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Clinical Trials in the UK / NCT07221149
Recruiting Phase 2/3

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)

NCT07221149 · tracked via the Priya Life Science UK tracker
Sponsor
Bristol-Myers Squibb
Phase
Phase 2/3
Started
2026-03-13
Last updated
2026-09-08

Condition(s) studied

Untreated Advanced or Metastatic Gastric, Gastroesophageal Junction, or Esophageal Adenocarcinoma

Investigational drug(s) / intervention(s)

PumitamigFolfoxCapoxNivolumab

Pumitamig: Specified dose on specified days

Folfox: Specified dose on specified days

Capox: Specified dose on specified days

Nivolumab: Specified dose on specified days

Study 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

Sex
ALL
Min age
18 Years
Max age
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 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.

Primary outcome measure(s)

Trial sites (161)

FacilityCityRegionStatus
Local Institution - 0284 Phoenix Arizona Not Yet Recruiting
USC/Norris Comprehensive Cancer Center Los Angeles California Recruiting
University of California, Irvine (UCI) Health - UC Irvine Medical Center Orange California Recruiting
Local Institution - 0428 San Francisco California Not Yet Recruiting
Florida Cancer Specialists - South Fort Myers Florida Recruiting
Local Institution - 0433 Jacksonville Florida Not Yet Recruiting
Florida Cancer Specialists - North St. Petersburg Florida Recruiting
Moffitt Cancer Center Tampa Florida Recruiting
Emory University Atlanta Georgia Recruiting
Local Institution - 0379 Chicago Illinois Not Yet Recruiting
Local Institution - 0268 Iowa City Iowa Not Yet Recruiting
Local Institution - 0259 Rochester Minnesota Not Yet Recruiting
Missouri Cancer Associates Columbia Missouri Recruiting
Local Institution - 0286 Omaha Nebraska Not Yet Recruiting
Northwell Health/ RJ Zuckerberg Cancer Center Lake Success New York Recruiting
Memorial Sloan Kettering Cancer Center New York New York Recruiting
Local Institution - 0274 Rochester New York Not Yet Recruiting
Local Institution - 0245 Chapel Hill North Carolina Not Yet Recruiting
Local Institution - 0443 Cleveland Ohio Not Yet Recruiting
Local Institution - 0222 Cleveland Ohio Not Yet Recruiting
Oncology Associates Of Oregon, Pc Eugene Oregon Recruiting
Northwest Cancer Specialists, P.C. Portland Oregon Recruiting
UPMC Hillman Cancer Center Pittsburgh Pennsylvania Recruiting
SCRI Oncology Partners Nashville Tennessee Recruiting
Tennessee Oncology Nashville Tennessee Recruiting
Texas Oncology - Amarillo Cancer Center Amarillo Texas Recruiting
Texas Oncology-Austin Central Austin Texas Recruiting
Texas Oncology Beaumont Texas Recruiting
Texas Oncology - Northeast Texas Denison Texas Recruiting
Texas Oncology - DFW Grapevine Texas Recruiting
University of Texas MD Anderson Cancer Center Houston Texas Recruiting
Texas Oncology - San Antonio San Antonio Texas Recruiting
Oncology and Hematology Associates of Southwest Virginia, Inc. - Salem Salem Virginia Recruiting
University of Wisconsin Carbone Cancer Center - University Hospital Madison Wisconsin Recruiting
Centro Médico Fleischer Ciudad Autónoma de Buenos Aires Buenos Aires Recruiting
Instituto Alexander Fleming Ciudad Autónoma de Buenos Aires Buenos Aires Recruiting
Hospital Italiano de Buenos Aires ABB Buenos Aires F.D. Recruiting
Centro de Educación Médica e Investigaciones clínicas "Dr. Norberto Quirno" (CEMIC) Buenos Aires Argentina Recruiting
Liverpool Hospital Liverpool New South Wales Recruiting
Sunshine Coast University Hospital Birtinya Queensland Recruiting

+ 121 more sites — see the full list on the official registry below.

On this site

📄 Opdivo (nivolumab) drug profile →

More Bristol-Myers Squibb trials in the UK

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07221149 on ClinicalTrials.gov ↗ ← All trials in the UK