RecruitingPhase 2Phase 3NCT07221149

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


Sponsor

Bristol-Myers Squibb

Enrollment

690 participants

Start Date

Mar 13, 2026

Study Type

INTERVENTIONAL

Conditions

Summary

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


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study (ROSETTA Gastric-204) is comparing a new immunotherapy drug called pumitamig against the standard immunotherapy nivolumab (Opdivo), both given alongside chemotherapy, as a first-line treatment for advanced stomach, gastroesophageal junction, or lower esophageal cancer. **You may be eligible if...** - You have advanced or metastatic stomach, gastroesophageal junction, or distal esophageal cancer (confirmed by biopsy) - You have not yet received any chemotherapy or other systemic treatment for the advanced/metastatic stage - Your tumor tests positive for a protein called PD-L1 (score of 1 or higher) - Your tumor is HER2-negative - You have measurable disease on imaging **You may NOT be eligible if...** - You have untreated brain metastases (cancer spread to the brain) - You have received prior systemic therapy for metastatic disease - You have certain autoimmune conditions or prior immune-related complications from cancer therapy Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGPumitamig

Specified dose on specified days

DRUGFolfox

Specified dose on specified days

DRUGCapox

Specified dose on specified days

DRUGNivolumab

Specified dose on specified days


Locations(163)

Local Institution - 0284

Phoenix, Arizona, United States

Local Institution - 0437

Los Angeles, California, United States

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

Orange, California, United States

Local Institution - 0428

San Francisco, California, United States

Florida Cancer Specialists - South

Fort Myers, Florida, United States

Local Institution - 0433

Jacksonville, Florida, United States

Florida Cancer Specialists - North

St. Petersburg, Florida, United States

Local Institution - 0246

Tampa, Florida, United States

Local Institution - 0377

Atlanta, Georgia, United States

Local Institution - 0379

Chicago, Illinois, United States

Local Institution - 0268

Iowa City, Iowa, United States

Local Institution - 0259

Rochester, Minnesota, United States

Missouri Cancer Associates

Columbia, Missouri, United States

Local Institution - 0286

Omaha, Nebraska, United States

Northwell Health/ RJ Zuckerberg Cancer Center

Lake Success, New York, United States

Memorial Sloan Kettering Cancer Center

New York, New York, United States

Local Institution - 0274

Rochester, New York, United States

Local Institution - 0245

Chapel Hill, North Carolina, United States

Local Institution - 0443

Cleveland, Ohio, United States

Local Institution - 0222

Cleveland, Ohio, United States

Oncology Associates Of Oregon, Pc

Eugene, Oregon, United States

Northwest Cancer Specialists, P.C.

Portland, Oregon, United States

Local Institution - 0407

Pittsburgh, Pennsylvania, United States

Local Institution - 0255

Nashville, Tennessee, United States

SCRI Oncology Partners

Nashville, Tennessee, United States

Texas Oncology - Amarillo Cancer Center

Amarillo, Texas, United States

Texas Oncology-Austin Central

Austin, Texas, United States

Texas Oncology

Beaumont, Texas, United States

Texas Oncology - Northeast Texas

Denison, Texas, United States

Texas Oncology - DFW

Grapevine, Texas, United States

Local Institution - 0233

Houston, Texas, United States

Texas Oncology - San Antonio

San Antonio, Texas, United States

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

Salem, Virginia, United States

Local Institution - 0271

Madison, Wisconsin, United States

Instituto Alexander Fleming

Ciudad Autónoma de Buenos Aires, Buenos Aires, Argentina

Hospital Italiano de Buenos Aires

ABB, Buenos Aires F.D., Argentina

Local Institution - 0069

Buenos Aires, Argentina

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

Buenos Aires, Argentina

Local Institution - 0176

Liverpool, New South Wales, Australia

Sunshine Coast University Hospital

Birtinya, Queensland, Australia

Lyell McEwin Hospital

Elizabeth Vale, South Australia, Australia

Monash Health

Clayton, Victoria, Australia

Warringal Medical Centre

Melbourne, Victoria, Australia

St. John of God Murdoch Hospital

Murdoch, Western Australia, Australia

Local Institution - 0208

Fortaleza, Ceará, Brazil

Local Institution - 0204

Belo Horizonte, Minas Gerais, Brazil

Local Institution - 0226

Natal/RN, Rio Grande do Norte, Brazil

Hospital de Clinicas de Porto Alegre

Porto Alegre, Rio Grande do Sul, Brazil

Clinica Viver

Santa Maria, Rio Grande do Sul, Brazil

Faculdade de Medicina de Sao Jose do Rio Preto

São José do Rio Preto, Brazil

Local Institution - 0088

Calgary, Alberta, Canada

Local Institution - 0119

Halifax, Nova Scotia, Canada

Local Institution - 0121

Toronto, Ontario, Canada

Local Institution - 0175

Sherbrooke, Quebec, Canada

Local Institution - 0068

Santiago, Santiago Metropolitan, Chile

Local Institution - 0056

Santiago, Santiago Metropolitan, Chile

Local Institution - 0055

Santiago, Santiago Metropolitan, Chile

Beijing Cancer hospital

Beijing, Beijing Municipality, China

Local Institution - 0276

Fuzhou, Fujian, China

Local Institution - 0232

Guangzhou, Guangdong, China

Local Institution - 0280

Guangzhou, Guangdong, China

Guangxi Medical University Affiliated Tumor Hospital

Nanning, Guangxi, China

Local Institution - 0237

Harbin, Heilongjiang, China

Local Institution - 0282

Weihui, Henan, China

Local Institution - 0249

Zhengzhou, Henan, China

Local Institution - 0279

Wuhan, Hubei, China

Local Institution - 0292

Changsha, Hunan, China

Local Institution - 0256

Nanjing, Jiangsu, China

Local Institution - 0440

Yangzhou, Jiangsu, China

Local Institution - 0409

Nanchang, Jiangxi, China

Local Institution - 0244

Shenyang, Liaoning, China

Local Institution - 0273

Jinan, Shandong, China

Local Institution - 0258

Shanghai, Shanghai Municipality, China

Local Institution - 0243

Taiyuan, Shanxi, China

Local Institution - 0260

Chengdu, Sichuan, China

Local Institution - 0248

Tianjin, Tianjin Municipality, China

Local Institution - 0408

Hangzhou, Zhejiang, China

Local Institution - 0252

Hangzhou, Zhejiang, China

Local Institution - 0269

Shanghai, China

Local Institution - 0399

Pasto, Departamento de Nariño, Colombia

Local Institution - 0398

Cali, Valle del Cauca Department, Colombia

Centre Leon Berard

Lyon Cedex08, Auvergne-Rhône-Alpes, France

CHRU de Brest

Brest, Finistère, France

Hopital Claude Huriez - CHU de Lille

Lille, Nord, France

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

Nantes, Pays de la Loire Region, France

Local Institution - 0046

Poitiers, Vienne, 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, Dādra and Nagar Haveli and Damān and Diu, India

Local Institution - 0305

Mumbai, Maharashtra, India

Local Institution - 0303

Delhi, India

Local Institution - 0403

Delhi, India

Local Institution - 0302

Puducherry, India

Local Institution - 0310

Pune, India

AOU della Campania Luigi Vanvitelli

Naples, Campania, Italy

Local Institution - 0166

Turin, Piedmont, Italy

Istituto Oncologico Veneto IRCCS

Padova, Veneto, Italy

Ospedale San Raffaele

Milan, Italy

Local Institution - 0163

Milan, Italy

Local Institution - 0170

Roma, Italy

Local Institution - 0014

Chiba, Chiba, Japan

National Cancer Center Hospital East

Kashiwa, Chiba, Japan

Local Institution - 0012

Matsuyama, Ehime, Japan

Local Institution - 0015

Yokohama, Kanagawa, Japan

Local Institution - 0029

Kurashiki, Okayama-ken, Japan

Local Institution - 0004

Osaka, Osaka, Japan

The University of Osaka Hospital

Suita, Osaka, Japan

Local Institution - 0376

Takatsuki, Osaka, Japan

Local Institution - 0026

Nagaizumi-cho,Sunto-gun, Shizuoka, Japan

National Cancer Center Hospital

Chuo-ku, Tokyo, Japan

The Cancer Institute Hospital of JFCR

Koto-ku, Tokyo, Japan

Local Institution - 0013

Chikusa-ku, Japan

Local Institution - 0006

Gifu, Japan

Local Institution - 0002

Minami-Ku, Fukuoka, Japan

Local Institution - 0024

Sendai, Japan

Local Institution - 0396

Mexico City, DIF, Mexico

Local Institution - 0395

Mexico City, Mexico City, Mexico

Local Institution - 0397

Mexico City, Mexico City, Mexico

Local Institution - 0394

Oaxaca City, Oaxaca, Mexico

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

Warsaw, Masovian Voivodeship, Poland

Local Institution - 0339

Wieliszew, Masovian Voivodeship, Poland

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

Opole, Opole Voivodeship, Poland

Local Institution - 0342

Gliwice, Silesian Voivodeship, Poland

Wojewódzkie Centrum Szpitalne Kotliny Jeleniogórskiej

Jelenia Góra, Poland

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

Cluj-Napoca, Cluj, Romania

SC Radiotherapy Center Cluj SRL

Florești, Cluj, Romania

Centrul de Oncologie "Sfântul Nectarie"

Craiova, Dolj, 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, Kyǒnggi-do, South Korea

Seoul National University Hospital

Seoul, Seoul-teukbyeolsi [Seoul], South Korea

Severance Hospital, Yonsei University Health System

Seoul, Seoul-teukbyeolsi [Seoul], South Korea

Asan Medical Center

Seoul, Seoul-teukbyeolsi [Seoul], South Korea

Samsung Medical Center

Seoul, Seoul-teukbyeolsi [Seoul], South Korea

Local Institution - 0388

Barcelona, Barcelona [Barcelona], Spain

Hospital Universitario Marqués de Valdecilla

Santander, Cantabria, Spain

Complejo Hospitalario de Navarra

Pamplona, Navarre, Spain

Local Institution - 0312

Valencia, Valenciana, Comunitat, Spain

Local Institution - 0389

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, London, City of, United Kingdom

Oxford University Hospitals NHS Trust

Oxford, Oxfordshire, United Kingdom

Local Institution - 0444

Sutton, Surrey, 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

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NCT07221149


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