Status:
NOT_YET_RECRUITING
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)
Lead Sponsor:
Bristol-Myers Squibb
Collaborating Sponsors:
BioNTech SE
Conditions:
Untreated Advanced or Metastatic Gastric, Gastroesophageal Junction, or Esophageal Adenocarcinoma
Eligibility:
All Genders
18+ years
Phase:
PHASE2
PHASE3
Brief Summary
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 untreat...
Eligibility Criteria
Inclusion
- 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.
- 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 prophylactic 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.
Exclusion
Key Trial Info
Start Date :
March 9 2026
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
September 11 2032
Estimated Enrollment :
690 Patients enrolled
Trial Details
Trial ID
NCT07221149
Start Date
March 9 2026
End Date
September 11 2032
Last Update
December 8 2025
Active Locations (158)
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1
Local Institution - 0284
Phoenix, Arizona, United States, 85054
2
Local Institution - 0240
Los Angeles, California, United States, 90095
3
Local Institution - 0277
Orange, California, United States, 92868
4
Local Institution - 0428
San Francisco, California, United States, 94158