Two-dose ONO-4578 with Opdivo plus mFOLFOX6 and bevacizumab versus standard treatment for advanced PD-L1–positive colorectal cancer

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

Eligible participants with PD-L1–positive, non-MSI-H/dMMR advanced colorectal cancer are randomized 1:1:1 to receive one of two dose levels of ONO-4578 plus Opdivo with mFOLFOX6 and bevacizumab or to receive the current standard-of-care regimen. Treatments are given in 28-day cycles and continued until disease progression, intolerable toxicity, investigator decision, withdrawal of consent, or sponsor termination. Key entry requirements include ECOG 0–1, no prior systemic therapy for advanced disease, PD-L1 positivity confirmed at a central lab, and exclusion of MSI-High/dMMR or BRAF V600E mutated tumors. Safety and anti-tumor activity endpoints will compare the combination arms against standard care to determine whether the addition of ONO-4578 improves outcomes.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* 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 Criteria:

* 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 it's running

• Mayo Clinic Arizona
  Phoenix, Arizona, United States Recruiting
• USC Norris Comprehensive Cancer Center
  Los Angeles, California, United States Recruiting
• Rocky Mountain Cancer Centers, LLP
  Lone Tree, Colorado, United States Recruiting
• Mayo Clinic Florida
  Jacksonville, Florida, United States Recruiting
• Advent Health
  Orlando, Florida, United States Recruiting
• May Clinic Rochester
  Rochester, Minnesota, United States Recruiting

Study contacts

• Study coordinator: North America Clinical Trial Support Desk
• Email: clinical_trial@ono-pharma.com
• Phone: +18665877745(Toll-Free)

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.