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OncoMatch/Clinical Trials/NCT07221149

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 NCT07221149 recruiting? Yes, currently enrolling (May 2026). This Phase 2/3 trial studies multiple treatments including Pumitamig and Folfox for untreated advanced or metastatic gastric, gastroesophageal junction, or esophageal adenocarcinoma.

Phase 2/3RecruitingBristol-Myers SquibbNCT07221149Data as of May 2026

Treatment: Pumitamig · Folfox · Capox · NivolumabThe purpose of this study is 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

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Extracted eligibility criteria

Cancer type

Gastric Cancer

Esophageal Carcinoma

Biomarker criteria

Required: PD-L1 (CD274) overexpression (PD-L1 ≥ 1)

Participants must have a documented programmed cell death-(ligand)1 (PD-L1) ≥ 1.

Required: HER2 (ERBB2) negative

Participants must have documented human epidermal growth factor receptor 2 (HER2)-negative cancer, as determined according to local guidelines.

Disease stage

Metastatic disease required

Prior therapy

No prior treatment (treatment-naive required)
Max 0 prior lines

Lab requirements

Cardiac function

No significant cardiovascular disease (myocardial infarction, unstable angina, arterial thrombosis, cerebrovascular accident within 6 months, uncontrolled hypertension ≥ 160/100 mm Hg despite optimal medical management, or congenital long QT syndrome)

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.

Structured fields extracted by AI. May contain errors — verify against the official protocol.

US trial sites

  • Local Institution - 0284 · Phoenix, Arizona
  • Local Institution - 0437 · Los Angeles, California
  • Local Institution - 0277 · Orange, California
  • Local Institution - 0428 · San Francisco, California
  • Florida Cancer Specialists - South · Fort Myers, Florida

Showing up to 5 US sites. See all sites on ClinicalTrials.gov →

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