Clinical Trial

A Study to Evaluate the Safety and Efficacy of Two Dose Levels of ONO-4578 With Opdivo®, in Combination With mFOLFOX6 and Bevacizumab Versus Standard of Care in Participants With Non-MSI-H/dMMR, PD-L1 Positive Advanced Colorectal Cancer

Recruiting Phase 2
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Summary
The purpose of this study is to evaluate the safety and efficacy of two dose levels of ONO-4578 with Opdivo® when added to mFOLFOX6 and bevacizumab versus SOC as first-line treatment for advanced CRC.
Protocol Amendment History 3 changes
notable Trial sites expanded: 35 -> 39 locations 2026-07-17
notable Trial sites expanded: 28 -> 33 locations 2026-05-19
notable Sponsor changed: Ono Pharmaceutical Co. Ltd -> Ono Pharmaceutical Co., Ltd. 2026-04-19
Trial Details
NCT Number NCT06948448
Lead Sponsor Ono Pharmaceutical Co., Ltd.
Conditions Colorectal Cancer
Enrollment 144 participants
Start Date 2025-11-18
Primary Completion 2028-02-15 (estimated)
Study Completion 2028-10-01 (estimated)
Updated on ClinicalTrials.gov 2026-07-16