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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
2026-09-30
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)
Mayo Clinic in Arizona - Phoenix
Phoenix, Arizona, United States
USC/Norris Comprehensive Cancer Center
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
Mayo Clinic in Florida
Jacksonville, Florida, United States
Florida Cancer Specialists - North
St. Petersburg, Florida, United States
Moffitt Cancer Center
Tampa, Florida, United States
Emory University
Atlanta, Georgia, United States
Local Institution - 0379
Chicago, Illinois, United States
Local Institution - 0268
Iowa City, Iowa, United States
Mayo Clinic in Rochester, Minnesota
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
University of North Carolina Medical Center
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
UPMC Hillman Cancer Center
Pittsburgh, Pennsylvania, United States
SCRI Oncology Partners
Nashville, Tennessee, United States
Tennessee Oncology
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
University of Texas MD Anderson Cancer Center
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
Centro Médico Fleischer
Ciudad Autónoma de Buenos Aires, Buenos Aires, Argentina
Instituto Alexander Fleming
Ciudad Autónoma de Buenos Aires, Buenos Aires, Argentina
Hospital Italiano de Buenos Aires
ABB, Buenos Aires F.D., Argentina
Centro de Educación Médica e Investigaciones clínicas "Dr. Norberto Quirno" (CEMIC)
Buenos Aires, Argentina
Liverpool Hospital
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
Núcleo de Oncologia e Hematologia do Ceará
Fortaleza, Ceará, Brazil
Centro de Investigação Clínica Ciências Médicas
Belo Horizonte, Minas Gerais, Brazil
Liga Norte Riograndense Contra o Câncer
Natal, 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
The Sixth Affiliated Hospital of Sun Yat-sen University
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