Study of Adjuvant ONO-4538 With Resected Gastric Cancer

• Status: Recruiting
• Trial end date: 2023-03-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of study is to evaluate the efficacy and safety of postoperative adjuvant chemotherapy with Nivolumab in combination with tegafur-gimeracil-oteracil potassium (S-1 therapy) or capecitabine + oxaliplatin (CapeOX therapy), in comparison with placebo in combination with S-1 therapy or CapeOX therapy, in pStage III gastric cancer (including esophagogastric junction cancer) after D2 or more extensive lymph node dissection.

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

Details

• Lead Sponsor: Ono Pharmaceutical Co. Ltd
• Collaborator: Bristol-Myers Squibb
• Treatments: Antibodies, Monoclonal; Capecitabine; Nivolumab; Oxaliplatin; Tegafur

Criteria

Inclusion Criteria:

• Patients with histologically confirmed adenocarcinoma of the stomach

• Patients without a remnant cancer (R0) who have undergone gastrectomy

• Gastric carcinoma according to the stage classification of AJCC/UICC TNM Classification, 7th Edition on the basis of overall postoperative findings

• Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) score of 0 or 1

Exclusion Criteria:

• Patients who have received non-surgical treatment (e.g., radiotherapy, chemotherapy, hormone therapy) for gastric cancer

• Multiple primary cancers

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

• Any concurrent autoimmune disease or past history of chronic or recurrent autoimmune disease