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
Research Site
Phoenix, Arizona, United States
Research Site
Los Angeles, California, United States
Research Site
Santa Monica, California, United States
Research Site
Derby, Connecticut, United States
Research Site
Fort Myers, Florida, United States
Research Site
Jacksonville, Florida, United States
Research Site
St. Petersburg, Florida, United States
Research Site
Boston, Massachusetts, United States
Research Site
New York, New York, United States
Research Site
New York, New York, United States
...and 33 more locations
Time frame: Up to 18 months
Percentage of participants with anti-drug antibodies to zimberelimab
Time frame: Up to 18 months