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Trials
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)

trialsTrialRecruiting

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)

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

Also called: ROSETTA Gastric-204

Overview Connected6

Overview

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.

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

Phase

Phase 2/3

Sponsor

Bristol-Myers Squibb

Registry

Started

2026-03-13

Enrolled

690 enrolled

Connected

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cancers

Gastric & gastro-oesophageal junction cancer

technologies

Immune checkpoint inhibitors

drugs

ApprovedMonoclonal antibody (anti-PD-1)

Nivolumab · Opdivo / Opdivo Qvantig (SC)

Phase 3bispecific antibody

companies

BioNTech Bristol Myers Squibb

Evidence strength41/100 · Emerging

How much and what kind of evidence, not how big the benefit. Click for the breakdown.

Phase 2/3+22
690 enrolled+14
No structured primary endpoint0
Result: recruiting0
No independent replication recorded0
A linked product is approved+5

Formula disclosed on the evidence page.

ProvenanceLast edited 2026-09-22 · Jude Gomila · Wave 2 corpus-only joins applied · diff · file

Sources & links

ClinicalTrials.gov NCT07221149

Data

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Cancers

Gastric & gastro-oesophageal junction cancer

Technologies

Immune checkpoint inhibitors

Products

PM8002
Nivolumab

Companies

Bristol Myers Squibb
BioNTech

Not yet reviewedNeeds expert (clinical) review. Review this page or see the review queue and roster.

Model panel commentary is coming to this page: machine commentary, not clinical review.

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