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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
2026-03-30
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 (49)
Mayo Clinic - Arizona
Phoenix, Arizona, United States
USC/Norris Comprehensive Cancer Center
Los Angeles, California, United States
Ronald Reagan UCLA Medical Center
Santa Monica, California, United States
Yale Cancer Center
Derby, Connecticut, United States
Florida Cancer Specialist - South
Fort Myers, Florida, United States
Mayo Clinic - Jacksonville
Jacksonville, Florida, United States
Florida Cancer Specialist - North
St. Petersburg, Florida, United States
Massachusetts General Hospital
Boston, Massachusetts, United States
Memorial Sloan Kettering Cancer Center
New York, New York, United States
Columbia University
New York, New York, United States
Duke University
Durham, North Carolina, United States
Zangmeister Cancer Center
Columbus, Ohio, United States
OU - Stephenson Cancer Center
Oklahoma City, Oklahoma, United States
SCRI Tennessee Oncology - Nashville
Nashville, Tennessee, United States
Vanderbilt-Ingram Cancer Center
Nashville, Tennessee, United States
Virginia Cancer Specialists
Fairfax, Virginia, United States
UHN - Princess Margaret Cancer Centre
Toronto, Canada
Clínica San Carlos de Apoquindo
Las Condes, Chile
Bradford Hill Centro de Investigaciones Clinicas
Recoleta, Chile
Centro de Estudios Clínicos SAGA
Santiago, Chile
Clínica Universidad Católica del Maule
Talca, Chile
Institut Bergonié _ Bordeaux
Bordeaux, France
CHU de Brest_Brest
Brest, France
Centre Baclesse - CAEN
Caen, France
Centre Oscar Lambret _ LILLE
Lille, France
Centre Léon Bérard _ Lyon
Lyon, France
Hôpital Timone - Marseille
Marseille, France
Institut de Recherche en Cancerologie de Montpellier
Montpellier, France
Centre Armoricain de Radiothérapie, d'Imagerie Médicale et d'Oncologie
Plérin, France
Pôle Régional de Cancérologie - Service d'Oncologie Médicale - Poitiers
Poitiers, France
CHU de Toulouse_Oncopole
Toulouse, France
Gustave Roussy - Villejuif
Villejuif, France
MSB - Medicinski Sistem Beograd
Belgrade, Serbia
University Clinical Center of Serbia
Belgrade, Serbia
University Hospital Medical Center (KBC) Bezanijska Kosa
Belgrade, Serbia
Institute of Oncology of Vojvodina
Kamenitz, Serbia
Clinical Center Kragujevac
Kragujevac, Serbia
Dong-A University Hospital
Busan, South Korea
Kyungpook National University Chilgok Hospital
Daegu, South Korea
Chonnam National University Hwasun Hospital
Hwasun, South Korea
CHA Bundang Medical Center
Seongnam-si, South Korea
Asan Medical Center Hospital
Seoul, South Korea
Korea University Anam Hospital
Seoul, South Korea
Korea University Guro Hospital
Seoul, South Korea
Samsung Medical Center
Seoul, South Korea
Seoul National University Hospital
Seoul, South Korea
Severance Hospital Cancer Center
Seoul, South Korea
Ajou University Hospital
Suwon, South Korea
St. Vincent's Hospital, The Catholic University of Korea
Suwon, South Korea