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

Plain Language Summary

Simplified for easier understanding

This study is testing a new drug combination for people with advanced colorectal cancer (cancer of the colon or rectum) that has spread and cannot be removed by surgery. Researchers are comparing a combination that includes an experimental drug called ONO-4578 along with existing cancer drugs (nivolumab, chemotherapy, and bevacizumab) against current standard treatment. **You may be eligible if...** - You have been diagnosed with advanced or metastatic colorectal cancer that cannot be surgically cured - Your cancer tests positive for a protein called PD-L1 - You have not received prior chemotherapy for your advanced cancer - You are otherwise relatively healthy (able to perform daily activities with little limitation) **You may NOT be eligible if...** - Your cancer has a specific genetic marker called MSI-High or dMMR - Your cancer has a BRAF V600E gene mutation - You have lung disease such as interstitial lung disease or pulmonary fibrosis - You have an active autoimmune disease - You have previously received immunotherapy checkpoint drugs Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

Interested in this trial?

Get notified about updates and connect with the research team.