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)

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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)

Status
Active
Cancer Type
Esophogeal Cancer
Stomach/ Gastric Cancer
Unknown Primary
Trial Phase
Phase II
Phase III
Eligibility
18 Years and older, Male and Female
Study Type
Treatment
NCT ID
NCT07221149
Protocol IDs
CA266-0004 (primary)
NCI-2026-01091
2025-523263-37
U1111-1325-8116
Study Sponsor
Bristol-Myers Squibb

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 untreated advanced or metastatic gastric, gastroesophageal
junction, or esophageal adenocarcinoma

Eligibility

  1. 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.
  2. 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.
  3. Participants must have documented human epidermal growth factor receptor 2 (HER2)-negative cancer, as determined according to local guidelines.
  4. Participants must have measurable disease as defined by RECIST v1.1.

Treatment Sites in Georgia

Emory Johns Creek Hospital


6325 Hospital Parkway
Johns Creek, GA 30097
www.emoryjohnscreek.com

Emory University Hospital - Midtown


550 Peachtree Street NE
Atlanta, GA 30308
404-686-4411
www.emoryhealthcare.org

Winship Cancer Institute of Emory University


1365 Clifton Road NE
Building C
Atlanta, GA 30322
winshipcancer.emory.edu

**Clinical trials are research studies that involve people. These studies test new ways to prevent, detect, diagnose, or treat diseases. People who take part in cancer clinical trials have an opportunity to contribute to scientists’ knowledge about cancer and to help in the development of improved cancer treatments. They also receive state-of-the-art care from cancer experts... Click here to learn more about clinical trials.