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).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
332
Administered as specified in the treatment arm
Administered as specified in the treatment arm
Administered as specified in the treatment arm
Number of Participants with Adverse Events (AEs)
Time frame: Up to 18 months
Objective Response Rate (ORR) as measured by Response Evaluation Criteria in Solid Tumors (RECIST) v1.1
Time frame: Up to 18 months
Objective Response Rate (ORR) as measured by PD-L1 Expression Level
Time frame: Up to 18 months
Overall survival (OS)
Time frame: From date of first dose until the date of death due to any cause (approximately 18 months)
Progression-free survival (PFS) as determined by the Investigator according to RECIST v1.1
Time frame: Up to 18 months
Disease Control (complete response, partial response, or stable disease) for greater than equal to 12 weeks
Time frame: Up to 18 months
Duration of response (DOR) as determined by the Investigator according to RECIST v1.1
Time frame: Up to 18 months
Plasma concentration of domvanalimab
Time frame: Up to 18 months
Plasma concentration of zimberelimab
Time frame: Up to 18 months
Plasma concentration of quemliclustat
Time frame: Up to 18 months
Percentage of participants with anti-drug antibodies to domvanalimab
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Administered as specified in the treatment arm
Administered as specified in the treatment arm
Administered as specified in the treatment arm
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
...and 39 more locations
Time frame: Up to 18 months
Percentage of participants with anti-drug antibodies to zimberelimab
Time frame: Up to 18 months