Tests new ONO-4578 with Opdivo for advanced colorectal cancer
Tests ONO-4578 with Opdivo and chemotherapy in adults with advanced colorectal cancer.
Plain-language title generated from the registry record
Registry title: 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
Key facts
- Where
- Montreal, Ottawa, and Toronto, CanadaSee the 3 sites
- Phase
- Phase 2
Where in Canada
- Jewish General HospitalMontreal, CanadaTaking people
- The Ottawa Hospital Cancer CentreOttawa, CanadaTaking people
- Princess Margaret Cancer Centre - University Health NetworkToronto, CanadaTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Ono Pharmaceutical Co., Ltd.
- Trial code
- NCT06948448
- Record updated
- 16 July 2026
- Original description
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.Read full original descriptionShow less
A Randomized, Open Label, Multicenter, Phase 2 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 for First-line Treatment of Non-MSI-H/dMMR, PD-L1 Positive Advanced Colorectal Cancer
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.
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: 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; Participants with complication or history of interstitial lung disease, pneumonitis or pulmonary fibrosis; Participants with an active, known or suspected autoimmune disease; Participants with high microsatellite instability (MSI-High), or mismatch repair deficient (dMMR) tumor; Participants with BRAF V600E mutation; Unable to swallow tablets.