Trials / Recruiting
RecruitingNCT07221149
A Study to Evaluate the Safety and Efficacy of Pumitamig in Combination With Chemotherapy Versus Nivolumab in Combination With Chemotherapy in Participants With Previously Untreated Advanced or Metastatic Gastric, Gastroesophageal Junction, or Esophageal Adenocarcinoma (ROSETTA Gastric-204)
ROSETTA Gastric-204: A Blinded, Randomized, Phase 2/3 Study of Pumitamig in Combination With Chemotherapy Versus Nivolumab in Combination With Chemotherapy in Participants With Previously Untreated Advanced or Metastatic Gastric, Gastroesophageal Junction, or Esophageal Adenocarcinoma
- Status
- Recruiting
- Phase
- Phase 2 / Phase 3
- Study type
- Interventional
- Enrollment
- 690 (estimated)
- Sponsor
- Bristol-Myers Squibb · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
The purpose of this study is to evaluate the safety and efficacy of Pumitamig in combination with chemotherapy versus Nivolumab in combination with chemotherapy in participants with previously untreated advanced or metastatic gastric, gastroesophageal junction, or esophageal adenocarcinoma
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Pumitamig | Specified dose on specified days |
| DRUG | Folfox | Specified dose on specified days |
| DRUG | Capox | Specified dose on specified days |
| DRUG | Nivolumab | Specified dose on specified days |
Timeline
- Start date
- 2026-03-13
- Primary completion
- 2030-11-08
- Completion
- 2032-09-11
- First posted
- 2025-10-27
- Last updated
- 2026-04-02
Locations
160 sites across 20 countries: United States, Argentina, Australia, Brazil, Canada, Chile, China, Colombia, France, Germany, India, Italy, Japan, Mexico, Poland, Romania, South Korea, Spain, Turkey (Türkiye), United Kingdom
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT07221149. Inclusion in this directory is not an endorsement.