Taking people in CanadaPhase 2/3
Pumitamig with chemotherapy tested against nivolumab for stomach and esophageal cancer
Tests pumitamig with chemotherapy against nivolumab with chemotherapy in adults with untreated advanced stomach cancer.
Key facts
- Who runs it
- Bristol-Myers Squibb
- Where
- Calgary, Halifax, Sherbrooke, and Toronto, CanadaSee the 4 sitesAlso in 19 other countries, 158 sites
- Trial code
- NCT07221149
- EU 2025-523263-37-00
- U1111-1325-8116
- Registry title
- 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
- Recruiting
- Phase
- Phase 2/3
- People taking part
- 690 people, planned
- Started
- 13 Mar 2026
- Expected to end
- 11 Sept 2032
- Type of study
- Interventional, 4 groups
- Treatments tested
- Pumitamig
- Folfox
- Capox
- Nivolumab
- Record updated
- 5 November 2026
Who can take part
AI summary
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for adults with advanced or metastatic gastric, gastroesophageal junction or esophageal adenocarcinoma who have not yet had treatment for it.
- Age
- 18 years or older
- Sex
- Women and men can join.
- Disease stage
- Advanced or metastatic gastric cancer, gastroesophageal junction adenocarcinoma or distal esophageal adenocarcinoma, confirmed by tissue or cell tests. The disease must be measurable by RECIST v1.1.
- Earlier treatment
- No earlier systemic treatment for advanced or metastatic disease.
- Biomarker or test result
- HER2-negative cancer is required. A documented PD-L1 status is needed: ≥ 1 or < 1 for Phase 2, and ≥ 1 for Phase 3.
Main reasons for not taking part
- Untreated known brain or spinal cord (CNS) metastases
- Significant heart or blood vessel disease, such as a heart attack or stroke within 6 months, or uncontrolled high blood pressure
- Major bleeding or clotting disorders, or a significant blood clot within 3 months unless fully treated
- Abdominal fistula or gut perforation within 6 months
- Major surgery, open biopsy or significant injury within 28 days
The registry criteria, word for word
Show all 11 criteriaShow less
Who can take part
- 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
Who cannot take part
- 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 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
- Participants must not have evidence of major coagulation disorders (eg, hemophilia)
- Participants must not have a history of abdominal fistula or gastrointestinal (GI) perforation within 6 months of randomization
- 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 untreated known central nervous system (CNS) metastases
- Other protocol-defined Inclusion/Exclusion criteria apply
Where in Canada
Also in 19 other countries, 158 sites
- Arthur J.E. Child Comprehensive Cancer CentreCalgary, CanadaContact: Hatim Karachiwala, Site 0088Taking people
- Halifax, Nova ScotiaHospital not named in the registryContact: Site 0119Not yet recruiting
- Sherbrooke, QuebecHospital not named in the registryContact: Site 0175Not yet recruiting
- Princess Margaret Cancer CentreToronto, CanadaContact: Elena Elimova, Site 0121Taking people
About the trial
What the trial wants to find out
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
The 4 groups in the trial
- Arm A1Treatment being tested
Treatment: Pumitamig, Folfox, and Capox
- Arm A2Treatment being tested
Treatment: Pumitamig, Folfox, and Capox
- Arm CTreatment being tested
Treatment: Pumitamig, Folfox, and Capox
- Arm DTreatment being tested
Treatment: Folfox, Capox, and Nivolumab
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorData and sources
- Registry record
- Listed on ClinicalTrials.gov and on the EU's official list of trials (CTIS).
- Official title
- ROSETTA Gastric-204: A Blinded, Randomized, Phase 2/3 Study 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
- Plain-language title
- Pumitamig with chemotherapy tested against nivolumab for stomach and esophageal cancerGenerated from the registry record. The registry title is the official one.
- AI summary
- From the trial's eligibility criteria. Read by machine on 12 November 2026.
- Record updated
- 5 November 2026