# 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)

Source: https://onco.cc/trials/nct07221149/  
OnCo record `nct07221149` (Trial). Data CC BY-NC 4.0, attribute "Data from OnCo (onco.cc)"; commercial use needs a licence.

## TL;DR

A phase 2/3 trial of PM8002 and Nivolumab in gastric & gastro-oesophageal junction cancer, run by Bristol-Myers Squibb, now recruiting.

## Summary

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) is a phase 2/3 interventional study registered as NCT07221149 by Bristol-Myers Squibb, with 690 participants planned, started 2026-03-13 and due to reach its primary completion in 2030-11-08. Interventions recorded: Pumitamig, Folfox, Capox and Nivolumab.

## Fields

- Kind: Trial
- Status: recruiting
- Last checked: 2026-09-16
- Tags: pipeline; ctgov-ingest
- Registry id: NCT07221149
- Phase: 2/3
- Setting: 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
- Enrolled: 690

## Sources

- ClinicalTrials.gov NCT07221149: https://clinicaltrials.gov/study/NCT07221149

## Connected records

- cancers: [Gastric & gastro-oesophageal junction cancer](https://onco.cc/cancers/gastric/)
- drugs: [Nivolumab](https://onco.cc/drugs/nivolumab/), [PM8002](https://onco.cc/drugs/pm8002/)
- companies: [BioNTech](https://onco.cc/companies/biontech/), [Bristol Myers Squibb](https://onco.cc/companies/bms/)

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