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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.

Phase 2RecruitingOno Pharmaceutical Co. LtdNCT06948448Data as of May 2026

Treatment: ONO-4578 · Opdivo® · Oxaliplatin · 5-Fluorouracil · Bevacizumab · LeucovorinThe 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.

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Extracted 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

No prior treatment (treatment-naive required)
Max 0 prior lines

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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