Study of ONO-4538 in Gastric Cancer

• Status: Active, not recruiting
• Trial end date: 2022-03-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2/Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Ono Pharmaceutical Co. Ltd
• Treatments: Antibodies, Monoclonal; Capecitabine; Nivolumab; Oxaliplatin; Tegafur

Criteria

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