Study of ONO-4538 in Unresectable Advanced or Recurrent Gastric Cancer

• Status: Completed
• Trial end date: 2021-01-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of study is to evaluate the efficacy and safety of ONO-4538 in patients with unresectable advanced or recurrent gastric cancer (including esophagogastric junction cancer) refractory to or intolerant of standard therapy.

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

Details

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

Criteria

Inclusion Criteria:

• Men & women ≥20 years of age

• Unresectable advanced or recurrent gastric cancer (including esophagogastric junction cancer)

• Histologically confirmed adenocarcinoma

• Refractory to or intolerant of standard therapy

• ECOG Performance Status score 0 or 1

• A life expectancy of at least 3 months

Exclusion Criteria:

• Current or past history of severe hypersensitivity to any other antibody products

• Patients with multiple primary cancers

• Patients with any metastasis in the brain or meninx that is symptomatic or requires treatment

• Patients with active, known or suspected autoimmune disease