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A Safety and Efficacy Study of Treatment Combinations With and Without Chemotherapy in Adult Participants With Advanced Upper Gastrointestinal Tract Malignancies
Sponsor: Arcus Biosciences, Inc.
Summary
The purpose of this study is to evaluate the safety and preliminary clinical activity of treatment combinations with and without chemotherapy in participants with locally advanced unresectable or metastatic gastric, GEJ, and esophageal adenocarcinoma. Chemotherapy will consist of FOLFOX (oxaliplatin, leucovorin, fluorouracil).
Official title: A Phase 2 Trial to Evaluate the Safety and Efficacy of Combination Therapies in Patients With Advanced Upper Gastrointestinal Tract Malignancies (EDGE-Gastric)
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
332
Start Date
2022-06-10
Completion Date
2027-06
Last Updated
2026-04-29
Healthy Volunteers
No
Conditions
Interventions
Domvanalimab
Administered as specified in the treatment arm
Quemliclustat
Administered as specified in the treatment arm
Zimberelimab
Administered as specified in the treatment arm
Fluorouracil
Administered as specified in the treatment arm
Leucovorin
Administered as specified in the treatment arm
Oxaliplatin
Administered as specified in the treatment arm
Locations (42)
Research Site
Phoenix, Arizona, United States
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Los Angeles, California, United States
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Santa Monica, California, United States
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Derby, Connecticut, United States
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Fort Myers, Florida, United States
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Jacksonville, Florida, United States
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St. Petersburg, Florida, United States
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Boston, Massachusetts, 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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Columbus, Ohio, United States
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Oklahoma City, Oklahoma, United States
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Nashville, Tennessee, United States
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Nashville, Tennessee, United States
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Fairfax, Virginia, United States
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Toronto, Canada
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Las Condes, Chile
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Recoleta, Chile
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Santiago, Chile
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Talca, Chile
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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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Marseille, France
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Montpellier, France
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Plérin, France
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Poitiers, France
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Rouen, France
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Toulouse, France
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Villejuif, France
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Belgrade, Serbia
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Kamenitz, 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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Hwasun, South Korea
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Seongnam-si, South Korea
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Seoul, South Korea
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Suwon, South Korea