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Trial ID CA224-061  |   NCT03704077

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

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Summary

  • Phase 2
  • Male and Female Gender icon
  • 18+
    Age Range
  • 78
    Locations
  • BMS Not Yet Recruiting Study icon
    Not Yet Recruiting

Overview

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.

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Key Eligibility Criteria

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

Treatment Options

Study Arms

ASSIGNED INTERVENTION

Study Arms

Experimental: Cohort A: nivolumab + paclitaxel

ASSIGNED INTERVENTION
  • Drug: Paclitaxel Biological: Nivolumab

Study Arms

Active Comparator: Cohort A: ramucirumab + paclitaxel

ASSIGNED INTERVENTION
  • Drug: Ramucirumab Drug: Paclitaxel

Study Arms

Experimental: Cohort A: relatlimab + nivolumab + paclitaxel

ASSIGNED INTERVENTION
  • Drug: Paclitaxel Biological: Nivolumab Biological: Relatlimab + Nivolumab

Study Arms

Active Comparator: Cohort B: nivolumab

ASSIGNED INTERVENTION
  • Biological: Nivolumab

Study Arms

Experimental: Cohort B: relatlimab + nivolumab

ASSIGNED INTERVENTION
  • Biological: Nivolumab Biological: Relatlimab + Nivolumab

Study Arms

Experimental: Cohort C: relatlimab + nivolumab

ASSIGNED INTERVENTION
  • Biological: Nivolumab Biological: Relatlimab + Nivolumab
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