessment
EG0000 events0 affected21 at risk
EG0010 events0 affected14 at risk
EG0020 events0 affected17 at risk
EG003
Fatigue
General disorders
MedDRA 26.0
Systematic Assessment
EG0008 events2 affected21 at risk
EG0013 events3 affected14 at risk
EG0024 events4 affected17 at risk
EG003
Influenza like illness
General disorders
MedDRA 26.0
Systematic Assessment
EG0000 events0 affected21 at risk
EG0010 events0 affected14 at risk
EG0020 events0 affected17 at risk
EG003
Injection site bruising
General disorders
MedDRA 26.0
Systematic Assessment
EG0000 events0 affected21 at risk
EG0011 events1 affected14 at risk
EG0020 events0 affected17 at risk
EG003
Injection site erythema
General disorders
MedDRA 26.0
Systematic Assessment
EG0000 events0 affected21 at risk
EG0010 events0 affected14 at risk
EG0020 events0 affected17 at risk
EG003
Injection site inflammation
General disorders
MedDRA 26.0
Systematic Assessment
EG0000 events0 affected21 at risk
EG0010 events0 affected14 at risk
EG0021 events1 affected17 at risk
EG003
Injection site oedema
General disorders
MedDRA 26.0
Systematic Assessment
EG0000 events0 affected21 at risk
EG0011 events1 affected14 at risk
EG0020 events0 affected17 at risk
EG003
Injection site pain
General disorders
MedDRA 26.0
Systematic Assessment
EG0005 events2 affected21 at risk
EG0012 events1 affected14 at risk
EG0022 events2 affected17 at risk
EG003
Injection site pruritus
General disorders
MedDRA 26.0
Systematic Assessment
EG0002 events1 affected21 at risk
EG0010 events0 affected14 at risk
EG0021 events1 affected17 at risk
EG003
Mucosal inflammation
General disorders
MedDRA 26.0
Systematic Assessment
EG0000 events0 affected21 at risk
EG0010 events0 affected14 at risk
EG0021 events1 affected17 at risk
EG003
Oedema
General disorders
MedDRA 26.0
Systematic Assessment
EG0000 events0 affected21 at risk
EG0010 events0 affected14 at risk
EG0021 events1 affected17 at risk
EG003
Oedema peripheral
General disorders
MedDRA 26.0
Systematic Assessment
EG0000 events0 affected21 at risk
EG0011 events1 affected14 at risk
EG0020 events0 affected17 at risk
EG003
Pain
General disorders
MedDRA 26.0
Systematic Assessment
EG0004 events4 affected21 at risk
EG0010 events0 affected14 at risk
EG0020 events0 affected17 at risk
EG003
Pyrexia
General disorders
MedDRA 26.0
Systematic Assessment
EG00010 events6 affected21 at risk
EG0012 events1 affected14 at risk
EG0022 events2 affected17 at risk
EG003
Swelling face
General disorders
MedDRA 26.0
Systematic Assessment
EG0000 events0 affected21 at risk
EG0011 events1 affected14 at risk
EG0020 events0 affected17 at risk
EG003
Bacteraemia
Infections and infestations
MedDRA 26.0
Systematic Assessment
EG0000 events0 affected21 at risk
EG0011 events1 affected14 at risk
EG0020 events0 affected17 at risk
EG003
COVID-19
Infections and infestations
MedDRA 26.0
Systematic Assessment
EG0000 events0 affected21 at risk
EG0015 events5 affected14 at risk
EG0024 events4 affected17 at risk
EG003
Conjunctivitis
Infections and infestations
MedDRA 26.0
Systematic Assessment
EG0000 events0 affected21 at risk
EG0010 events0 affected14 at risk
EG0021 events1 affected17 at risk
EG003
Gingivitis
Infections and infestations
MedDRA 26.0
Systematic Assessment
EG0000 events0 affected21 at risk
EG0011 events1 affected14 at risk
EG0020 events0 affected17 at risk
EG003
Herpes zoster
Infections and infestations
MedDRA 26.0
Systematic Assessment
EG0000 events0 affected21 at risk
EG0010 events0 affected14 at risk
EG0021 events1 affected17 at risk
EG003
Influenza
Infections and infestations
MedDRA 26.0
Systematic Assessment
EG0000 events0 affected21 at risk
EG0010 events0 affected14 at risk
EG0021 events1 affected17 at risk
EG003
Myiasis
Infections and infestations
MedDRA 26.0
Systematic Assessment
EG0000 events0 affected21 at risk
EG0010 events0 affected14 at risk
EG0021 events1 affected17 at risk
EG003
Oral candidiasis
Infections and infestations
MedDRA 26.0
Systematic Assessment
EG0000 events0 affected21 at risk
EG0011 events1 affected14 at risk
EG0020 events0 affected17 at risk
EG003
Pneumonia
Infections and infestations
MedDRA 26.0
Systematic Assessment
EG0000 events0 affected21 at risk
EG0012 events2 affected14 at risk
EG0020 events0 affected17 at risk
EG003
Pneumonia aspiration
Infections and infestations
MedDRA 26.0
Systematic Assessment
EG0000 events0 affected21 at risk
EG0011 events1 affected14 at risk
EG0020 events0 affected17 at risk
EG003
Respiratory tract infection
Infections and infestations
MedDRA 26.0
Systematic Assessment
EG0000 events0 affected21 at risk
EG0010 events0 affected14 at risk
EG0021 events1 affected17 at risk
EG003
Rhinitis
Infections and infestations
MedDRA 26.0
Systematic Assessment
EG0000 events0 affected21 at risk
EG0010 events0 affected14 at risk
EG0021 events1 affected17 at risk
EG003
Skin infection
Infections and infestations
MedDRA 26.0
Systematic Assessment
EG0001 events1 affected21 at risk
EG0010 events0 affected14 at risk
EG0021 events1 affected17 at risk
EG003
Upper respiratory tract infection
Infections and infestations
MedDRA 26.0
Systematic Assessment
EG0000 events0 affected21 at risk
EG0010 events0 affected14 at risk
EG0021 events1 affected17 at risk
EG003
Urinary tract infection
Infections and infestations
MedDRA 26.0
Systematic Assessment
EG0002 events2 affected21 at risk
EG0010 events0 affected14 at risk
EG0023 events2 affected17 at risk
EG003
Viral infection
Infections and infestations
MedDRA 26.0
Systematic Assessment
EG0000 events0 affected21 at risk
EG0010 events0 affected14 at risk
EG0020 events0 affected17 at risk
EG003
Arthropod sting
Injury, poisoning and procedural complications
MedDRA 26.0
Systematic Assessment
EG0000 events0 affected21 at risk
EG0010 events0 affected14 at risk
EG0021 events1 affected17 at risk
EG003
Fall
Injury, poisoning and procedural complications
MedDRA 26.0
Systematic Assessment
EG0000 events0 affected21 at risk
EG0011 events1 affected14 at risk
EG0020 events0 affected17 at risk
EG003
Fibula fracture
Injury, poisoning and procedural complications
MedDRA 26.0
Systematic Assessment
EG0000 events0 affected21 at risk
EG0010 events0 affected14 at risk
EG0021 events1 affected17 at risk
EG003
Limb injury
Injury, poisoning and procedural complications
MedDRA 26.0
Systematic Assessment
EG0000 events0 affected21 at risk
EG0011 events1 affected14 at risk
EG0020 events0 affected17 at risk
EG003
Nasal injury
Injury, poisoning and procedural complications
MedDRA 26.0
Systematic Assessment
EG0000 events0 affected21 at risk
EG0011 events1 affected14 at risk
EG0020 events0 affected17 at risk
EG003
Skin abrasion
Injury, poisoning and procedural complications
MedDRA 26.0
Systematic Assessment
EG0000 events0 affected21 at risk
EG0011 events1 affected14 at risk
EG0020 events0 affected17 at risk
EG003
Skin wound
Injury, poisoning and procedural complications
MedDRA 26.0
Systematic Assessment
EG0000 events0 affected21 at risk
EG0010 events0 affected14 at risk
EG0022 events2 affected17 at risk
EG003
Spinal compression fracture
Injury, poisoning and procedural complications
MedDRA 26.0
Systematic Assessment
EG0000 events0 affected21 at risk
EG0011 events1 affected14 at risk
EG0020 events0 affected17 at risk
EG003
Stoma complication
Injury, poisoning and procedural complications
MedDRA 26.0
Systematic Assessment
EG0000 events0 affected21 at risk
EG0011 events1 affected14 at risk
EG0020 events0 affected17 at risk
EG003
Alanine aminotransferase increased
Investigations
MedDRA 26.0
Systematic Assessment
EG0004 events4 affected21 at risk
EG0010 events0 affected14 at risk
EG0022 events2 affected17 at risk
EG003
Amylase increased
Investigations
MedDRA 26.0
Systematic Assessment
EG0000 events0 affected21 at risk
EG0010 events0 affected14 at risk
EG0022 events2 affected17 at risk
EG003
Aspartate aminotransferase increased
Investigations
MedDRA 26.0
Systematic Assessment
EG0004 events4 affected21 at risk
EG0010 events0 affected14 at risk
EG0023 events3 affected17 at risk
EG003
Bilirubin conjugated increased
Investigations
MedDRA 26.0
Systematic Assessment
EG0000 events0 affected21 at risk
EG0010 events0 affected14 at risk
EG0022 events2 affected17 at risk
EG003
Blood alkaline phosphatase increased
Investigations
MedDRA 26.0
Systematic Assessment
EG0000 events0 affected21 at risk
EG0010 events0 affected14 at risk
EG0020 events0 affected17 at risk
EG003
Blood bilirubin increased
Investigations
MedDRA 26.0
Systematic Assessment
EG0001 events1 affected21 at risk
EG0010 events0 affected14 at risk
EG0020 events0 affected17 at risk
EG003
Blood creatine increased
Investigations
MedDRA 26.0
Systematic Assessment
EG0000 events0 affected21 at risk
EG0010 events0 affected14 at risk
EG0021 events1 affected17 at risk
EG003
Blood creatine phosphokinase increased
Investigations
MedDRA 26.0
Systematic Assessment
EG0003 events3 affected21 at risk
EG0010 events0 affected14 at risk
EG0021 events1 affected17 at risk
EG003
Blood lactate dehydrogenase increased
Investigations
MedDRA 26.0
Systematic Assessment
EG0000 events0 affected21 at risk
EG0010 events0 affected14 at risk
EG0020 events0 affected17 at risk
EG003
Blood urea increased
Investigations
MedDRA 26.0
Systematic Assessment
EG0000 events0 affected21 at risk
EG0010 events0 affected14 at risk
EG0020 events0 affected17 at risk
EG003
C-reactive protein increased
Investigations
MedDRA 26.0
Systematic Assessment
EG0000 events0 affected21 at risk
EG0010 events0 affected14 at risk
EG0020 events0 affected17 at risk
EG003
CD4 lymphocytes increased
Investigations
MedDRA 26.0
Systematic Assessment
EG0000 events0 affected21 at risk
EG0010 events0 affected14 at risk
EG0021 events1 affected17 at risk
EG003
Gamma-glutamyltransferase increased
Investigations
MedDRA 26.0
Systematic Assessment
EG0002 events2 affected21 at risk
EG0010 events0 affected14 at risk
EG0020 events0 affected17 at risk
EG003
Lymphocyte count decreased
Investigations
MedDRA 26.0
Systematic Assessment
EG0000 events0 affected21 at risk
EG0010 events0 affected14 at risk
EG0020 events0 affected17 at risk
EG003
Neutrophil count decreased
Investigations
MedDRA 26.0
Systematic Assessment
EG0000 events0 affected21 at risk
EG0010 events0 affected14 at risk
EG0020 events0 affected17 at risk
EG003
Neutrophil count increased
Investigations
MedDRA 26.0
Systematic Assessment
EG0000 events0 affected21 at risk
EG0010 events0 affected14 at risk
EG0021 events1 affected17 at risk
EG003
Platelet count decreased
Investigations
MedDRA 26.0
Systematic Assessment
EG0000 events0 affected21 at risk
EG0010 events0 affected14 at risk
EG0020 events0 affected17 at risk
EG003
Protein total decreased
Investigations
MedDRA 26.0
Systematic Assessment
EG0000 events0 affected21 at risk
EG0010 events0 affected14 at risk
EG0020 events0 affected17 at risk
EG003
Thyroxine free increased
Investigations
MedDRA 26.0
Systematic Assessment
EG0000 events0 affected21 at risk
EG0010 events0 affected14 at risk
EG0021 events1 affected17 at risk
EG003
Thyroxine increased
Investigations
MedDRA 26.0
Systematic Assessment
EG0000 events0 affected21 at risk
EG0010 events0 affected14 at risk
EG0021 events1 affected17 at risk
EG003
Troponin T increased
Investigations
MedDRA 26.0
Systematic Assessment
EG0000 events0 affected21 at risk
EG0010 events0 affected14 at risk
EG0021 events1 affected17 at risk
EG003
Weight decreased
Investigations
MedDRA 26.0
Systematic Assessment
EG0000 events0 affected21 at risk
EG0010 events0 affected14 at risk
EG0020 events0 affected17 at risk
EG003
White blood cell count decreased
Investigations
MedDRA 26.0
Systematic Assessment
EG0000 events0 affected21 at risk
EG0010 events0 affected14 at risk
EG0020 events0 affected17 at risk
EG003
Decreased appetite
Metabolism and nutrition disorders
MedDRA 26.0
Systematic Assessment
EG0001 events1 affected21 at risk
EG0010 events0 affected14 at risk
EG0024 events4 affected17 at risk
EG003
Hypercalcaemia
Metabolism and nutrition disorders
MedDRA 26.0
Systematic Assessment
EG0000 events0 affected21 at risk
EG0010 events0 affected14 at risk
EG0020 events0 affected17 at risk
EG003
Hyperkalaemia
Metabolism and nutrition disorders
MedDRA 26.0
Systematic Assessment
EG0000 events0 affected21 at risk
EG0012 events2 affected14 at risk
EG0020 events0 affected17 at risk
EG003
Hypoalbuminaemia
Metabolism and nutrition disorders
MedDRA 26.0
Systematic Assessment
EG0000 events0 affected21 at risk
EG0010 events0 affected14 at risk
EG0022 events2 affected17 at risk
EG003
Hypokalaemia
Metabolism and nutrition disorders
MedDRA 26.0
Systematic Assessment
EG0001 events1 affected21 at risk
EG0012 events1 affected14 at risk
EG0020 events0 affected17 at risk
EG003
Hypomagnesaemia
Metabolism and nutrition disorders
MedDRA 26.0
Systematic Assessment
EG0002 events2 affected21 at risk
EG0010 events0 affected14 at risk
EG0021 events1 affected17 at risk
EG003
Hyponatraemia
Metabolism and nutrition disorders
MedDRA 26.0
Systematic Assessment
EG0001 events1 affected21 at risk
EG0010 events0 affected14 at risk
EG0020 events0 affected17 at risk
EG003
Hypophosphataemia
Metabolism and nutrition disorders
MedDRA 26.0
Systematic Assessment
EG0001 events1 affected21 at risk
EG0011 events1 affected14 at risk
EG0021 events1 affected17 at risk
EG003
Arthralgia
Musculoskeletal and connective tissue disorders
MedDRA 26.0
Systematic Assessment
EG0000 events0 affected21 at risk
EG0012 events1 affected14 at risk
EG0024 events4 affected17 at risk
EG003
Back pain
Musculoskeletal and connective tissue disorders
MedDRA 26.0
Systematic Assessment
EG0002 events2 affected21 at risk
EG0011 events1 affected14 at risk
EG0021 events1 affected17 at risk
EG003
Bone pain
Musculoskeletal and connective tissue disorders
MedDRA 26.0
Systematic Assessment
EG0000 events0 affected21 at risk
EG0010 events0 affected14 at risk
EG0020 events0 affected17 at risk
EG003
Flank pain
Musculoskeletal and connective tissue disorders
MedDRA 26.0
Systematic Assessment
EG0000 events0 affected21 at risk
EG0011 events1 affected14 at risk
EG0020 events0 affected17 at risk
EG003
Muscle spasms
Musculoskeletal and connective tissue disorders
MedDRA 26.0
Systematic Assessment
EG0003 events1 affected21 at risk
EG0011 events1 affected14 at risk
EG0020 events0 affected17 at risk
EG003
Musculoskeletal chest pain
Musculoskeletal and connective tissue disorders
MedDRA 26.0
Systematic Assessment
EG0001 events1 affected21 at risk
EG0010 events0 affected14 at risk
EG0020 events0 affected17 at risk
EG003
Musculoskeletal pain
Musculoskeletal and connective tissue disorders
MedDRA 26.0
Systematic Assessment
EG0002 events2 affected21 at risk
EG0010 events0 affected14 at risk
EG0020 events0 affected17 at risk
EG003
Musculoskeletal stiffness
Musculoskeletal and connective tissue disorders
MedDRA 26.0
Systematic Assessment
EG0000 events0 affected21 at risk
EG0011 events1 affected14 at risk
EG0020 events0 affected17 at risk
EG003
Myalgia
Musculoskeletal and connective tissue disorders
MedDRA 26.0
Systematic Assessment
EG0003 events2 affected21 at risk
EG0010 events0 affected14 at risk
EG0021 events1 affected17 at risk
EG003
Neck pain
Musculoskeletal and connective tissue disorders
MedDRA 26.0
Systematic Assessment
EG0000 events0 affected21 at risk
EG0011 events1 affected14 at risk
EG0020 events0 affected17 at risk
EG003
Pain in extremity
Musculoskeletal and connective tissue disorders
MedDRA 26.0
Systematic Assessment
EG0001 events1 affected21 at risk
EG0011 events1 affected14 at risk
EG0020 events0 affected17 at risk
EG003
Cancer pain
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 26.0
Systematic Assessment
EG0000 events0 affected21 at risk
EG0012 events2 affected14 at risk
EG0020 events0 affected17 at risk
EG003
Haemangioma of spleen
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 26.0
Systematic Assessment
EG0000 events0 affected21 at risk
EG0010 events0 affected14 at risk
EG0021 events1 affected17 at risk
EG003
Melanocytic naevus
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 26.0
Systematic Assessment
EG0000 events0 affected21 at risk
EG0011 events1 affected14 at risk
EG0020 events0 affected17 at risk
EG003
Tumour pain
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 26.0
Systematic Assessment
EG0001 events1 affected21 at risk
EG0011 events1 affected14 at risk
EG0023 events3 affected17 at risk
EG003
Cerebrovascular accident
Nervous system disorders
MedDRA 26.0
Systematic Assessment
EG0000 events0 affected21 at risk
EG0010 events0 affected14 at risk
EG0020 events0 affected17 at risk
EG003
Dizziness
Nervous system disorders
MedDRA 26.0
Systematic Assessment
EG0001 events1 affected21 at risk
EG0011 events1 affected14 at risk
EG0020 events0 affected17 at risk
EG003
Encephalopathy
Nervous system disorders
MedDRA 26.0
Systematic Assessment
EG0000 events0 affected21 at risk
EG0010 events0 affected14 at risk
EG0020 events0 affected17 at risk
EG003
Headache
Nervous system disorders
MedDRA 26.0
Systematic Assessment
EG0006 events2 affected21 at risk
EG0012 events2 affected14 at risk
EG0025 events4 affected17 at risk
EG003
Hypoaesthesia
Nervous system disorders
MedDRA 26.0
Systematic Assessment
EG0000 events0 affected21 at risk
EG0011 events1 affected14 at risk
EG0021 events1 affected17 at risk
EG003
Neuropathy peripheral
Nervous system disorders
MedDRA 26.0
Systematic Assessment
EG0001 events1 affected21 at risk
EG0010 events0 affected14 at risk
EG0022 events2 affected17 at risk
EG003
Post herpetic neuralgia
Nervous system disorders
MedDRA 26.0
Systematic Assessment
EG0000 events0 affected21 at risk
EG0010 events0 affected14 at risk
EG0021 events1 affected17 at risk
EG003
Somnolence
Nervous system disorders
MedDRA 26.0
Systematic Assessment
EG0000 events0 affected21 at risk
EG0010 events0 affected14 at risk
EG0020 events0 affected17 at risk
EG003
Anxiety
Psychiatric disorders
MedDRA 26.0
Systematic Assessment
EG0001 events1 affected21 at risk
EG0010 events0 affected14 at risk
EG0022 events2 affected17 at risk
EG003
Confusional state
Psychiatric disorders
MedDRA 26.0
Systematic Assessment
EG0000 events0 affected21 at risk
EG0011 events1 affected14 at risk
EG0020 events0 affected17 at risk
EG003
Depression
Psychiatric disorders
MedDRA 26.0
Systematic Assessment
EG0000 events0 affected21 at risk
EG0010 events0 affected14 at risk
EG0021 events1 affected17 at risk
EG003
Hallucination, visual
Psychiatric disorders
MedDRA 26.0
Systematic Assessment
EG0000 events0 affected21 at risk
EG0010 events0 affected14 at risk
EG0021 events1 affected17 at risk
EG003
Insomnia
Psychiatric disorders
MedDRA 26.0
Systematic Assessment
EG0000 events0 affected21 at risk
EG0012 events2 affected14 at risk
EG0020 events0 affected17 at risk
EG003
Chronic kidney disease
Renal and urinary disorders
MedDRA 26.0
Systematic Assessment
EG0000 events0 affected21 at risk
EG0010 events0 affected14 at risk
EG0021 events1 affected17 at risk
EG003
Nocturia
Renal and urinary disorders
MedDRA 26.0
Systematic Assessment
EG0000 events0 affected21 at risk
EG0011 events1 affected14 at risk
EG0020 events0 affected17 at risk
EG003
Pollakiuria
Renal and urinary disorders
MedDRA 26.0
Systematic Assessment
EG0001 events1 affected21 at risk
EG0010 events0 affected14 at risk
EG0020 events0 affected17 at risk
EG003
Breast pain
Reproductive system and breast disorders
MedDRA 26.0
Systematic Assessment
EG0004 events4 affected21 at risk
EG0010 events0 affected14 at risk
EG0020 events0 affected17 at risk
EG003
Pelvic discomfort
Reproductive system and breast disorders
MedDRA 26.0
Systematic Assessment
EG0000 events0 affected21 at risk
EG0010 events0 affected14 at risk
EG0020 events0 affected17 at risk
EG003
Perineal pain
Reproductive system and breast disorders
MedDRA 26.0
Systematic Assessment
EG0000 events0 affected21 at risk
EG0010 events0 affected14 at risk
EG0020 events0 affected17 at risk
EG003
Chronic obstructive pulmonary disease
Respiratory, thoracic and mediastinal disorders
MedDRA 26.0
Systematic Assessment
EG0000 events0 affected21 at risk
EG0011 events1 affected14 at risk
EG0020 events0 affected17 at risk
EG003
Cough
Respiratory, thoracic and mediastinal disorders
MedDRA 26.0
Systematic Assessment
EG0005 events5 affected21 at risk
EG0011 events1 affected14 at risk
EG0022 events2 affected17 at risk
EG003
Dyspnoea
Respiratory, thoracic and mediastinal disorders
MedDRA 26.0
Systematic Assessment
EG0003 events3 affected21 at risk
EG0010 events0 affected14 at risk
EG0021 events1 affected17 at risk
EG003
Dyspnoea exertional
Respiratory, thoracic and mediastinal disorders
MedDRA 26.0
Systematic Assessment
EG0000 events0 affected21 at risk
EG0011 events1 affected14 at risk
EG0020 events0 affected17 at risk
EG003
Epistaxis
Respiratory, thoracic and mediastinal disorders
MedDRA 26.0
Systematic Assessment
EG0000 events0 affected21 at risk
EG0011 events1 affected14 at risk
EG0021 events1 affected17 at risk
EG003
Haemoptysis
Respiratory, thoracic and mediastinal disorders
MedDRA 26.0
Systematic Assessment
EG0000 events0 affected21 at risk
EG0011 events1 affected14 at risk
EG0021 events1 affected17 at risk
EG003
Hiccups
Respiratory, thoracic and mediastinal disorders
MedDRA 26.0
Systematic Assessment
EG0001 events1 affected21 at risk
EG0010 events0 affected14 at risk
EG0020 events0 affected17 at risk
EG003
Lower respiratory tract congestion
Respiratory, thoracic and mediastinal disorders
MedDRA 26.0
Systematic Assessment
EG0000 events0 affected21 at risk
EG0010 events0 affected14 at risk
EG0021 events1 affected17 at risk
EG003
Oropharyngeal pain
Respiratory, thoracic and mediastinal disorders
MedDRA 26.0
Systematic Assessment
EG0000 events0 affected21 at risk
EG0011 events1 affected14 at risk
EG0020 events0 affected17 at risk
EG003
Orthopnoea
Respiratory, thoracic and mediastinal disorders
MedDRA 26.0
Systematic Assessment
EG0000 events0 affected21 at risk
EG0011 events1 affected14 at risk
EG0020 events0 affected17 at risk
EG003
Productive cough
Respiratory, thoracic and mediastinal disorders
MedDRA 26.0
Systematic Assessment
EG0000 events0 affected21 at risk
EG0010 events0 affected14 at risk
EG0022 events2 affected17 at risk
EG003
Rhinorrhoea
Respiratory, thoracic and mediastinal disorders
MedDRA 26.0
Systematic Assessment
EG0000 events0 affected21 at risk
EG0013 events3 affected14 at risk
EG0020 events0 affected17 at risk
EG003
Stridor
Respiratory, thoracic and mediastinal disorders
MedDRA 26.0
Systematic Assessment
EG0000 events0 affected21 at risk
EG0011 events1 affected14 at risk
EG0020 events0 affected17 at risk
EG003
Acne
Skin and subcutaneous tissue disorders
MedDRA 26.0
Systematic Assessment
EG0000 events0 affected21 at risk
EG0011 events1 affected14 at risk
EG0020 events0 affected17 at risk
EG003
Actinic keratosis
Skin and subcutaneous tissue disorders
MedDRA 26.0
Systematic Assessment
EG0000 events0 affected21 at risk
EG0010 events0 affected14 at risk
EG0022 events2 affected17 at risk
EG003
Blister
Skin and subcutaneous tissue disorders
MedDRA 26.0
Systematic Assessment
EG0000 events0 affected21 at risk
EG0010 events0 affected14 at risk
EG0021 events1 affected17 at risk
EG003
Dermatitis
Skin and subcutaneous tissue disorders
MedDRA 26.0
Systematic Assessment
EG0000 events0 affected21 at risk
EG0010 events0 affected14 at risk
EG0021 events1 affected17 at risk
EG003
Dermatitis bullous
Skin and subcutaneous tissue disorders
MedDRA 26.0
Systematic Assessment
EG0000 events0 affected21 at risk
EG0011 events1 affected14 at risk
EG0020 events0 affected17 at risk
EG003
Hyperhidrosis
Skin and subcutaneous tissue disorders
MedDRA 26.0
Systematic Assessment
EG0001 events1 affected21 at risk
EG0010 events0 affected14 at risk
EG0020 events0 affected17 at risk
EG003
Night sweats
Skin and subcutaneous tissue disorders
MedDRA 26.0
Systematic Assessment
EG0000 events0 affected21 at risk
EG0010 events0 affected14 at risk
EG0021 events1 affected17 at risk
EG003
Pruritus
Skin and subcutaneous tissue disorders
MedDRA 26.0
Systematic Assessment
EG0001 events1 affected21 at risk
EG0014 events4 affected14 at risk
EG0022 events2 affected17 at risk
EG003
Rash
Skin and subcutaneous tissue disorders
MedDRA 26.0
Systematic Assessment
EG0001 events1 affected21 at risk
EG0014 events3 affected14 at risk
EG0021 events1 affected17 at risk
EG003
Rash macular
Skin and subcutaneous tissue disorders
MedDRA 26.0
Systematic Assessment
EG0000 events0 affected21 at risk
EG0010 events0 affected14 at risk
EG0020 events0 affected17 at risk
EG003
Skin erosion
Skin and subcutaneous tissue disorders
MedDRA 26.0
Systematic Assessment
EG0000 events0 affected21 at risk
EG0010 events0 affected14 at risk
EG0021 events1 affected17 at risk
EG003
Skin haemorrhage
Skin and subcutaneous tissue disorders
MedDRA 26.0
Systematic Assessment
EG0000 events0 affected21 at risk
EG0010 events0 affected14 at risk
EG0021 events1 affected17 at risk
EG003
Vitiligo
Skin and subcutaneous tissue disorders
MedDRA 26.0
Systematic Assessment
EG0000 events0 affected21 at risk
EG0010 events0 affected14 at risk
EG0020 events0 affected17 at risk
EG003
Embolism
Vascular disorders
MedDRA 26.0
Systematic Assessment
EG0000 events0 affected21 at risk
EG0010 events0 affected14 at risk
EG0020 events0 affected17 at risk
EG003
Hypertension
Vascular disorders
MedDRA 26.0
Systematic Assessment
EG0002 events2 affected21 at risk
EG0010 events0 affected14 at risk
EG0021 events1 affected17 at risk
EG003
Hypotension
Vascular disorders
MedDRA 26.0
Systematic Assessment
EG0000 events0 affected21 at risk
EG0011 events1 affected14 at risk
EG0020 events0 affected17 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 will generally support publication of multicenter studies only in their entirety and not as individual site data. In this case, a coordinating investigator will be designated by mutual agreement. If publication activity is not directed by the Sponsor, the investigator agrees to submit all manuscripts or abstracts to the Sponsor before submission. This allows the Sponsor to protect proprietary information and to provide comments.
Point of Contact
Title
Organization
Phone
Extension
Email
Senior Vice President, Global Clinical Development
Part 1, Cohort B: Head and Neck Squamous Cell Carcinoma
Participants with head and neck squamous cell carcinoma (HNSCC) solid tumors received 3 X 10^8 TCID50 of gebasaxturev intratumorally for 8 cycles, and pembrolizumab intravenously for a maximum of 35 cycles. Cycle 1 was 28 days, and cycles 2-35 were 21 days.
OG002
Part 1, Cohort C: Cutaneous Squamous Cell Carcinoma
Participants with cutaneous squamous cell carcinoma (cSCC) solid tumors received 3 X 10^8 TCID50 of gebasaxturev intratumorally for 8 cycles, and pembrolizumab intravenously for a maximum of 35 cycles. Cycle 1 was 28 days, and cycles 2-35 were 21 days.
OG003
Part 2 Dose Level 1, Solid Tumors + Liver Metastases
Participants with solid tumors with liver metastases received 3 X 10^7 TCID50 of gebasaxturev intratumorally for 8 cycles, and pembrolizumab intravenously for a maximum of 35 cycles. Cycle 1 was 28 days, and cycles 2-35 were 21 days.
OG004
Part 2 Dose Level 2, Solid Tumors + Liver Metastases
Participants with solid tumors with liver metastases received 1 X 10^8 TCID50 of gebasaxturev intratumorally for 8 cycles, and pembrolizumab intravenously for a maximum of 35 cycles. Cycle 1 was 28 days, and cycles 2-35 were 21 days.
OG005
Part 2 Dose Level 3, Solid Tumors + Liver Metastases
Participants with solid tumors with liver metastases received 3 X 10^8 TCID50 of gebasaxturev intratumorally for 8 cycles, and pembrolizumab intravenously for a maximum of 35 cycles. Cycle 1 was 28 days, and cycles 2-35 were 21 days.
Units
Counts
Participants
OG0000
OG0010
OG0020
OG0036
OG0043
OG00514
Title
Denominators
Categories
Title
Measurements
OG0031
OG0040
OG0051
Part 1, Cohort C: Cutaneous Squamous Cell Carcinoma
Participants with cutaneous squamous cell carcinoma (cSCC) solid tumors received 3 X 10^8 TCID50 of gebasaxturev intratumorally for 8 cycles, and pembrolizumab intravenously for a maximum of 35 cycles. Cycle 1 was 28 days, and cycles 2-35 were 21 days.
OG003
Part 2 Dose Level 1, Solid Tumors + Liver Metastases
Participants with solid tumors with liver metastases received 3 X 10^7 TCID50 of gebasaxturev intratumorally for 8 cycles, and pembrolizumab intravenously for a maximum of 35 cycles. Cycle 1 was 28 days, and cycles 2-35 were 21 days.
OG004
Part 2 Dose Level 2, Solid Tumors + Liver Metastases
Participants with solid tumors with liver metastases received 1 X 10^8 TCID50 of gebasaxturev intratumorally for 8 cycles, and pembrolizumab intravenously for a maximum of 35 cycles. Cycle 1 was 28 days, and cycles 2-35 were 21 days.
OG005
Part 2 Dose Level 3, Solid Tumors + Liver Metastases
Participants with solid tumors with liver metastases received 3 X 10^8 TCID50 of gebasaxturev intratumorally for 8 cycles, and pembrolizumab intravenously for a maximum of 35 cycles. Cycle 1 was 28 days, and cycles 2-35 were 21 days.
Units
Counts
Participants
OG0000
OG0010
OG0020
OG0036
OG0043
OG00514
Title
Denominators
Categories
Title
Measurements
OG0036
OG0042
OG00514
Part 1, Cohort C: Cutaneous Squamous Cell Carcinoma
Participants with cutaneous squamous cell carcinoma (cSCC) solid tumors received 3 X 10^8 TCID50 of gebasaxturev intratumorally for 8 cycles, and pembrolizumab intravenously for a maximum of 35 cycles. Cycle 1 was 28 days, and cycles 2-35 were 21 days.
OG003
Part 2 Dose Level 1, Solid Tumors + Liver Metastases
Participants with solid tumors with liver metastases received 3 X 10^7 TCID50 of gebasaxturev intratumorally for 8 cycles, and pembrolizumab intravenously for a maximum of 35 cycles. Cycle 1 was 28 days, and cycles 2-35 were 21 days.
OG004
Part 2 Dose Level 2, Solid Tumors + Liver Metastases
Participants with solid tumors with liver metastases received 1 X 10^8 TCID50 of gebasaxturev intratumorally for 8 cycles, and pembrolizumab intravenously for a maximum of 35 cycles. Cycle 1 was 28 days, and cycles 2-35 were 21 days.
OG005
Part 2 Dose Level 3, Solid Tumors + Liver Metastases
Participants with solid tumors with liver metastases received 3 X 10^8 TCID50 of gebasaxturev intratumorally for 8 cycles, and pembrolizumab intravenously for a maximum of 35 cycles. Cycle 1 was 28 days, and cycles 2-35 were 21 days.
Units
Counts
Participants
OG0000
OG0010
OG0020
OG0036
OG0043
OG00514
Title
Denominators
Categories
Title
Measurements
OG0030
OG0040
OG0051
Participants with cutaneous squamous cell carcinoma (cSCC) solid tumors received 3 X 10^8 TCID50 of gebasaxturev intratumorally for 8 cycles, and pembrolizumab intravenously for a maximum of 35 cycles. Cycle 1 was 28 days, and cycles 2-35 were 21 days.
OG003
Part 2 Dose Level 1, Solid Tumors + Liver Metastases
Participants with solid tumors with liver metastases received 3 X 10^7 TCID50 of gebasaxturev intratumorally for 8 cycles, and pembrolizumab intravenously for a maximum of 35 cycles. Cycle 1 was 28 days, and cycles 2-35 were 21 days.
OG004
Part 2 Dose Level 2, Solid Tumors + Liver Metastases
Participants with solid tumors with liver metastases received 1 X 10^8 TCID50 of gebasaxturev intratumorally for 8 cycles, and pembrolizumab intravenously for a maximum of 35 cycles. Cycle 1 was 28 days, and cycles 2-35 were 21 days.
OG005
Part 2 Dose Level 3, Solid Tumors + Liver Metastases
Participants with solid tumors with liver metastases received 3 X 10^8 TCID50 of gebasaxturev intratumorally for 8 cycles, and pembrolizumab intravenously for a maximum of 35 cycles. Cycle 1 was 28 days, and cycles 2-35 were 21 days.
Units
Counts
Participants
OG00021
OG00114
OG00217
OG0030
OG0040
OG0050
Title
Denominators
Categories
Title
Measurements
OG00019
OG00114
OG00217
Part 1, Cohort C: Cutaneous Squamous Cell Carcinoma
Participants with cutaneous squamous cell carcinoma (cSCC) solid tumors received 3 X 10^8 TCID50 of gebasaxturev intratumorally for 8 cycles, and pembrolizumab intravenously for a maximum of 35 cycles. Cycle 1 was 28 days, and cycles 2-35 were 21 days.
OG003
Part 2 Dose Level 1, Solid Tumors + Liver Metastases
Participants with solid tumors with liver metastases received 3 X 10^7 TCID50 of gebasaxturev intratumorally for 8 cycles, and pembrolizumab intravenously for a maximum of 35 cycles. Cycle 1 was 28 days, and cycles 2-35 were 21 days.
OG004
Part 2 Dose Level 2, Solid Tumors + Liver Metastases
Participants with solid tumors with liver metastases received 1 X 10^8 TCID50 of gebasaxturev intratumorally for 8 cycles, and pembrolizumab intravenously for a maximum of 35 cycles. Cycle 1 was 28 days, and cycles 2-35 were 21 days.
OG005
Part 2 Dose Level 3, Solid Tumors + Liver Metastases
Participants with solid tumors with liver metastases received 3 X 10^8 TCID50 of gebasaxturev intratumorally for 8 cycles, and pembrolizumab intravenously for a maximum of 35 cycles. Cycle 1 was 28 days, and cycles 2-35 were 21 days.
Units
Counts
Participants
OG00021
OG00114
OG00217
OG0030
OG0040
OG0050
Title
Denominators
Categories
Title
Measurements
OG0001
OG0013
OG0023
Participants with head and neck squamous cell carcinoma (HNSCC) solid tumors received 3 X 10^8 TCID50 of gebasaxturev intratumorally for 8 cycles, and pembrolizumab intravenously for a maximum of 35 cycles. Cycle 1 was 28 days, and cycles 2-35 were 21 days.
OG002
Part 1, Cohort C: Cutaneous Squamous Cell Carcinoma
Participants with cutaneous squamous cell carcinoma (cSCC) solid tumors received 3 X 10^8 TCID50 of gebasaxturev intratumorally for 8 cycles, and pembrolizumab intravenously for a maximum of 35 cycles. Cycle 1 was 28 days, and cycles 2-35 were 21 days.
OG003
Part 2 Dose Level 1, Solid Tumors + Liver Metastases
Participants with solid tumors with liver metastases received 3 X 10^7 TCID50 of gebasaxturev intratumorally for 8 cycles, and pembrolizumab intravenously for a maximum of 35 cycles. Cycle 1 was 28 days, and cycles 2-35 were 21 days.
OG004
Part 2 Dose Level 2, Solid Tumors + Liver Metastases
Participants with solid tumors with liver metastases received 1 X 10^8 TCID50 of gebasaxturev intratumorally for 8 cycles, and pembrolizumab intravenously for a maximum of 35 cycles. Cycle 1 was 28 days, and cycles 2-35 were 21 days.
OG005
Part 2 Dose Level 3, Solid Tumors + Liver Metastases
Participants with solid tumors with liver metastases received 3 X 10^8 TCID50 of gebasaxturev intratumorally for 8 cycles, and pembrolizumab intravenously for a maximum of 35 cycles. Cycle 1 was 28 days, and cycles 2-35 were 21 days.
Units
Counts
Participants
OG00021
OG00114
OG00217
OG0030
OG0040
OG0050
Title
Denominators
Categories
Title
Measurements
OG0002.1(1.5 to 3.1)
OG0013.3(1.7 to NA)NA = Upper limit not reached at time of data cut-off due to insufficient number of participants with an event.
OG00215.4(2.4 to NA)NA = Upper limit not reached at time of data cut-off due to insufficient number of participants with an event.
Participants with head and neck squamous cell carcinoma (HNSCC) solid tumors received 3 X 10^8 TCID50 of gebasaxturev intratumorally for 8 cycles, and pembrolizumab intravenously for a maximum of 35 cycles. Cycle 1 was 28 days, and cycles 2-35 were 21 days.
OG002
Part 1, Cohort C: Cutaneous Squamous Cell Carcinoma
Participants with cutaneous squamous cell carcinoma (cSCC) solid tumors received 3 X 10^8 TCID50 of gebasaxturev intratumorally for 8 cycles, and pembrolizumab intravenously for a maximum of 35 cycles. Cycle 1 was 28 days, and cycles 2-35 were 21 days.
OG003
Part 2 Dose Level 1, Solid Tumors + Liver Metastases
Participants with solid tumors with liver metastases received 3 X 10^7 TCID50 of gebasaxturev intratumorally for 8 cycles, and pembrolizumab intravenously for a maximum of 35 cycles. Cycle 1 was 28 days, and cycles 2-35 were 21 days.
OG004
Part 2 Dose Level 2, Solid Tumors + Liver Metastases
Participants with solid tumors with liver metastases received 1 X 10^8 TCID50 of gebasaxturev intratumorally for 8 cycles, and pembrolizumab intravenously for a maximum of 35 cycles. Cycle 1 was 28 days, and cycles 2-35 were 21 days.
OG005
Part 2 Dose Level 3, Solid Tumors + Liver Metastases
Participants with solid tumors with liver metastases received 3 X 10^8 TCID50 of gebasaxturev intratumorally for 8 cycles, and pembrolizumab intravenously for a maximum of 35 cycles. Cycle 1 was 28 days, and cycles 2-35 were 21 days.
Units
Counts
Participants
OG0000
OG0015
OG00211
OG0030
OG0040
OG0050
Title
Denominators
Categories
Title
Measurements
OG001NA(4.4 to NA)NA = Median and upper limit not reached at time of data cut-off due to insufficient number of responding participants with relapse.
OG002NA(4.6 to NA)NA = Median and upper limit not reached at time of data cut-off due to insufficient number of responding participants with relapse.
OG002
Part 1, Cohort C: Cutaneous Squamous Cell Carcinoma
Participants with cutaneous squamous cell carcinoma (cSCC) solid tumors received 3 X 10^8 TCID50 of gebasaxturev intratumorally for 8 cycles, and pembrolizumab intravenously for a maximum of 35 cycles. Cycle 1 was 28 days, and cycles 2-35 were 21 days.
OG003
Part 2 Dose Level 1, Solid Tumors + Liver Metastases
Participants with solid tumors with liver metastases received 3 X 10^7 TCID50 of gebasaxturev intratumorally for 8 cycles, and pembrolizumab intravenously for a maximum of 35 cycles. Cycle 1 was 28 days, and cycles 2-35 were 21 days.
OG004
Part 2 Dose Level 2, Solid Tumors + Liver Metastases
Participants with solid tumors with liver metastases received 1 X 10^8 TCID50 of gebasaxturev intratumorally for 8 cycles, and pembrolizumab intravenously for a maximum of 35 cycles. Cycle 1 was 28 days, and cycles 2-35 were 21 days.
OG005
Part 2 Dose Level 3, Solid Tumors + Liver Metastases
Participants with solid tumors with liver metastases received 3 X 10^8 TCID50 of gebasaxturev intratumorally for 8 cycles, and pembrolizumab intravenously for a maximum of 35 cycles. Cycle 1 was 28 days, and cycles 2-35 were 21 days.
Units
Counts
Participants
OG00021
OG00114
OG00217
OG0030
OG0040
OG0050
Title
Denominators
Categories
Title
Measurements
OG0003.3(1.3 to 4.3)
OG0018.2(2.1 to NA)NA = Upper limit not reached at time of data cut-off due to insufficient number of participants with an event.
OG00220.4(3.3 to NA)NA = Upper limit not reached at time of data cut-off due to insufficient number of participants with an event.
OG001
Part 1, Cohort B: Head and Neck Squamous Cell Carcinoma
Participants with head and neck squamous cell carcinoma (HNSCC) solid tumors received 3 X 10^8 TCID50 of gebasaxturev intratumorally for 8 cycles, and pembrolizumab intravenously for a maximum of 35 cycles. Cycle 1 was 28 days, and cycles 2-35 were 21 days.
OG002
Part 1, Cohort C: Cutaneous Squamous Cell Carcinoma
Participants with cutaneous squamous cell carcinoma (cSCC) solid tumors received 3 X 10^8 TCID50 of gebasaxturev intratumorally for 8 cycles, and pembrolizumab intravenously for a maximum of 35 cycles. Cycle 1 was 28 days, and cycles 2-35 were 21 days.
OG003
Part 2 Dose Level 1, Solid Tumors + Liver Metastases
Participants with solid tumors with liver metastases received 3 X 10^7 TCID50 of gebasaxturev intratumorally for 8 cycles, and pembrolizumab intravenously for a maximum of 35 cycles. Cycle 1 was 28 days, and cycles 2-35 were 21 days.
OG004
Part 2 Dose Level 2, Solid Tumors + Liver Metastases
Participants with solid tumors with liver metastases received 1 X 10^8 TCID50 of gebasaxturev intratumorally for 8 cycles, and pembrolizumab intravenously for a maximum of 35 cycles. Cycle 1 was 28 days, and cycles 2-35 were 21 days.
OG005
Part 2 Dose Level 3, Solid Tumors + Liver Metastases
Participants with solid tumors with liver metastases received 3 X 10^8 TCID50 of gebasaxturev intratumorally for 8 cycles, and pembrolizumab intravenously for a maximum of 35 cycles. Cycle 1 was 28 days, and cycles 2-35 were 21 days.
Units
Counts
Participants
OG0000
OG0016
OG00211
OG0030
OG0040
OG0050
Title
Denominators
Categories
Title
Measurements
OG001NA(4.4 to NA)NA = Median and upper limit not reached at time of data cut-off due to insufficient number of responding participants with relapse.
OG002NA(4.6 to NA)NA = Median and upper limit not reached at time of data cut-off due to insufficient number of responding participants with relapse.
OG002
Part 1, Cohort C: Cutaneous Squamous Cell Carcinoma
Participants with cutaneous squamous cell carcinoma (cSCC) solid tumors received 3 X 10^8 TCID50 of gebasaxturev intratumorally for 8 cycles, and pembrolizumab intravenously for a maximum of 35 cycles. Cycle 1 was 28 days, and cycles 2-35 were 21 days.
OG003
Part 2 Dose Level 1, Solid Tumors + Liver Metastases
Participants with solid tumors with liver metastases received 3 X 10^7 TCID50 of gebasaxturev intratumorally for 8 cycles, and pembrolizumab intravenously for a maximum of 35 cycles. Cycle 1 was 28 days, and cycles 2-35 were 21 days.
OG004
Part 2 Dose Level 2, Solid Tumors + Liver Metastases
Participants with solid tumors with liver metastases received 1 X 10^8 TCID50 of gebasaxturev intratumorally for 8 cycles, and pembrolizumab intravenously for a maximum of 35 cycles. Cycle 1 was 28 days, and cycles 2-35 were 21 days.
OG005
Part 2 Dose Level 3, Solid Tumors + Liver Metastases
Participants with solid tumors with liver metastases received 3 X 10^8 TCID50 of gebasaxturev intratumorally for 8 cycles, and pembrolizumab intravenously for a maximum of 35 cycles. Cycle 1 was 28 days, and cycles 2-35 were 21 days.
Units
Counts
Participants
OG00021
OG00114
OG00217
OG0036
OG0043
OG00514
Title
Denominators
Categories
Title
Measurements
OG0000.0(0.0 to 16.1)
OG00142.9(17.7 to 71.1)
OG00264.7(38.3 to 85.8)
OG00316.7(0.4 to 64.1)
OG0040.0(0.0 to 70.8)
OG0050.0(0.0 to 23.2)
Participants with cutaneous squamous cell carcinoma (cSCC) solid tumors received 3 X 10^8 TCID50 of gebasaxturev intratumorally for 8 cycles, and pembrolizumab intravenously for a maximum of 35 cycles. Cycle 1 was 28 days, and cycles 2-35 were 21 days.
OG003
Part 2 Dose Level 1, Solid Tumors + Liver Metastases
Participants with solid tumors with liver metastases received 3 X 10^7 TCID50 of gebasaxturev intratumorally for 8 cycles, and pembrolizumab intravenously for a maximum of 35 cycles. Cycle 1 was 28 days, and cycles 2-35 were 21 days.
OG004
Part 2 Dose Level 2, Solid Tumors + Liver Metastases
Participants with solid tumors with liver metastases received 1 X 10^8 TCID50 of gebasaxturev intratumorally for 8 cycles, and pembrolizumab intravenously for a maximum of 35 cycles. Cycle 1 was 28 days, and cycles 2-35 were 21 days.
OG005
Part 2 Dose Level 3, Solid Tumors + Liver Metastases
Participants with solid tumors with liver metastases received 3 X 10^8 TCID50 of gebasaxturev intratumorally for 8 cycles, and pembrolizumab intravenously for a maximum of 35 cycles. Cycle 1 was 28 days, and cycles 2-35 were 21 days.
Units
Counts
Participants
OG00021
OG00114
OG00217
OG0030
OG0040
OG0050
Title
Denominators
Categories
Title
Measurements
OG0007.5(4.3 to 15.0)
OG00111.8(3.0 to NA)NA = Upper limit not reached at time of data cut-off due to insufficient number of participants with an event.
OG00220.4(3.3 to NA)NA = Upper limit not reached at time of data cut-off due to insufficient number of participants with an event.
OG002
Part 1, Cohort C: Cutaneous Squamous Cell Carcinoma
Participants with cutaneous squamous cell carcinoma (cSCC) solid tumors received 3 X 10^8 TCID50 of gebasaxturev intratumorally for 8 cycles, and pembrolizumab intravenously for a maximum of 35 cycles. Cycle 1 was 28 days, and cycles 2-35 were 21 days.
OG003
Part 2 Dose Level 1, Solid Tumors + Liver Metastases
Participants with solid tumors with liver metastases received 3 X 10^7 TCID50 of gebasaxturev intratumorally for 8 cycles, and pembrolizumab intravenously for a maximum of 35 cycles. Cycle 1 was 28 days, and cycles 2-35 were 21 days.
OG004
Part 2 Dose Level 2, Solid Tumors + Liver Metastases
Participants with solid tumors with liver metastases received 1 X 10^8 TCID50 of gebasaxturev intratumorally for 8 cycles, and pembrolizumab intravenously for a maximum of 35 cycles. Cycle 1 was 28 days, and cycles 2-35 were 21 days.
OG005
Part 2 Dose Level 3, Solid Tumors + Liver Metastases
Participants with solid tumors with liver metastases received 3 X 10^8 TCID50 of gebasaxturev intratumorally for 8 cycles, and pembrolizumab intravenously for a maximum of 35 cycles. Cycle 1 was 28 days, and cycles 2-35 were 21 days.