NCT07221149 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)
| NCT ID | NCT07221149 |
| Status | Recruiting |
| Phase | Phase 2, Phase 3 |
| Sponsor | Bristol-Myers Squibb |
| Condition | Untreated Advanced or Metastatic Gastric, Gastroesophageal Junction, or Esophageal Adenocarcinoma |
| Study Type | INTERVENTIONAL |
| Enrollment | 690 participants |
| Start Date | 2026-03-13 |
| Primary Completion | 2030-11-08 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 690 participants in total. It began in 2026-03-13 with a primary completion date of 2030-11-08.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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 untreated advanced or metastatic gastric, gastroesophageal junction, or esophageal adenocarcinoma
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 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.
Contact & Investigator
BMS Clinical Trials Contact Center www.BMSClinicalTrials.com
✉ Clinical.Trials@bms.com📞 855-907-3286
Bristol-Myers Squibb
STUDY DIRECTOR
Bristol-Myers Squibb
Frequently Asked Questions
Who can join the NCT07221149 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Untreated Advanced or Metastatic Gastric, Gastroesophageal Junction, or Esophageal Adenocarcinoma. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07221149 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT07221149 currently recruiting?
Yes, NCT07221149 is actively recruiting participants. Contact the research team at Clinical.Trials@bms.com for enrollment information.
Where is the NCT07221149 trial being conducted?
This trial is being conducted at Phoenix, United States, Los Angeles, United States, Orange, United States, San Francisco, United States and 11 additional locations.
Who is sponsoring the NCT07221149 clinical trial?
NCT07221149 is sponsored by Bristol-Myers Squibb. The principal investigator is Bristol-Myers Squibb at Bristol-Myers Squibb. The trial plans to enroll 690 participants.