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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)
Sponsor: Bristol-Myers Squibb
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
Official title: 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
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
690
Start Date
2026-03-13
Completion Date
2032-09-11
Last Updated
2026-06-26
Healthy Volunteers
No
Conditions
Interventions
Pumitamig
Specified dose on specified days
Folfox
Specified dose on specified days
Capox
Specified dose on specified days
Nivolumab
Specified dose on specified days
Locations (161)
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
University of Wisconsin Carbone Cancer Center - University Hospital
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
Centro de Investigação Clínica Ciências Médicas
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
Princess Margaret Cancer Centre
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
Fujian Cancer Hospital
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
Shanghai East Hospital
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
Centre Hospitalier Universitaire de Poitiers
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 - 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
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
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
Mazowiecki Szpital Onkologiczny
Warsaw, Masovian Voivodeship, Poland
SP ZOZ Opolskie Centrum Onkologii im. prof. Tadeusza Koszarowskiego w Opolu
Opole, Opole 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
Hospital Clinico de Valencia
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