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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)

RecruitingPhase 2/3

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

Who can join

Ages 18 and older · All sexes

Full eligibility 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.

About the study

The 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

What is being tested

Sponsor: Bristol-Myers Squibb · Participants: 690 · Started: Mar 13, 2026

Contact the study team

Official record on ClinicalTrials.gov — NCT07221149

Locations in the U.S.

ArizonaLocal Institution - 0284, Phoenix (Not yet recruiting)
CaliforniaUSC/Norris Comprehensive Cancer Center, Los Angeles
University of California, Irvine (UCI) Health - UC Irvine Medical Center, Orange
Local Institution - 0428, San Francisco (Not yet recruiting)
FloridaFlorida Cancer Specialists - South, Fort Myers
Local Institution - 0433, Jacksonville (Not yet recruiting)
Florida Cancer Specialists - North, St. Petersburg
Moffitt Cancer Center, Tampa
GeorgiaEmory University, Atlanta
IllinoisLocal Institution - 0379, Chicago (Not yet recruiting)
IowaLocal Institution - 0268, Iowa City (Not yet recruiting)
MinnesotaLocal Institution - 0259, Rochester (Not yet recruiting)
MissouriMissouri Cancer Associates, Columbia
NebraskaLocal Institution - 0286, Omaha (Not yet recruiting)
New YorkNorthwell Health/ RJ Zuckerberg Cancer Center, Lake Success
Memorial Sloan Kettering Cancer Center, New York
Local Institution - 0274, Rochester (Not yet recruiting)
North CarolinaLocal Institution - 0245, Chapel Hill (Not yet recruiting)
OhioLocal Institution - 0222, Cleveland (Not yet recruiting)
Local Institution - 0443, Cleveland (Not yet recruiting)
OregonOncology Associates Of Oregon, Pc, Eugene
Northwest Cancer Specialists, P.C., Portland
PennsylvaniaUPMC Hillman Cancer Center, Pittsburgh
TennesseeSCRI Oncology Partners, Nashville
Tennessee Oncology, Nashville
TexasTexas Oncology - Amarillo Cancer Center, Amarillo
Texas Oncology-Austin Central, Austin
Texas Oncology, Beaumont
Texas Oncology - Northeast Texas, Denison
Texas Oncology - DFW, Grapevine
University of Texas MD Anderson Cancer Center, Houston
Texas Oncology - San Antonio, San Antonio
VirginiaOncology and Hematology Associates of Southwest Virginia, Inc. - Salem, Salem
WisconsinUniversity of Wisconsin Carbone Cancer Center - University Hospital, Madison

Conditions

From ClinicalTrials.gov, data retrieved Sep 30, 2026. Each study sets its own eligibility; the study team decides who can join.