A Study of Etigilimab and Nivolumab in Participants With... | NCT04761198 | Trialant
NCT04761198
Sponsor
Mereo BioPharma
Status
Completed
Last Update Posted
Mar 17, 2025Actual
Enrollment
76Actual
Phase
Phase 1Phase 2
Conditions
Solid Tumor, Adult
Advanced Solid Tumor
Metastatic Solid Tumor
Interventions
Etigilimab
Nivolumab
Countries
United States
United Kingdom
Protocol Section
Identification Module
NCT ID
NCT04761198
Obsolete or Duplicate NCT IDs
Not provided
Organization Study
MPH313-1-02
Secondary IDs
ID
Type
Description
Link
2020-004222-37
EudraCT Number
Brief Title
A Study of Etigilimab and Nivolumab in Participants With Locally Advanced or Metastatic Tumors
Official Title
A Phase 1b/2 Open-Label Study of the Efficacy and Safety of Etigilimab (MPH313) Administered in Combination With Nivolumab to Subjects With Locally Advanced or Metastatic Solid Tumors (ACTIVATE)
Acronym
Not provided
Organization
Mereo BioPharmaINDUSTRY
Status Module
Record Verification Date
Mar 2025
Overall Recruitment Status or Expanded Access Status
Completed
Last Known Status
Not provided
Delayed Posting
Not provided
Why Stopped
Not provided
Expanded Access Info
No
Start Date
Mar 23, 2021Actual
Primary Completion Date
Oct 30, 2023Actual
Completion Date
Oct 30, 2023Actual
First Submitted Date
Feb 12, 2021
First Submission Date that Met QC Criteria
Feb 17, 2021
First Posted Date
Feb 18, 2021Actual
Results Waived
Not provided
Results First Submitted Date
Jan 31, 2025
Results First Submitted that Met QC Criteria
Mar 7, 2025
Results First Posted Date
Mar 17, 2025Actual
Certification/Extension (aka Delayed Results) First Submitted Date
Oct 28, 2024
Certification/Extension First Submitted that Passed QC Review
Not provided
Certification/Extension First Posted Date
Mar 17, 2025Actual
Last Update Submitted Date
Mar 7, 2025
Last Update Posted Date
Mar 17, 2025Actual
Sponsor/Collaborators Module
Responsible Party, by Official Title
Sponsor
Lead Sponsor
Mereo BioPharmaINDUSTRY
Collaborators
Name
Class
ICON Clinical Research
INDUSTRY
Oversight Module
Has Data Monitoring Committee (DMC)
Yes
Is FDA Regulated Drug
Yes
Is FDA Regulated Device
No
Is Unapproved Device
Not provided
Pediatric Postmarket Surveillance of a Device Product
Not provided
Product Exported from US
Not provided
FDAAA801 Violation
Not provided
Description Module
Brief Summary
This is an open-label, phase 1b/2, multicenter study designed to evaluate the efficacy, safety, tolerability, pharmacokinetics (PK), and pharmacodynamics of etigilimab in combination with nivolumab in participants with locally advanced or metastatic solid tumors. Participants will be assigned to receive etigilimab (every 2 weeks) in combination with nivolumab (240 milligrams [mg] every 2 weeks).
Detailed Description
This is an open-label, phase 1b/2, multicenter study designed to evaluate the efficacy, safety, tolerability, PK, and pharmacodynamics of etigilimab in combination with nivolumab in participants with locally advanced or metastatic solid tumors. Participants will be assigned to receive etigilimab (every 2 weeks) in combination with nivolumab (240 mg every 2 weeks) and will continue until either unacceptable toxicity or disease progression. Participants may continue to receive treatment beyond documented Response Evaluation Criteria in Solid Tumours Version 1.1 (RECIST v1.1) or disease progression. Participants who are both checkpoint inhibitor (CPI) naive as well as participants who have received or progressed following a CPI will be eligible and include the following tumor types: head and neck squamous cell carcinoma (HNSCC), cervical carcinoma, gastric or gastroesophageal carcinoma, endometrial carcinoma, tumor mutation burden high (TMB-H), select rare tumors and ovarian carcinoma.
Conditions Module
Conditions
Solid Tumor, Adult
Advanced Solid Tumor
Metastatic Solid Tumor
Keywords
etigilimab
nivolumab
anti-TIGIT antibody
MPH313
Opdivo
ACTIVATE
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
Cohort A: Endometrial Cancer CPI (PD-1/PD-L1) Naive
Experimental
Participants with endometrial cancer CPI (programmed death-1 [PD-1]/ programmed death ligand-1 [PD-L1]) naive will receive etigilimab in combination with nivolumab every 2 weeks and will continue treatment until protocol-defined discontinuation criteria are met.
Drug: Etigilimab
Drug: Nivolumab
Cohort B: Head and Neck Squamous Cell Carcinoma
Experimental
Participants with head and neck cell carcinoma will receive etigilimab in combination with nivolumab every 2 weeks and will continue treatment until protocol-defined discontinuation criteria are met.
Drug: Etigilimab
Drug: Nivolumab
Cohort C: Cervical Carcinoma
Experimental
Participants with cervical carcinoma will receive etigilimab in combination with nivolumab every 2 weeks and will continue treatment until protocol-defined discontinuation criteria are met.
Drug: Etigilimab
Drug: Nivolumab
Cohort D (Recurrent Advanced and/or Metastatic Gastric or Gastroesophageal Junction Adenocarcinoma)
Experimental
Participants with recurrent advanced and/or metastatic gastric or gastroesophageal junction adenocarcinoma will receive etigilimab in combination with nivolumab every 2 weeks and will continue treatment until protocol-defined discontinuation criteria are met.
Interventions
Name
Type
Description
Arm Group Labels
Other Names
Etigilimab
Drug
IV infusion of IV etigilimab every 2 weeks
Cohort A: Endometrial Cancer CPI (PD-1/PD-L1) Naive
Cohort B: Head and Neck Squamous Cell Carcinoma
Outcomes Module
Primary Outcomes
Measure
Description
Time Frame
Objective Response Rate (ORR) as Assessed Based on Response Evaluation Criteria in Solid Tumours Version 1.1 (RECIST v1.1)
The ORR was defined as the percentage of participants who achieved a best overall response (BOR) of confirmed complete response (CR) or confirmed partial response (PR) per RECIST v1.1. CR: Disappearance of all target or non-target lesions and normalization of tumor marker level. Any pathological lymph node (whether target or non-target) must have reduction in short axis to <10 millimeters (mm). PR: At least a 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum diameters.
From first dose of study drug until the date of first objective response (CR or PR) (maximum exposure: 638 days)
Secondary Outcomes
Measure
Description
Time Frame
Number of Participants WithTreatment-emergent Adverse Events (TEAEs), Any Adverse Events of Special Interests (AESIs), AESI Immune Related AEs, and AESI Infusion Reactions
TEAEs were defined as adverse events (AEs) with an onset date on or after the date of first administration of study drug up to 100 days after the last dose of study drug and before starting any subsequent cancer treatment. An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. AESIs were defined as events (serious or non-serious) which were of scientific and medical concern specific to the sponsor's product or program, for which ongoing monitoring and rapid communication by the investigator to the sponsor might be appropriate. A summary of other non-serious AEs and all SAEs, regardless of causality is located in the 'Reported AE section'.
Other Outcomes
Not provided
Eligibility Module
Eligibility Criteria
Inclusion Criteria:
Histological or cytological diagnosis of a relevant tumor type as per the study protocol and not candidates for curative surgery or radiation therapy
Available tumor tissue (archival or newly obtained core or excisional biopsy)
Adequate hematologic and end organ function as measured by laboratory screening panel in the 14 days prior to treatment
Life expectancy greater than 12 weeks.
Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1
Adequate contraception for women of childbearing potential
Pre-specified wash-out of prior anti-PD1/PDL-1 therapy
Exclusion Criteria:
Concurrent active malignancy
Major surgery within 4 weeks of treatment
Participants with active, known or suspected autoimmune diseases
Prior treatment with cluster of differentiation (CD) 137 agonists, anti-cytotoxic T-lymphocyte-associated protein 4 (CTLA-4) and anti-T-cell immunoreceptor with immunoglobulin (Ig) and immunoreceptor tyrosine-based inhibitory motif domains (TIGIT) antibodies
History of any Grade 3 or 4 immune-related adverse event (AE) toxicity from prior immunotherapy that resulted in treatment discontinuation
History of immune-related adverse events that lead to discontinuation of anti-PD-1 or PDL-1 therapy
Active infections of human immunodeficiency virus (HIV), hepatitis B, hepatitis C
Medical illness or abnormal laboratory finding that would, in the Study Investigator's judgement, increase the risk to the participant associated with participation in the study
Pregnancy in female participants
Accepts Healthy Volunteers
No
Sex
All
Sex/Gender Based
Not provided
Sex/Gender Description
Not provided
Minimum Age
18 Years
Maximum Age
Not provided
Standard Ages
AdultOlder Adult
Study Population
Not provided
Sampling Method
Not provided
Contacts/Locations Module
Central Contacts
Not provided
Overall Officials
Not provided
Locations
Facility
Status
City
State
ZIP
Country
Contacts
Mereo Investigator Site
Phoenix
Arizona
85054
United States
Mereo Investigator Site
References Module
No data available
No data is available for this block.
IPD Sharing Statement Module
Plan to Share IPD
No
Description
Not provided
Types
Not provided
Time Frame
Not provided
Access Criteria
Not provided
URL
Not provided
Results Section
Participant Flow Module
Pre-assignment Details
Cohort D (Recurrent advanced and/or metastatic gastric or gastroesophageal junction adenocarcinoma) did not enroll any participants due to closure of the cohort by the Sponsor.
Recruitment Details
Not provided
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
FG000
Cohort A: Endometrial Cancer CPI (PD-1/PD-L1) Naive
Participants with endometrial cancer checkpoint inhibitors (CPI) (programmed death-1 [PD-1]/ programmed death ligand-1 [PD-L1]) naive received etigilimab in combination with nivolumab every 2 weeks and continued treatment until protocol-defined discontinuation criteria were met.
Periods
Title
Milestones
Reasons Not Completed
Overall Study
Type
Comment
Milestone Data
STARTED
Baseline Characteristics Module
Baseline Analysis Population Description
Outcome Measures Module
Outcome Measures
Adverse Events Module
Frequency Threshold
5
More Info Module
Limitations and Caveats
Not provided
Annotation Section
No data available
No data is available for this block.
Document Section
Large Document Module
Document Has No Statistical Analysis Plan (SAP)
Not provided
Uploaded Document Information
Type
Includes Protocol
Includes SAP
Includes ICF
Document Label
Document Date
Document Uploaded Date
Document File Name
Prot
Yes
No
No
Study Protocol
Jun 29, 2022
Jan 28, 2025
Derived Section
Miscellaneous Info Module
Version Holder
Jul 10, 2026
Removed Countries
Not provided
Submission Tracking
Estimated Results First Submitted Date
Not provided
Condition Browse Module
MeSH Terms
Intervention Browse Module
MeSH Terms
Non-Randomized
Intervention Model
Parallel Assignment
Intervention Model Description
Basket study
Primary Purpose
Basic Science
Observational Model
Not provided
Time Perspective
Not provided
Masking Info
Masking
None (Open Label)
Masking Description
Not provided
Who Masked
Not provided
Drug: Etigilimab
Drug: Nivolumab
Cohort E: TMB-H + MSS Solid Tumors
Experimental
Participants with tumour mutational burden-high (TMB-H) and microsatellite stable (MSS) solid tumors will receive etigilimab in combination with nivolumab every 2 weeks and will continue treatment until protocol-defined discontinuation criteria are met.
Participants with rare tumors (sarcoma, uveal melanoma, and germ cell) will receive etigilimab in combination with nivolumab every 2 weeks and will continue treatment until protocol-defined discontinuation criteria are met.
Drug: Etigilimab
Drug: Nivolumab
Cohort G: Endometrial Cancer Post- CPI (PD-1/PD-L1 Treated)
Experimental
Participants with endometrial cancer (PD-1/PD-L1 treated) will receive etigilimab in combination with nivolumab every 2 weeks and will continue treatment until protocol-defined discontinuation criteria are met.
Drug: Etigilimab
Drug: Nivolumab
Cohort H: Ovarian Cancer
Experimental
Participants with ovarian cancer will receive etigilimab in combination with nivolumab every 2 weeks and will continue treatment until protocol-defined discontinuation criteria are met.
Drug: Etigilimab
Drug: Nivolumab
Cohort C: Cervical Carcinoma
Cohort D (Recurrent Advanced and/or Metastatic Gastric or Gastroesophageal Junction Adenocarcinoma)
Cohort G: Endometrial Cancer Post- CPI (PD-1/PD-L1 Treated)
Cohort H: Ovarian Cancer
Opdivo
From first dose of study drug until 100 days after the last dose of study drug or the initiation of any subsequent cancer treatment, whichever occurs first (maximum exposure: 638 days)
Disease Control Rate (DCR) as Assessed Based on RECIST v1.1
The DCR was defined as the percentage of participants who achieved CR, PR, and stable disease (SD). CR: Disappearance of all target or non-target lesions and normalization of tumor marker level. Any pathological lymph node (whether target or non-target) must have reduction in short axis to <10 mm. PR: At least a 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum diameters. SD: Persistence of one or more non-target lesion(s) and/or maintenance of tumor marker level above the normal limits; and no new lesions.
From first dose of study drug until the date of first BOR (CR, PR, or SD) (maximum exposure: 638 days)
Duration of Response (DoR) as Assessed Based on RECIST v1.1
The DoR was defined as the time, in days, from the first of the 2 assessments required for confirmed PR or CR to the time of the progressive disease (PD) or death due to underlying cancer. CR: Disappearance of all target or non-target lesions and normalization of tumor marker level. Any pathological lymph node (whether target or non-target) must have reduction in short axis to <10 mm. PR: At least a 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum diameters. PD: At least a 20% increase in the sum of the diameters of target lesions, taking as reference the smallest sum on study. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. Unequivocal progression of the existing non-target lesions. The appearance of one or more new lesions was also considered progression.
From first dose of study drug until the date of first overall response of PD or date of death due to underlying cancer (maximum exposure: 638 days)
Duration of Stable Disease (DoSD) as Assessed Based on RECIST v1.1
The DoSD was defined as the time, in days, from the first date of treatment until the first date at which PD was experienced or the participant died due to underlying cancer. PD: At least a 20% increase in the sum of the diameters of target lesions, taking as reference the smallest sum on study. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. Unequivocal progression of the existing non-target lesions. The appearance of one or more new lesions was also considered progression.
From first dose of study drug until the date of first overall response of PD or date of death due to underlying cancer (up to a maximum of 680 days)
Serum Concentrations of Etigilimab
Pre-infusion and 15 minutes post-infusion on Cycle 1 Day 1 and Cycle 4 Day 43
Number of Participants With Anti-drug Antibodies (ADA) to Etigilimab
From first dose of study drug until 100 days after the last dose of study drug or the initiation of any subsequent cancer treatment, whichever occurs first (maximum exposure: 638 days)
Greenbrae
California
94904
United States
Mereo Investigator Site
Los Angeles
California
90025
United States
Mereo Investigator Site
Jacksonville
Florida
32224
United States
Mereo Investigator Site
Boston
Massachusetts
02215
United States
Mereo Investigator Site
Ann Arbor
Michigan
48109
United States
Mereo Investigator Site
Rochester
Minnesota
55905
United States
Mereo Investigator Site
New York
New York
10065
United States
Mereo Investigator Site
Durham
North Carolina
27710
United States
Mereo Investigator Site
Oklahoma City
Oklahoma
73104
United States
Mereo Investigator Site
Nashville
Tennessee
37203
United States
Mereo Investigator Site
Houston
Texas
77030
United States
Mereo Investigator Site
West Valley City
Utah
84119
United States
Mereo Investigator Site
Fairfax
Virginia
22031
United States
Royal Marsden
London
United Kingdom
Sarah Cannon UK
London
United Kingdom
FG001
Cohort B: Head and Neck Squamous Cell Carcinoma
Participants with head and neck cell carcinoma received etigilimab in combination with nivolumab every 2 weeks and continued treatment until protocol-defined discontinuation criteria were met.
FG002
Cohort C: Cervical Carcinoma
Participants with cervical carcinoma received etigilimab in combination with nivolumab every 2 weeks and continued treatment until protocol-defined discontinuation criteria were met.
FG003
Cohort E: TMB-H + MSS Solid Tumors
Participants with tumour mutational burden-high (TMB-H) and microsatellite stable (MSS) solid tumors received etigilimab in combination with nivolumab every 2 weeks and continued treatment until protocol-defined discontinuation criteria were met.
Participants with rare tumors (sarcoma, uveal melanoma, and germ cell) received etigilimab in combination with nivolumab every 2 weeks and continued treatment until protocol-defined discontinuation criteria were met.
FG005
Cohort G: Endometrial Cancer Post- CPI (PD-1/PD-L1 Treated)
Participants with endometrial cancer (PD-1/PD-L1 treated) received etigilimab in combination with nivolumab every 2 weeks and continued treatment until protocol-defined discontinuation criteria were met.
FG006
Cohort H: Ovarian Cancer
Participants with ovarian cancer received etigilimab in combination with nivolumab every 2 weeks and continued treatment until protocol-defined discontinuation criteria were met.
FG00011 subjects
FG0011 subjects
FG0028 subjects
FG0039 subjects
FG00433 subjects
FG0054 subjects
FG00610 subjects
Received at Least 1 Dose of Study Drug
FG00011 subjects
FG0011 subjects
FG0028 subjects
FG0039 subjects
FG00433 subjects
FG0054 subjects
FG00610 subjects
Response-Evaluable (RE) Analysis Set
Participants with measurable disease at baseline who received study drug and had at least 1 post-baseline response assessment or discontinued treatment due to disease progression (including death due to disease progression) within 16 weeks (+ a 2-week window) of the first dose of study drug.
FG00010 subjects
FG0011 subjects
FG0028 subjects
FG0039 subjects
FG00431 subjects
FG0053 subjects
FG00610 subjects
COMPLETED
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG0041 subjects
FG0050 subjects
FG0060 subjects
NOT COMPLETED
FG00011 subjects
FG0011 subjects
FG0028 subjects
FG0039 subjects
FG00432 subjects
FG0054 subjects
FG00610 subjects
Type
Comment
Reasons
Progressive Disease
FG0001 subjects
FG0010 subjects
FG0020 subjects
FG0031 subjects
FG0044 subjects
FG0051 subjects
FG0062 subjects
Protocol Violation
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
Death
FG0002 subjects
FG0011 subjects
FG0022 subjects
FG0035 subjects
FG004
Lost to Follow-up
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
Withdrawal by Subject
FG0002 subjects
FG0010 subjects
FG0021 subjects
FG0030 subjects
FG004
Study Terminated by Sponsor
FG0006 subjects
FG0010 subjects
FG0025 subjects
FG0033 subjects
FG004
Safety Analysis Set included all participants who received any amount of study drug.
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
BG000
Cohort A: Endometrial Cancer CPI (PD-1/PD-L1) Naive
Participants with endometrial cancer CPI (PD-1/PD-L1) naive received etigilimab in combination with nivolumab every 2 weeks and continued treatment until protocol-defined discontinuation criteria were met.
BG001
Cohort B: Head and Neck Squamous Cell Carcinoma
Participants with head and neck cell carcinoma received etigilimab in combination with nivolumab every 2 weeks and continued treatment until protocol-defined discontinuation criteria were met.
BG002
Cohort C: Cervical Carcinoma
Participants with cervical carcinoma received etigilimab in combination with nivolumab every 2 weeks and continued treatment until protocol-defined discontinuation criteria were met.
BG003
Cohort E: TMB-H + MSS Solid Tumors
Participants with TMB-H and MSS solid tumors received etigilimab in combination with nivolumab every 2 weeks and continued treatment until protocol-defined discontinuation criteria were met.
Participants with rare tumors (sarcoma, uveal melanoma, and germ cell) received etigilimab in combination with nivolumab every 2 weeks and continued treatment until protocol-defined discontinuation criteria were met.
BG005
Cohort G: Endometrial Cancer Post- CPI (PD-1/PD-L1 Treated)
Participants with endometrial cancer (PD-1/PD-L1 treated) received etigilimab in combination with nivolumab every 2 weeks and continued treatment until protocol-defined discontinuation criteria were met.
BG006
Cohort H: Ovarian Cancer
Participants with ovarian cancer received etigilimab in combination with nivolumab every 2 weeks and continued treatment until protocol-defined discontinuation criteria were met.
BG007
Total
Total of all reporting groups
Denominators
Units
Counts
Participants
BG00011
BG0011
BG0028
BG0039
BG00433
BG0054
BG00610
BG00776
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
BG00065.7± 10.20
BG00169.0
BG00249.1± 13.53
BG003
Sex: Female, Male
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
Female
BG00011
BG0010
BG002
Ethnicity (NIH/OMB)
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
Hispanic or Latino
BG0001
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
Objective Response Rate (ORR) as Assessed Based on Response Evaluation Criteria in Solid Tumours Version 1.1 (RECIST v1.1)
The ORR was defined as the percentage of participants who achieved a best overall response (BOR) of confirmed complete response (CR) or confirmed partial response (PR) per RECIST v1.1. CR: Disappearance of all target or non-target lesions and normalization of tumor marker level. Any pathological lymph node (whether target or non-target) must have reduction in short axis to <10 millimeters (mm). PR: At least a 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum diameters.
RE Analysis Set included all participants with measurable disease at baseline who received study drug and had at least 1 post-baseline response assessment or discontinued treatment due to disease progression (including death due to disease progression) within 16 weeks (+ a 2-week window) of the first dose of study drug. Per planned analysis, the efficacy data for Cohort F were collected and analyzed separately per tumor type.
Posted
Number
95% Confidence Interval
percentage of participants
From first dose of study drug until the date of first objective response (CR or PR) (maximum exposure: 638 days)
ID
Title
Description
OG000
Cohort A: Endometrial Cancer CPI (PD-1/PD-L1) Naive
Participants with endometrial cancer CPI (PD-1/PD-L1) naive received etigilimab in combination with nivolumab every 2 weeks and continued treatment until protocol-defined discontinuation criteria were met.
OG001
Cohort B: Head and Neck Squamous Cell Carcinoma
Participants with head and neck cell carcinoma received etigilimab in combination with nivolumab every 2 weeks and continued treatment until protocol-defined discontinuation criteria were met.
OG002
Cohort C: Cervical Carcinoma
Participants with cervical carcinoma received etigilimab in combination with nivolumab every 2 weeks and continued treatment until protocol-defined discontinuation criteria were met.
OG003
Cohort E: TMB-H + MSS Solid Tumors
Participants with TMB-H and MSS solid tumors received etigilimab in combination with nivolumab every 2 weeks and continued treatment until protocol-defined discontinuation criteria were met.
OG004
Cohort F: Rare Tumors (Uveal)
Participants with rare tumors (uveal) received etigilimab in combination with nivolumab every 2 weeks and continued treatment until protocol-defined discontinuation criteria were met.
OG005
Cohort F: Rare Tumors (De-diff LPS)
Participants with rare tumors (de-differentiated liposarcoma [de-diff LPS]) received etigilimab in combination with nivolumab every 2 weeks and continued treatment until protocol-defined discontinuation criteria were met.
Units
Counts
Participants
OG00010
OG0011
OG0028
OG003
Title
Denominators
Categories
Title
Measurements
OG00020.0(2.52 to 55.61)
OG0010(0.00 to 97.50)
OG00237.5(8.52 to 75.51)
OG003
Secondary
Number of Participants WithTreatment-emergent Adverse Events (TEAEs), Any Adverse Events of Special Interests (AESIs), AESI Immune Related AEs, and AESI Infusion Reactions
TEAEs were defined as adverse events (AEs) with an onset date on or after the date of first administration of study drug up to 100 days after the last dose of study drug and before starting any subsequent cancer treatment. An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. AESIs were defined as events (serious or non-serious) which were of scientific and medical concern specific to the sponsor's product or program, for which ongoing monitoring and rapid communication by the investigator to the sponsor might be appropriate. A summary of other non-serious AEs and all SAEs, regardless of causality is located in the 'Reported AE section'.
Safety Analysis Set included all participants who received any amount of study drug.
Posted
Count of Participants
Participants
From first dose of study drug until 100 days after the last dose of study drug or the initiation of any subsequent cancer treatment, whichever occurs first (maximum exposure: 638 days)
ID
Title
Description
OG000
Cohort A: Endometrial Cancer CPI (PD-1/PD-L1) Naive
Participants with endometrial cancer CPI (PD-1/PD-L1) naive received etigilimab in combination with nivolumab every 2 weeks and continued treatment until protocol-defined discontinuation criteria were met.
OG001
Cohort B: Head and Neck Squamous Cell Carcinoma
Secondary
Disease Control Rate (DCR) as Assessed Based on RECIST v1.1
The DCR was defined as the percentage of participants who achieved CR, PR, and stable disease (SD). CR: Disappearance of all target or non-target lesions and normalization of tumor marker level. Any pathological lymph node (whether target or non-target) must have reduction in short axis to <10 mm. PR: At least a 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum diameters. SD: Persistence of one or more non-target lesion(s) and/or maintenance of tumor marker level above the normal limits; and no new lesions.
RE Analysis Set included all participants with measurable disease at baseline who received study drug and had at least 1 post-baseline response assessment or discontinued treatment due to disease progression (including death due to disease progression) within 16 weeks (+ a 2-week window) of the first dose of study drug. Per planned analysis, the efficacy data for Cohort F were collected and analyzed separately per tumor type.
Posted
Number
95% Confidence Interval
percentage of participants
From first dose of study drug until the date of first BOR (CR, PR, or SD) (maximum exposure: 638 days)
ID
Title
Description
OG000
Cohort A: Endometrial Cancer CPI (PD-1/PD-L1) Naive
Participants with endometrial cancer CPI (PD-1/PD-L1) naive received etigilimab in combination with nivolumab every 2 weeks and continued treatment until protocol-defined discontinuation criteria were met.
OG001
Cohort B: Head and Neck Squamous Cell Carcinoma
Secondary
Duration of Response (DoR) as Assessed Based on RECIST v1.1
The DoR was defined as the time, in days, from the first of the 2 assessments required for confirmed PR or CR to the time of the progressive disease (PD) or death due to underlying cancer. CR: Disappearance of all target or non-target lesions and normalization of tumor marker level. Any pathological lymph node (whether target or non-target) must have reduction in short axis to <10 mm. PR: At least a 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum diameters. PD: At least a 20% increase in the sum of the diameters of target lesions, taking as reference the smallest sum on study. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. Unequivocal progression of the existing non-target lesions. The appearance of one or more new lesions was also considered progression.
RE Analysis Set: all participants with measurable disease at baseline who received study drug and had at least 1 post-baseline response assessment or discontinued treatment due to disease progression (including death due to disease progression) within 16 weeks of first dose of study drug. Per planned analysis, the efficacy data for Cohort F were collected and analyzed separately per tumor type. 'Overall number of participants analyzed' = participants evaluable for this outcome measure.
Posted
Median
Full Range
days
From first dose of study drug until the date of first overall response of PD or date of death due to underlying cancer (maximum exposure: 638 days)
ID
Title
Description
OG000
Cohort A: Endometrial Cancer CPI (PD-1/PD-L1) Naive
Participants with endometrial cancer CPI (PD-1/PD-L1) naive received etigilimab in combination with nivolumab every 2 weeks and continued treatment until protocol-defined discontinuation criteria were met.
Secondary
Duration of Stable Disease (DoSD) as Assessed Based on RECIST v1.1
The DoSD was defined as the time, in days, from the first date of treatment until the first date at which PD was experienced or the participant died due to underlying cancer. PD: At least a 20% increase in the sum of the diameters of target lesions, taking as reference the smallest sum on study. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. Unequivocal progression of the existing non-target lesions. The appearance of one or more new lesions was also considered progression.
RE Analysis Set included all participants with measurable disease at baseline who received study drug and had at least 1 post-baseline response assessment or discontinued treatment due to disease progression (including death due to disease progression) within 16 weeks (+ a 2-week window) of the first dose of study drug. Per planned analysis, the efficacy data for Cohort F were collected and analyzed separately per tumor type.
Posted
Median
Full Range
days
From first dose of study drug until the date of first overall response of PD or date of death due to underlying cancer (up to a maximum of 680 days)
ID
Title
Description
OG000
Cohort A: Endometrial Cancer CPI (PD-1/PD-L1) Naive
Participants with endometrial cancer CPI (PD-1/PD-L1) naive received etigilimab in combination with nivolumab every 2 weeks and continued treatment until protocol-defined discontinuation criteria were met.
OG001
Cohort B: Head and Neck Squamous Cell Carcinoma
Secondary
Serum Concentrations of Etigilimab
The pharmacokinetic (PK) analysis set included all participants with sufficient plasma concentration data to allow the characterization of the PK parameters. Per planned analysis, PK data were collected and analyzed combined for all arm groups. 'Number analyzed' = participants evaluable at specified timepoint.
Posted
Geometric Mean
Geometric Coefficient of Variation
micrograms (μg)/milliliter (mL)
Pre-infusion and 15 minutes post-infusion on Cycle 1 Day 1 and Cycle 4 Day 43
ID
Title
Description
OG000
Etigilimab
Participants received etigilimab in combination with nivolumab every 2 weeks and continued treatment until protocol-defined discontinuation criteria were met.
Units
Counts
Participants
OG000
Secondary
Number of Participants With Anti-drug Antibodies (ADA) to Etigilimab
The immunogenicity analysis set included all participants with at least 1 evaluable post-treatment immunogenicity sample.
Posted
Count of Participants
Participants
From first dose of study drug until 100 days after the last dose of study drug or the initiation of any subsequent cancer treatment, whichever occurs first (maximum exposure: 638 days)
ID
Title
Description
OG000
Cohort A: Endometrial Cancer CPI (PD-1/PD-L1) Naive
Participants with endometrial cancer CPI (PD-1/PD-L1) naive received etigilimab in combination with nivolumab every 2 weeks and continued treatment until protocol-defined discontinuation criteria were met.
OG001
Cohort B: Head and Neck Squamous Cell Carcinoma
Participants with head and neck cell carcinoma received etigilimab in combination with nivolumab every 2 weeks and continued treatment until protocol-defined discontinuation criteria were met.
OG002
Cohort C: Cervical Carcinoma
Participants with cervical carcinoma received etigilimab in combination with nivolumab every 2 weeks and continued treatment until protocol-defined discontinuation criteria were met.
Time Frame
From first dose of study drug until 100 days after the last dose of study drug or the initiation of any subsequent cancer treatment, whichever occurs first (maximum exposure: 638 days)
Description
Safety Analysis Set included all participants who received any amount of study drug.
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
Cohort A: Endometrial Cancer CPI (PD-1/PD-L1) Naive
Participants with endometrial cancer CPI (PD-1/PD-L1) naive received etigilimab in combination with nivolumab every 2 weeks and continued treatment until protocol-defined discontinuation criteria were met.
2
11
2
11
11
11
EG001
Cohort B: Head and Neck Squamous Cell Carcinoma
Participants with head and neck cell carcinoma received etigilimab in combination with nivolumab every 2 weeks and continued treatment until protocol-defined discontinuation criteria were met.
1
1
0
1
1
1
EG002
Cohort C: Cervical Carcinoma
Participants with cervical carcinoma received etigilimab in combination with nivolumab every 2 weeks and continued treatment until protocol-defined discontinuation criteria were met.
2
8
2
8
8
8
EG003
Cohort E: TMB-H + MSS Solid Tumors
Participants with TMB-H and MSS solid tumors received etigilimab in combination with nivolumab every 2 weeks and continued treatment until protocol-defined discontinuation criteria were met.
Participants with rare tumors (sarcoma, uveal melanoma, and germ cell) received etigilimab in combination with nivolumab every 2 weeks and continued treatment until protocol-defined discontinuation criteria were met.
14
33
8
33
33
33
EG005
Cohort G: Endometrial Cancer Post- CPI (PD-1/PD-L1 Treated)
Participants with endometrial cancer (PD-1/PD-L1 treated) received etigilimab in combination with nivolumab every 2 weeks and continued treatment until protocol-defined discontinuation criteria were met.
2
4
2
4
4
4
EG006
Cohort H: Ovarian Cancer
Participants with ovarian cancer received etigilimab in combination with nivolumab every 2 weeks and continued treatment until protocol-defined discontinuation criteria were met.
5
10
3
10
9
10
Serious Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Pneumonia
Infections and infestations
MedDRA 26.0
Systematic Assessment
EG0000 affected11 at risk
EG0010 affected1 at risk
EG0021 affected8 at risk
EG0031 affected9 at risk
EG0042 affected33 at risk
EG0050 affected4 at risk
EG0060 affected10 at risk
Sepsis
Infections and infestations
MedDRA 26.0
Systematic Assessment
EG0000 affected11 at risk
EG0010 affected1 at risk
EG0021 affected8 at risk
EG003
Abdominal sepsis
Infections and infestations
MedDRA 26.0
Systematic Assessment
EG0000 affected11 at risk
EG0010 affected1 at risk
EG0020 affected8 at risk
EG003
Peritonitis
Infections and infestations
MedDRA 26.0
Systematic Assessment
EG0001 affected11 at risk
EG0010 affected1 at risk
EG0020 affected8 at risk
EG003
Septic shock
Infections and infestations
MedDRA 26.0
Systematic Assessment
EG0000 affected11 at risk
EG0010 affected1 at risk
EG0020 affected8 at risk
EG003
Abdominal pain
Gastrointestinal disorders
MedDRA 26.0
Systematic Assessment
EG0000 affected11 at risk
EG0010 affected1 at risk
EG0020 affected8 at risk
EG003
Ascites
Gastrointestinal disorders
MedDRA 26.0
Systematic Assessment
EG0000 affected11 at risk
EG0010 affected1 at risk
EG0020 affected8 at risk
EG003
Immune-mediated gastritis
Gastrointestinal disorders
MedDRA 26.0
Systematic Assessment
EG0000 affected11 at risk
EG0010 affected1 at risk
EG0021 affected8 at risk
EG003
Intestinal obstruction
Gastrointestinal disorders
MedDRA 26.0
Systematic Assessment
EG0000 affected11 at risk
EG0010 affected1 at risk
EG0020 affected8 at risk
EG003
Malignant ascites
Gastrointestinal disorders
MedDRA 26.0
Systematic Assessment
EG0000 affected11 at risk
EG0010 affected1 at risk
EG0020 affected8 at risk
EG003
Small intestinal obstruction
Gastrointestinal disorders
MedDRA 26.0
Systematic Assessment
EG0000 affected11 at risk
EG0010 affected1 at risk
EG0020 affected8 at risk
EG003
Pleural effusion
Respiratory, thoracic and mediastinal disorders
MedDRA 26.0
Systematic Assessment
EG0000 affected11 at risk
EG0010 affected1 at risk
EG0020 affected8 at risk
EG003
Chylothorax
Respiratory, thoracic and mediastinal disorders
MedDRA 26.0
Systematic Assessment
EG0000 affected11 at risk
EG0010 affected1 at risk
EG0020 affected8 at risk
EG003
Haemoptysis
Respiratory, thoracic and mediastinal disorders
MedDRA 26.0
Systematic Assessment
EG0000 affected11 at risk
EG0010 affected1 at risk
EG0020 affected8 at risk
EG003
Disease progression
General disorders
MedDRA 26.0
Systematic Assessment
EG0000 affected11 at risk
EG0010 affected1 at risk
EG0020 affected8 at risk
EG003
Fatigue
General disorders
MedDRA 26.0
Systematic Assessment
EG0000 affected11 at risk
EG0010 affected1 at risk
EG0020 affected8 at risk
EG003
Pyrexia
General disorders
MedDRA 26.0
Systematic Assessment
EG0000 affected11 at risk
EG0010 affected1 at risk
EG0020 affected8 at risk
EG003
Urinary tract obstruction
Renal and urinary disorders
MedDRA 26.0
Systematic Assessment
EG0000 affected11 at risk
EG0010 affected1 at risk
EG0021 affected8 at risk
EG003
Acute kidney injury
Renal and urinary disorders
MedDRA 26.0
Systematic Assessment
EG0000 affected11 at risk
EG0010 affected1 at risk
EG0020 affected8 at risk
EG003
Atrial fibrillation
Cardiac disorders
MedDRA 26.0
Systematic Assessment
EG0000 affected11 at risk
EG0010 affected1 at risk
EG0020 affected8 at risk
EG003
Myocardial infarction
Cardiac disorders
MedDRA 26.0
Systematic Assessment
EG0000 affected11 at risk
EG0010 affected1 at risk
EG0020 affected8 at risk
EG003
Arthralgia
Musculoskeletal and connective tissue disorders
MedDRA 26.0
Systematic Assessment
EG0000 affected11 at risk
EG0010 affected1 at risk
EG0020 affected8 at risk
EG003
Muscular weakness
Musculoskeletal and connective tissue disorders
MedDRA 26.0
Systematic Assessment
EG0000 affected11 at risk
EG0010 affected1 at risk
EG0020 affected8 at risk
EG003
Musculoskeletal chest pain
Musculoskeletal and connective tissue disorders
MedDRA 26.0
Systematic Assessment
EG0000 affected11 at risk
EG0010 affected1 at risk
EG0020 affected8 at risk
EG003
Adrenal insufficiency
Endocrine disorders
MedDRA 26.0
Systematic Assessment
EG0001 affected11 at risk
EG0010 affected1 at risk
EG0020 affected8 at risk
EG003
Decreased appetite
Metabolism and nutrition disorders
MedDRA 26.0
Systematic Assessment
EG0000 affected11 at risk
EG0010 affected1 at risk
EG0020 affected8 at risk
EG003
Hypoaesthesia
Nervous system disorders
MedDRA 26.0
Systematic Assessment
EG0000 affected11 at risk
EG0010 affected1 at risk
EG0020 affected8 at risk
EG003
Pelvic pain
Reproductive system and breast disorders
MedDRA 26.0
Systematic Assessment
EG0000 affected11 at risk
EG0010 affected1 at risk
EG0020 affected8 at risk
EG003
Other Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Nausea
Gastrointestinal disorders
MedDRA 26.0
Systematic Assessment
EG0004 affected11 at risk
EG0010 affected1 at risk
EG0023 affected8 at risk
EG0033 affected9 at risk
EG0046 affected33 at risk
EG0050 affected4 at risk
EG0065 affected10 at risk
Diarrhoea
Gastrointestinal disorders
MedDRA 26.0
Systematic Assessment
EG0004 affected11 at risk
EG0010 affected1 at risk
EG0024 affected8 at risk
EG003
Constipation
Gastrointestinal disorders
MedDRA 26.0
Systematic Assessment
EG0002 affected11 at risk
EG0010 affected1 at risk
EG0023 affected8 at risk
EG003
Vomiting
Gastrointestinal disorders
MedDRA 26.0
Systematic Assessment
EG0004 affected11 at risk
EG0010 affected1 at risk
EG0022 affected8 at risk
EG003
Abdominal pain
Gastrointestinal disorders
MedDRA 26.0
Systematic Assessment
EG0001 affected11 at risk
EG0010 affected1 at risk
EG0022 affected8 at risk
EG003
Rash
Skin and subcutaneous tissue disorders
MedDRA 26.0
Systematic Assessment
EG0004 affected11 at risk
EG0010 affected1 at risk
EG0021 affected8 at risk
EG003
Pruritus
Skin and subcutaneous tissue disorders
MedDRA 26.0
Systematic Assessment
EG0002 affected11 at risk
EG0010 affected1 at risk
EG0022 affected8 at risk
EG003
Rash maculo-papular
Skin and subcutaneous tissue disorders
MedDRA 26.0
Systematic Assessment
EG0001 affected11 at risk
EG0010 affected1 at risk
EG0022 affected8 at risk
EG003
Dry skin
Skin and subcutaneous tissue disorders
MedDRA 26.0
Systematic Assessment
EG0000 affected11 at risk
EG0010 affected1 at risk
EG0021 affected8 at risk
EG003
Dermatitis
Skin and subcutaneous tissue disorders
MedDRA 26.0
Systematic Assessment
EG0000 affected11 at risk
EG0010 affected1 at risk
EG0020 affected8 at risk
EG003
Fatigue
General disorders
MedDRA 26.0
Systematic Assessment
EG0003 affected11 at risk
EG0010 affected1 at risk
EG0022 affected8 at risk
EG003
Oedema peripheral
General disorders
MedDRA 26.0
Systematic Assessment
EG0000 affected11 at risk
EG0010 affected1 at risk
EG0021 affected8 at risk
EG003
Chills
General disorders
MedDRA 26.0
Systematic Assessment
EG0002 affected11 at risk
EG0010 affected1 at risk
EG0020 affected8 at risk
EG003
Influenza like illness
General disorders
MedDRA 26.0
Systematic Assessment
EG0002 affected11 at risk
EG0010 affected1 at risk
EG0020 affected8 at risk
EG003
Pyrexia
General disorders
MedDRA 26.0
Systematic Assessment
EG0002 affected11 at risk
EG0010 affected1 at risk
EG0020 affected8 at risk
EG003
Decreased appetite
Metabolism and nutrition disorders
MedDRA 26.0
Systematic Assessment
EG0003 affected11 at risk
EG0011 affected1 at risk
EG0024 affected8 at risk
EG003
Hyponatraemia
Metabolism and nutrition disorders
MedDRA 26.0
Systematic Assessment
EG0001 affected11 at risk
EG0010 affected1 at risk
EG0020 affected8 at risk
EG003
Dehydration
Metabolism and nutrition disorders
MedDRA 26.0
Systematic Assessment
EG0001 affected11 at risk
EG0011 affected1 at risk
EG0021 affected8 at risk
EG003
Hypoalbuminaemia
Metabolism and nutrition disorders
MedDRA 26.0
Systematic Assessment
EG0000 affected11 at risk
EG0010 affected1 at risk
EG0020 affected8 at risk
EG003
Dyspnoea
Respiratory, thoracic and mediastinal disorders
MedDRA 26.0
Systematic Assessment
EG0001 affected11 at risk
EG0010 affected1 at risk
EG0023 affected8 at risk
EG003
Cough
Respiratory, thoracic and mediastinal disorders
MedDRA 26.0
Systematic Assessment
EG0003 affected11 at risk
EG0010 affected1 at risk
EG0022 affected8 at risk
EG003
Arthralgia
Musculoskeletal and connective tissue disorders
MedDRA 26.0
Systematic Assessment
EG0001 affected11 at risk
EG0010 affected1 at risk
EG0023 affected8 at risk
EG003
Back pain
Musculoskeletal and connective tissue disorders
MedDRA 26.0
Systematic Assessment
EG0001 affected11 at risk
EG0010 affected1 at risk
EG0022 affected8 at risk
EG003
Pain in extremity
Musculoskeletal and connective tissue disorders
MedDRA 26.0
Systematic Assessment
EG0002 affected11 at risk
EG0010 affected1 at risk
EG0021 affected8 at risk
EG003
Muscular weakness
Musculoskeletal and connective tissue disorders
MedDRA 26.0
Systematic Assessment
EG0000 affected11 at risk
EG0010 affected1 at risk
EG0021 affected8 at risk
EG003
COVID-19
Infections and infestations
MedDRA 26.0
Systematic Assessment
EG0001 affected11 at risk
EG0010 affected1 at risk
EG0021 affected8 at risk
EG003
Upper respiratory tract infection
Infections and infestations
MedDRA 26.0
Systematic Assessment
EG0001 affected11 at risk
EG0010 affected1 at risk
EG0020 affected8 at risk
EG003
Urinary tract infection
Infections and infestations
MedDRA 26.0
Systematic Assessment
EG0000 affected11 at risk
EG0010 affected1 at risk
EG0021 affected8 at risk
EG003
Aspartate aminotransferase increased
Investigations
MedDRA 26.0
Systematic Assessment
EG0002 affected11 at risk
EG0010 affected1 at risk
EG0023 affected8 at risk
EG003
Weight decreased
Investigations
MedDRA 26.0
Systematic Assessment
EG0001 affected11 at risk
EG0011 affected1 at risk
EG0021 affected8 at risk
EG003
Alanine aminotransferase increased
Investigations
MedDRA 26.0
Systematic Assessment
EG0001 affected11 at risk
EG0010 affected1 at risk
EG0021 affected8 at risk
EG003
Blood creatinine increased
Investigations
MedDRA 26.0
Systematic Assessment
EG0000 affected11 at risk
EG0010 affected1 at risk
EG0020 affected8 at risk
EG003
Anaemia
Blood and lymphatic system disorders
MedDRA 26.0
Systematic Assessment
EG0002 affected11 at risk
EG0011 affected1 at risk
EG0021 affected8 at risk
EG003
Dizziness
Nervous system disorders
MedDRA 26.0
Systematic Assessment
EG0000 affected11 at risk
EG0010 affected1 at risk
EG0022 affected8 at risk
EG003
Headache
Nervous system disorders
MedDRA 26.0
Systematic Assessment
EG0000 affected11 at risk
EG0010 affected1 at risk
EG0022 affected8 at risk
EG003
Paraesthesia
Nervous system disorders
MedDRA 26.0
Systematic Assessment
EG0000 affected11 at risk
EG0010 affected1 at risk
EG0021 affected8 at risk
EG003
Hypertension
Vascular disorders
MedDRA 26.0
Systematic Assessment
EG0000 affected11 at risk
EG0010 affected1 at risk
EG0020 affected8 at risk
EG003
Infusion related reaction
Injury, poisoning and procedural complications
MedDRA 26.0
Systematic Assessment
EG0002 affected11 at risk
EG0011 affected1 at risk
EG0021 affected8 at risk
EG003
Fall
Injury, poisoning and procedural complications
MedDRA 26.0
Systematic Assessment
EG0001 affected11 at risk
EG0010 affected1 at risk
EG0020 affected8 at risk
EG003
Anxiety
Psychiatric disorders
MedDRA 26.0
Systematic Assessment
EG0000 affected11 at risk
EG0010 affected1 at risk
EG0020 affected8 at risk
EG003
Insomnia
Psychiatric disorders
MedDRA 26.0
Systematic Assessment
EG0000 affected11 at risk
EG0010 affected1 at risk
EG0020 affected8 at risk
EG003
Hypothyroidism
Endocrine disorders
MedDRA 26.0
Systematic Assessment
EG0001 affected11 at risk
EG0010 affected1 at risk
EG0021 affected8 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
All PIs must seek written permission from the sponsor before publication of any trial results.
Participants with rare tumors (undifferentiated pleomorphic sarcoma [UPS]) received etigilimab in combination with nivolumab every 2 weeks and continued treatment until protocol-defined discontinuation criteria were met.
OG007
Cohort F: Rare Tumors (Other Sarcoma)
Participants with rare tumors (other sarcoma) received etigilimab in combination with nivolumab every 2 weeks and continued treatment until protocol-defined discontinuation criteria were met.
OG008
Cohort F: Rare Tumors (GCT)
Participants with rare tumors (germ cell tumours [GCT]) received etigilimab in combination with nivolumab every 2 weeks and continued treatment until protocol-defined discontinuation criteria were met.
OG009
Cohort G: Endometrial Cancer Post- CPI (PD-1/PD-L1 Treated)
Participants with endometrial cancer (PD-1/PD-L1 treated) received etigilimab in combination with nivolumab every 2 weeks and continued treatment until protocol-defined discontinuation criteria were met.
OG010
Cohort H: Ovarian Cancer
Participants with ovarian cancer received etigilimab in combination with nivolumab every 2 weeks and continued treatment until protocol-defined discontinuation criteria were met.
9
OG0048
OG00510
OG0066
OG0073
OG0084
OG0093
OG01010
0
(0.00 to 33.63)
OG00425.0(3.19 to 65.09)
OG00510.0(0.25 to 44.50)
OG00616.7(0.42 to 64.12)
OG0070(0.00 to 70.76)
OG0080(0.00 to 60.24)
OG0090(0.00 to 70.76)
OG01010.0(0.25 to 44.50)
Participants with head and neck cell carcinoma received etigilimab in combination with nivolumab every 2 weeks and continued treatment until protocol-defined discontinuation criteria were met.
OG002
Cohort C: Cervical Carcinoma
Participants with cervical carcinoma received etigilimab in combination with nivolumab every 2 weeks and continued treatment until protocol-defined discontinuation criteria were met.
OG003
Cohort E: TMB-H + MSS Solid Tumors
Participants with TMB-H and MSS solid tumors received etigilimab in combination with nivolumab every 2 weeks and continued treatment until protocol-defined discontinuation criteria were met.
Participants with rare tumors (sarcoma, uveal melanoma, and germ cell) received etigilimab in combination with nivolumab every 2 weeks and continued treatment until protocol-defined discontinuation criteria were met.
OG005
Cohort G: Endometrial Cancer Post- CPI (PD-1/PD-L1 Treated)
Participants with endometrial cancer (PD-1/PD-L1 treated) received etigilimab in combination with nivolumab every 2 weeks and continued treatment until protocol-defined discontinuation criteria were met.
OG006
Cohort H: Ovarian Cancer
Participants with ovarian cancer received etigilimab in combination with nivolumab every 2 weeks and continued treatment until protocol-defined discontinuation criteria were met.
Units
Counts
Participants
OG00011
OG0011
OG0028
OG0039
OG00433
OG0054
OG00610
Title
Denominators
Categories
Any TEAEs
Title
Measurements
OG00011
OG0011
OG0028
OG0038
OG00433
OG0054
OG0069
Any AESIs
Title
Measurements
OG0004
OG0010
OG0023
OG003
AESI Immune Related AEs
Title
Measurements
OG0002
OG0010
OG0022
OG003
AESI Infusion Reactions
Title
Measurements
OG0002
OG0010
OG0021
OG003
Participants with head and neck cell carcinoma received etigilimab in combination with nivolumab every 2 weeks and continued treatment until protocol-defined discontinuation criteria were met.
OG002
Cohort C: Cervical Carcinoma
Participants with cervical carcinoma received etigilimab in combination with nivolumab every 2 weeks and continued treatment until protocol-defined discontinuation criteria were met.
OG003
Cohort E: TMB-H + MSS Solid Tumors
Participants with TMB-H and MSS solid tumors received etigilimab in combination with nivolumab every 2 weeks and continued treatment until protocol-defined discontinuation criteria were met.
OG004
Cohort F: Rare Tumors (Uveal)
Participants with rare tumors (uveal) received etigilimab in combination with nivolumab every 2 weeks and continued treatment until protocol-defined discontinuation criteria were met.
OG005
Cohort F: Rare Tumors (De-diff LPS)
Participants with rare tumors (de-diff LPS) received etigilimab in combination with nivolumab every 2 weeks and continued treatment until protocol-defined discontinuation criteria were met.
OG006
Cohort F: Rare Tumors (UPS)
Participants with rare tumors (UPS) received etigilimab in combination with nivolumab every 2 weeks and continued treatment until protocol-defined discontinuation criteria were met.
OG007
Cohort F: Rare Tumors (Other Sarcoma)
Participants with rare tumors (other sarcoma) received etigilimab in combination with nivolumab every 2 weeks and continued treatment until protocol-defined discontinuation criteria were met.
OG008
Cohort F: Rare Tumors (GCT)
Participants with rare tumors (GCT) received etigilimab in combination with nivolumab every 2 weeks and continued treatment until protocol-defined discontinuation criteria were met.
OG009
Cohort G: Endometrial Cancer Post- CPI (PD-1/PD-L1 Treated)
Participants with endometrial cancer (PD-1/PD-L1 treated) received etigilimab in combination with nivolumab every 2 weeks and continued treatment until protocol-defined discontinuation criteria were met.
OG010
Cohort H: Ovarian Cancer
Participants with ovarian cancer received etigilimab in combination with nivolumab every 2 weeks and continued treatment until protocol-defined discontinuation criteria were met.
Units
Counts
Participants
OG00010
OG0011
OG0028
OG0039
OG0048
OG00510
OG0066
OG0073
OG0084
OG0093
OG01010
Title
Denominators
Categories
Title
Measurements
OG00050.0(18.71 to 81.29)
OG0010(0.00 to 97.50)
OG00262.5(24.49 to 91.48)
OG00333.3(7.49 to 70.07)
OG00450.0(15.70 to 84.3)
OG00550.0(18.71 to 81.29)
OG00633.3(4.33 to 77.72)
OG00733.3(0.84 to 90.57)
OG0080(0.00 to 60.24)
OG0090(0.00 to 70.76)
OG01060.0(26.24 to 87.84)
OG001
Cohort B: Head and Neck Squamous Cell Carcinoma
Participants with head and neck cell carcinoma received etigilimab in combination with nivolumab every 2 weeks and continued treatment until protocol-defined discontinuation criteria were met.
OG002
Cohort C: Cervical Carcinoma
Participants with cervical carcinoma received etigilimab in combination with nivolumab every 2 weeks and continued treatment until protocol-defined discontinuation criteria were met.
OG003
Cohort E: TMB-H + MSS Solid Tumors
Participants with TMB-H and MSS solid tumors received etigilimab in combination with nivolumab every 2 weeks and continued treatment until protocol-defined discontinuation criteria were met.
OG004
Cohort F: Rare Tumors (Uveal)
Participants with rare tumors (uveal) received etigilimab in combination with nivolumab every 2 weeks and continued treatment until protocol-defined discontinuation criteria were met.
OG005
Cohort F: Rare Tumors (De-diff LPS)
Participants with rare tumors (de-diff LPS) received etigilimab in combination with nivolumab every 2 weeks and continued treatment until protocol-defined discontinuation criteria were met.
OG006
Cohort F: Rare Tumors (UPS)
Participants with rare tumors (UPS) received etigilimab in combination with nivolumab every 2 weeks and continued treatment until protocol-defined discontinuation criteria were met.
OG007
Cohort F: Rare Tumors (Other Sarcoma)
Participants with rare tumors (other sarcoma) received etigilimab in combination with nivolumab every 2 weeks and continued treatment until protocol-defined discontinuation criteria were met.
OG008
Cohort F: Rare Tumors (GCT)
Participants with rare tumors (GCT) received etigilimab in combination with nivolumab every 2 weeks and continued treatment until protocol-defined discontinuation criteria were met.
OG009
Cohort G: Endometrial Cancer Post- CPI (PD-1/PD-L1 Treated)
Participants with endometrial cancer (PD-1/PD-L1 treated) received etigilimab in combination with nivolumab every 2 weeks and continued treatment until protocol-defined discontinuation criteria were met.
OG010
Cohort H: Ovarian Cancer
Participants with ovarian cancer received etigilimab in combination with nivolumab every 2 weeks and continued treatment until protocol-defined discontinuation criteria were met.
Units
Counts
Participants
OG0002
OG0010
OG0023
OG0030
OG0042
OG0051
OG0061
OG0070
OG0080
OG0090
OG0101
Title
Denominators
Categories
Title
Measurements
OG000197.0(57 to 337)
OG002183.0(64 to 360)
OG004307.0(92 to 522)
OG005464.0(464 to 464)
OG006145.0(145 to 145)
OG010442.0(442 to 442)
Participants with head and neck cell carcinoma received etigilimab in combination with nivolumab every 2 weeks and continued treatment until protocol-defined discontinuation criteria were met.
OG002
Cohort C: Cervical Carcinoma
Participants with cervical carcinoma received etigilimab in combination with nivolumab every 2 weeks and continued treatment until protocol-defined discontinuation criteria were met.
OG003
Cohort E: TMB-H + MSS Solid Tumors
Participants with TMB-H and MSS solid tumors received etigilimab in combination with nivolumab every 2 weeks and continued treatment until protocol-defined discontinuation criteria were met.
OG004
Cohort F: Rare Tumors (Uveal)
Participants with rare tumors (uveal) received etigilimab in combination with nivolumab every 2 weeks and continued treatment until protocol-defined discontinuation criteria were met.
OG005
Cohort F: Rare Tumors (De-diff LPS)
Participants with rare tumors (de-diff LPS) received etigilimab in combination with nivolumab every 2 weeks and continued treatment until protocol-defined discontinuation criteria were met.
OG006
Cohort F: Rare Tumors (UPS)
Participants with rare tumors (UPS) received etigilimab in combination with nivolumab every 2 weeks and continued treatment until protocol-defined discontinuation criteria were met.
OG007
Cohort F: Rare Tumors (Other Sarcoma)
Participants with rare tumors (other sarcoma) received etigilimab in combination with nivolumab every 2 weeks and continued treatment until protocol-defined discontinuation criteria were met.
OG008
Cohort F: Rare Tumors (GCT)
Participants with rare tumors (GCT) received etigilimab in combination with nivolumab every 2 weeks and continued treatment until protocol-defined discontinuation criteria were met.
OG009
Cohort G: Endometrial Cancer Post- CPI (PD-1/PD-L1 Treated)
Participants with endometrial cancer (PD-1/PD-L1 treated) received etigilimab in combination with nivolumab every 2 weeks and continued treatment until protocol-defined discontinuation criteria were met.
OG010
Cohort H: Ovarian Cancer
Participants with ovarian cancer received etigilimab in combination with nivolumab every 2 weeks and continued treatment until protocol-defined discontinuation criteria were met.
Units
Counts
Participants
OG00010
OG0011
OG0028
OG0039
OG0048
OG00510
OG0066
OG0073
OG0084
OG0093
OG01010
Title
Denominators
Categories
Title
Measurements
OG00081.5(50 to 423)
OG00145.0(45 to 45)
OG002120.0(50 to 414)
OG00357.0(45 to 140)
OG004109.5(52 to 680)
OG005108.0(36 to 568)
OG00655.5(16 to 337)
OG00753.0(52 to 60)
OG00857.5(56 to 58)
OG00950.0(50 to 58)
OG01070.0(37 to 547)
30
Title
Denominators
Categories
Cycle 1 Day 1 (Pre-infusion)
ParticipantsOG00030
Title
Measurements
OG000NA± NASample below the limit of quantification (0.200 μg/mL).
Cycle 1 Day 1 (15 minutes post-infusion)
ParticipantsOG00029
Title
Measurements
OG000262± 22
Cycle 4 Day 43 (Pre-infusion)
ParticipantsOG00025
Title
Measurements
OG00020.1± 82
Cycle 4 Day 43 (15 minutes post-infusion)
ParticipantsOG00025
Title
Measurements
OG000273± 27
OG003
Cohort E: TMB-H + MSS Solid Tumors
Participants with TMB-H and MSS solid tumors received etigilimab in combination with nivolumab every 2 weeks and continued treatment until protocol-defined discontinuation criteria were met.
Participants with rare tumors (sarcoma, uveal melanoma, and germ cell) received etigilimab in combination with nivolumab every 2 weeks and continued treatment until protocol-defined discontinuation criteria were met.
OG005
Cohort G: Endometrial Cancer Post- CPI (PD-1/PD-L1 Treated)
Participants with endometrial cancer (PD-1/PD-L1 treated) received etigilimab in combination with nivolumab every 2 weeks and continued treatment until protocol-defined discontinuation criteria were met.
OG006
Cohort H: Ovarian Cancer
Participants with ovarian cancer received etigilimab in combination with nivolumab every 2 weeks and continued treatment until protocol-defined discontinuation criteria were met.