An Investigational Immuno-therapy Study of Relatlimab Plus Nivolumab Compared to Various Standard-of-Care Therapies in Previously Treated Participants With Recurrent, Advanced or Metastatic Gastric Cancer or Gastroesophageal Junction Adenocarcinoma

Study Overview
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Brief Summary
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The purpose of this study is to determine the effectiveness of relatlimab plus nivolumab, alone or in combination with various standard-of-care treatments in participants with gastric cancer (GC) or gastroesophageal junction (GEJ) adenocarcinoma that has come back or spread to other places in the body after prior therapy.

Official Title
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A Randomized, Active-Controlled, Open-Label, Phase 2 Clinical Trial of BMS-986213, in Combination With Various Standard-of-Care Therapeutic Regimens, in Participants With Recurrent, Locally Advanced, or Metastatic Gastric Cancer (GC) or Gastroesophageal Junction (GEJ) Adenocarcinoma

Conditions
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Gastric Cancer, Cancer of the Stomach, Stomach Cancer, Gastroesophageal Junction

Intervention / Treatment
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* Biological: Relatlimab + Nivolumab
* Biological: Nivolumab
* Drug: Paclitaxel
* Drug: Ramucirumab


Participation Criteria
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Eligibility Criteria
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For more information regarding Bristol-Myers Squibb Clinical Trial participation, please visit www.BMSStudyConnect.com Inclusion Criteria: Histologically or cytologically confirmed locally advanced or recurrent or metastatic GC or GEJ adenocarcinoma that is considered incurable by local therapies such as radiation or surgery Evidence of progressive disease (PD) on at least one prior platinum- and fluoropyrimidine-containing chemotherapy regimen Available tumor tissue for biomarker analysis Exclusion Criteria: Must not have squamous cell or undifferentiated GC or GEJ Untreated known central nervous system (CNS) metastases Uncontrolled or significant cardiovascular disease Other protocol defined inclusion/exclusion criteria could 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: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Cohort A: relatlimab + nivolumab + paclitaxel<br> | Biological: Relatlimab + Nivolumab<br>* Specified dose on specified days<br>* Other names: BMS-986213;Biological: Nivolumab<br>* Specified dose on specified days<br>* Other names: Opdivo;Drug: Paclitaxel<br>* Specified dose on specified days<br>* Other names: Onxal;|
| Experimental: Cohort A: nivolumab + paclitaxel<br> | Biological: Nivolumab<br>* Specified dose on specified days<br>* Other names: Opdivo;Drug: Paclitaxel<br>* Specified dose on specified days<br>* Other names: Onxal;|
| Active Comparator: Cohort A: ramucirumab + paclitaxel<br>Standard-of-care | Drug: Paclitaxel<br>* Specified dose on specified days<br>* Other names: Onxal;Drug: Ramucirumab<br>* Specified dose on specified days<br>* Other names: Cyramza;|
| Experimental: Cohort B: relatlimab + nivolumab<br> | Biological: Relatlimab + Nivolumab<br>* Specified dose on specified days<br>* Other names: BMS-986213;Biological: Nivolumab<br>* Specified dose on specified days<br>* Other names: Opdivo;|
| Active Comparator: Cohort B: nivolumab<br>Standard-of-care | Biological: Nivolumab<br>* Specified dose on specified days<br>* Other names: Opdivo;|
| Experimental: Cohort C: relatlimab + nivolumab<br> | Biological: Relatlimab + Nivolumab<br>* Specified dose on specified days<br>* Other names: BMS-986213;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 |
| --- | --- | --- |
| Overall response rate (ORR) |  | Approximately 31 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of adverse events (AEs) |  | Approximately 5 years | 
| Incidence of serious adverse events (SAEs) |  | Approximately 5 years | 
| Incidence of AEs leading to discontinuation |  | Approximately 5 years | 
| Incidence of deaths |  | Approximately 5 years | 
| Incidence of laboratory abnormalities |  | Approximately 5 years | 
| ORR | Cohort A1 | Approximately 5 years | 
| Duration of response (DOR) |  | Approximately 5 years | 
| Progression free survival (PFS) |  | Approximately 5 years | 
| Overall survival (OS) |  | Approximately 5 years |