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)
← catalyst calendarNCT07221149 · readout in 1,542 d
Sponsored by Bristol-Myers Squibb (industry) · BMY — their whole pipeline →. With BioNTech SE.
Phase
Phase 2/3
Status
Recruiting
Study type
Interventional
Design
Randomized · Double · Treatment
Enrollment
690estimated
Sites
161
Countries
Argentina, Australia, Brazil +17
Every value on this page is a field the sponsor filed with ClinicalTrials.gov, reproduced. Dates are their own estimates, revised as a study runs, unless the registry marks them actual. sources →
Source: ClinicalTrials.gov, retrieved 2026-08-19
Dates
each axis at the precision it was filed, with the registry's own basis| Date | Filed | Basis | What it is |
|---|---|---|---|
| Start | 2026-03-13 | actual | When the study began enrolling |
| Primary completion | 2030-11-08 | estimated | The date the last participant is measured for the primary outcome — the readout window |
| Study completion | 2032-09-11 | estimated | The whole study's end, after follow-up |
| First posted | 2025-10-27 | actual | When this record first appeared on the registry |
| Results posted | — | When the sponsor posted results to the registry | |
| Record updated | 2026-08-12 | actual | The sponsor's own last edit to this record — every projection above is as current as this date |
What it studies
Condition
- Untreated Advanced or Metastatic Gastric, Gastroesophageal Junction, or Esophageal Adenocarcinoma
Interventions
- Drug: Pumitamig — also filed as BMS-986545, BNT327, PM8002
- Drug: Folfox
- Drug: Capox
- Drug: Nivolumab
Primary outcomes
what the primary-completion date above is the date OFObjective Response (OR) (confirmed complete response (CR) or partial response (PR)) by Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 per investigator assessment
measured Up to 2 years after the last participant is randomized
Progression Free Survival (PFS) by RECIST v1.1 per blinded independent central review (BICR)
measured Up to approximately 33 months
Overall survival (OS)
measured Up to approximately 47 months
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