NCT06948448RecruitingPhase 2
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
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
Source: ClinicalTrials.gov · Last updated 16 Jul 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 144 (estimated)
- First submitted
- 21 Apr 2025
- Start date
- 18 Nov 2025
- Primary completion date
- 15 Feb 2028
- Lead sponsor
- Ono Pharmaceutical Co., Ltd.
- Diseases
- Colorectal cancer
- NCT number
- NCT06948448
What you commit to
- Study type: Interventional · Phase 2
- Planned participants: 144
- From 18 Nov 2025 to the primary completion date, 15 Feb 2028
- 39 sites in 6 countries
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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
Other illness
- Participants with complication or history of interstitial lung disease, pneumonitis or pulmonary fibrosis
- Participants with an active, known or suspected autoimmune disease.
Other
- Participants with high microsatellite instability (MSI-High), or mismatch repair deficient (dMMR) tumor
- Participants with BRAF V600E mutation
- Unable to swallow tablets.
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (39)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Jewish General Hospital Coordinator of this site? Confirm its status | Montreal | Canada | Recruiting |
| The Ottawa Hospital Cancer Centre Coordinator of this site? Confirm its status | Ottawa | Canada | Recruiting |
| Princess Margaret Cancer Centre - University Health Network Coordinator of this site? Confirm its status | Toronto | Canada | Recruiting |
| Institut Catala d'Oncologia (H. Germans Trias I Pujol, ICO-Barcelona) Coordinator of this site? Confirm its status | Badalona | Spain | Recruiting |
| Hosptial Universitari Vall d'Hebron Coordinator of this site? Confirm its status | Barcelona | Spain | Recruiting |
| Hospital Universitario Reina Sofia Coordinator of this site? Confirm its status | Córdoba | Spain | Recruiting |
| Hospital Universitario 12 de Octubre Coordinator of this site? Confirm its status | Madrid | Spain | Recruiting |
| Hospital Regional Universitario de Malaga Coordinator of this site? Confirm its status | Málaga | Spain | Recruiting |
| Hospital Universitario Virgen del Rocio Coordinator of this site? Confirm its status | Seville | Spain | Recruiting |
| Hospital General Universitario de Valencia Coordinator of this site? Confirm its status | Valencia | Spain | Recruiting |
| CHU Besancon - Hopital Jean Minjoz Coordinator of this site? Confirm its status | Besançon | France | Recruiting |
| Centre Leon Berard Coordinator of this site? Confirm its status | Lyon | France | Recruiting |
| Hopital de la Timone Coordinator of this site? Confirm its status | Marseille | France | Recruiting |
| Chru De Nantes Hotel-Dieu Coordinator of this site? Confirm its status | Nantes | France | Recruiting |
| Hôpital Saint-Antoine Coordinator of this site? Confirm its status | Paris | France | Recruiting |
| Hôpital Européen Georges Pompidou Coordinator of this site? Confirm its status | Paris | France | Recruiting |
| CHU Bordeaux - Hopital Haut-Leveque Coordinator of this site? Confirm its status | Pessac | France | Recruiting |
| CHU Poitiers - Hôpital la Milétrie Coordinator of this site? Confirm its status | Poitiers | France | Recruiting |
| Azienda Socio Sanitaria Territoriale Niguarda Coordinator of this site? Confirm its status | Milan | Italy | Recruiting |
| Istituto Europeo di Oncologia Coordinator of this site? Confirm its status | Milan | Italy | Recruiting |
| Istituto Clinico Humanitas Coordinator of this site? Confirm its status | Milan | Italy | Recruiting |
| AOU Uni degli Studi Della Campania Lugi Vanvitelli Coordinator of this site? Confirm its status | Naples | Italy | Recruiting |
| Istituto Nazionale Tumori Fondazione G. Pascale Coordinator of this site? Confirm its status | Naples | Italy | Recruiting |
| IOV-Istituto Oncologico Coordinator of this site? Confirm its status | Padova | Italy | Recruiting |
| Kobe City Medical Center General Hospital Coordinator of this site? Confirm its status | Hyōgo | Japan | Recruiting |
| Osaka General Medical Center Coordinator of this site? Confirm its status | Osaka | Japan | Recruiting |
| Osaka International Cancer Institute Coordinator of this site? Confirm its status | Osaka | Japan | Recruiting |
| National Hospital Organization Osaka National Hospital Coordinator of this site? Confirm its status | Osaka | Japan | Recruiting |
| The Ohio State University Comprehensive Cancer Center Coordinator of this site? Confirm its status | Columbus | United States | Recruiting |
| Mayo Clinic Florida Coordinator of this site? Confirm its status | Jacksonville | United States | Recruiting |
| Rocky Mountain Cancer Centers,LLP Coordinator of this site? Confirm its status | Lone Tree | United States | Recruiting |
| USC / Norris Comprehensive Cancer Center Coordinator of this site? Confirm its status | Los Angeles | United States | Recruiting |
| Virginia Oncology Associates Coordinator of this site? Confirm its status | Norfolk | United States | Recruiting |
| Advent Health Coordinator of this site? Confirm its status | Orlando | United States | Recruiting |
| Thomas Jefferson University, Sidney Kimmel Cancer Center Coordinator of this site? Confirm its status | Philadelphia | United States | Recruiting |
| Mayo Clinic - Arizona Coordinator of this site? Confirm its status | Phoenix | United States | Recruiting |
| May Clinic Rochester Coordinator of this site? Confirm its status | Rochester | United States | Recruiting |
| Blue Ridge Cancer Care Coordinator of this site? Confirm its status | Salem | United States | Recruiting |
| Baylor Scott & White Medical Center Coordinator of this site? Confirm its status | Temple | United States | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.