Status:
RECRUITING
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
Lead Sponsor:
Ono Pharmaceutical Co. Ltd
Conditions:
Colorectal Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief 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.
Detailed Description
Potential participants will be consented and screened for study eligibility. Eligible participants will be randomized in a 1:1:1 ratio to one of the three study intervention arms. Study intervention w...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
November 18 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
October 1 2028
Estimated Enrollment :
144 Patients enrolled
Trial Details
Trial ID
NCT06948448
Start Date
November 18 2025
End Date
October 1 2028
Last Update
December 15 2025
Active Locations (12)
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1
Mayo Clinic Arizona
Phoenix, Arizona, United States, 85054
2
USC Norris Comprehensive Cancer Center
Los Angeles, California, United States, 90033
3
Mayo Clinic Florida
Jacksonville, Florida, United States, 32224
4
The Ohio State University Comprehensive Cancer Center
Columbus, Ohio, United States, 43221