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.
Plain-language title generated from the registry record
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)
Key facts
- Where
- Mexico City and Oaxaca City, MexicoSee the 4 sites
- Phase
- Phase 2/3
Where in Mexico
- Mexico CityMexico City, MexicoNot yet recruiting
- Mexico CityMexico City, MexicoNot yet recruiting
- Mexico CityMexico City, MexicoNot yet recruiting
- Oaxaca CityOaxaca City, MexicoNot yet recruiting
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?
Trial details
- Who runs it
- Bristol-Myers Squibb
- Trial code
- NCT07221149EU 2025-523263-37-00
- Record updated
- 5 November 2026
- Original description
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 adenocarcinomaRead full original descriptionShow less
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
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
Inclusion: 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: 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.