Trials / Completed
CompletedNCT03662659
An Investigational Study of Immunotherapy Combinations With Chemotherapy in Patients With Gastric or Gastroesophageal Junction (GEJ) Cancers
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
- Status
- Completed
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 274 (actual)
- Sponsor
- Bristol-Myers Squibb · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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
| Type | Name | Description |
|---|---|---|
| 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 |
Timeline
- Start date
- 2018-10-16
- Primary completion
- 2020-08-27
- Completion
- 2024-01-18
- First posted
- 2018-09-07
- Last updated
- 2025-02-05
- Results posted
- 2022-05-09
Locations
79 sites across 17 countries: United States, Argentina, Australia, Austria, Belgium, Canada, Chile, Czechia, France, Germany, Italy, Norway, Poland, Puerto Rico, Singapore, Spain, United Kingdom
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT03662659. Inclusion in this directory is not an endorsement.