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

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

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(160)

Local Institution - 0284

Phoenix, Arizona, United States

Local Institution - 0437

Los Angeles, California, United States

Local Institution - 0277

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

Local Institution - 0242

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 - 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

Local Institution - 0061

Ciudad Autónoma de Buenos Aires, Buenos Aires, Argentina

Local Institution - 0066

ABB, Buenos Aires F.D., Argentina

Local Institution - 0069

Buenos Aires, Argentina

Local Institution - 0054

Buenos Aires, Argentina

Local Institution - 0176

Liverpool, New South Wales, Australia

Local Institution - 0080

Birtinya, Queensland, Australia

Lyell McEwin Hospital

Elizabeth Vale, South Australia, Australia

Local Institution - 0085

Clayton, Victoria, Australia

Local Institution - 0400

Melbourne, Victoria, Australia

Local Institution - 0083

Perth, 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

Local Institution - 0210

Porto Alegre, Rio Grande do Sul, Brazil

Local Institution - 0425

Santa Maria, Rio Grande do Sul, Brazil

Local Institution - 0221

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

Local Institution - 0231

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 - 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

Local Institution - 0064

Brest, Finistère, France

Local Institution - 0062

Nantes, Pays de la Loire Region, France

Local Institution - 0051

Lille, France

Local Institution - 0058

Lyon, France

Local Institution - 0060

Marseille, France

Local Institution - 0049

Paris, France

Local Institution - 0046

Poitiers, France

Local Institution - 0089

Berlin, Germany

Local Institution - 0134

Frankfurt, Germany

Local Institution - 0090

Hamburg, Germany

Local Institution - 0100

Heidelberg, Germany

Local Institution - 0112

Leipzig, Germany

Local Institution - 0105

Mainz, Germany

Local Institution - 0101

Mannheim, Germany

Local Institution - 0117

Ulm, Germany

Local Institution - 0306

Nashik, Dādra and Nagar Haveli and Damān and Diu, India

Local Institution - 0305

Mumbai, Maharashtra, India

Local Institution - 0404

Mumbai, Maharashtra, India

Local Institution - 0303

Delhi, India

Local Institution - 0403

Delhi, India

Local Institution - 0302

Puducherry, India

Local Institution - 0310

Pune, India

Local Institution - 0167

Naples, Campania, Italy

Local Institution - 0166

Turin, Piedmont, Italy

Local Institution - 0171

Milan, Italy

Local Institution - 0163

Milan, Italy

Local Institution - 0168

Padova, Italy

Local Institution - 0170

Roma, Italy

Local Institution - 0014

Chiba, 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

Local Institution - 0008

Koto-ku, Tokyo, Japan

Local Institution - 0013

Chikusa-ku, Japan

Local Institution - 0006

Gifu, Japan

Local Institution - 0033

Kashiwa, 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

Local Institution - 0336

Jelenia Góra, Lower Silesian Voivodeship, Poland

Local Institution - 0339

Wieliszew, Masovian Voivodeship, Poland

Local Institution - 0342

Krakow, Poland

Local Institution - 0361

Krakow, Poland

Local Institution - 0320

Opole, Poland

Local Institution - 0010

Cluj-Napoca, Cluj, Romania

Local Institution - 0019

Cluj-Napoca, Romania

Local Institution - 0011

Craiova, Romania

Local Institution - 0030

Floresti/ Cluj, Romania

Local Institution - 0021

Iași, Romania

Local Institution - 0005

Iași, Romania

Local Institution - 0034

Seongnam, Kyǒnggi-do, South Korea

Local Institution - 0027

Seoul, Seoul Teugbyeolsi, South Korea

Severance Hospital, Yonsei University Health System

Seoul, Seoul-teukbyeolsi [Seoul], South Korea

Asan Medical Center

Seoul, Seoul-teukbyeolsi [Seoul], South Korea

Local Institution - 0001

Seoul, Seoul-teukbyeolsi [Seoul], South Korea

Local Institution - 0388

Barcelona, Barcelona [Barcelona], Spain

Local Institution - 0350

Santander, Cantabria, Spain

Local Institution - 0391

Pamplona, Navarre, Spain

Local Institution - 0312

Valencia, Valenciana, Comunitat, Spain

Local Institution - 0389

Madrid, Spain

Local Institution - 0358

Madrid, Spain

Local Institution - 0360

Madrid, Spain

Local Institution - 0390

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)

Local Institution - 0316

London, London, City of, United Kingdom

Local Institution - 0317

Oxford, Oxfordshire, United Kingdom

Local Institution - 0354

Glasgow, United Kingdom

The Christie NHS Foundation Trust

Manchester, United Kingdom

Local Institution - 0357

Sutton, United Kingdom

View Full Details on ClinicalTrials.gov

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NCT07221149