RecruitingPhase II/III🇵🇱 PolandEN originalGastric cancerHER2 positiveMetastatic / advanced

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)

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This is not medical advice. AI-assisted translation — inaccuracies may occur. Always verify the original and consult your oncologist before taking any steps.

About the 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

Original English text from ClinicalTrials.gov

Who can (and can't) join

✓ Qualifies

  • Wcześniej nieleczeni systemowo pacjenci z zaawansowanym lub przerzutowym rakiem żołądka, przełyku lub złączenia przełyku ze żołądkiem potwierdzonymi biopsją
  • Potwierdzony status markerów PD-L1 (≥1 lub <1 w fazie 2, ≥1 w fazie 3)
  • Potwierdzony brak receptora HER2 w komórkach rakowych
  • Mierzalna choroba według standardowych kryteriów oceny (RECIST v1.1)

✗ Disqualifies

  • Przerzuty do mózgu bez leczenia
  • Poważne choroby sercowo-naczyniowe (zawał serca, niestabilna dusznica, udar w ciągu 6 miesięcy) lub niekontrolowane wysokie ciśnienie krwi
  • Poważne zaburzenia krzepnięcia (np. hemofilия)
  • Przedziały lub zakrzepy krwi w ciągu 3 miesięcy przed włączeniem do badania
  • Otwarcia lub perforacje w przewodzie pokarmowym w ciągu 6 miesięcy
  • Duża operacja lub znaczny uraz w ciągu 28 dni przed włączeniem do badania

Simplified criteria — AI translation

Trial details

Minimum age
18 Years
Last updated (source)
July 20, 2026
Sex
No restrictions

Therapies / drugs in trial

Locations (161)

Local Institution - 0284

Phoenix, United States

Local Institution - 0437

Los Angeles, United States

University of California, Irvine (UCI) Health - UC Irvine Medical Center

Orange, United States

Local Institution - 0428

San Francisco, United States

Florida Cancer Specialists - South

Fort Myers, United States

Local Institution - 0433

Jacksonville, United States

Florida Cancer Specialists - North

St. Petersburg, United States

Local Institution - 0246

Tampa, United States

Emory University

Atlanta, United States

Local Institution - 0379

Chicago, United States

Local Institution - 0268

Iowa City, United States

Local Institution - 0259

Rochester, United States

Missouri Cancer Associates

Columbia, United States

Local Institution - 0286

Omaha, United States

Northwell Health/ RJ Zuckerberg Cancer Center

Lake Success, United States

Memorial Sloan Kettering Cancer Center

New York, United States

Local Institution - 0274

Rochester, United States

Local Institution - 0245

Chapel Hill, United States

Local Institution - 0443

Cleveland, United States

Local Institution - 0222

Cleveland, United States

Oncology Associates Of Oregon, Pc

Eugene, United States

Northwest Cancer Specialists, P.C.

Portland, United States

UPMC Hillman Cancer Center

Pittsburgh, United States

Local Institution - 0255

Nashville, United States

SCRI Oncology Partners

Nashville, United States

Texas Oncology - Amarillo Cancer Center

Amarillo, United States

Texas Oncology-Austin Central

Austin, United States

Texas Oncology

Beaumont, United States

Texas Oncology - Northeast Texas

Denison, United States

Texas Oncology - DFW

Grapevine, United States

Local Institution - 0233

Houston, United States

Texas Oncology - San Antonio

San Antonio, United States

Oncology and Hematology Associates of Southwest Virginia, Inc. - Salem

Salem, United States

University of Wisconsin Carbone Cancer Center - University Hospital

Madison, United States

Centro Médico Fleischer

Ciudad Autónoma de Buenos Aires, Argentina

Instituto Alexander Fleming

Ciudad Autónoma de Buenos Aires, Argentina

Hospital Italiano de Buenos Aires

ABB, Argentina

Centro de Educación Médica e Investigaciones clínicas "Dr. Norberto Quirno" (CEMIC)

Buenos Aires, Argentina

Local Institution - 0176

Liverpool, Australia

Sunshine Coast University Hospital

Birtinya, Australia

Lyell McEwin Hospital

Elizabeth Vale, Australia

Monash Health

Clayton, Australia

Warringal Medical Centre

Melbourne, Australia

St. John of God Murdoch Hospital

Murdoch, Australia

Núcleo de Oncologia e Hematologia do Ceará

Fortaleza, Brazil

Centro de Investigação Clínica Ciências Médicas

Belo Horizonte, Brazil

Liga Norte Riograndense Contra o Câncer

Natal, Brazil

Hospital de Clinicas de Porto Alegre

Porto Alegre, Brazil

Clinica Viver

Santa Maria, Brazil

Faculdade de Medicina de Sao Jose do Rio Preto

São José do Rio Preto, Brazil

Local Institution - 0088

Calgary, Canada

Local Institution - 0119

Halifax, Canada

Princess Margaret Cancer Centre

Toronto, Canada

Local Institution - 0175

Sherbrooke, Canada

Local Institution - 0068

Santiago, Chile

Local Institution - 0056

Santiago, Chile

Local Institution - 0055

Santiago, Chile

Beijing Cancer hospital

Beijing, China

Fujian Cancer Hospital

Fuzhou, China

Local Institution - 0232

Guangzhou, China

The Sixth Affiliated Hospital of Sun Yat-sen University

Guangzhou, China

Guangxi Medical University Affiliated Tumor Hospital

Nanning, China

Local Institution - 0237

Harbin, China

Local Institution - 0282

Weihui, China

Local Institution - 0249

Zhengzhou, China

Local Institution - 0279

Wuhan, China

Local Institution - 0292

Changsha, China

Local Institution - 0256

Nanjing, China

Local Institution - 0440

Yangzhou, China

Local Institution - 0409

Nanchang, China

Local Institution - 0244

Shenyang, China

Local Institution - 0273

Jinan, China

Shanghai East Hospital

Shanghai, China

Local Institution - 0243

Taiyuan, China

Local Institution - 0260

Chengdu, China

Local Institution - 0248

Tianjin, China

Local Institution - 0408

Hangzhou, China

Local Institution - 0252

Hangzhou, China

Local Institution - 0269

Shanghai, China

Local Institution - 0399

Pasto, Colombia

Local Institution - 0398

Cali, Colombia

Centre Leon Berard

Lyon Cedex08, France

CHRU de Brest

Brest, France

Hopital Claude Huriez - CHU de Lille

Lille, France

Centre Hospitalier Universitaire de Nantes - L' Hopital l'hôtel-Dieu

Nantes, France

Centre Hospitalier Universitaire de Poitiers

Poitiers, France

Local Institution - 0060

Marseille, France

Hôpital Européen Georges Pompidou

Paris, France

Charité - Universitaetsmedizin Berlin - Campus Bejnamin Franklin

Berlin, Germany

Krankenhaus Nordwest GmbH

Frankfurt, Germany

Facharztzentrum Eppendorf

Hamburg, Germany

Nationales Centrum Fur Tumorerkrankungen (Nct)

Heidelberg, Germany

Local Institution - 0112

Leipzig, Germany

Universitaetsmedizin der Johannes Gutenberg-Universitaet Mainz

Mainz, Germany

Universitätsmedizin Mannheim

Mannheim, Germany

Universitaetsklinikum Ulm

Ulm, Germany

Local Institution - 0306

Nashik, India

Local Institution - 0305

Mumbai, India

Local Institution - 0403

Delhi, India

Local Institution - 0302

Puducherry, India

Local Institution - 0310

Pune, India

AOU della Campania Luigi Vanvitelli

Naples, Italy

Local Institution - 0166

Turin, Italy

Istituto Oncologico Veneto IRCCS

Padova, Italy

Fondazione IRCCS Istituto Nazionale dei Tumori

Milan, Italy

Ospedale San Raffaele

Milan, Italy

Fondazione Policlinico Universitario Agostino Gemelli IRCCS - Università Cattolica del Sacro Cuore

Roma, Italy

Aichi Cancer Center Hospital

Nagoya, Japan

Local Institution - 0014

Chiba, Japan

National Cancer Center Hospital East

Kashiwa, Japan

Local Institution - 0012

Matsuyama, Japan

Local Institution - 0015

Yokohama, Japan

Local Institution - 0029

Kurashiki, Japan

Local Institution - 0004

Osaka, Japan

The University of Osaka Hospital

Suita, Japan

Local Institution - 0376

Takatsuki, Japan

Local Institution - 0026

Nagaizumi-cho,Sunto-gun, Japan

National Cancer Center Hospital

Chuo-ku, Japan

The Cancer Institute Hospital of JFCR

Koto-ku, Japan

Local Institution - 0006

Gifu, Japan

Local Institution - 0002

Minami-Ku, Fukuoka, Japan

Local Institution - 0024

Sendai, Japan

Local Institution - 0396

Mexico City, Mexico

Local Institution - 0395

Mexico City, Mexico

Local Institution - 0397

Mexico City, Mexico

Local Institution - 0394

Oaxaca City, Mexico

Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie - Panstwowy Instytut Badawczy w Warszawie

Warsaw, Poland

Mazowiecki Szpital Onkologiczny

Warsaw, Poland

SP ZOZ Opolskie Centrum Onkologii im. prof. Tadeusza Koszarowskiego w Opolu

Opole, Poland

Wojewódzkie Centrum Szpitalne Kotliny Jeleniogórskiej

Jelenia Góra, Poland

Institutul Regional de Gastroenterologie și Hepatologie Prof. Dr. Octavian Fodor

Cluj-Napoca, Romania

SC Radiotherapy Center Cluj SRL

Florești, Romania

Centrul de Oncologie "Sfântul Nectarie"

Craiova, Romania

Institutul Oncologic Cluj

Cluj-Napoca, Romania

S.C. Centrul de Oncologie Euroclinic S.R.L.

Iași, Romania

Institutul Regional de Oncologie

Iași, Romania

Seoul National University Bundang Hospital

Seongnam, South Korea

Seoul National University Hospital

Seoul, South Korea

Severance Hospital, Yonsei University Health System

Seoul, South Korea

Asan Medical Center

Seoul, South Korea

Samsung Medical Center

Seoul, South Korea

Local Institution - 0388

Barcelona, Spain

Hospital Universitario Marqués de Valdecilla

Santander, Spain

Complejo Hospitalario de Navarra

Pamplona, Spain

Hospital Clinico de Valencia

Valencia, Spain

Hospital General Universitario Gregorio Marañon

Madrid, Spain

Hospital Clinico San Carlos

Madrid, Spain

Hospital Universitario La Paz

Madrid, Spain

H.R.U Málaga - Hospital General

Málaga, Spain

Local Institution - 0111

Ankara, Turkey (Türkiye)

Local Institution - 0108

Edirne, Turkey (Türkiye)

Local Institution - 0125

Kadiköy/Istanbul, Turkey (Türkiye)

Local Institution - 0093

Manisa, Turkey (Türkiye)

Local Institution - 0128

Sakarya, Turkey (Türkiye)

St Bartholomew's Hospital

London, United Kingdom

Oxford University Hospitals NHS Trust

Oxford, United Kingdom

Local Institution - 0444

Sutton, United Kingdom

Local Institution - 0354

Glasgow, United Kingdom

The Christie NHS Foundation Trust

Manchester, United Kingdom

Local Institution - 0357

Sutton, United Kingdom

Local Institution - 0300

Trial contact

BMS Clinical Trials Contact Center www.BMSClinicalTrials.com

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

Contact information from ClinicalTrials.gov. Contact in English.

Share this trial

Data from ClinicalTrials.gov. AI-assisted translation, last sync: 7/21/2026.

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