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Looking for participantsPhase2/Phase3

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)

Sponsor: Bristol-Myers Squibb

NCT ID: NCT07221149

View on ClinicalTrials.gov ↗

At a glance

What the study gets you
Access to the study treatment being tested
Type of study
Interventional (receives a drug or procedure)
Time in hospital
In-person visits at study sites — visit count not specified by the sponsor
Drug or intervention
Pumitamig (drug), Folfox (drug), Capox (drug), Nivolumab (drug)
How long the study runs
Study runs about 78 months (dates as stated)
About the drug or intervention
Pumitamig — drug: Specified dose on specified days · Folfox — drug: Specified dose on specified days · Capox — drug: Specified dose on specified days · Nivolumab — drug: Specified dose on specified days
Patient visit burden
Not specified by the sponsor
Type of study
Testing a treatment
Ages
18 Years and over
Who
All
Number of participants
690
Started
2026-03-13
Last checked
2026-09

Plain English Summary

What is this study?

  • • Testing a new treatment for untreated advanced or metastatic gastric, gastroesophageal junction, or esophageal adenocarcinoma
  • • Phase2/Phase3 - 690 participants
  • • 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

Who can take part?

  • • Ages 18 Years and over
  • • Diagnosed with untreated advanced or metastatic gastric, gastroesophageal junction, or esophageal adenocarcinoma

Where?

  • • London - St Bartholomew's Hospital
  • • Oxford - Oxford University Hospitals NHS Trust
  • • Sutton - The Royal Marsden NHS Foundation Trust - Royal Marsden Hospital (RMH) - Sutton
  • • Glasgow - Local Institution - 0354
  • • +2 more UK sites

This is a simplified summary. Always discuss with your doctor before making any decisions.

About This Trial

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

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

How this trial compares with your answers

Answer 2 more questions to improve match

What we know so far

Condition· Matched your search
Age· Tell us your age for better matching
Gender· Tell us your sex for better matching

Still need:

  • • Tell us your age for better matching
  • • Tell us your sex for better matching

Preliminary match based on your answers. Full eligibility requires on-site assessment including medical history, physical exam, and lab tests. This does not guarantee enrolment.

Eligibility at a Glance

Key info

  • Age: 18 Years and over
  • Who can join: All genders

Biomarkers mentioned

PD-L1PD-L1 ≥ 1HER2

Treatment history

Treatments you must have had:

  • ✓ measurable disease as defined by RECIST v1

What the study is looking for

  • ✓Inclusion Criteria
  • ✓Participants must have a documented programmed cell death-(ligand)1 (PD-L1) ≥ 1 or \< 1 status for Phase 2, and...
  • ✓Participants must have documented human epidermal growth factor receptor 2 (HER2)-negative cancer, as determined...
  • ✓Participants must have cancer that can be measured on scans as defined by (standard scan measurements).
  • ✓Exclusion Criteria
See the full 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.

Where Is This Study? (6 UK sites)

St Bartholomew's Hospital

London EC1A 7BE, United Kingdom

Recruiting
Site contact (verified)
Marco Gerlinger, Site 0316020 7377 7000

Oxford University Hospitals NHS Trust

Oxford OX3 7LJ, United Kingdom

Recruiting
Site contact (verified)
Elizabeth Smyth, Site 0317+44 300 304 7777

The Royal Marsden NHS Foundation Trust - Royal Marsden Hospital (RMH) - Sutton

Sutton SM2 5PT, United Kingdom

Recruiting
Site contact (verified)
Elizabeth Cartwright, Site 0444020 7811 8460

Local Institution - 0354

Glasgow G12 0YN, United Kingdom

NOT_YET_RECRUITING

Royal Marsden Hospital

London SW3 6JJ, United Kingdom

Recruiting
Site contact (verified)
Elizabeth Cartwright, Site 0357020 7811 8460

The Christie NHS Foundation Trust

Manchester M20 4BX, United Kingdom

Recruiting
Site contact (verified)
Wasat Mansoor, Site 03310161 446 8217

How to Get in Touch

BMS Clinical Trials Contact Center www.BMSClinicalTrials.com

Sponsor contact

CONTACT

855-907-3286 Clinical.Trials@bms.com

First line of the email MUST contain NCT # and Site #.

Sponsor contact

CONTACT

Data sourced from ClinicalTrials.gov · Last verified: 2026-09