Pumitamig plus chemotherapy versus nivolumab plus chemotherapy for untreated advanced gastric, gastroesophageal junction, or distal esophageal adenocarcinoma

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This Phase 2/3 randomized trial compares Pumitamig combined with a standard chemotherapy backbone (FOLFOX or CAPOX) to nivolumab combined with the same chemotherapy regimens in patients with measurable, HER2-negative advanced or metastatic gastric, gastroesophageal junction, or distal esophageal adenocarcinoma. Phase 2 enrolls participants with documented PD-L1 ≥1 or <1 status, while the Phase 3 portion enrolls participants with PD-L1 ≥1. Key eligibility includes no prior systemic therapy for advanced disease and absence of untreated central nervous system metastases. Outcomes include safety, objective response, and survival measures using RECIST v1.1 and standard oncology endpoints.

Why it matters

Who can join: the full rules

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 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.

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 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's running

• Mayo Clinic in Arizona - Phoenix
  Phoenix, Arizona, United States Recruiting
• USC/Norris Comprehensive Cancer Center
  Los Angeles, California, United States Recruiting
• University of California, Irvine (UCI) Health - UC Irvine Medical Center
  Orange, California, United States Recruiting
• Florida Cancer Specialists - South
  Fort Myers, Florida, United States Recruiting
• Mayo Clinic in Florida
  Jacksonville, Florida, United States Recruiting
• Florida Cancer Specialists - North
  St. Petersburg, Florida, United States Recruiting

+111 more sites. See ClinicalTrials.gov for the full list.

Study contacts

• Study coordinator: BMS Clinical Trials Contact Center www.BMSClinicalTrials.com
• Email: Clinical.Trials@bms.com
• Phone: 855-907-3286

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.