Study Comparing Pumitamig and Chemotherapy to Nivolumab and Chemotherapy for Advanced Stomach and Esophageal Cancer
Sponsor: Bristol-Myers Squibb
ClinicalTrials ID:NCT07221149
This clinical trial is testing two different treatment combinations for people with advanced or metastatic stomach, gastroesophageal junction, or esophageal cancer who have not received prior treatment. The study aims to compare the safety and effectiveness of Pumitamig with chemotherapy against Nivolumab with chemotherapy.
Patient Parameters
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Program Overview
The goal of this study is to find out which treatment combination is safer and more effective for patients with advanced or metastatic stomach, gastroesophageal junction, or esophageal cancer. Participants will receive either Pumitamig with chemotherapy or Nivolumab with chemotherapy to see which approach better controls the cancer and improves patient outcomes.
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.
- 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.
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