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A Clinical Trial of a New Combination Treatment, Domvanalimab and Zimberelimab, Plus Chemotherapy, for People With an Upper Gastrointestinal Tract Cancer That Cannot be Removed With Surgery That Has Spread to Other Parts of the Body
Sponsor: Arcus Biosciences, Inc.
Summary
This randomized Phase 3 open-label study will compare the efficacy of the T-cell immunoglobulin and immunoreceptor tyrosine-based inhibitory motif (ITIM) domain (TIGIT) monoclonal antibody domvanalimab, the anti programmed cell death protein 1 (PD-1) monoclonal antibody zimberelimab, and multiagent chemotherapy versus the anti PD-1 monoclonal antibody nivolumab and multiagent chemotherapy in the first-line treatment of participants with locally advanced unresectable or metastatic gastric, gastroesophageal junction (GEJ), and esophageal adenocarcinoma.
Official title: A Randomized, Open-Label, Multicenter Phase 3 Trial of Domvanalimab, Zimberelimab, and Chemotherapy Versus Nivolumab and Chemotherapy in Participants With Previously Untreated Locally Advanced Unresectable or Metastatic Gastric, Gastroesophageal Junction, and Esophageal Adenocarcinoma
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
1040
Start Date
2022-11-21
Completion Date
2026-06
Last Updated
2026-05-08
Healthy Volunteers
No
Interventions
Domvanalimab
Intravenous (IV) Aqueous Solution
Zimberelimab
IV Aqueous Solution
Capecitabine
Oral Tablets
Fluorouracil
IV Aqueous Solution
Leucovorin
IV Aqueous Solution
Oxaliplatin
IV Aqueous Solution
Nivolumab
IV Aqueous Solution
Locations (170)
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Hot Springs, Arkansas, United States
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Los Angeles, California, United States
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Los Angeles, California, United States
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Orange, California, United States
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Santa Monica, California, United States
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New Haven, Connecticut, United States
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Washington D.C., District of Columbia, United States
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Fort Myers, Florida, United States
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St. Petersburg, Florida, United States
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Tallahassee, Florida, United States
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Louisville, Kentucky, United States
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Louisville, Kentucky, United States
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New Orleans, Louisiana, United States
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Boston, Massachusetts, United States
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Ann Arbor, Michigan, United States
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Saint Louis Park, Minnesota, United States
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Mineola, New York, United States
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New York, New York, United States
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New York, New York, United States
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Durham, North Carolina, United States
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Cleveland, Ohio, United States
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Cleveland, Ohio, United States
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Columbus, Ohio, United States
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Mayfield Heights, Ohio, United States
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Portland, Oregon, United States
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Nashville, Tennessee, United States
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Nashville, Tennessee, United States
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Dallas, Texas, United States
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Fort Worth, Texas, United States
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Houston, Texas, United States
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Fairfax, Virginia, United States
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Seattle, Washington, United States
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Milwaukee, Wisconsin, United States
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Buenos Aires, Argentina
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La Rioja, Argentina
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Mar del Plata, Argentina
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Clayton, Australia
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Murdoch, Australia
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Barretos, Brazil
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Ijuí, Brazil
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Natal, Brazil
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Porto Alegre, Brazil
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Halifax, Canada
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Montreal, Canada
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Ottawa, Canada
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Toronto, Canada
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La Florida, Chile
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Port Montt, Chile
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Providencia, Chile
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Recoleta, Chile
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Santiago, Chile
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Talca, Chile
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Changchun, China
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Changzhou, China
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Fuzhou, China
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Guangzhou, China
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Haikou, China
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Hangzhou, China
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Hefei, China
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Shanghai, China
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Tianjin, China
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Zhengzhou, China
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Bordeaux, France
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Brest, France
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Caen, France
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Lille, France
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Lyon, France
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Montpellier, France
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Plérin, France
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Poitiers, France
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Toulouse, France
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Villejuif, France
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Kutaisi, Georgia
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Tbilisi, Georgia
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Tbilisi, Georgia
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Tbilisi, Georgia
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Tbilisi, Georgia
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Guatemala City, Guatemala
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Quetzaltenango, Guatemala
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Happy Valley, Hong Kong
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Hong Kong, Hong Kong
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Tuenmen, Hong Kong
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Budapest, Hungary
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Kecskemét, Hungary
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Pécs, Hungary
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Jerusalem, Israel
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Petah Tikva, Israel
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Tel Aviv, Israel
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Florence, Italy
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Milan, Italy
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Milan, Italy
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Ravenna, Italy
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Rozzano, Italy
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Udine, Italy
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Akashi, Japan
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Bunkyō City, Japan
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Chiba, Japan
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Fukuoka, Japan
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Kashiwa-shi, Japan
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Kawasaki, Japan
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Kōtō City, Japan
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Matsuyama, Japan
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Nagaizumi-cho, Japan
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Nagoya, Japan
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Niigata, Japan
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Osaka, Japan
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Osakasayama-shi, Japan
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Ota-shi, Japan
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Saitama, Japan
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Tokyo, Japan
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Yokohama, Japan
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Kaunas, Lithuania
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Klaipėda, Lithuania
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Vilnius, Lithuania
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George Town, Malaysia
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Kuala Lumpur, Malaysia
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Kuching, Malaysia
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Colonia Centro, Mexico
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Mexico City, Mexico
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Mérida, Mexico
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San Pedro Garza García, Mexico
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Toluca, Mexico
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San Isidro, Peru
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San Juán de Miraflores, Peru
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Surquillo, Peru
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Bacolod City, Philippines
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Baguio City, Philippines
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Cebu City, Philippines
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Manila, Philippines
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Lublin, Poland
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Tychy, Poland
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Warsaw, Poland
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Coimbra, Portugal
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Lisbon, Portugal
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Porto, Portugal
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Baia Mare, Romania
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Bucharest, Romania
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Cluj-Napoca, Romania
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Craiova, Romania
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Florești, Romania
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Iași, Romania
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Suceava, Romania
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Belgrade, Serbia
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Kragujevac, Serbia
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Busan, South Korea
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Daegu, South Korea
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Seongnam, South Korea
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Seoul, South Korea
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Barcelona, Spain
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Madrid, Spain
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Santander, Spain
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Valencia, Spain
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Zaragoza, Spain
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Bang Phlat, Thailand
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Hat Yai, Thailand
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Ubon Ratchathani, Thailand
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Adana, Turkey (Türkiye)
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Ankara, Turkey (Türkiye)
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Edirne, Turkey (Türkiye)
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Istanbul, Turkey (Türkiye)
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İzmit, Turkey (Türkiye)
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Malatya, Turkey (Türkiye)
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Mamak, Turkey (Türkiye)
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Van, Turkey (Türkiye)
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Yakutiye, Turkey (Türkiye)
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Yüreğir, Turkey (Türkiye)
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London, United Kingdom
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Manchester, United Kingdom
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Oxford, United Kingdom
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Sutton, United Kingdom