Study of Relatlimab in Combination With Nivolumab in Chinese Participants

Study Overview
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Brief Summary
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The purpose of this study is to evaluate the safety and drug levels of relatlimab combined with nivolumab in Chinese participants with advanced solid tumors.

Official Title
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A Phase 1 Study of Relatlimab (Anti-LAG-3 Monoclonal Antibody) in Combination With Nivolumab (Anti-PD-1 Monoclonal Antibody) in Chinese Participants With Advanced Solid Tumors

Conditions
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Advanced Solid Tumors

Intervention / Treatment
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* Biological: Relatlimab
* Biological: Nivolumab


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Participants must have histologic or cytological confirmation of an incurable solid malignancy that is advanced (metastatic and/or unresectable) except for participants with primary central nervous system (CNS) tumors. Participants must have received, and then progressed or been intolerant to at least 1 standard treatment regimen in the advanced or metastatic setting (immune check inhibitor-experienced or non-experienced population may be included), if such a therapy exists. Participants who refuse or are ineligible for standard therapy will be allowed to enroll provided their refusal/ineligibility is documented in medical records. Eastern Cooperative Oncology Group (ECOG) 0 to 1. Exclusion Criteria: Participants with history of severe and/or life-threatening toxicity related to prior immune therapy (eg, anti-cytotoxic T-lymphocyte-associated protein 4 [anti-CTLA-4] or anti-programmed cell death protein 1 [anti-PD-1]/programmed death-ligand 1 [PD-L1] treatment or any other antibody or drug specifically targeting T cell co-stimulation or immune checkpoint pathways) except those that are unlikely to re-occur with standard countermeasures (eg, hormone replacement after endocrinopathy). Participants with an active, known, or suspected autoimmune disease. Participants with type I diabetes mellitus, hypothyroidism only requiring hormone replacement, skin disorders (such as vitiligo, psoriasis, or alopecia) not requiring systemic treatment, or conditions not expected to recur in the absence of an external trigger are permitted to enroll. Prior treatment with LAG-3 targeted agents. Other protocol-defined inclusion/exclusion criteria apply

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: Sequential Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Cohort 1: Relatlimab Dose 1 + Nivolumab<br> | Biological: Relatlimab<br>* Specified dose on specified days<br>* Other names: BMS-986016;Biological: Nivolumab<br>* Specified dose on specified days<br>* Other names: Opdivo;|
| Experimental: Cohort 2: Relatlimab Dose 2 + Nivolumab<br> | Biological: Relatlimab<br>* Specified dose on specified days<br>* Other names: BMS-986016;Biological: Nivolumab<br>* Specified dose on specified days<br>* Other names: Opdivo;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants with Adverse Events (AEs) |  | Up to 123 Weeks | 
| Number of Participants with Immune-mediated Adverse Events (IMAEs) |  | Up to 123 Weeks | 
| Number of Participants with Serious Adverse Events (SAEs) |  | Up to 123 Weeks | 
| Number of Deaths |  | Up to 123 Weeks | 
| Number of Participants with AEs Leading to Discontinuation |  | Up to 123 Weeks | 
| Number of Participants with Dose-Limiting Toxicities (DLTs) |  | Up to 123 Weeks | 
| Number of Participants with Clinical Laboratory Abnormalities |  | Up to 123 Weeks | 
| Maximum Observed Plasma Concentration (Cmax) of Relatlimab |  | Up to 123 Weeks | 
| Time of Maximum Observed Plasma Concentration (Tmax) of Relatlimab |  | Up to 123 Weeks | 
| Trough-observed serum concentration (Ctrough) of Relatlimab |  | Up to 123 Weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Objective Response Rate (ORR) per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 by Investigator |  | Up to 123 Weeks | 
| Disease Control Rate (DCR) per RECIST v1.1 by Investigator |  | Up to 123 Weeks | 
| Duration of Response (DOR) per RECIST v1.1 by Investigator |  | Up to 123 Weeks | 
| Best Overall Response (BOR) per RECIST v1.1 by Investigator |  | Up to 123 Weeks | 
| Ctrough of Nivolumab |  | Up to 123 Weeks | 
| Observed Serum Concentration at End of Infusion (Ceoi) of Nivolumab |  | Up to 123 Weeks | 
| Percentage of Participants Positive for Anti-drug Antibodies (ADAs) to Relatlimab |  | Up to 123 Weeks | 
| Percentage of Participants Positive for ADAs to Nivolumab |  | Up to 123 Weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Advanced Solid Tumors, Relatlimab, Nivolumab