NCT07221149RecruitingPhase 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)
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
Source: ClinicalTrials.gov · Last updated 5 Nov 2026
Brief summary (registry, in English)
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
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 2/3
- Study type
- Interventional
- Enrollment
- 690 (estimated)
- First submitted
- 23 Oct 2025
- Start date
- 13 Mar 2026
- Primary completion date
- 8 Nov 2030
- Lead sponsor
- Bristol-Myers Squibb
- Diseases
- Gastric and esophageal cancer
- NCT number
- NCT07221149
- EU CT number
- 2025-523263-37-00
- EudraCT number
- 2025-523263-37
What you commit to
- Study type: Interventional · Phase 2/3
- Planned participants: 690
- From 13 Mar 2026 to the primary completion date, 8 Nov 2030
- 162 sites in 20 countries
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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.
Other illness
- 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.
Lab values
- 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.
Other
- Participants must not have untreated known central nervous system (CNS) metastases.
- Other protocol-defined Inclusion/Exclusion criteria apply.
Who the study is looking for
- 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.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (162)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Hospital Italiano de Buenos Aires Coordinator of this site? Confirm its status | ABB | Argentina | Recruiting |
| Centro de Educación Médica e Investigaciones clínicas "Dr. Norberto Quirno" (CEMIC) Coordinator of this site? Confirm its status | Buenos Aires | Argentina | Recruiting |
| Centro Médico Fleischer Coordinator of this site? Confirm its status | Ciudad Autónoma de Buenos Aires | Argentina | Recruiting |
| Instituto Alexander Fleming Coordinator of this site? Confirm its status | Ciudad Autónoma de Buenos Aires | Argentina | Recruiting |
| Sunshine Coast University Hospital Coordinator of this site? Confirm its status | Birtinya | Australia | Recruiting |
| Monash Health Coordinator of this site? Confirm its status | Clayton | Australia | Recruiting |
| Lyell McEwin Hospital Coordinator of this site? Confirm its status | Elizabeth Vale | Australia | Recruiting |
| Liverpool Hospital Coordinator of this site? Confirm its status | Liverpool | Australia | Recruiting |
| Warringal Medical Centre Coordinator of this site? Confirm its status | Melbourne | Australia | Recruiting |
| St John of God Murdoch Hospital Coordinator of this site? Confirm its status | Murdoch | Australia | Recruiting |
| Centro de Investigação Clínica Ciências Médicas Coordinator of this site? Confirm its status | Belo Horizonte | Brazil | Recruiting |
| Núcleo de Oncologia e Hematologia do Ceará Coordinator of this site? Confirm its status | Fortaleza | Brazil | Recruiting |
| Liga Norte Riograndense Contra o Cancer Coordinator of this site? Confirm its status | Natal | Brazil | Recruiting |
| Hospital de Clinicas de Porto Alegre Coordinator of this site? Confirm its status | Porto Alegre | Brazil | Recruiting |
| Clinica Viver Coordinator of this site? Confirm its status | Santa Maria | Brazil | Recruiting |
| Faculdade de Medicina de Sao Jose do Rio Preto Coordinator of this site? Confirm its status | São José do Rio Preto | Brazil | Recruiting |
| Arthur J.E. Child Comprehensive Cancer Centre Coordinator of this site? Confirm its status | Calgary | Canada | Recruiting |
| - Coordinator of this site? Confirm its status | Halifax | Canada | Not yet recruiting |
| - Coordinator of this site? Confirm its status | Sherbrooke | Canada | Not yet recruiting |
| Princess Margaret Cancer Centre Coordinator of this site? Confirm its status | Toronto | Canada | Recruiting |
| - Coordinator of this site? Confirm its status | Santiago | Chile | Not yet recruiting |
| - Coordinator of this site? Confirm its status | Santiago | Chile | Not yet recruiting |
| - Coordinator of this site? Confirm its status | Santiago | Chile | Not yet recruiting |
| Beijing Cancer Hospital Coordinator of this site? Confirm its status | Beijing | China | Recruiting |
| - Coordinator of this site? Confirm its status | Changsha | China | Not yet recruiting |
| - Coordinator of this site? Confirm its status | Chengdu | China | Not yet recruiting |
| Fujian Cancer Hospital Coordinator of this site? Confirm its status | Fuzhou | China | Recruiting |
| The Sixth Affiliated Hospital of Sun Yat-sen University Coordinator of this site? Confirm its status | Guangzhou | China | Recruiting |
| - Coordinator of this site? Confirm its status | Guangzhou | China | Not yet recruiting |
| - Coordinator of this site? Confirm its status | Hangzhou | China | Not yet recruiting |
| - Coordinator of this site? Confirm its status | Hangzhou | China | Not yet recruiting |
| - Coordinator of this site? Confirm its status | Harbin | China | Not yet recruiting |
| - Coordinator of this site? Confirm its status | Jinan | China | Not yet recruiting |
| - Coordinator of this site? Confirm its status | Nanchang | China | Not yet recruiting |
| - Coordinator of this site? Confirm its status | Nanjing | China | Not yet recruiting |
| Guangxi Medical University Affiliated Tumor Hospital Coordinator of this site? Confirm its status | Nanning | China | Recruiting |
| - Coordinator of this site? Confirm its status | Shanghai | China | Not yet recruiting |
| Shanghai East Hospital Coordinator of this site? Confirm its status | Shanghai | China | Recruiting |
| - Coordinator of this site? Confirm its status | Shenyang | China | Not yet recruiting |
| - Coordinator of this site? Confirm its status | Taiyuan | China | Not yet recruiting |
| - Coordinator of this site? Confirm its status | Tianjin | China | Not yet recruiting |
| - Coordinator of this site? Confirm its status | Weihui | China | Not yet recruiting |
| - Coordinator of this site? Confirm its status | Wuhan | China | Not yet recruiting |
| - Coordinator of this site? Confirm its status | Yangzhou | China | Not yet recruiting |
| - Coordinator of this site? Confirm its status | Zhengzhou | China | Not yet recruiting |
| - Coordinator of this site? Confirm its status | Cali | Colombia | Not yet recruiting |
| - Coordinator of this site? Confirm its status | Pasto | Colombia | Not yet recruiting |
| Charite Universitaetsmedizin Berlin KöR Coordinator of this site? Confirm its status | Berlin | Germany | Recruiting |
| Krankenhaus Nordwest GmbH Coordinator of this site? Confirm its status | Frankfurt am Main | Germany | Recruiting |
| Haematologisch Onkologische Praxis Eppendorf Coordinator of this site? Confirm its status | Hamburg | Germany | Recruiting |
| Universitaetsklinikum Heidelberg AöR Coordinator of this site? Confirm its status | Heidelberg | Germany | Recruiting |
| Universitaet Leipzig Coordinator of this site? Confirm its status | Leipzig | Germany | Recruiting |
| Universitaetsmedizin der Johannes Gutenberg-Universitaet Mainz KöR Coordinator of this site? Confirm its status | Mainz | Germany | Recruiting |
| Heidelberg University Coordinator of this site? Confirm its status | Mannheim | Germany | Recruiting |
| Universitaetsklinikum Ulm AoR Coordinator of this site? Confirm its status | Ulm | Germany | Recruiting |
| Hospital Universitari Vall d'Hebron Coordinator of this site? Confirm its status | Barcelona | Spain | Recruiting |
| Hospital Clínico San Carlos Coordinator of this site? Confirm its status | Madrid | Spain | Recruiting |
| Hospital Universitario La Paz Coordinator of this site? Confirm its status | Madrid | Spain | Recruiting |
| Hospital General Universitario Gregorio Marañón Coordinator of this site? Confirm its status | Madrid | Spain | Recruiting |
| Hospital Universitario Regional de Málaga Coordinator of this site? Confirm its status | Málaga | Spain | Recruiting |
| Hospital Universitario de Navarra Coordinator of this site? Confirm its status | Pamplona | Spain | Recruiting |
| Hospital Universitario Marqués de Valdecilla Coordinator of this site? Confirm its status | Santander | Spain | Recruiting |
| Hospital Clinico Universitario de Valencia Coordinator of this site? Confirm its status | Valencia | Spain | Recruiting |
| Centre Hospitalier Régional et Universitaire de Brest Coordinator of this site? Confirm its status | Brest | France | Recruiting |
| Centre Hospitalier Universitaire De Lille Coordinator of this site? Confirm its status | Lille Cedex | France | Recruiting |
| Centre Leon Berard Coordinator of this site? Confirm its status | Lyon | France | Recruiting |
| Centre Hospitalier Regional De Marseille Coordinator of this site? Confirm its status | Marseille | France | Recruiting |
| Centre Hospitalier Universitaire de Nantes Coordinator of this site? Confirm its status | Nantes | France | Recruiting |
| Assistance Publique Hopitaux de Paris Coordinator of this site? Confirm its status | Paris | France | Recruiting |
| Centre Hospitalier Universitaire de Poitiers Coordinator of this site? Confirm its status | Poitiers | France | Recruiting |
| - Coordinator of this site? Confirm its status | Glasgow | United Kingdom | Not yet recruiting |
| St. Bartholomew's Hospital Coordinator of this site? Confirm its status | London | United Kingdom | Recruiting |
| Royal Marsden Hospital Coordinator of this site? Confirm its status | London | United Kingdom | Recruiting |
| The Christie NHS Foundation Trust Coordinator of this site? Confirm its status | Manchester | United Kingdom | Recruiting |
| Oxford University Hospitals NHS Trust Coordinator of this site? Confirm its status | Oxford | United Kingdom | Recruiting |
| The Royal Marsden NHS Foundation Trust - Royal Marsden Hospital (RMH) - Sutton Coordinator of this site? Confirm its status | Sutton | United Kingdom | Recruiting |
| - Coordinator of this site? Confirm its status | Delhi | India | Not yet recruiting |
| - Coordinator of this site? Confirm its status | Mumbai | India | Not yet recruiting |
| - Coordinator of this site? Confirm its status | Nashik | India | Not yet recruiting |
| - Coordinator of this site? Confirm its status | Puducherry | India | Not yet recruiting |
| - Coordinator of this site? Confirm its status | Pune | India | Not yet recruiting |
| Fondazione IRCCS - Istituto Nazionale dei Tumori Coordinator of this site? Confirm its status | Milan | Italy | Recruiting |
| Ospedale San Raffaele S.r.l. Coordinator of this site? Confirm its status | Milan | Italy | Recruiting |
| Azienda Ospedaliera Universitaria - Universita degli Studi della Campania Luigi Vanvitelli Coordinator of this site? Confirm its status | Naples | Italy | Recruiting |
| Istituto Oncologico Veneto Coordinator of this site? Confirm its status | Padova | Italy | Recruiting |
| Fondazione Policlinico Universitario Agostino Gemelli IRCCS Coordinator of this site? Confirm its status | Rome | Italy | Recruiting |
| Azienda Ospedaliera Universitaria Citta Della Salute E Della Scienza Di Torino Coordinator of this site? Confirm its status | Turin | Italy | Recruiting |
| - Coordinator of this site? Confirm its status | Chiba | Japan | Not yet recruiting |
| National Cancer Center Hospital Coordinator of this site? Confirm its status | Chuo Ku | Japan | Recruiting |
| Gifu University Hospital Coordinator of this site? Confirm its status | Gifu | Japan | Recruiting |
| National Cancer Center Hospital East Coordinator of this site? Confirm its status | Kashiwa | Japan | Recruiting |
| The Cancer Institute Hospital of JFCR Coordinator of this site? Confirm its status | Koto-ku | Japan | Recruiting |
| - Coordinator of this site? Confirm its status | Kurashiki | Japan | Not yet recruiting |
| - Coordinator of this site? Confirm its status | Matsuyama | Japan | Not yet recruiting |
| - Coordinator of this site? Confirm its status | Minami-Ku, Fukuoka | Japan | Not yet recruiting |
| Shizuoka Cancer Center Coordinator of this site? Confirm its status | Nagaizumi-cho,Sunto-gun | Japan | Recruiting |
| Aichi Cancer Center Hospital Coordinator of this site? Confirm its status | Nagoya | Japan | Recruiting |
| - Coordinator of this site? Confirm its status | Osaka | Japan | Not yet recruiting |
| - Coordinator of this site? Confirm its status | Sendai | Japan | Not yet recruiting |
| The University of Osaka Hospital Coordinator of this site? Confirm its status | Suita | Japan | Recruiting |
| - Coordinator of this site? Confirm its status | Takatsuki | Japan | Not yet recruiting |
| Kanagawa Cancer Center Coordinator of this site? Confirm its status | Yokohama | Japan | Recruiting |
| Seoul National University Bundang Hospital Coordinator of this site? Confirm its status | Seongnam | South Korea | Recruiting |
| Asan Medical Center Coordinator of this site? Confirm its status | Seoul | South Korea | Recruiting |
| Severance Hospital, Yonsei University Health System Coordinator of this site? Confirm its status | Seoul | South Korea | Recruiting |
| Seoul National University Hospital Coordinator of this site? Confirm its status | Seoul | South Korea | Recruiting |
| Samsung Medical Center Coordinator of this site? Confirm its status | Seoul | South Korea | Recruiting |
| - Coordinator of this site? Confirm its status | Mexico City | Mexico | Not yet recruiting |
| - Coordinator of this site? Confirm its status | Mexico City | Mexico | Not yet recruiting |
| - Coordinator of this site? Confirm its status | Mexico City | Mexico | Not yet recruiting |
| - Coordinator of this site? Confirm its status | Oaxaca City | Mexico | Not yet recruiting |
| Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie Panstwowy Instytut Badawczy Coordinator of this site? Confirm its status | Gliwice | Poland | Recruiting |
| Wojewódzkie Centrum Szpitalne Kotliny Jeleniogórskiej Coordinator of this site? Confirm its status | Jelenia Góra | Poland | Recruiting |
| Opolskie Centrum Onkologii Im. Prof. Tadeusza Koszarowskiego W Opolu Samodzielny Publiczny Zaklad Opieki Zdrowotnej Coordinator of this site? Confirm its status | Opole | Poland | Recruiting |
| Narodowy Instytut Onkologii im Marii Sklodowskiej Curie Panstwowy Instytut Badawczy Coordinator of this site? Confirm its status | Warsaw | Poland | Recruiting |
| Mazowiecki Szpital Onkologiczny Sp. z o.o. Coordinator of this site? Confirm its status | Wieliszew | Poland | Recruiting |
| Institute Of Oncology Prof. Dr. Ion Chiricuta Cluj-Napoca Coordinator of this site? Confirm its status | Cluj-Napoca | Romania | Recruiting |
| Institutul Regional De Gastroenterologie Hepatologie Prof. Dr. Octavian Fodor Cluj Coordinator of this site? Confirm its status | Cluj-Napoca | Romania | Recruiting |
| Centrul De Oncologie SF Nectarie S.R.L. Coordinator of this site? Confirm its status | Craiova | Romania | Recruiting |
| Radiotherapy Center Cluj S.R.L. Coordinator of this site? Confirm its status | Floresti | Romania | Recruiting |
| Centrul De Oncologie-Euroclinic S.R.L. Coordinator of this site? Confirm its status | Iasi | Romania | Recruiting |
| Institutul Regional de Oncologie Iasi Coordinator of this site? Confirm its status | Iași | Romania | Recruiting |
| Texas Oncology - Amarillo Cancer Center Coordinator of this site? Confirm its status | Amarillo | United States | Recruiting |
| Emory University Coordinator of this site? Confirm its status | Atlanta | United States | Recruiting |
| Texas Oncology - Austin Central Coordinator of this site? Confirm its status | Austin | United States | Recruiting |
| Texas Oncology Coordinator of this site? Confirm its status | Beaumont | United States | Recruiting |
| University of North Carolina Medical Center Coordinator of this site? Confirm its status | Chapel Hill | United States | Recruiting |
| - Coordinator of this site? Confirm its status | Chicago | United States | Not yet recruiting |
| Cleveland Clinic Coordinator of this site? Confirm its status | Cleveland | United States | Recruiting |
| - Coordinator of this site? Confirm its status | Cleveland | United States | Not yet recruiting |
| Missouri Cancer Associates Coordinator of this site? Confirm its status | Columbia | United States | Recruiting |
| Texas Oncology - Northeast Texas Coordinator of this site? Confirm its status | Denison | United States | Recruiting |
| Oncology Associates Of Oregon, Pc Coordinator of this site? Confirm its status | Eugene | United States | Recruiting |
| Florida Cancer Specialists - South Coordinator of this site? Confirm its status | Fort Myers | United States | Recruiting |
| Texas Oncology - DFW Coordinator of this site? Confirm its status | Grapevine | United States | Recruiting |
| University of Texas - MD Anderson Cancer Center Coordinator of this site? Confirm its status | Houston | United States | Recruiting |
| - Coordinator of this site? Confirm its status | Iowa City | United States | Not yet recruiting |
| Mayo Clinic in Florida Coordinator of this site? Confirm its status | Jacksonville | United States | Recruiting |
| Northwell Health/ RJ Zuckerberg Cancer Center Coordinator of this site? Confirm its status | Lake Success | United States | Recruiting |
| USC / Norris Comprehensive Cancer Center Coordinator of this site? Confirm its status | Los Angeles | United States | Recruiting |
| University of Wisconsin Carbone Cancer Center - University Hospital Coordinator of this site? Confirm its status | Madison | United States | Recruiting |
| Tennessee Oncology Coordinator of this site? Confirm its status | Nashville | United States | Recruiting |
| SCRI Oncology Partners Coordinator of this site? Confirm its status | Nashville | United States | Recruiting |
| Memorial Sloan-Kettering Cancer Center Coordinator of this site? Confirm its status | New York | United States | Recruiting |
| University of Nebraska Medical Center Coordinator of this site? Confirm its status | Omaha | United States | Recruiting |
| University of California, Irvine (UCI) Health - UC Irvine Medical Center Coordinator of this site? Confirm its status | Orange | United States | Recruiting |
| Mayo Clinic in Arizona - Phoenix Coordinator of this site? Confirm its status | Phoenix | United States | Recruiting |
| UPMC Hillman Cancer Center Coordinator of this site? Confirm its status | Pittsburgh | United States | Recruiting |
| Northwest Cancer Specialists, P.C. Coordinator of this site? Confirm its status | Portland | United States | Recruiting |
| - Coordinator of this site? Confirm its status | Rochester | United States | Not yet recruiting |
| Mayo Clinic in Rochester, Minnesota Coordinator of this site? Confirm its status | Rochester | United States | Recruiting |
| Oncology and Hematology Associates of Southwest Virginia, Inc. - Salem Coordinator of this site? Confirm its status | Salem | United States | Recruiting |
| Texas Oncology - San Antonio Coordinator of this site? Confirm its status | San Antonio | United States | Recruiting |
| - Coordinator of this site? Confirm its status | San Francisco | United States | Not yet recruiting |
| Florida Cancer Specialists - North Coordinator of this site? Confirm its status | St. Petersburg | United States | Recruiting |
| Moffitt Cancer Center Coordinator of this site? Confirm its status | Tampa | United States | Recruiting |
| - Coordinator of this site? Confirm its status | Ankara | Turkey (Türkiye) | Not yet recruiting |
| - Coordinator of this site? Confirm its status | Edirne | Turkey (Türkiye) | Not yet recruiting |
| - Coordinator of this site? Confirm its status | Kadiköy/Istanbul | Turkey (Türkiye) | Not yet recruiting |
| - Coordinator of this site? Confirm its status | Manisa | Turkey (Türkiye) | Not yet recruiting |
| - Coordinator of this site? Confirm its status | Sakarya | Turkey (Türkiye) | Not yet recruiting |
| - Coordinator of this site? Confirm its status | - | - | Not yet recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.