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RecruitingLast updated: 10 June 2026

ROSETTA Gastric-204: Comparing two different treatment combinations that include immunotherapy and chemotherapy for advanced stomach or oesophageal cancerA 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

Trial purpose

Medical clipboardCancer treatment

Tumor type

Upper gastrointestinal tract Cancers Upper gastrointestinal tract

Age

People18+

Trial acronym

ROSETTA Gastric-204

Clinical summary

Summary

This study is being done to find out how safe and how well a new treatment combination works for people with advanced stomach and oesophageal cancers.

You may be eligible for this study if you have advanced or metastatic gastric cancer (stomach), gastrooesophageal junction cancer or distal oesophageal cancer. You must not have received any systemic treatment for your advanced of metastatic disease, but treatment for an earlier stage may be permitted. Speak with your doctor about whether your previous treatment history is eligible.

Eligible participants will be randomly allocated (by chance) to one of four treatment arms, to receive:

  • Arms A1, A2 and C: Pumitamig combined with chemotherapy; or
  • Arm D: Novulumab combined with chemotherapy.

Conditions

This trial is treating people with stomach, oesophageal or gastro-oesophageal junction cancers

Eligibility

Inclusion

  • 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

  • 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, cerebrovascular accident within 6 months prior to randomization, uncontrolled hypertension (≥ 160 systolic, ≥ 100 diastolic mm Hg) despite optimal medical management, or congenital long QT syndrome.
  • Participants must not have evidence of major coagulation disorders (eg, hemophilia).
  • Participants must not have a history of deep vein thrombosis, pulmonary embolism, or any other significant thromboembolism within 3 months prior to randomization, unless the participant has been fully treated (eg, inferior vena cava filter placed) and/or adequately anticoagulated on a stable dose.
  • Participants must not have a history of abdominal fistula or gastrointestinal (GI) perforation within 6 months of randomization.
  • Participants must not have had major surgery, open biopsy, or significant traumatic injury within 28 days prior to randomization, or anticipation of the need for major surgery during the course of study intervention.
  • Other protocol-defined Inclusion/Exclusion criteria apply.

Inclusion

  • Your cancer has spread to other parts of the body (metastatic) or has grown into nearby parts of the body (locally advanced).

Exclusion

  • You have certain types of non-cancer medical conditions.
  • You have had certain treatments, surgical procedures or drugs.
Message

Clinical trials have complex eligibility criteria, and other criteria may apply for this trial. Ask your doctor about whether this trial could be right for you.

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Recruiting hospitals

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More information

Trial Identifiers

Information on this page is partially produced from ClinicalTrials.gov, EU Clinical Trials Register *. View further details about this trial on the registry via the links below:

  • NCT07221149 *
  • 2025-523263-37 *
  • CA266-0004; U1111-1325-8116

Trial sponsor

Bristol-Myers Squibb

Scientific Title

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

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