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Pumitamig plus chemotherapy versus nivolumab plus chemotherapy for untreated advanced gastric, gastroesophageal junction, or distal esophageal adenocarcinoma

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

Phase2; Phase3 Interventional Bristol-Myers Squibb · NCT07221149

This trial will try Pumitamig with chemotherapy versus nivolumab with chemotherapy in people with previously untreated advanced or metastatic gastric, gastroesophageal junction, or distal esophageal adenocarcinoma.

Quick facts

PhasePhase2; Phase3
Study typeInterventional
Enrollment690 (estimated)
Ages18 Years and up
SexAll
SponsorBristol-Myers Squibb Industry-sponsored
Drugs / interventionsNivolumab, chemotherapy
Locations161 sites (Phoenix, Arizona and 160 other locations)
Trial IDNCT07221149 on ClinicalTrials.gov

What this trial studies

This Phase 2/3 randomized trial compares Pumitamig combined with a standard chemotherapy backbone (FOLFOX or CAPOX) to nivolumab combined with the same chemotherapy regimens in patients with measurable, HER2-negative advanced or metastatic gastric, gastroesophageal junction, or distal esophageal adenocarcinoma. Phase 2 enrolls participants with documented PD-L1 ≥1 or <1 status, while the Phase 3 portion enrolls participants with PD-L1 ≥1. Key eligibility includes no prior systemic therapy for advanced disease and absence of untreated central nervous system metastases. Outcomes include safety, objective response, and survival measures using RECIST v1.1 and standard oncology endpoints.

Who should consider this trial

Good fit: Adults with previously untreated, measurable, HER2-negative advanced or metastatic gastric, gastroesophageal junction, or distal esophageal adenocarcinoma who meet the trial's PD-L1 requirement (Phase 3: PD-L1 ≥1) and have no untreated brain metastases are ideal candidates.

Not a fit: Patients with HER2-positive tumors, untreated central nervous system metastases, significant uncontrolled cardiovascular disease, or prior systemic treatment for advanced disease are unlikely to qualify or to receive benefit from this trial.

Why it matters

Potential benefit: If successful, the Pumitamig combination could provide an alternative first-line immunotherapy strategy that improves tumor response or survival for patients with HER2-negative advanced gastric or related cancers.

How similar studies have performed: Nivolumab plus chemotherapy has demonstrated benefit in prior first-line trials for similar cancers, while Pumitamig as a comparator agent is a newer approach with less public efficacy data available.

Eligibility criteria

Show full inclusion / exclusion criteria 
Inclusion Criteria

* 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 Criteria

* 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.

Where this trial is running

Phoenix, Arizona and 160 other locations

+111 more sites — see ClinicalTrials.gov for the full list.

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Untreated Advanced or Metastatic Gastric, Gastroesophageal Junction, or Esophageal AdenocarcinomaGastric CancerGastroesophageal Junction CancerEsophageal Adenocarcinoma
Last reviewed 2026-06-10 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.