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
- Badalona, Barcelona, Córdoba, Madrid, Málaga, Seville, and Valencia, SpainSee the 7 sites
- Phase
- Phase 2
AI summary: who the study is looking for
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for adults with advanced colorectal cancer that cannot be removed by surgery. They must not have had drug treatment for it yet, and the tumor must be PD-L1 positive.
- Age
- 18 years or older
- Sex
- All sexes can join
- Disease stage
- Advanced (locally advanced or metastatic) colorectal cancer that cannot be cured by surgery to remove it
- Earlier treatment
- No earlier systemic (whole-body) treatment for advanced colorectal cancer. No earlier anti-PD-1, anti-PD-L1, anti-PD-L2 or anti-CTLA-4 antibody, or similar immune checkpoint drug.
- Biomarker or test result
- Tumor must be positive for PD-L1, checked at a central laboratory. Tumors with high microsatellite instability (MSI-High) or mismatch repair deficiency (dMMR) cannot join.
Main reasons for not taking part
- MSI-High or dMMR tumor
- BRAF V600E mutation
- Cannot swallow tablets
- Interstitial lung disease, pneumonitis or pulmonary fibrosis, now or in the past
- Active, known or suspected autoimmune disease
Read by machine on 12 November 2026.
Where in Spain
- Institut Catala d'Oncologia (H. Germans Trias I Pujol, ICO-Barcelona)Badalona, SpainContact: North America Clinical Trial Support DeskTaking people
- Hosptial Universitari Vall d'HebronBarcelona, SpainContact: North America Clinical Trial Support DeskTaking people
- Hospital Universitario Reina SofiaCórdoba, SpainContact: North America Clinical Trial Support DeskTaking people
- Hospital Universitario 12 de OctubreMadrid, SpainContact: North America Clinical Trial Support DeskTaking people
- Hospital Regional Universitario de MalagaMálaga, SpainContact: North America Clinical Trial Support DeskTaking people
- Hospital Universitario Virgen del RocioSeville, SpainContact: North America Clinical Trial Support DeskTaking people
- Hospital General Universitario de ValenciaValencia, SpainContact: North America Clinical Trial Support DeskTaking 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?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorTrial 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.