A Study to Investigate the Efficacy and Safety of ONO-4578 in Combination With Nivolumab and Chemotherapy in Chemotherapy-naïve Participants With HER2-negative Unresectable Advanced or Recurrent Gastric Cancer (Including Esophagogastric Junction Cancer)
A Randomized, Multicenter, Double-blind, Phase II Study to Compare the Efficacy and Safety of the Treatment With ONO-4578 in Combination With Nivolumab, Fluoropyrimidine-based and Platinum- Based Chemotherapy (Hereinafter Referred to as Chemotherapy) With Those of the Treatment With Placebo in Combination With Nivolumab and Chemotherapy in Chemotherapy-naïve Participants With Human Epidermal Growth Factor Receptor 2 (HER2)-Negative Unresectable Advanced or Recurrent Gastric Cancer (Including Esophagogastric Junction Cancer)
Sponsor: Ono Pharmaceutical Co., Ltd.
Open for Predictions · 1 endpoint
Key Facts
Primary Endpoints (CT.gov)
Progression-free survival (PFS) (site investigator assessment)
Time frame: up to 2years
Secondary Endpoints
Overall survival (OS)
Objective response rate (ORR) (site investigator assessment)
Best overall response (BOR) (site investigator assessment)
Eligibility Criteria
Inclusion Criteria: * Patients with gastric or esophagogastric junction cancer histologically diagnosed as adenocarcinoma * Patients have not been treated with systemic chemotherapy as first-line therapy * Patients who can provide tumor tissue samples Exclusion Criteria: * Patients unable to take oral medicines * Patients with HER2-positive * Patients with contraindications to nivolumab, oxaliplatin, S-1, or capecitabine * Patients who have a history of severe drug-related adverse reactions caused by non- steroidal anti-inflammatory drugs (NSAIDs) or who have complications caused by NSAIDs requiring treatment * Patients with concurrent autoimmune disease or a history of chronic or recurrent autoimmune disease, such as rheumatoid arthritis * Patients with headache and/or nausea associated with brain metastasis
✦ Analyst Commentary
Expert commentary on why this trial matters and what to watch for.
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