An Investigational Study of Immunotherapy Combinations With Chemotherapy in Patients With Gastric or Gastroesophageal Junction (GEJ) Cancers

NCT03662659 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 274

Last updated 2025-02-05

Study results available
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Summary

The purpose of this study is to determine the efficacy and safety of investigational drug relatlimab plus nivolumab in combination with chemotherapy in participants with unresectable, untreated, locally advanced or metastatic gastric or GEJ cancer.

Conditions

Interventions

BIOLOGICAL

BMS-986213

Relatlimab + Nivolumab specified dose on specified days

BIOLOGICAL

Nivolumab

Specified dose on specified days

DRUG

XELOX

Oxaliplatin + capecitabine

DRUG

FOLFOX

Oxaliplatin + leucovorin + fluorouracil

DRUG

SOX

Oxaliplatin + tegafur/gimeracil/oteracil potassium

Sponsors & Collaborators

Principal Investigators

  • Bristol-Myers Squibb · Bristol-Myers Squibb

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-10-16
Primary Completion
2020-08-27
Completion
2024-01-18
FDA Drug
Yes

Countries

  • United States
  • Argentina
  • Australia
  • Austria
  • Belgium
  • Canada
  • Chile
  • Czechia
  • France
  • Germany
  • Italy
  • Norway
  • Poland
  • Puerto Rico
  • Singapore
  • Spain
  • United Kingdom

Study Locations

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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03662659 on ClinicalTrials.gov