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

What this study is about

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.

Who can join (things the study team will check)

✅ You may be able to join if…

• 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

🚫 You may not be able to join if…

• 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. Other protocol-defined inclusion/exclusion criteria apply

Where this trial is running

• Mayo Clinic Arizona, Phoenix, Arizona, United States
• USC Norris Comprehensive Cancer Center, Los Angeles, California, United States
• Rocky Mountain Cancer Centers, LLP, Lone Tree, Colorado, United States
• Mayo Clinic Florida, Jacksonville, Florida, United States
• Advent Health, Orlando, Florida, United States
• May Clinic Rochester, Rochester, Minnesota, United States
• The Ohio State University Comprehensive Cancer Center, Columbus, Ohio, United States
• Thomas Jefferson University, Sidney Kimmel Cancer Center, Philadelphia, Pennsylvania, United States
• Baylor Scott & White Medical Center, Temple, Texas, United States
• Virginia Oncology Associates, Norfolk, Virginia, United States
• Blue Ridge Cancer Care, Salem, Virginia, United States
• Princess Margaret Cancer Centre- University Health Network, Toronto, Ontario, Canada

+ 23 more sites.

Who to contact

North America Clinical Trial Support Desk · +18665877745(Toll-Free) · clinical_trial@ono-pharma.com

It's completely normal to call and ask questions before deciding anything. Mention the study ID: NCT06948448.