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 now · Phase 2/Phase 3

Conditions studied: Untreated Advanced or Metastatic Gastric, Gastroesophageal Junction, or Esophageal Adenocarcinoma

In brief

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

Key facts

Study ID

NCT07221149

Run by

Bristol-Myers Squibb

People needed

690

Starts

2026-03-13

Expected to finish

2032-09-11

Last updated by the study team

2026-07-20

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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 it is running

• Centro Médico Fleischer — Ciudad Autónoma de Buenos Aires, Buenos Aires, Argentina (enrolling)
• Sunshine Coast University Hospital — Birtinya, Queensland, Australia (enrolling)
• Texas Oncology - DFW — Grapevine, Texas, United States (enrolling)
• University of Wisconsin Carbone Cancer Center - University Hospital — Madison, Wisconsin, United States (enrolling)
• Hospital Italiano de Buenos Aires — ABB, Buenos Aires F.D., Argentina (enrolling)
• Centro de Educación Médica e Investigaciones clínicas "Dr. Norberto Quirno" (CEMIC) — Buenos Aires, Argentina (enrolling)
• Texas Oncology-Austin Central — Austin, Texas, United States (enrolling)
• Texas Oncology - Northeast Texas — Denison, Texas, United States (enrolling)
• Texas Oncology - San Antonio — San Antonio, Texas, United States (enrolling)
• Oncology and Hematology Associates of Southwest Virginia, Inc. - Salem — Salem, Virginia, United States (enrolling)
• Instituto Alexander Fleming — Ciudad Autónoma de Buenos Aires, Buenos Aires, Argentina (enrolling)
• Missouri Cancer Associates — Columbia, Missouri, United States (enrolling)
• Florida Cancer Specialists - North — St. Petersburg, Florida, United States (enrolling)
• Northwell Health/ RJ Zuckerberg Cancer Center — Lake Success, New York, United States (enrolling)
• Memorial Sloan Kettering Cancer Center — New York, New York, United States (enrolling)
• Texas Oncology - Amarillo Cancer Center — Amarillo, Texas, United States (enrolling)
• Emory University — Atlanta, Georgia, United States (enrolling)
• Texas Oncology — Beaumont, Texas, United States (enrolling)
• Florida Cancer Specialists - South — Fort Myers, Florida, United States (enrolling)
• Oncology Associates Of Oregon, Pc — Eugene, Oregon, United States (enrolling)
• Northwest Cancer Specialists, P.C. — Portland, Oregon, United States (enrolling)
• UPMC Hillman Cancer Center — Pittsburgh, Pennsylvania, United States (enrolling)
• University of California, Irvine (UCI) Health - UC Irvine Medical Center — Orange, California, United States (enrolling)
• SCRI Oncology Partners — Nashville, Tennessee, United States (enrolling)
• Lyell McEwin Hospital — Elizabeth Vale, South Australia, Australia (enrolling)

Full record on ClinicalTrials.gov

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