Phase 1/2 Study Exploring the Safety, Tolerability, and Efficacy of INCAGN01876 Combined With Immune Therapies in Advanced or Metastatic Malignancies

Study Overview
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Brief Summary
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The purpose of this study is to determine the safety, tolerability, and efficacy of INCAGN01876 when given in combination with immune therapies in subjects with advanced or metastatic malignancies.

Official Title
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A Phase 1/2 Study Exploring the Safety, Tolerability, and Efficacy of INCAGN01876 in Combination With Immune Therapies in Subjects With Advanced or Metastatic Malignancies

Conditions
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Advanced Malignancies, Metastatic Cancer

Intervention / Treatment
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* Drug: INCAGN01876
* Drug: Nivolumab
* Drug: Ipilimumab


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Locally advanced or metastatic disease; locally advanced disease must not be amenable to resection with curative intent. Phase 1: Subjects with advanced or metastatic solid tumors. Phase 1: Subjects who have disease progression after treatment with available therapies. Phase 2: Subjects with advanced or metastatic cervical cancer, gastric cancer (including stomach, esophageal, and GEJ), SCCHN, PD-1 refractory SCCHN and PD-1/PD-L1 relapsed melanoma. Presence of measurable disease based on RECIST v1.1. Eastern Cooperative Oncology Group (ECOG) performance status 0 to 1. Exclusion Criteria: Laboratory and medical history parameters not within the Protocol-defined range Prior treatment with any tumor necrosis factor super family agonist. Receipt of anticancer medications or investigational drugs within protocol-defined intervals before the first administration of study drug. Has not recovered to ≤ Grade 1 from toxic effects of prior therapy. Active autoimmune disease. Known active central nervous system metastases and/or carcinomatous meningitis. Evidence of active, noninfectious pneumonitis or history of interstitial lung disease. Evidence of hepatitis B virus or hepatitis C virus infection or risk of reactivation. Known history of human immunodeficiency virus (HIV; HIV 1/2 antibodies).

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Phase 1 Group A: INCAGN01876 1.0 mg/kg Q2W + nivolumab 240 mg Q2W<br>Participants received INCAGN01876 1.0 milligrams per kilogram (mg/kg) administered intravenously (IV) every 2 weeks (Q2W) in combination with nivolumab 240 mg administered IV Q2W. | Drug: INCAGN01876<br>* In Phase 1 participants will receive INCAGN01876 administered intravenously (IV) at the protocol-defined dose according to cohort enrollment. In Phase 2, participants will be administered IV study drug at the recommended dose from Phase 1 ().<br>Drug: Nivolumab<br>* Nivolumab will be administered IV at the protocol-defined dose according to assigned treatment group.<br>|
| Experimental: Phase 1 Group A: INCAGN01876 3.0 mg/kg Q2W + nivolumab 240 mg Q2W<br>Participants received INCAGN01876 3.0 mg/kg administered IV Q2W in combination with nivolumab 240 mg administered IV Q2W. | Drug: INCAGN01876<br>* In Phase 1 participants will receive INCAGN01876 administered intravenously (IV) at the protocol-defined dose according to cohort enrollment. In Phase 2, participants will be administered IV study drug at the recommended dose from Phase 1 ().<br>Drug: Nivolumab<br>* Nivolumab will be administered IV at the protocol-defined dose according to assigned treatment group.<br>|
| Experimental: Phase 1 Group A: INCAGN01876 5.0 mg/kg Q2W + nivolumab 240 mg Q2W<br>Participants received INCAGN01876 5.0 mg/kg administered IV Q2W in combination with nivolumab 240 mg administered IV Q2W. | Drug: INCAGN01876<br>* In Phase 1 participants will receive INCAGN01876 administered intravenously (IV) at the protocol-defined dose according to cohort enrollment. In Phase 2, participants will be administered IV study drug at the recommended dose from Phase 1 ().<br>Drug: Nivolumab<br>* Nivolumab will be administered IV at the protocol-defined dose according to assigned treatment group.<br>|
| Experimental: Phase 1 Group A: INCAGN01876 10.0 mg/kg Q2W + nivolumab 240 mg Q2W<br>Participants received INCAGN01876 10.0 mg/kg administered IV Q2W in combination with nivolumab 240 mg administered IV Q2W. | Drug: INCAGN01876<br>* In Phase 1 participants will receive INCAGN01876 administered intravenously (IV) at the protocol-defined dose according to cohort enrollment. In Phase 2, participants will be administered IV study drug at the recommended dose from Phase 1 ().<br>Drug: Nivolumab<br>* Nivolumab will be administered IV at the protocol-defined dose according to assigned treatment group.<br>|
| Experimental: Phase 1 Group B: INCAGN01876 1.0 mg/kg Q2W, then nivolumab 240 mg Q2W<br>Participants received INCAGN01876 1.0 mg/kg administered IV Q2W for a total of 2 doses as run-in, followed by INCAGN01876 1.0 mg/kg Q2W in combination with nivolumab 240 mg administered IV Q2W starting at Cycle 3. | Drug: INCAGN01876<br>* In Phase 1 participants will receive INCAGN01876 administered intravenously (IV) at the protocol-defined dose according to cohort enrollment. In Phase 2, participants will be administered IV study drug at the recommended dose from Phase 1 ().<br>Drug: Nivolumab<br>* Nivolumab will be administered IV at the protocol-defined dose according to assigned treatment group.<br>|
| Experimental: Phase 1 Group B: INCAGN01876 3.0 mg/kg Q2W, then nivolumab 240 mg Q2W<br>Participants received INCAGN01876 1.0 mg/kg administered IV Q2W for a total of 2 doses as run-in, followed by INCAGN01876 1.0 mg/kg Q2W in combination with nivolumab 240 mg administered IV Q2W starting at Cycle 3. | Drug: INCAGN01876<br>* In Phase 1 participants will receive INCAGN01876 administered intravenously (IV) at the protocol-defined dose according to cohort enrollment. In Phase 2, participants will be administered IV study drug at the recommended dose from Phase 1 ().<br>Drug: Nivolumab<br>* Nivolumab will be administered IV at the protocol-defined dose according to assigned treatment group.<br>|
| Experimental: Phase 1 Group B: INCAGN01876 5.0 mg/kg Q2W, then nivolumab 240 mg Q2W<br>Participants received INCAGN01876 5.0 mg/kg administered IV Q2W for a total of 2 doses as run-in, followed by INCAGN01876 5.0 mg/kg Q2W in combination with nivolumab 240 mg administered IV Q2W starting at Cycle 3. | Drug: INCAGN01876<br>* In Phase 1 participants will receive INCAGN01876 administered intravenously (IV) at the protocol-defined dose according to cohort enrollment. In Phase 2, participants will be administered IV study drug at the recommended dose from Phase 1 ().<br>Drug: Nivolumab<br>* Nivolumab will be administered IV at the protocol-defined dose according to assigned treatment group.<br>|
| Experimental: Phase 1 Group C: INCAGN01876 1.0 mg/kg Q2W + ipilimumab 1 mg/kg Q6W<br>Participants received INCAGN01876 1.0 mg/kg administered IV Q2W in combination with ipilimumab 1 mg/kg administered IV every 6 weeks (Q6W). | Drug: INCAGN01876<br>* In Phase 1 participants will receive INCAGN01876 administered intravenously (IV) at the protocol-defined dose according to cohort enrollment. In Phase 2, participants will be administered IV study drug at the recommended dose from Phase 1 ().<br>Drug: Ipilimumab<br>* Ipilimumab will be administered IV at the protocol-defined dose according to assigned treatment group.<br>|
| Experimental: Phase 1 Group C: INCAGN01876 3.0 mg/kg Q2W + ipilimumab 1 mg/kg Q6W<br>Participants received INCAGN01876 3.0 mg/kg administered IV Q2W in combination with ipilimumab 1 mg/kg administered IV Q6W. | Drug: INCAGN01876<br>* In Phase 1 participants will receive INCAGN01876 administered intravenously (IV) at the protocol-defined dose according to cohort enrollment. In Phase 2, participants will be administered IV study drug at the recommended dose from Phase 1 ().<br>Drug: Ipilimumab<br>* Ipilimumab will be administered IV at the protocol-defined dose according to assigned treatment group.<br>|
| Experimental: Phase 1 Group C: INCAGN01876 5.0 mg/kg Q2W + ipilimumab 1 mg/kg Q6W<br>Participants received INCAGN01876 5.0 mg/kg administered IV Q2W in combination with ipilimumab 1 mg/kg administered IV Q6W. | Drug: INCAGN01876<br>* In Phase 1 participants will receive INCAGN01876 administered intravenously (IV) at the protocol-defined dose according to cohort enrollment. In Phase 2, participants will be administered IV study drug at the recommended dose from Phase 1 ().<br>Drug: Ipilimumab<br>* Ipilimumab will be administered IV at the protocol-defined dose according to assigned treatment group.<br>|
| Experimental: Phase 1 Group D: INCAGN01876 + Nivolumab + Ipilimumab<br>Participants received INCAGN01876 1.0 mg/kg administered IV Q2W in combination with nivolumab 3 mg/kg administered IV Q2W and ipilimumab 1 mg/kg administered IV Q6W. | Drug: INCAGN01876<br>* In Phase 1 participants will receive INCAGN01876 administered intravenously (IV) at the protocol-defined dose according to cohort enrollment. In Phase 2, participants will be administered IV study drug at the recommended dose from Phase 1 ().<br>Drug: Nivolumab<br>* Nivolumab will be administered IV at the protocol-defined dose according to assigned treatment group.<br>Drug: Ipilimumab<br>* Ipilimumab will be administered IV at the protocol-defined dose according to assigned treatment group.<br>|
| Experimental: Phase 2 Group C2 PD-1/PD-L1: INCAGN01876 300 mg + ipilimumab 1 mg/kg<br>Participants with programmed cell death protein/programmed cell death ligand 1 (PD-1/PD-L1) relapsed melanoma received INCAGN01876 300 mg administered IV Q2W in combination with ipilimumab 1 mg/kg administered IV Q6W. | Drug: INCAGN01876<br>* In Phase 1 participants will receive INCAGN01876 administered intravenously (IV) at the protocol-defined dose according to cohort enrollment. In Phase 2, participants will be administered IV study drug at the recommended dose from Phase 1 ().<br>Drug: Ipilimumab<br>* Ipilimumab will be administered IV at the protocol-defined dose according to assigned treatment group.<br>|
| Experimental: Phase 2 Group F GC: INCAGN01876 300 mg + nivolumab 240 mg<br>Participants with gastric cancer (GC) received INCAGN01876 300 mg administered IV Q2W in combination with nivolumab 240 mg administered IV Q2W. | Drug: INCAGN01876<br>* In Phase 1 participants will receive INCAGN01876 administered intravenously (IV) at the protocol-defined dose according to cohort enrollment. In Phase 2, participants will be administered IV study drug at the recommended dose from Phase 1 ().<br>Drug: Nivolumab<br>* Nivolumab will be administered IV at the protocol-defined dose according to assigned treatment group.<br>|
| Experimental: Phase 2 Group F SCCHN INCAGN01876 300 mg + nivolumab 240 mg<br>Participants with squamous cell carcinoma of the head and neck (SCCHN) received INCAGN01876 300 mg administered IV Q2W in combination with nivolumab 240 mg administered IV Q2W. | Drug: INCAGN01876<br>* In Phase 1 participants will receive INCAGN01876 administered intravenously (IV) at the protocol-defined dose according to cohort enrollment. In Phase 2, participants will be administered IV study drug at the recommended dose from Phase 1 ().<br>Drug: Nivolumab<br>* Nivolumab will be administered IV at the protocol-defined dose according to assigned treatment group.<br>|
| Experimental: Phase 2 Group F CC: INCAGN01876 300 mg + nivolumab 240 mg<br>Participants with cervical cancer (CC) received INCAGN01876 300 mg administered IV Q2W in combination with nivolumab 240 mg administered IV Q2W. | Drug: INCAGN01876<br>* In Phase 1 participants will receive INCAGN01876 administered intravenously (IV) at the protocol-defined dose according to cohort enrollment. In Phase 2, participants will be administered IV study drug at the recommended dose from Phase 1 ().<br>Drug: Nivolumab<br>* Nivolumab will be administered IV at the protocol-defined dose according to assigned treatment group.<br>|
| Experimental: Phase 2 Group F PD-1/PD-L1: INCAGN01876 300 mg + nivolumab 240 mg<br>Participants with PD-1/PD-L1 relapsed melanoma received INCAGN01876 300 mg administered IV Q2W in combination with nivolumab 240 mg administered IV Q2W. | Drug: INCAGN01876<br>* In Phase 1 participants will receive INCAGN01876 administered intravenously (IV) at the protocol-defined dose according to cohort enrollment. In Phase 2, participants will be administered IV study drug at the recommended dose from Phase 1 ().<br>Drug: Nivolumab<br>* Nivolumab will be administered IV at the protocol-defined dose according to assigned treatment group.<br>|
| Experimental: Phase 2 Group F Biopsy: INCAGN01876 300 mg + nivolumab 240 mg<br>Participants with gastric cancer, squamous cell carcinoma of the head and neck, cervical cancer, or PD-1/PD-L1 relapsed melanoma who had tumor lesions that were amenable to percutaneous biopsy received INCAGN01876 300 mg administered IV Q2W in combination with nivolumab 240 mg administered IV Q2W. | Drug: INCAGN01876<br>* In Phase 1 participants will receive INCAGN01876 administered intravenously (IV) at the protocol-defined dose according to cohort enrollment. In Phase 2, participants will be administered IV study drug at the recommended dose from Phase 1 ().<br>Drug: Nivolumab<br>* Nivolumab will be administered IV at the protocol-defined dose according to assigned treatment group.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Phase 1: Number of Participants With Any Treatment-emergent Adverse Event (TEAE) | An adverse event (AE) was defined as any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related, that occurred after a participant provided informed consent. Abnormal laboratory values or test results occurring after informed consent constituted AEs only if they induced clinical signs or symptoms, were considered clinically meaningful, required therapy (e.g., hematologic abnormality that required transfusion), or required changes in the study drug(s). A TEAE was defined as any AE either reported for the first time or the worsening of a pre-existing event after the first dose of study medication. | up to approximately 27.4 months | 
| Phase 2: Objective Response Rate (ORR) Per RECIST v1.1 | ORR was defined as the percentage of participants with a best overall response of confirmed complete response (CR) or partial response (PR), determined by investigator assessment of radiographic disease assessments per Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 (v1.1). CR: disappearance of all target and non-target lesions and no appearance of any new lesions. Any pathological lymph nodes (whether target or non-target) must have a reduction in the short axis to <10 millimeters (mm). PR: complete disappearance or at least a 30% decrease in the sum of the diameters of target lesions, taking as a reference the baseline sum diameters, no new lesions, and no progression of non-target lesions. | up to approximately 44.7 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Phase 1: ORR Per RECIST v1.1 | ORR was defined as the percentage of participants with a best overall response of unconfirmed CR or PR, determined by investigator assessment of radiographic disease assessments per RECIST v1.1. CR: disappearance of all target and non-target lesions and no appearance of any new lesions. Any pathological lymph nodes (whether target or non-target) must have a reduction in the short axis to <10 mm. PR: complete disappearance or at least a 30% decrease in the sum of the diameters of target lesions, taking as a reference the baseline sum diameters, no new lesions, and no progression of non-target lesions. | up to approximately 44.7 months | 
| Phase 1: ORR Per Modified RECIST (mRECIST) v1.1 | ORR was defined as the percentage of participants with a best overall response of unconfirmed CR or PR, determined by investigator assessment of radiographic disease assessments per mRECIST v1.1. The response of target lesions was evaluated from the percentage change in the sum of the diameters of the viable portions (portions enhanced during the arterial phase). CR: Disappearance of any intratumoral arterial enhancement during in target lesions, disappearance of all non-target lesions, and no appearance of any new lesions. PR: ≥30% of the sum of the diameters of viable portions (enhancement on arterial phase) of target lesions taking as reference the Baseline sum, no new lesions, and no progression of non-target lesions. | up to approximately 44.7 months | 
| Phase 2: ORR Per mRECIST v1.1 | ORR was defined as the percentage of participants with a best overall response of confirmed CR or PR, determined by investigator assessment of radiographic disease assessments per mRECIST v1.1. The response of target lesions was evaluated from the percentage change in the sum of the diameters of the viable portions (portions enhanced during the arterial phase). CR: Disappearance of any intratumoral arterial enhancement during in target lesions, disappearance of all non-target lesions, and no appearance of any new lesions. PR: ≥30% of the sum of the diameters of viable portions (enhancement on arterial phase) of target lesions taking as reference the Baseline sum, no new lesions, and no progression of non-target lesions. | up to approximately 44.7 months | 
| Phase 1: Duration of Response (DOR) Per RECIST v1.1 | DOR was defined as the time from the first overall response contributing to an unconfirmed objective response (CR or PR) to the earlier of the participant's death from any cause or the first assessment of PD, determined by investigator assessment of radiographic disease assessment per RECIST v1.1. CR: disappearance of all target and non-target lesions and no appearance of any new lesions. Any pathological lymph nodes (whether target or non-target) must have a reduction in the short axis to <10 mm. PR: complete disappearance or at least a 30% decrease in the sum of the diameters of target lesions, taking as a reference the baseline sum diameters, no new lesions, and no progression of non-target lesions. PD: progression of a target or non-target lesion or presence of a new lesion. | up to approximately 44.7 months | 
| Phase 2: DOR Per RECIST v1.1 | DOR was defined as the time from the first overall response contributing to a confirmed objective response (CR or PR) to the earlier of the participant's death from any cause or the first assessment of PD, determined by investigator assessment of radiographic disease assessment per RECIST v1.1. CR: disappearance of all target and non-target lesions and no appearance of any new lesions. Any pathological lymph nodes (whether target or non-target) must have a reduction in the short axis to <10 mm. PR: complete disappearance or at least a 30% decrease in the sum of the diameters of target lesions, taking as a reference the baseline sum diameters, no new lesions, and no progression of non-target lesions. PD: progression of a target or non-target lesion or presence of a new lesion. | up to approximately 44.7 months | 
| Phase 1: DOR Per mRECIST v1.1 | DOR was defined as the time from the first unconfirmed overall response contributing to an unconfirmed objective response (CR or PR) to the earlier of the participant's death from any cause or the first confirmed assessment of PD, determined by investigator assessment of radiographic disease assessment per mRECIST v1.1. The response of target lesions was evaluated from the percentage change in the sum of the diameters of the viable portions (portions enhanced during the arterial phase). CR: Disappearance of any intratumoral arterial enhancement during in target lesions, disappearance of all non-target lesions, and no appearance of any new lesions. PR: ≥30% of the sum of the diameters of viable portions (enhancement on arterial phase) of target lesions taking as reference the Baseline sum, no new lesions, and no progression of non-target lesions. PD: progression of a target or non-target lesion or presence of a new lesion. | up to approximately 44.7 months | 
| Phase 2: DOR Per mRECIST v1.1 | DOR was defined as the time from the first overall response contributing to a confirmed objective response (CR or PR) to the earlier of the participant's death from any cause or the first assessment of PD, determined by investigator assessment of radiographic disease assessment per mRECIST v1.1. CR: disappearance of all target and non-target lesions and no appearance of any new lesions. Any pathological lymph nodes (whether target or non-target) must have a reduction in the short axis to <10 mm. PR: complete disappearance or at least a 30% decrease in the sum of the diameters of target lesions, taking as a reference the baseline sum diameters, no new lesions, and no progression of non-target lesions. PD: progression of a target or non-target lesion or presence of a new lesion. | up to approximately 44.7 months | 
| Phase 1: Disease Control Rate (DCR) Per RECIST v1.1 | DCR was defined as the percentage of participants with a best overall response of unconfirmed CR, unconfirmed PR, or stable disease (SD; ≥49 days), determined by investigator assessment of radiographic disease assessments per RECIST v1.1. CR: disappearance of all target and non-target lesions and no appearance of any new lesions. Any pathological lymph nodes (whether target or non-target) must have a reduction in the short axis to <10 mm. PR: complete disappearance or at least a 30% decrease in the sum of the diameters of target lesions, taking as a reference the baseline sum diameters, no new lesions, and no progression of non-target lesions. PD: progression of a target or non-target lesion or presence of a new lesion. SD: no change in target lesions to qualify for CR, PR, or PD. | up to approximately 44.7 months | 
| Phase 2: DCR Per RECIST v1.1 | DCR was defined as the percentage of participants with a best overall response of confirmed CR, confirmed PR, or SD (≥49 days), determined by investigator assessment of radiographic disease assessments per RECIST v1.1. CR: disappearance of all target and non-target lesions and no appearance of any new lesions. Any pathological lymph nodes (whether target or non-target) must have a reduction in the short axis to <10 mm. PR: complete disappearance or at least a 30% decrease in the sum of the diameters of target lesions, taking as a reference the baseline sum diameters, no new lesions, and no progression of non-target lesions. PD: progression of a target or non-target lesion or presence of a new lesion. SD: no change in target lesions to qualify for CR, PR, or PD. | up to approximately 44.7 months | 
| Phase 1: DCR Per mRECIST v1.1 | DCR was defined as the percentage of participants with a best overall response of unconfirmed CR, unconfirmed PR, or stable disease (SD; ≥49 days), determined by investigator assessment of radiographic disease assessments per RECIST v1.1. CR: disappearance of all target and non-target lesions and no appearance of any new lesions. Any pathological lymph nodes (whether target or non-target) must have a reduction in the short axis to <10 mm. PR: complete disappearance or at least a 30% decrease in the sum of the diameters of target lesions, taking as a reference the baseline sum diameters, no new lesions, and no progression of non-target lesions. PD: progression of a target or non-target lesion or presence of a new lesion. SD: no change in target lesions to qualify for CR, PR, or PD. | up to approximately 44.7 months | 
| Phase 2: DCR Per mRECIST v1.1 | DCR was defined as the percentage of participants with a best overall response of confirmed CR, confirmed PR, or SD (≥49 days), determined by investigator assessment of radiographic disease assessments per mRECIST v1.1. The response of target lesions was evaluated from the percentage change in the sum of the diameters of the viable portions (portions enhanced during the arterial phase). CR: Disappearance of any intratumoral arterial enhancement during in target lesions, disappearance of all non-target lesions, and no appearance of any new lesions. PR: ≥30% of the sum of the diameters of viable portions (enhancement on arterial phase) of target lesions taking as reference the Baseline sum, no new lesions, and no progression of non-target lesions. PD: progression of a target or non-target lesion or presence of a new lesion. SD: no change in target lesions to qualify for CR, PR, or PD. | up to approximately 44.7 months | 
| Phase 1: Duration of Disease Control Per RECIST v1.1 | Duration of disease control (CR, PR, and SD [≥49 days]) was measured from the start of treatment until PD or death from any cause, if occurring sooner than progression, determined by investigator assessment of radiographic disease per RECIST v1.1. CR: disappearance of all target and non-target lesions and no appearance of any new lesions. Any pathological lymph nodes (whether target or non-target) must have a reduction in the short axis to <10 mm. PR: complete disappearance or at least a 30% decrease in the sum of the diameters of target lesions, taking as a reference the baseline sum diameters, no new lesions, and no progression of non-target lesions. PD: progression of a target or non-target lesion or presence of a new lesion. SD: no change in target lesions to qualify for CR, PR, or PD. | up to approximately 44.7 months | 
| Phase 2: Duration of Disease Control Per RECIST v1.1 | Duration of disease control (CR, PR, and SD [≥49 days]) was measured from the start of treatment until PD or death from any cause, if occurring sooner than progression, determined by investigator assessment of radiographic disease per RECIST v1.1. CR: disappearance of all target and non-target lesions and no appearance of any new lesions. Any pathological lymph nodes (whether target or non-target) must have a reduction in the short axis to <10 mm. PR: complete disappearance or at least a 30% decrease in the sum of the diameters of target lesions, taking as a reference the baseline sum diameters, no new lesions, and no progression of non-target lesions. PD: progression of a target or non-target lesion or presence of a new lesion. SD: no change in target lesions to qualify for CR, PR, or PD. | up to approximately 44.7 months | 
| Phase 1: Duration of Disease Control Per mRECIST v1.1 | Duration of disease control (CR, PR, and SD [≥49 days]) was measured from the start of treatment until PD or death from any cause, if occurring sooner than progression, determined by investigator assessment of radiographic disease per RECIST v1.1. The response of target lesions was evaluated from the percentage change in the sum of the diameters of the viable portions (portions enhanced during the arterial phase). CR: Disappearance of any intratumoral arterial enhancement during in target lesions, disappearance of all non-target lesions, and no appearance of any new lesions. PR: ≥30% of the sum of the diameters of viable portions (enhancement on arterial phase) of target lesions taking as reference the Baseline sum, no new lesions, and no progression of non-target lesions. PD: progression of a target or non-target lesion or presence of a new lesion. SD: no change in target lesions to qualify for CR, PR, or PD. | up to approximately 44.7 months | 
| Phase 2: Duration of Disease Control Per mRECIST v1.1 | Duration of disease control (CR, PR, and SD [≥49 days]) was measured from the start of treatment until PD or death from any cause, if occurring sooner than progression, determined by investigator assessment of radiographic disease per RECIST v1.1. The response of target lesions was evaluated from the percentage change in the sum of the diameters of the viable portions (portions enhanced during the arterial phase). CR: Disappearance of any intratumoral arterial enhancement during in target lesions, disappearance of all non-target lesions, and no appearance of any new lesions. PR: ≥30% of the sum of the diameters of viable portions (enhancement on arterial phase) of target lesions taking as reference the Baseline sum, no new lesions, and no progression of non-target lesions. PD: progression of a target or non-target lesion or presence of a new lesion. SD: no change in target lesions to qualify for CR, PR, or PD. [ | up to approximately 44.7 months | 
| Phase 1: Progression-free Survival (PFS) Per RECIST v1.1 | According to RECIST 1.1, PFS was defined as the length of time between the Baseline visit (Day 1) and the earlier of death or the first assessment of PD, as determined by investigator assessment of objective radiographic disease assessments. | up to approximately 44.7 months | 
| Phase 2: PFS Per RECIST v1.1 | According to RECIST 1.1, PFS was defined as the length of time between the Baseline visit (Day 1) and the earlier of death or the first assessment of PD, as determined by investigator assessment of objective radiographic disease assessments. | up to approximately 44.7 months | 
| Phase 1: PFS Per mRECIST v1.1 | According to mRECIST 1.1, PFS was defined as the length of time between the Baseline visit (Day 1) and the earlier of the participant's death or the first confirmed assessment of PD, as determined by investigator assessment of objective radiographic disease assessments. The response of target lesions was evaluated from the percentage change in the sum of the diameters of the viable portions (portions enhanced during the arterial phase). | up to approximately 44.7 months | 
| Phase 2: PFS Per mRECIST v1.1 | According to mRECIST 1.1, PFS was defined as the length of time between the Baseline visit (Day 1) and the earlier of the participant's death or the first confirmed assessment of PD, as determined by investigator assessment of objective radiographic disease assessments. The response of target lesions was evaluated from the percentage change in the sum of the diameters of the viable portions (portions enhanced during the arterial phase). | up to approximately 44.7 months | 
| Phase 1: Overall Survival | Overall survival was defined as the interval between the Baseline visit (Day 1) and the date of death due to any cause. | up to approximately 44.7 months | 
| Phase 2: Overall Survival | Overall survival was defined as the interval between the Baseline visit (Day 1) and the date of death due to any cause. | up to approximately 44.7 months | 
| Phase 2: : Number of Participants With Any TEAE | An AE was defined as any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related, that occurred after a participant provided informed consent. Abnormal laboratory values or test results occurring after informed consent constituted AEs only if they induced clinical signs or symptoms, were considered clinically meaningful, required therapy (e.g., hematologic abnormality that required transfusion), or required changes in the study drug(s). A TEAE was defined as any AE either reported for the first time or the worsening of a pre-existing event after the first dose of study medication. | up to approximately 27.4 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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cervical cancer, endometrial cancer, gastric cancer (stomach, esophageal, and gastroesophageal junction [GEJ]), hepatocellular carcinoma (HCC), melanoma, Merkel cell carcinoma, mesothelioma, microsatellite instability-high (MSI-H) colorectal cancer (CRC), non-small cell lung cancer (NSCLC), ovarian cancer, squamous cell carcinoma of the head and neck (SCCHN), small cell lung cancer (SCLC), renal cell carcinoma (RCC), triple-negative breast cancer (TNBC), urothelial carcinoma, glucocorticoid-induced tumor necrosis factor receptor (GITR)