The purpose of this study is to evaluate the efficacy and safety of ONO-4578 in combination nivolumab and chemotherapy in participants with advanced or metastatic gastric cancer, esophagogastric junction cancer, or esophageal adenocarcinoma. Participants will: * Receive either ONO-4578 with nivolumab and chemotherapy or placebo with nivolumab and chemotherapy. * Make visits to the clinic for checkups and tests. * Answer questions about their health throughout the trial.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
600
ONO-4578 will be administered to participants at a specified dose once daily.
Matching placebo for ONO-4578 will be administered to participants once daily.
Nivolumab will be administered to participants at a specified dose on specified days.
Oxaliplatin will be administered to participants at a specified dose on specified days.
Capecitabine will be administered to participants at a specified dose on specified days.
S-1 will be administered to participants at a specified dose on specified days.
Fluorouracil will be administered to participants at a specified dose on specified days.
Leucovorin Calcium will be administered to participants at a specified dose on specified days.
Levoleucovorin will be administered to participants at a specified dose on specified days.
Overall Survival (OS)
Time frame: Up to approximately 4 years
Progression-Free Survival (PFS) per Blinded Independent Central Review (BICR)
Time frame: Up to approximately 4 years
PFS per Investigator Assessment
Time frame: Up to approximately 4 years
Objective Response Rate (ORR) per BICR
Time frame: Up to approximately 4 years
Duration of Response (DOR) per BICR
Time frame: Up to approximately 4 years
Disease Control Rate (DCR) per BICR
Time frame: Up to approximately 4 years
Time to Response (TTR) per BICR
Time frame: Up to approximately 4 years
PFS After the Next-line of Therapy (PFS2) per Investigator Assessment
Time frame: Up to approximately 4 years
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.