Description:
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.
Title
- Brief Title: An Investigational Study of Immunotherapy Combinations With Chemotherapy in Patients With Gastric or Gastroesophageal Junction (GEJ) Cancers
- 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
Clinical Trial IDs
- ORG STUDY ID:
CA224-060
- SECONDARY ID:
2018-001069-18
- NCT ID:
NCT03662659
Conditions
- Gastric Cancer
- Cancer of the Stomach
- Esophagogastric Junction
Interventions
Drug | Synonyms | Arms |
---|
BMS-986213 | | BMS-986213 + investigator's choice chemotherapy |
Nivolumab | Opdivo, BMS-936558 | BMS-986213 + investigator's choice chemotherapy |
XELOX | | BMS-986213 + investigator's choice chemotherapy |
FOLFOX | | BMS-986213 + investigator's choice chemotherapy |
SOX | | BMS-986213 + investigator's choice chemotherapy |
Purpose
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.
Trial Arms
Name | Type | Description | Interventions |
---|
BMS-986213 + investigator's choice chemotherapy | Experimental | BMS-986213 + XELOX or BMS-986213 + FOLFOX or BMS-986213 + SOX | - BMS-986213
- Nivolumab
- XELOX
- FOLFOX
- SOX
|
Nivolumab + investigator's choice chemotherapy | Experimental | Nivolumab + XELOX or Nivolumab + FOLFOX or Nivolumab + SOX | |
Eligibility Criteria
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
Maximum Eligible Age: | N/A |
Minimum Eligible Age: | 18 Years |
Eligible Gender: | All |
Healthy Volunteers: | No |
Primary Outcome Measures
Measure: | Objective Response Rate (ORR) |
Time Frame: | Up to 22 months |
Safety Issue: | |
Description: | |
Secondary Outcome Measures
Measure: | Incidence of Adverse Events (AEs) |
Time Frame: | Up to 5 years |
Safety Issue: | |
Description: | |
Measure: | Incidence of Serious Adverse Events (SAEs) |
Time Frame: | Up to 5 years |
Safety Issue: | |
Description: | |
Measure: | Incidence of AEs leading to discontinuation |
Time Frame: | Up to 5 years |
Safety Issue: | |
Description: | |
Measure: | Incidence of death |
Time Frame: | Up to 5 years |
Safety Issue: | |
Description: | |
Measure: | Incidence of laboratory abnormalities |
Time Frame: | Up to 5 years |
Safety Issue: | |
Description: | |
Measure: | Duration of Response (DOR) |
Time Frame: | Up to 5 years |
Safety Issue: | |
Description: | |
Measure: | Overall survival (OS) |
Time Frame: | Up to 5 years |
Safety Issue: | |
Description: | |
Measure: | Progression Free Survival (PFS) |
Time Frame: | Up to 5 years |
Safety Issue: | |
Description: | |
Details
Phase: | Phase 2 |
Primary Purpose: | Interventional |
Overall Status: | Active, not recruiting |
Lead Sponsor: | Bristol-Myers Squibb |
Last Updated
August 31, 2021