Clinical Trial

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)

Recruiting Phase 2/3
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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
Protocol Amendment History 1 change
minor Trial arms changed: 5 -> 4 2026-05-07
Trial Details
NCT Number NCT07221149
Lead Sponsor Bristol-Myers Squibb
Collaborators: BioNTech SE
Conditions Untreated Advanced or Metastatic Gastric, Gastroesophageal Junction, or Esophageal Adenocarcinoma
Enrollment 690 participants
Start Date 2026-03-13
Primary Completion 2030-11-08 (estimated)
Study Completion 2032-09-11 (estimated)
Updated on ClinicalTrials.gov 2026-08-12