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
Bristol-Myers Squibb
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
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria * Participants must be previously untreated with systemic treatment for advanced/metastatic disease, histologically or cytologically confirmed advanced or metastatic gastric cancer (GC), gastroesophageal junction adenocarcinoma (GEJC) or distal esophageal adenocarcinoma (EAC). GEJ involvement can be confirmed via biopsy, endoscopy, or imaging. * Participants must have a documented programmed cell death-(ligand)1 (PD-L1) ≥ 1 or \< 1 status for Phase 2, and document PD-L1 ≥ 1 status for the Phase 3 part of the study. * Participants must have documented human epidermal growth…
Interventions
- DrugPumitamig
Specified dose on specified days
- DrugFolfox
Specified dose on specified days
- DrugCapox
Specified dose on specified days
- DrugNivolumab
Specified dose on specified days
Locations (161)
- Local Institution - 0284Phoenix, Arizona
- Local Institution - 0437Los Angeles, California
- Local Institution - 0277Orange, California
- Local Institution - 0428San Francisco, California
- Florida Cancer Specialists - SouthFort Myers, Florida
- Local Institution - 0433Jacksonville, Florida