Cancer of the Stomach, Gastric Cancer, Gastroesophageal Junction, Stomach Cancer
Conditions
Brief summary
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.
Interventions
BIOLOGICALRelatlimab + Nivolumab
Specified dose on specified days
BIOLOGICALNivolumab
Specified dose on specified days
DRUGPaclitaxel
Specified dose on specified days
DRUGRamucirumab
Specified dose on specified days
Sponsors
Bristol-Myers Squibb
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion 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/
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Overall response rate (ORR) | Approximately 31 months |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of serious adverse events (SAEs) | Approximately 5 years | — |
| Incidence of AEs leading to discontinuation | Approximately 5 years | — |
| Incidence of deaths | Approximately 5 years | — |
| Incidence of laboratory abnormalities | Approximately 5 years | — |
| Incidence of adverse events (AEs) | Approximately 5 years | — |
| Duration of response (DOR) | Approximately 5 years | — |
| Progression free survival (PFS) | Approximately 5 years | — |
| Overall survival (OS) | Approximately 5 years | — |
| ORR | Approximately 5 years | Cohort A1 |
Countries
Argentina, Australia, Brazil, Canada, Chile, Colombia, Germany, Italy, Mexico, Portugal, Puerto Rico, Romania, Spain, United States
Outcome results
None listed