The purpose of study is to evaluate the efficacy and safety of ONO-4538 with chemotherapy in unresectable advanced or recurrent gastric cancer (including esophagogastric junction cancer) not previously treated with the first-line therapy. Part 1 is intended to evaluate the tolerability, safety, and efficacy of ONO-4538 in combination with SOX therapy (Tegafur / gimeracil / oteracil potassium + Oxaliplatin) or CapeOX therapy (Capecitabine + Oxaliplatin). In part 2, the investigator or the subinvestigator will choose a chemotherapy (SOX or CapeOX therapy), taking into account the condition of each subject. Part 2 is planned to evaluate the efficacy and safety of ONO-4538 + chemotherapy in comparison with placebo + chemotherapy.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
680
Aichi Clinical Site
Nagoya, Aichi-ken, Japan
Aomori Clinical Site
Hirosaki, Aomori, Japan
Aomori Clinical Site
Misawa, Aomori, Japan
Chiba Clinical Site
Funabashi, Chiba, Japan
Chiba Clinical Site
Kamogawa, Chiba, Japan
Chiba Clinical Site
Progression-free survival (central assessment by IRRC) (only Part 2)
Time frame: Up to study completion (estimated time frame: 48 months)
Overall survival (only Part 2)
Time frame: Up to study completion (estimated time frame: 54 months)
Objective response rate (only Part 2)
Time frame: Up to study completion (estimated time frame: 54 months)
Progression-free survival (assessment by the site investigator)(only Part 2)
Time frame: Up to study completion (estimated time frame: 54 months)
Duration of response (only Part 2)
Time frame: Up to study completion (estimated time frame: 54 months)
Disease control rate (only Part 2)
Time frame: Up to study completion (estimated time frame: 54 months)
Time to response (only Part 2)
Time frame: Up to study completion (estimated time frame: 54 months)
Best overall response (only Part 2)
Time frame: Up to study completion (estimated time frame: 54 months)
Percent change in the sum of diameters of target lesions (only Part 2)
Time frame: Up to study completion (estimated time frame: 54 months)
Safety will be analyzed through the incidence of adverse events, serious adverse events
Time frame: Up to 28 days from last dose
Safety will be analyzed through the incidence of laboratory abnormalities
Time frame: Up to 28 days from last dose
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Kashiwa, Chiba, Japan
Ehime Clinical Site1
Matsuyama, Ehime, Japan
Ehime Clinical Site2
Matsuyama, Ehime, Japan
Fukuoka Clinical Site
Iizuka, Fukuoka, Japan
Fukuoka Clinical Site1
Kitakyushu, Fukuoka, Japan
...and 120 more locations