A Study to Assess Relatlimab and Nivolumab Fixed-dose Combination in Chinese Participants With Advanced Solid Tumors

Study Overview
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Brief Summary
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The purpose of this study is to assess the safety, drug levels, immunogenicity and preliminary efficacy of BMS-986213 (nivolumab-relatlimab fixed-dose combination) in Chinese participants with advanced solid tumors.

Official Title
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A Phase 1/2 Study of Relatlimab (Anti-LAG-3 Monoclonal Antibody) and Nivolumab (Anti-PD-1 Monoclonal Antibody) Fixed-dose Combination in Chinese Participants With Advanced Solid Tumors (RELATIVITY 059)

Conditions
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Advanced Solid Tumors

Intervention / Treatment
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* Drug: BMS-986213


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Presence of at least one lesion with measurable disease as defined by RECIST v1.1 criteria for response assessment Participants must have received, and then progressed, or been intolerant to at least one standard treatment regimen in the advanced or metastatic setting, if such a therapy exists ECOG status of 0 or 1 Life expectancy of ≥ 12 weeks at the time of informed consent per Investigator assessment Exclusion Criteria: Participants with history of severe and/or life-threatening toxicity related to prior immune therapy (eg, anti-CTLA-4 or anti-PD-1/PD-L1 treatment or any other antibody or drug specifically targeting T-cell co-stimulation or immune checkpoint pathways) Participants with an active, known or suspected autoimmune disease Participants with primary CNS tumors 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 A: BMS-986213 Fixed Dose Combination<br> | Drug: BMS-986213<br>* Specified dose on specified days<br>|
| Experimental: Cohort B: BMS-986213 Fixed Dose Combination<br> | Drug: BMS-986213<br>* Specified dose on specified days<br>|

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) |  | Approximately 3 years | 
| Number of Participants with Immune-mediated Adverse Events (IMAEs) |  | Approximately 3 years | 
| Number of Participants with Serious Adverse Events (SAEs) |  | Approximately 3 years | 
| Number of Deaths |  | Approximately 3 years | 
| Number of Participants with AEs Leading to Discontinuation |  | Approximately 3 years | 
| Number of Participants with Laboratory Abnormalities |  | Approximately 3 years | 
| Maximum Observed Plasma Concentration (Cmax) of Relatlimab |  | Approximately 3 years | 
| Time of Maximum Observed Plasma Concentration (Tmax) of Relatlimab |  | Approximately 3 years | 
| Trough Observed Plasma Concentration (Ctrough) of Relatlimab |  | Approximately 3 years | 
| Concentration of Relatlimab at the end of a dosing interval (Ctau) |  | Approximately 3 years | 
| Average concentration of Relatlimab over a dosing interval (Cavg(TAU)) |  | Approximately 3 years | 
| Area under the concentration-time curve in one dosing interval (AUC(TAU)) of Relatlimab |  | Approximately 3 years | 
| Total Body Clearance (CLT) of Relatlimab |  | Approximately 3 years | 
| Observed Concentration of Relatlimab at End of Infusion (Ceoi) |  | Approximately 3 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Objective Response Rate (ORR) by Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 by Investigator |  | Approximately 3 years | 
| Disease Control Rate (DCR) by RECIST v1.1 by Investigator |  | Approximately 3 years | 
| Duration of Response (DOR) by RECIST v1.1 by Investigator |  | Approximately 3 years | 
| Best Overall Response (BOR) by RECIST v1.1 by Investigator |  | Approximately 3 years | 
| Ctrough of Nivolumab |  | Approximately 3 years | 
| Ceoi of Nivolumab |  | Approximately 3 years | 
| Number of Anti-drug Antibodies (ADAs) to Relatlimab |  | Approximately 3 years | 
| Number of ADAs to Nivolumab |  | Approximately 3 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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BMS-986213