OncoMatch/Clinical Trials/NCT06948448
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
Is NCT06948448 recruiting? Yes, currently enrolling (May 2026). This Phase 2 trial studies multiple treatments for colorectal cancer.
Treatment: ONO-4578 · Opdivo® · Oxaliplatin · 5-Fluorouracil · Bevacizumab · Leucovorin — 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.
Check if I qualifyExtracted eligibility criteria
Cancer type
Colorectal Cancer
Biomarker criteria
Required: PD-L1 (CD274) positive expression (positive)
Participants whose tumor is positive for PD-L1 expression as determined at a central laboratory
Excluded: BRAF V600E
Participants with BRAF V600E mutation
Excluded: MSH2 deficient mismatch repair
mismatch repair deficient (dMMR) tumor
Excluded: MSH6 deficient mismatch repair
mismatch repair deficient (dMMR) tumor
Excluded: MLH1 deficient mismatch repair
mismatch repair deficient (dMMR) tumor
Excluded: PMS2 deficient mismatch repair
mismatch repair deficient (dMMR) tumor
Excluded: MSI high microsatellite instability
Participants with high microsatellite instability (MSI-High)
Performance status
ECOG 0–1(Restricted strenuous activity)
Prior therapy
Cannot have received: anti-PD-1 therapy
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.
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- Mayo Clinic Arizona · Phoenix, Arizona
- USC Norris Comprehensive Cancer Center · Los Angeles, California
- Rocky Mountain Cancer Centers, LLP · Lone Tree, Colorado
- Mayo Clinic Florida · Jacksonville, Florida
- The Ohio State University Comprehensive Cancer Center · Columbus, Ohio
Showing up to 5 US sites. See all sites on ClinicalTrials.gov →
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