NCT07221149PHASE2, PHASE3Recruiting

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)

Bristol-Myers Squibb

Start Date

3/13/2026

Completion Date

9/11/2032

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 Criteria

Age Range: 18 years to No maximum

Inclusion Criteria * 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 Criteria * Participants must not have untreated known central nervous system (CNS) metastases. * 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 evidence of major coagulation disorders (eg, hemophilia). * 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 a history of abdominal fistula or gastrointestinal (GI) perforation within 6 months of randomization. * 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 protocol-defined Inclusion/Exclusion criteria apply.

Interventions

DRUG

Pumitamig

DRUG

Folfox

DRUG

Capox

DRUG

Nivolumab

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Conditions

Untreated Advanced or Metastatic Gastric, Gastroesophageal Junction, or Esophageal Adenocarcinoma

Locations

Local Institution - 0284

Phoenix, Arizona 85054

United States

Local Institution - 0437

Los Angeles, California 90033

United States

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

Orange, California 92868

United States

Local Institution - 0428

San Francisco, California 94158

United States

Florida Cancer Specialists - South

Fort Myers, Florida 33901

United States

Local Institution - 0433

Jacksonville, Florida 32224

United States

Florida Cancer Specialists - North

St. Petersburg, Florida 33701

United States

Local Institution - 0246

Tampa, Florida 33612

United States

Emory University

Atlanta, Georgia 30308

United States

Local Institution - 0379

Chicago, Illinois 60637

United States

Local Institution - 0268

Iowa City, Iowa 52242

United States

Local Institution - 0259

Rochester, Minnesota 55905

United States

Missouri Cancer Associates

Columbia, Missouri 65201

United States

Local Institution - 0286

Omaha, Nebraska 68198

United States

Northwell Health/ RJ Zuckerberg Cancer Center

Lake Success, New York 11042

United States

Memorial Sloan Kettering Cancer Center

New York, New York 10065

United States

Local Institution - 0274

Rochester, New York 14642

United States

Local Institution - 0245

Chapel Hill, North Carolina 27599

United States

Local Institution - 0443

Cleveland, Ohio 44106

United States

Local Institution - 0222

Cleveland, Ohio 44195

United States

Oncology Associates Of Oregon, Pc

Eugene, Oregon 97401

United States

Northwest Cancer Specialists, P.C.

Portland, Oregon 97213-2982

United States

UPMC Hillman Cancer Center

Pittsburgh, Pennsylvania 15232

United States

Local Institution - 0255

Nashville, Tennessee 37203

United States

SCRI Oncology Partners

Nashville, Tennessee 37203

United States

Texas Oncology - Amarillo Cancer Center

Amarillo, Texas 79124

United States

Texas Oncology-Austin Central

Austin, Texas 78731

United States

Texas Oncology

Beaumont, Texas 77702

United States

Texas Oncology - Northeast Texas

Denison, Texas 75020

United States

Texas Oncology - DFW

Grapevine, Texas 76051

United States

Local Institution - 0233

Houston, Texas 77030

United States

Texas Oncology - San Antonio

San Antonio, Texas 78240

United States

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

Salem, Virginia 24153

United States

University of Wisconsin Carbone Cancer Center - University Hospital

Madison, Wisconsin 53792

United States

Centro Médico Fleischer

Ciudad Autónoma de Buenos Aires, Buenos Aires C1414

Argentina

Instituto Alexander Fleming

Ciudad Autónoma de Buenos Aires, Buenos Aires C1426ANZ

Argentina

Hospital Italiano de Buenos Aires

ABB, Buenos Aires F.D. C1199ABB

Argentina

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

Buenos Aires, C1431FWO

Argentina

Local Institution - 0176

Liverpool, New South Wales 2170

Australia

Sunshine Coast University Hospital

Birtinya, Queensland 4575

Australia

Lyell McEwin Hospital

Elizabeth Vale, South Australia 5112

Australia

Monash Health

Clayton, Victoria 3168

Australia

Warringal Medical Centre

Melbourne, Victoria 3084

Australia

St. John of God Murdoch Hospital

Murdoch, Western Australia 6150

Australia

Núcleo de Oncologia e Hematologia do Ceará

Fortaleza, Ceará 60115-281

Brazil

Centro de Investigação Clínica Ciências Médicas

Belo Horizonte, Minas Gerais 30140-085

Brazil

Liga Norte Riograndense Contra o Câncer

Natal, Rio Grande do Norte 59062-000

Brazil

Hospital de Clinicas de Porto Alegre

Porto Alegre, Rio Grande do Sul 90035-903

Brazil

Clinica Viver

Santa Maria, Rio Grande do Sul 97015-373

Brazil

Faculdade de Medicina de Sao Jose do Rio Preto

São José do Rio Preto, 15090-000

Brazil

Local Institution - 0088

Calgary, Alberta T2N 5G2

Canada

Local Institution - 0119

Halifax, Nova Scotia B3H 3A7

Canada

Princess Margaret Cancer Centre

Toronto, Ontario M5G 2M9

Canada

Local Institution - 0175

Sherbrooke, Quebec J1H 5N4

Canada

Local Institution - 0068

Santiago, Santiago Metropolitan 7500921

Chile

Local Institution - 0056

Santiago, Santiago Metropolitan 7710007

Chile

Local Institution - 0055

Santiago, Santiago Metropolitan 8420383

Chile

Beijing Cancer hospital

Beijing, Beijing Municipality 100142

China

Fujian Cancer Hospital

Fuzhou, Fujian 350014

China

Local Institution - 0232

Guangzhou, Guangdong 510000

China

The Sixth Affiliated Hospital of Sun Yat-sen University

Guangzhou, Guangdong 510655

China

Guangxi Medical University Affiliated Tumor Hospital

Nanning, Guangxi 530200

China

Local Institution - 0237

Harbin, Heilongjiang 150081

China

Local Institution - 0282

Weihui, Henan 453100

China

Local Institution - 0249

Zhengzhou, Henan 450008

China

Local Institution - 0279

Wuhan, Hubei 430079

China

Local Institution - 0292

Changsha, Hunan 410031

China

Local Institution - 0256

Nanjing, Jiangsu 210009

China

Local Institution - 0440

Yangzhou, Jiangsu 225001

China

Local Institution - 0409

Nanchang, Jiangxi 330006

China

Local Institution - 0244

Shenyang, Liaoning 110042

China

Local Institution - 0273

Jinan, Shandong 250117

China

Shanghai East Hospital

Shanghai, Shanghai Municipality 200120

China

Local Institution - 0243

Taiyuan, Shanxi 030001

China

Local Institution - 0260

Chengdu, Sichuan 610041

China

Local Institution - 0248

Tianjin, Tianjin Municipality 300060

China

Local Institution - 0408

Hangzhou, Zhejiang 310003

China

Local Institution - 0252

Hangzhou, Zhejiang 310052

China

Local Institution - 0269

Shanghai, 200032

China

Local Institution - 0399

Pasto, Departamento de Nariño 520001

Colombia

Local Institution - 0398

Cali, Valle del Cauca Department 760032

Colombia

Centre Leon Berard

Lyon Cedex08, Auvergne-Rhône-Alpes 69373

France

CHRU de Brest

Brest, Finistère 29609

France

Hopital Claude Huriez - CHU de Lille

Lille, Nord 59000

France

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

Nantes, Pays de la Loire Region 44093

France

Centre Hospitalier Universitaire de Poitiers

Poitiers, Vienne 86021

France

Local Institution - 0060

Marseille, 13385

France

Hôpital Européen Georges Pompidou

Paris, 75015

France

Charité - Universitaetsmedizin Berlin - Campus Bejnamin Franklin

Berlin, 10117

Germany

Krankenhaus Nordwest GmbH

Frankfurt, 60488

Germany

Facharztzentrum Eppendorf

Hamburg, 20249

Germany

Nationales Centrum Fur Tumorerkrankungen (Nct)

Heidelberg, 69120

Germany

Local Institution - 0112

Leipzig, 04103

Germany

Universitaetsmedizin der Johannes Gutenberg-Universitaet Mainz

Mainz, 55131

Germany

Universitätsmedizin Mannheim

Mannheim, 68167

Germany

Universitaetsklinikum Ulm

Ulm, 89081

Germany

Local Institution - 0306

Nashik, Dādra and Nagar Haveli and Damān and Diu 422001

India

Local Institution - 0305

Mumbai, Maharashtra 400012

India

Local Institution - 0403

Delhi, 110029

India

Local Institution - 0302

Puducherry, 605006

India

Local Institution - 0310

Pune, 411001

India

AOU della Campania Luigi Vanvitelli

Naples, Campania 80138

Italy

Local Institution - 0166

Turin, Piedmont 10126

Italy

Istituto Oncologico Veneto IRCCS

Padova, Veneto 35128

Italy

Fondazione IRCCS Istituto Nazionale dei Tumori

Milan, 20133

Italy

Ospedale San Raffaele

Milan, 20132

Italy

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

Roma, 00168

Italy

Aichi Cancer Center Hospital

Nagoya, Aichi-ken 464-8681

Japan

Local Institution - 0014

Chiba, Chiba 260-8717

Japan

National Cancer Center Hospital East

Kashiwa, Chiba 277-8577

Japan

Local Institution - 0012

Matsuyama, Ehime 791-0280

Japan

Local Institution - 0015

Yokohama, Kanagawa 2418515

Japan

Local Institution - 0029

Kurashiki, Okayama-ken 710-8602

Japan

Local Institution - 0004

Osaka, Osaka 5418567

Japan

The University of Osaka Hospital

Suita, Osaka 565-0871

Japan

Local Institution - 0376

Takatsuki, Osaka 569-8686

Japan

Local Institution - 0026

Nagaizumi-cho,Sunto-gun, Shizuoka 411-8777

Japan

National Cancer Center Hospital

Chuo-ku, Tokyo 104-0045

Japan

The Cancer Institute Hospital of JFCR

Koto-ku, Tokyo 135-8550

Japan

Local Institution - 0006

Gifu, 501-1194

Japan

Local Institution - 0002

Minami-Ku, Fukuoka, 811-1347

Japan

Local Institution - 0024

Sendai, 980-8574

Japan

Local Institution - 0396

Mexico City, DIF 03100

Mexico

Local Institution - 0395

Mexico City, Mexico City 14000

Mexico

Local Institution - 0397

Mexico City, Mexico City 14000

Mexico

Local Institution - 0394

Oaxaca City, Oaxaca 68020

Mexico

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

Warsaw, Masovian Voivodeship 02-034

Poland

Mazowiecki Szpital Onkologiczny

Warsaw, Masovian Voivodeship 03-411

Poland

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

Opole, Opole Voivodeship 45-061

Poland

Wojewódzkie Centrum Szpitalne Kotliny Jeleniogórskiej

Jelenia Góra, 58-506

Poland

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

Cluj-Napoca, Cluj 400162

Romania

SC Radiotherapy Center Cluj SRL

Florești, Cluj 407280

Romania

Centrul de Oncologie "Sfântul Nectarie"

Craiova, Dolj 200542

Romania

Institutul Oncologic Cluj

Cluj-Napoca, 400015

Romania

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

Iași, 700106

Romania

Institutul Regional de Oncologie

Iași, 700483

Romania

Seoul National University Bundang Hospital

Seongnam, Kyǒnggi-do 13620

South Korea

Seoul National University Hospital

Seoul, Seoul-teukbyeolsi [Seoul] 03080

South Korea

Severance Hospital, Yonsei University Health System

Seoul, Seoul-teukbyeolsi [Seoul] 03722

South Korea

Asan Medical Center

Seoul, Seoul-teukbyeolsi [Seoul] 05505

South Korea

Samsung Medical Center

Seoul, Seoul-teukbyeolsi [Seoul] 06351

South Korea

Local Institution - 0388

Barcelona, Barcelona [Barcelona] 08035

Spain

Hospital Universitario Marqués de Valdecilla

Santander, Cantabria 39008

Spain

Complejo Hospitalario de Navarra

Pamplona, Navarre 31009

Spain

Hospital Clinico de Valencia

Valencia, Valenciana, Comunitat 46010

Spain

Hospital General Universitario Gregorio Marañon

Madrid, 28007

Spain

Hospital Clinico San Carlos

Madrid, 28040

Spain

Hospital Universitario La Paz

Madrid, 28046

Spain

H.R.U Málaga - Hospital General

Málaga, 29011

Spain

Local Institution - 0111

Ankara, 06230

Turkey (Türkiye)

Local Institution - 0108

Edirne, 22030

Turkey (Türkiye)

Local Institution - 0125

Kadiköy/Istanbul, 41380

Turkey (Türkiye)

Local Institution - 0093

Manisa, 45030

Turkey (Türkiye)

Local Institution - 0128

Sakarya, 54100

Turkey (Türkiye)

St Bartholomew's Hospital

London, London, City of EC1A 7BE

United Kingdom

Oxford University Hospitals NHS Trust

Oxford, Oxfordshire OX3 7LJ

United Kingdom

Local Institution - 0444

Sutton, Surrey SM2 5PT

United Kingdom

Local Institution - 0354

Glasgow, G12 0YN

United Kingdom

The Christie NHS Foundation Trust

Manchester, M20 4BX

United Kingdom

Local Institution - 0357

Sutton, SM2 5PT

United Kingdom