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 (Jun 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
Treatments studied
Immunotherapy
Targeted therapy
Chemotherapy
Other
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 →Frequently asked questions
Is NCT06948448 currently recruiting?
Yes, this trial is currently recruiting patients.
Can patients have received prior systemic therapy?
No. This trial requires treatment-naive patients — prior systemic therapy is an exclusion criterion.
Does this trial require CD274?
Yes, CD274 positive expression is a required biomarker for enrollment.
Are patients with BRAF alterations eligible?
No. BRAF V600E is an exclusion criterion.
Are patients with MSH2 alterations eligible?
No. MSH2 deficient mismatch repair is an exclusion criterion.
Could you qualify for this trial?
Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.
Check if I qualifyRelated pages