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A Study of Pumitamig or Nivolumab with Chemotherapy for Advanced Gastric, GEJ, or Esophageal Adenocarcinoma

This study is looking at two different treatment combinations for people with previously untreated advanced or metastatic gastric (stomach), gastroesophageal junction (GEJ), or esophageal (food pipe) adenocarcinoma. You would receive either Pumitamig with chemotherapy (Folfox or Capox) or Nivolumab with chemotherapy (Folfox or Capox). Researchers want to see how safe and effective these combinations are. To join, you must be at least 18 years old and have this type of cancer that has not been treated with systemic therapy before. The study will measure how many people respond to treatment (Objective Response), how long people live without their cancer growing (Progression Free Survival), and overall survival. The current status of this study is unclear, but it plans to enroll about 690 participants.

Study design
This is an interventional study comparing two different treatment combinations. It plans to enroll about 690 participants.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
Your response to treatment will be assessed for up to 2 years, and you will be followed for progression-free survival for up to approximately 33 months and overall survival for up to approximately 47 months.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

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)

Recruiting
PHASE2Ages 18+InterventionalTreatment
Bristol-Myers Squibb
~690 participants
Updated 2026-08-12 on ClinicalTrials.gov
What's tested:PumitamigFolfoxCapoxNivolumab

At a glance

Recruiting sites
93 of 161 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Objective Response (OR) (confirmed complete response (CR) or partial response (PR)) by Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 per investigator assessment
Measured over Up to 2 years after the last participant is randomized
+2 more outcomes measured

Conditions

Untreated Advanced or Metastatic Gastric, Gastroesophageal Junction, or Esophageal Adenocarcinoma

Explore related trials

Esophageal AdenocarcinomaGastric CarcinomaGastroesophageal Junction AdenocarcinomaProgrammed Cell Death 1 Ligand 1

Where it's being run

161 sites across 101 states
Germany8
Texas7
Turkey (Türkiye)5
Florida4
Seoul-teukbyeolsi [Seoul]4
Spain4
California3
New York3

Study leadership

  • Bristol-Myers Squibb · STUDY_DIRECTOR · Bristol-Myers Squibb

Who to contact

BMS Clinical Trials Contact Center www.BMSClinicalTrials.com
[email protected]
855-907-3286
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

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.

What this trial measures

  • Objective Response (OR) (confirmed complete response (CR) or partial response (PR)) by Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 per investigator assessmentUp to 2 years after the last participant is randomized

    Phase 2

  • Progression Free Survival (PFS) by RECIST v1.1 per blinded independent central review (BICR)Up to approximately 33 months

    Phase 3

  • Overall survival (OS)Up to approximately 47 months

    Phase 3