An Investigational Study of Immunotherapy Combinations in Participants With Solid Cancers That Are Advanced or Have Spread

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to demonstrate the safety and preliminary activity with triple combinations of relatlimab in combination with nivolumab and BMS-986205, or in combination with nivolumab and ipilimumab in immunotherapy-naive and pretreated populations across select advanced tumor types.

Official Title
-----------------
A Phase 1/2 Study of Relatlimab (Anti-LAG-3 Monoclonal Antibody) Administered in Combination With Both Nivolumab (Anti-PD-1 Monoclonal Antibody) and BMS-986205 (IDO1 Inhibitor) or in Combination With Both Nivolumab and Ipilimumab (Anti-CTLA-4 Monoclonal Antibody) in Advanced Malignant Tumors

Conditions
-----------------
Advanced Cancer

Intervention / Treatment
-----------------
* Biological: Relatlimab
* Biological: Nivolumab
* Drug: BMS-986205
* Biological: Ipilimumab


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Histologic or cytologic confirmation of select incurable solid malignancies that are advanced (metastatic and/or unresectable), with measurable disease per RECIST v1.1 Available tumor tissue for biomarker analysis Eastern Cooperative Oncology Group Performance Status (ECOG) status of 0 or 1 Exclusion Criteria: Known or suspected central nervous system (CNS) metastases or with the CNS as the only site of active disease History of interstitial lung disease / pneumonitis Prior malignancy active within the previous 2 years except for locally curable cancers that have been cured, such as basal or squamous cell skin cancer Encephalitis, meningitis, or uncontrolled seizures in the year prior to informed consent Other protocol-defined inclusion/exclusion criteria apply

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

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: Arm A<br>Relatlimab + Nivolumab + BMS-986205 | Biological: Relatlimab<br>* Specified dose on specified days<br>* Other names: BMS-986016;Biological: Nivolumab<br>* Specified dose on specified days<br>* Other names: BMS-936558;Drug: BMS-986205<br>* Specified dose on specified days<br>* Other names: Linrodostat;|
| Experimental: Arm B<br>Relatlimab + Nivolumab + Ipilimumab | Biological: Relatlimab<br>* Specified dose on specified days<br>* Other names: BMS-986016;Biological: Nivolumab<br>* Specified dose on specified days<br>* Other names: BMS-936558;Biological: Ipilimumab<br>* Specified dose on specified days<br>* Other names: BMS-734016;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of clinical laboratory test abnormalities |  | Approximately 4 years | 
| Number of Adverse Events (AEs) |  | Approximately 4 years | 
| Number of Serious Adverse Events (SAEs) |  | Approximately 4 years | 
| Number of AEs meeting protocol defined dose-limiting toxicity (DLT) criteria |  | Up to 6 weeks | 
| Number of AEs leading to discontinuation |  | Approximately 4 years | 
| Number of AEs leading to death |  | Approximately 4 years | 
| Objective Response Rate (ORR) |  | Approximately 4 years | 
| Disease Control Rate (DCR) |  | Approximately 4 years | 
| Median Duration of Response (mDOR) |  | Approximately 4 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Progression-Free Survival (PFS) |  | Up to 4 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Nivolumab, Ipilimumab, BMS-986205, Immunotherapy, Relatlimab