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)

What this study is about

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

Who can join (things the study team will check)

✅ You may be able to join 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 be able to join 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 this trial is running

• Local Institution - 0284, Phoenix, Arizona, United States
• Local Institution - 0437, Los Angeles, California, United States
• University of California, Irvine (UCI) Health - UC Irvine Medical Center, Orange, California, United States
• Local Institution - 0428, San Francisco, California, United States
• Florida Cancer Specialists - South, Fort Myers, Florida, United States
• Local Institution - 0433, Jacksonville, Florida, United States
• Florida Cancer Specialists - North, St. Petersburg, Florida, United States
• Local Institution - 0246, Tampa, Florida, United States
• Local Institution - 0377, Atlanta, Georgia, United States
• Local Institution - 0379, Chicago, Illinois, United States
• Local Institution - 0268, Iowa City, Iowa, United States
• Local Institution - 0259, Rochester, Minnesota, United States

+ 149 more sites.

Who to contact

BMS Clinical Trials Contact Center www.BMSClinicalTrials.com · 855-907-3286 · Clinical.Trials@bms.com

It's completely normal to call and ask questions before deciding anything. Mention the study ID: NCT07221149.