Clinical Trial

A Study to Evaluate the Efficacy and Safety of ONO-4538 in Combination With Ipilimumab and Chemotherapy in Chemotherapy-naïve Participants With HER2-negative Unresectable Advanced or Recurrent Gastric Cancer (Including Esophagogastric Junction Cancer)

Active, Not Recruiting Phase 3
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Summary
This study is to compare and evaluate the efficacy and safety of ONO-4538 in combination with ipilimumab and chemotherapy versus chemotherapy in chemotherapy-naïve participants with HER2-negative unresectable advanced or recurrent gastric cancer (including esophagogastric junction cancer).
Protocol Amendment History 12 amendments
This ClinicalTrials.gov record has been amended 12 times since 2021-12-01; most recent amendment 2026-06-23.
Status change: Recruiting → Active, Not Recruiting 2023-09-01
Status change: Not Yet Recruiting → Recruiting 2022-02-17
Trial Details
NCT Number NCT05144854
Lead Sponsor Ono Pharmaceutical Co., Ltd.
Conditions Gastric Cancer
Enrollment 626 participants
Start Date 2021-11-05
Primary Completion 2025-10-20 (estimated)
Study Completion 2027-05 (estimated)
Updated on ClinicalTrials.gov 2026-06-25