A Phase 23 Study Comparing Pumitamig Plus Chemotherapy to Nivolumab Plus Chemotherapy in Adults With Untreated Advanced or Metastatic Gastric, Gastroesophageal Junction, or Esophageal Adenocarcinoma

What this Trial Is About

This trial investigates the safety and efficacy of Pumitamig combined with chemotherapy compared to Nivolumab combined with chemotherapy in adults with previously untreated advanced or metastatic gastric, gastroesophageal junction, or esophageal adenocarcinoma. Participants must have specific tumor characteristics including PD-L1 and HER2 status, and measurable disease according to established criteria. The study is a blinded, randomized phase 23 trial sponsored by Bristol-Myers Squibb. Participants will receive either Pumitamig or Nivolumab alongside chemotherapy regimens such as Folfox or Capox, with dosing given on specified days. The study uses a parallel design with multiple experimental arms to evaluate these combinations. Treatments and assessments will continue over several months following randomization. During the study, participants will undergo regular evaluations including tumor response assessments by RECIST criteria, survival monitoring, and safety checks. Researchers will measure objective response rates, progression-free survival, and overall survival up to several years after treatment starts. The trial includes long-term follow-up to monitor outcomes and safety over time, with the primary outcome tracked for up to two years after the last participant is randomized.

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)