Trials / Completed
CompletedNCT02872116
Efficacy Study of Nivolumab Plus Ipilimumab or Nivolumab Plus Chemotherapy Against Chemotherapy in Stomach Cancer or Stomach/Esophagus Junction Cancer
A Randomized, Multicenter, Open-Label, Phase 3 Study of Nivolumab Plus Ipilimumab or Nivolumab in Combination With Oxaliplatin Plus Fluoropyrimidine Versus Oxaliplatin Plus Fluoropyrimidine in Subjects With Previously Untreated Advanced or Metastatic Gastric or Gastroesophageal Junction Cancer
- Status
- Completed
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 2,031 (actual)
- Sponsor
- Bristol-Myers Squibb · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
The main purpose of this study is to compare how long patients with gastric or gastroesophageal junction cancer live after receiving nivolumab and ipilimumab or nivolumab and chemotherapy compared with patients receiving chemotherapy alone.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Nivolumab | Specified dose on specified days |
| DRUG | Ipilimumab | Specified dose on specified days |
| DRUG | Oxaliplatin | Specified dose on specified days |
| DRUG | Capecitabine | Specified dose on specified days |
| DRUG | Leucovorin | Specified dose on specified days |
| DRUG | Fluorouracil | Specified dose on specified days |
Timeline
- Start date
- 2016-10-12
- Primary completion
- 2020-05-27
- Completion
- 2024-06-06
- First posted
- 2016-08-19
- Last updated
- 2025-08-07
- Results posted
- 2022-06-28
Locations
179 sites across 29 countries: United States, Argentina, Australia, Brazil, Canada, Chile, China, Colombia, Czechia, France, Germany, Greece, Hong Kong, Hungary, Israel, Italy, Japan, Mexico, Peru, Poland, Portugal, Romania, Russia, Singapore, South Korea, Spain, Taiwan, Turkey (Türkiye), United Kingdom
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT02872116. Inclusion in this directory is not an endorsement.