This study is in progress, not accepting new patients

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

a study on Stomach Cancer Esophagogastric Junction Gastroesophageal Junction Cancer Immunotherapy

Summary

Eligibility
for people ages 18 years and up (full criteria)
Location
at Clovis, California and other locations
Dates
study started
estimated completion

Description

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.

Official Title

A Randomized, Open-label, Phase II Clinical Trial of Relatlimab (Anti-LAG-3) and Nivolumab in Combination With Chemotherapy Versus Nivolumab in Combination With Chemotherapy as First-Line Treatment in Patients With Gastric or Gastroesophageal Junction Adenocarcinoma

Keywords

Gastric Cancer Cancer of the Stomach Esophagogastric Junction Stomach Neoplasms Nivolumab BMS-986213 XELOX FOLFOX SOX BMS-986213 + investigator's choice chemotherapy Nivolumab + investigator's choice chemotherapy

Eligibility

For people ages 18 years and up

For more information regarding Bristol-Myers Squibb Clinical Trial participation, please visit www.BMSStudyConnect.com

Inclusion Criteria:

  • Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1
  • Histologically- or cytologically-confirmed diagnosis of unresectable and either locally advanced, or metastatic gastric cancer or GEJ adenocarcinoma
  • No prior treatment with systemic treatment (including HER 2 inhibitors) given as primary therapy for unresectable and either locally advanced, or metastatic GC or GEJ adenocarcinoma
  • Tumor tissue must be provided for biomarker analyses

Exclusion Criteria:

  • Participants with HER2 positive status
  • Participants with known untreated central nervous system (CNS) metastases
  • Uncontrolled or significant cardiovascular disease

Other protocol defined inclusion/exclusion criteria could apply

Locations

  • University Of California San Francisco-Fresno
    Clovis California 93611 United States
  • Usc/Norris Comprehensive Cancer Center
    Los Angeles California 90033 United States
  • City Of Hope National Medical Center
    Duarte California 91010-3000 United States

Details

Status
in progress, not accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Bristol-Myers Squibb
Links
BMS Clinical Trial Information BMS Clinical Trial Patient Recruiting Investigator Inquiry Form FDA Safety Alerts and Recalls
ID
NCT03662659
Phase
Phase 2
Study Type
Interventional
Last Updated