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)
Purpose
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
Condition
- Untreated Advanced or Metastatic Gastric, Gastroesophageal Junction, or Esophageal Adenocarcinoma
Eligibility
- Eligible Ages
- Over 18 Years
- Eligible Sex
- All
- Accepts Healthy Volunteers
- No
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.
Study Design
- Phase
- Phase 2/Phase 3
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel Assignment
- Primary Purpose
- Treatment
- Masking
- Double (Participant, Investigator)
Arm Groups
| Arm | Description | Assigned Intervention |
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Experimental Arm A1 |
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Experimental Arm A2 |
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Experimental Arm B |
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Experimental Arm C |
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Experimental Arm D |
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Recruiting Locations
Missouri Cancer Associates
Columbia 4381982, Missouri 4398678 65201
Columbia 4381982, Missouri 4398678 65201
Contact:
Caleb Smith, Site 0426
573-874-7800
Caleb Smith, Site 0426
573-874-7800
SCRI Oncology Partners
Nashville 4644585, Tennessee 4662168 37203
Nashville 4644585, Tennessee 4662168 37203
Contact:
Meredith Pelster, Site 0417
615-986-4366
Meredith Pelster, Site 0417
615-986-4366
Texas Oncology-Austin Central
Austin 4671654, Texas 4736286 78731
Austin 4671654, Texas 4736286 78731
Contact:
Vivian Cline, Site 0416
512-427-9400
Vivian Cline, Site 0416
512-427-9400
More Details
- Status
- Recruiting
- Sponsor
- Bristol-Myers Squibb
Study Contact
BMS Clinical Trials Contact Center www.BMSClinicalTrials.com855-907-3286
Clinical.Trials@bms.com