Gastric Cancer
Conditions
Brief summary
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.
Interventions
Sponsors
Ono Pharmaceutical Co. Ltd
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
20 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Patients with unresectable advanced or recurrent gastric cancer (including esophagogastric junction cancer) that has not been treated with the first-line therapy with systemic antitumor agents for advanced or recurrent gastric cancer (including esophagogastric junction cancer) * Have measurable lesions as defined in RECIST Guideline Version 1.1 * ECOG PS score 0 or 1 * Have a life expectancy of at least 3 months
Exclusion criteria
* Have multiple cancers * Have a current or past history of severe hypersensitivity to any other antibody products * Patients with any metastasis in the brain or meninx that is symptomatic or requires treatment * Patients with active, known or suspected autoimmune disease
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Progression-free survival (central assessment by IRRC) (only Part 2) | Up to study completion (estimated time frame: 48 months) |
| Overall survival (only Part 2) | Up to study completion (estimated time frame: 54 months) |
Secondary
| Measure | Time frame |
|---|---|
| Duration of response (only Part 2) | Up to study completion (estimated time frame: 54 months) |
| Disease control rate (only Part 2) | Up to study completion (estimated time frame: 54 months) |
| Time to response (only Part 2) | Up to study completion (estimated time frame: 54 months) |
| Objective response rate (only Part 2) | Up to study completion (estimated time frame: 54 months) |
| Percent change in the sum of diameters of target lesions (only Part 2) | Up to study completion (estimated time frame: 54 months) |
| Safety will be analyzed through the incidence of adverse events, serious adverse events | Up to 28 days from last dose |
| Safety will be analyzed through the incidence of laboratory abnormalities | Up to 28 days from last dose |
| Best overall response (only Part 2) | Up to study completion (estimated time frame: 54 months) |
| Progression-free survival (assessment by the site investigator)(only Part 2) | Up to study completion (estimated time frame: 54 months) |
Countries
Japan, South Korea, Taiwan
Outcome results
None listed