RecruitingPhase 2NCT06948448

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

A Randomized, Open Label, Multicenter, Phase 2 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 for First-line Treatment of Non-MSI-H/dMMR, PD-L1 Positive Advanced Colorectal Cancer

Sponsor

Ono Pharmaceutical Co. Ltd

Enrollment

144 participants

Start Date

Nov 18, 2025

Study Type

INTERVENTIONAL

Conditions

Colorectal, Cancer

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.

Eligibility

Min Age: 18 Years

Inclusion Criteria4

Histologically confirmed advanced (locally advanced or metastatic) colorectal cancer not amenable to curative resection
ECOG Performance Status of 0-1
No prior systemic treatment for advanced local or mCRC
Participants whose tumor is positive for PD-L1 expression as determined at a central laboratory

Exclusion Criteria6

Participants with high microsatellite instability (MSI-High), or mismatch repair deficient (dMMR) tumor
Participants with BRAF V600E mutation
Unable to swallow tablets.
Participants with complication or history of interstitial lung disease, pneumonitis or pulmonary fibrosis
Participants with an active, known or suspected autoimmune disease.
Prior treatment with an anti-PD-1, anti-PD-L1, anti-PD-L2, or anti-CTLA-4 antibody, or any other antibody or drug specifically targeting T-cell co-stimulation or immune checkpoint pathways.