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)

NCT07221149 | Recruiting Phase 2 DMC FDA Drug

• 3 other identifiers: CA266-00042025-523263-37U1111-1325-8116
• Study Type: interventional
• Target: 690
• Locations: 20 countries
• Sites: 162

Brief 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

Conditions

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

Keywords

Gastric Cancer; Gastroesophageal Junction Cancer; Esophageal Adenocarcinoma

Outcome Measures

Primary Outcomes (3)

• Objective Response (OR) (confirmed complete response (CR) or partial response (PR)) by Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 per investigator assessment

  Phase 2

  Up to 2 years after the last participant is randomized

• Progression Free Survival (PFS) by RECIST v1.1 per blinded independent central review (BICR)

  Phase 3

  Up to approximately 33 months

• Overall survival (OS)

  Phase 3

  Up to approximately 47 months

Secondary Outcomes (7)

• PFS by RECIST v1.1 per investigator assessment

  Up to approximately 33 months

• Duration of Response (DOR) (CR or PR) by RECIST v1.1 per investigator assessment

  Up to approximately 33 months

• Time to Response (TTR) (CR or PR) by RECIST v1.1 per investigator assessment

  Up to approximately 33 months

• Disease control (Best Overall Response (BOR) of confirmed CR, confirmed PR, or Stable Disease (SD)) by RECIST v1.1 per investigator assessment

  Up to approximately 33 months

• Recommended dose of Pumitamig for Phase 3

  Up to approximately 33 months

Study Arms (4)

Arm A1

EXPERIMENTAL

Drug: Pumitamig; Drug: Folfox; Drug: Capox

Arm A2

EXPERIMENTAL

Drug: Pumitamig; Drug: Folfox; Drug: Capox

Arm C

EXPERIMENTAL

Drug: Pumitamig; Drug: Folfox; Drug: Capox

Arm D

EXPERIMENTAL

Drug: Folfox; Drug: Capox; Drug: Nivolumab

Interventions

Capox DRUG

Specified dose on specified days

Arm A1; Arm A2; Arm C; Arm D

Nivolumab DRUG

Specified dose on specified days

Arm D

Pumitamig DRUG

Specified dose on specified days

Also known as: BMS-986545, BNT327, PM8002

Arm A1; Arm A2; Arm C

Folfox DRUG

Specified dose on specified days

Arm A1; Arm A2; Arm C; Arm D

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Bristol-Myers Squibb: lead
• BioNTech SE: collaborator

Study Sites (163)

Local Institution - 0284

Phoenix, Arizona, 85054, United States

NOT YET RECRUITING

Local Institution - 0437

Los Angeles, California, 90033, United States

NOT YET RECRUITING

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

Orange, California, 92868, United States

RECRUITING

Local Institution - 0428

San Francisco, California, 94158, United States

NOT YET RECRUITING

Florida Cancer Specialists - South

Fort Myers, Florida, 33901, United States

RECRUITING

Local Institution - 0433

Jacksonville, Florida, 32224, United States

NOT YET RECRUITING

Florida Cancer Specialists - North

St. Petersburg, Florida, 33701, United States

RECRUITING

Local Institution - 0246

Tampa, Florida, 33612, United States

NOT YET RECRUITING

Local Institution - 0377

Atlanta, Georgia, 30308, United States

NOT YET RECRUITING

Local Institution - 0379

Chicago, Illinois, 60637, United States

NOT YET RECRUITING

Local Institution - 0268

Iowa City, Iowa, 52242, United States

NOT YET RECRUITING

Local Institution - 0259

Rochester, Minnesota, 55905, United States

NOT YET RECRUITING

Missouri Cancer Associates

Columbia, Missouri, 65201, United States

RECRUITING

Local Institution - 0286

Omaha, Nebraska, 68198, United States

NOT YET RECRUITING

Northwell Health/ RJ Zuckerberg Cancer Center

Lake Success, New York, 11042, United States

RECRUITING

Memorial Sloan Kettering Cancer Center

New York, New York, 10065, United States

RECRUITING

Local Institution - 0274

Rochester, New York, 14642, United States

NOT YET RECRUITING

Local Institution - 0245

Chapel Hill, North Carolina, 27599, United States

NOT YET RECRUITING

Local Institution - 0443

Cleveland, Ohio, 44106, United States

NOT YET RECRUITING

Local Institution - 0222

Cleveland, Ohio, 44195, United States

NOT YET RECRUITING

Oncology Associates Of Oregon, Pc

Eugene, Oregon, 97401, United States

RECRUITING

Northwest Cancer Specialists, P.C.

Portland, Oregon, 97213-2982, United States

RECRUITING

Local Institution - 0407

Pittsburgh, Pennsylvania, 15213, United States

NOT YET RECRUITING

Local Institution - 0255

Nashville, Tennessee, 37203, United States

NOT YET RECRUITING

SCRI Oncology Partners

Nashville, Tennessee, 37203, United States

RECRUITING

Texas Oncology - Amarillo Cancer Center

Amarillo, Texas, 79124, United States

RECRUITING

Texas Oncology-Austin Central

Austin, Texas, 78731, United States

RECRUITING

Texas Oncology

Beaumont, Texas, 77702, United States

RECRUITING

Texas Oncology - Northeast Texas

Denison, Texas, 75020, United States

RECRUITING

Texas Oncology - DFW

Grapevine, Texas, 76051, United States

RECRUITING

Local Institution - 0233

Houston, Texas, 77030, United States

NOT YET RECRUITING

Texas Oncology - San Antonio

San Antonio, Texas, 78240, United States

RECRUITING

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

Salem, Virginia, 24153, United States

RECRUITING

Local Institution - 0271

Madison, Wisconsin, 53792, United States

NOT YET RECRUITING

Instituto Alexander Fleming

Ciudad Autónoma de Buenos Aires, Buenos Aires, C1426ANZ, Argentina

RECRUITING

Hospital Italiano de Buenos Aires

ABB, Buenos Aires F.D., C1199ABB, Argentina

RECRUITING

Local Institution - 0069

Buenos Aires, 1039, Argentina

NOT YET RECRUITING

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

Buenos Aires, C1431FWO, Argentina

RECRUITING

Local Institution - 0176

Liverpool, New South Wales, 2170, Australia

NOT YET RECRUITING

Sunshine Coast University Hospital

Birtinya, Queensland, 4575, Australia

RECRUITING

Lyell McEwin Hospital

Elizabeth Vale, South Australia, 5112, Australia

RECRUITING

Monash Health

Clayton, Victoria, 3168, Australia

RECRUITING

Warringal Medical Centre

Melbourne, Victoria, 3084, Australia

RECRUITING

St. John of God Murdoch Hospital

Murdoch, Western Australia, 6150, Australia

RECRUITING

Local Institution - 0208

Fortaleza, Ceará, 60115-280, Brazil

NOT YET RECRUITING

Local Institution - 0204

Belo Horizonte, Minas Gerais, 30140-073, Brazil

NOT YET RECRUITING

Local Institution - 0226

Natal/RN, Rio Grande do Norte, 59062-000, Brazil

NOT YET RECRUITING

Hospital de Clinicas de Porto Alegre

Porto Alegre, Rio Grande do Sul, 90035-903, Brazil

RECRUITING

Clinica Viver

Santa Maria, Rio Grande do Sul, 97015-373, Brazil

RECRUITING

Faculdade de Medicina de Sao Jose do Rio Preto

São José do Rio Preto, 15090-000, Brazil

RECRUITING

Local Institution - 0088

Calgary, Alberta, T2N 5G2, Canada

NOT YET RECRUITING

Local Institution - 0119

Halifax, Nova Scotia, B3H 3A7, Canada

NOT YET RECRUITING

Local Institution - 0121

Toronto, Ontario, M5G 2M9, Canada

NOT YET RECRUITING

Local Institution - 0175

Sherbrooke, Quebec, J1H 5N4, Canada

NOT YET RECRUITING

Local Institution - 0068

Santiago, Santiago Metropolitan, 7500921, Chile

NOT YET RECRUITING

Local Institution - 0056

Santiago, Santiago Metropolitan, 7710007, Chile

NOT YET RECRUITING

Local Institution - 0055

Santiago, Santiago Metropolitan, 8420383, Chile

NOT YET RECRUITING

Beijing Cancer hospital

Beijing, Beijing Municipality, 100142, China

RECRUITING

Local Institution - 0276

Fuzhou, Fujian, 350014, China

NOT YET RECRUITING

Local Institution - 0232

Guangzhou, Guangdong, 510000, China

NOT YET RECRUITING

Local Institution - 0280

Guangzhou, Guangdong, 510655, China

NOT YET RECRUITING

Guangxi Medical University Affiliated Tumor Hospital

Nanning, Guangxi, 530200, China

RECRUITING

Local Institution - 0237

Harbin, Heilongjiang, 150081, China

NOT YET RECRUITING

Local Institution - 0282

Weihui, Henan, 453100, China

NOT YET RECRUITING

Local Institution - 0249

Zhengzhou, Henan, 450008, China

NOT YET RECRUITING

Local Institution - 0279

Wuhan, Hubei, 430079, China

NOT YET RECRUITING

Local Institution - 0292

Changsha, Hunan, 410031, China

NOT YET RECRUITING

Local Institution - 0256

Nanjing, Jiangsu, 210009, China

NOT YET RECRUITING

Local Institution - 0440

Yangzhou, Jiangsu, 225001, China

NOT YET RECRUITING

Local Institution - 0409

Nanchang, Jiangxi, 330006, China

NOT YET RECRUITING

Local Institution - 0244

Shenyang, Liaoning, 110042, China

NOT YET RECRUITING

Local Institution - 0273

Jinan, Shandong, 250117, China

NOT YET RECRUITING

Local Institution - 0258

Shanghai, Shanghai Municipality, 200120, China

NOT YET RECRUITING

Local Institution - 0243

Taiyuan, Shanxi, 030001, China

NOT YET RECRUITING

Local Institution - 0260

Chengdu, Sichuan, 610041, China

NOT YET RECRUITING

Local Institution - 0248

Tianjin, Tianjin Municipality, 300060, China

NOT YET RECRUITING

Local Institution - 0408

Hangzhou, Zhejiang, 310003, China

NOT YET RECRUITING

Local Institution - 0252

Hangzhou, Zhejiang, 310052, China

NOT YET RECRUITING

Local Institution - 0269

Shanghai, 200032, China

NOT YET RECRUITING

Local Institution - 0399

Pasto, Departamento de Nariño, 520001, Colombia

NOT YET RECRUITING

Local Institution - 0398

Cali, Valle del Cauca Department, 760032, Colombia

NOT YET RECRUITING

Centre Leon Berard

Lyon Cedex08, Auvergne-Rhône-Alpes, 69373, France

RECRUITING

CHRU de Brest

Brest, Finistère, 29609, France

RECRUITING

Hopital Claude Huriez - CHU de Lille

Lille, Nord, 59000, France

RECRUITING

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

Nantes, Pays de la Loire Region, 44093, France

RECRUITING

Local Institution - 0046

Poitiers, Vienne, 86021, France

NOT YET RECRUITING

Local Institution - 0060

Marseille, 13385, France

NOT YET RECRUITING

Hôpital Européen Georges Pompidou

Paris, 75015, France

RECRUITING

Charité - Universitaetsmedizin Berlin - Campus Bejnamin Franklin

Berlin, 10117, Germany

RECRUITING

Krankenhaus Nordwest GmbH

Frankfurt, 60488, Germany

RECRUITING

Facharztzentrum Eppendorf

Hamburg, 20249, Germany

RECRUITING

Nationales Centrum Fur Tumorerkrankungen (Nct)

Heidelberg, 69120, Germany

RECRUITING

Local Institution - 0112

Leipzig, 04103, Germany

NOT YET RECRUITING

Universitaetsmedizin der Johannes Gutenberg-Universitaet Mainz

Mainz, 55131, Germany

RECRUITING

Universitätsmedizin Mannheim

Mannheim, 68167, Germany

RECRUITING

Universitaetsklinikum Ulm

Ulm, 89081, Germany

RECRUITING

Local Institution - 0306

Nashik, Dādra and Nagar Haveli and Damān and Diu, 422001, India

NOT YET RECRUITING

Local Institution - 0305

Mumbai, Maharashtra, 400012, India

NOT YET RECRUITING

Local Institution - 0303

Delhi, 110029, India

NOT YET RECRUITING

Local Institution - 0403

Delhi, 110029, India

NOT YET RECRUITING

Local Institution - 0302

Puducherry, 605006, India

NOT YET RECRUITING

Local Institution - 0310

Pune, 411001, India

NOT YET RECRUITING

AOU della Campania Luigi Vanvitelli

Naples, Campania, 80138, Italy

RECRUITING

Local Institution - 0166

Turin, Piedmont, 10126, Italy

NOT YET RECRUITING

Istituto Oncologico Veneto IRCCS

Padova, Veneto, 35128, Italy

RECRUITING

Ospedale San Raffaele

Milan, 20132, Italy

RECRUITING

Local Institution - 0163

Milan, 20133, Italy

NOT YET RECRUITING

Local Institution - 0170

Roma, 00168, Italy

NOT YET RECRUITING

Local Institution - 0014

Chiba, Chiba, 260-8717, Japan

NOT YET RECRUITING

National Cancer Center Hospital East

Kashiwa, Chiba, 277-8577, Japan

RECRUITING

Local Institution - 0012

Matsuyama, Ehime, 791-0280, Japan

NOT YET RECRUITING

Local Institution - 0015

Yokohama, Kanagawa, 2418515, Japan

NOT YET RECRUITING

Local Institution - 0029

Kurashiki, Okayama-ken, 710-8602, Japan

NOT YET RECRUITING

Local Institution - 0004

Osaka, Osaka, 5418567, Japan

NOT YET RECRUITING

The University of Osaka Hospital

Suita, Osaka, 565-0871, Japan

RECRUITING

Local Institution - 0376

Takatsuki, Osaka, 569-8686, Japan

NOT YET RECRUITING

Local Institution - 0026

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

NOT YET RECRUITING

National Cancer Center Hospital

Chuo-ku, Tokyo, 104-0045, Japan

RECRUITING

The Cancer Institute Hospital of JFCR

Koto-ku, Tokyo, 135-8550, Japan

RECRUITING

Local Institution - 0013

Chikusa-ku, 464-8681, Japan

NOT YET RECRUITING

Local Institution - 0006

Gifu, 501-1194, Japan

NOT YET RECRUITING

Local Institution - 0002

Minami-Ku, Fukuoka, 811-1347, Japan

NOT YET RECRUITING

Local Institution - 0024

Sendai, 980-8574, Japan

NOT YET RECRUITING

Local Institution - 0396

Mexico City, DIF, 03100, Mexico

NOT YET RECRUITING

Local Institution - 0395

Mexico City, Mexico City, 14000, Mexico

NOT YET RECRUITING

Local Institution - 0397

Mexico City, Mexico City, 14000, Mexico

NOT YET RECRUITING

Local Institution - 0394

Oaxaca City, Oaxaca, 68020, Mexico

NOT YET RECRUITING

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

Warsaw, Masovian Voivodeship, 02-034, Poland

RECRUITING

Local Institution - 0339

Wieliszew, Masovian Voivodeship, 05-135, Poland

NOT YET RECRUITING

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

Opole, Opole Voivodeship, 45-061, Poland

RECRUITING

Local Institution - 0342

Gliwice, Silesian Voivodeship, 44-101, Poland

NOT YET RECRUITING

Wojewódzkie Centrum Szpitalne Kotliny Jeleniogórskiej

Jelenia Góra, 58-506, Poland

RECRUITING

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

Cluj-Napoca, Cluj, 400162, Romania

RECRUITING

SC Radiotherapy Center Cluj SRL

Florești, Cluj, 407280, Romania

RECRUITING

Centrul de Oncologie "Sfântul Nectarie"

Craiova, Dolj, 200542, Romania

RECRUITING

Institutul Oncologic Cluj

Cluj-Napoca, 400015, Romania

RECRUITING

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

Iași, 700106, Romania

RECRUITING

Institutul Regional de Oncologie

Iași, 700483, Romania

RECRUITING

Seoul National University Bundang Hospital

Seongnam, Kyǒnggi-do, 13620, South Korea

RECRUITING

Seoul National University Hospital

Seoul, Seoul-teukbyeolsi [Seoul], 03080, South Korea

RECRUITING

Severance Hospital, Yonsei University Health System

Seoul, Seoul-teukbyeolsi [Seoul], 03722, South Korea

RECRUITING

Asan Medical Center

Seoul, Seoul-teukbyeolsi [Seoul], 05505, South Korea

RECRUITING

Samsung Medical Center

Seoul, Seoul-teukbyeolsi [Seoul], 06351, South Korea

RECRUITING

Local Institution - 0388

Barcelona, Barcelona [Barcelona], 08035, Spain

NOT YET RECRUITING

Hospital Universitario Marqués de Valdecilla

Santander, Cantabria, 39008, Spain

RECRUITING

Complejo Hospitalario de Navarra

Pamplona, Navarre, 31009, Spain

RECRUITING

Local Institution - 0312

Valencia, Valenciana, Comunitat, 46010, Spain

NOT YET RECRUITING

Local Institution - 0389

Madrid, 28028, Spain

NOT YET RECRUITING

Hospital Clinico San Carlos

Madrid, 28040, Spain

RECRUITING

Hospital Universitario La Paz

Madrid, 28046, Spain

RECRUITING

H.R.U Málaga - Hospital General

Málaga, 29011, Spain

RECRUITING

Local Institution - 0111

Ankara, 06230, Turkey (Türkiye)

NOT YET RECRUITING

Local Institution - 0108

Edirne, 22030, Turkey (Türkiye)

NOT YET RECRUITING

Local Institution - 0125

Kadiköy/Istanbul, 41380, Turkey (Türkiye)

NOT YET RECRUITING

Local Institution - 0093

Manisa, 45030, Turkey (Türkiye)

NOT YET RECRUITING

Local Institution - 0128

Sakarya, 54100, Turkey (Türkiye)

NOT YET RECRUITING

St Bartholomew's Hospital

London, London, City of, EC1A 7BE, United Kingdom

RECRUITING

Oxford University Hospitals NHS Trust

Oxford, Oxfordshire, OX3 7LJ, United Kingdom

RECRUITING

Local Institution - 0444

Sutton, Surrey, SM2 5PT, United Kingdom

NOT YET RECRUITING

Local Institution - 0354

Glasgow, G12 0YN, United Kingdom

NOT YET RECRUITING

The Christie NHS Foundation Trust

Manchester, M20 4BX, United Kingdom

RECRUITING

Local Institution - 0357

Sutton, SM2 5PT, United Kingdom

NOT YET RECRUITING

Local Institution - 0300

NOT YET RECRUITING

Related Links

• BMS Clinical Trial Information
• BMS Clinical Trial Patient Recruiting

MeSH Terms

Conditions

Stomach Neoplasms; Adenocarcinoma Of Esophagus

Interventions

Folfox protocol; Nivolumab

Condition Hierarchy (Ancestors)

Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Stomach Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Study Officials

• Bristol-Myers Squibb

  Bristol-Myers Squibb

  STUDY DIRECTOR

Central Study Contacts

BMS Clinical Trials Contact Center www.BMSClinicalTrials.com

CONTACT

855-907-3286; Clinical.Trials@bms.com

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

CONTACT

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 23, 2025
• First Posted: October 27, 2025
• Study Start: March 13, 2026
• Primary Completion (Estimated): November 8, 2030
• Study Completion (Estimated): September 11, 2032
• Last Updated: June 4, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, CSR
• Time Frame: See Plan Description
• Access Criteria: See Plan Description

Locations

CN (22); BR (6); IN (6); ME (4); CL (3); IT (6); AU (6); JP (15); KR (5); AR (4); DE (8); ES (8); CA (4); FR (7); US (34); PL (5); CO (2); GB (6); RO (6); TU (5)