Summary

for people ages 18 years and up (full criteria)
at UCSFUCLAUC Irvine
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, 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, 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 accepting new patients
    Clovis California 93611 United States
  • UCLA accepting new patients
    Los Angeles California 90095 United States
  • Uc Irvine Medical Center accepting new patients
    Orange California 92868-3201 United States
  • Local Institution not yet accepting patients
    La Jolla California 92037 United States
  • Hoag Memorial Hospital Presbyterian accepting new patients
    Newport Beach California 92663 United States

Details

Status
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