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
Sponsor: Bristol-Myers Squibb + BioNTech SE
No open prediction endpoints
Endpoints are classified and published by ProgramSignal analysts.
Request endpoint coverageKey Facts
Primary Endpoints (CT.gov)
Objective Response (OR) (confirmed complete response (CR) or partial response (PR)) by Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 per investigator assessment
Time frame: Up to 2 years after the last participant is randomized
Progression Free Survival (PFS) by RECIST v1.1 per blinded independent central review (BICR)
Time frame: Up to approximately 33 months
Overall survival (OS)
Time frame: Up to approximately 47 months
Secondary Endpoints
PFS by RECIST v1.1 per investigator assessment
Duration of Response (DOR) (CR or PR) by RECIST v1.1 per investigator assessment
Time to Response (TTR) (CR or PR) by RECIST v1.1 per investigator assessment
Eligibility Criteria
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 factor receptor 2 (HER2)-negative cancer, as determined according to local guidelines. * Participants must have measurable disease as defined by RECIST v1.1. Exclusion Criteria * Participants must not have untreated known central nervous system (CNS) metastases. * Participants must not have significant cardiovascular disease, such as myocardial infarction, unstable angina, arterial thrombosis, c…
Read full criteria on CT.gov →✦ Analyst Commentary
Expert commentary on why this trial matters and what to watch for.
Request coverage →