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
This is not medical advice. AI-assisted translation — inaccuracies may occur. Always verify the original and consult your oncologist before taking any steps.
About the trial
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.
Original English text from ClinicalTrials.gov
Who can (and can't) join
✓ Qualifies
- •Potwierdzony zaawansowany rak jelita grubego, który nie może być operacyjnie usunięty
- •Dobry ogólny stan zdrowia (ECOG 0-1)
- •Brak wcześniejszego leczenia systemowego (chemioterapii) zaawansowanego raka jelita grubego
- •Guz z dodatnią ekspresją PD-L1 (wynik z centralnego laboratorium)
✗ Disqualifies
- •Wysoka niestabilność mikrosatelitów (MSI-H) lub defekt naprawy błędów DNA (dMMR)
- •Mutacja BRAF V600E
- •Niemożność przełykania tabletek
- •Historia lub obecne schorzenie płuc (włóknienie, zapalenie, fibróza płucna)
- •Aktywna choroba autoimmunologiczna
- •Wcześniejsze leczenie immunoterapią checkpoint (anti-PD-1, anti-PD-L1, anti-CTLA-4)
Simplified criteria — AI translation
Trial details
- Minimum age
- 18 Years
- Last updated (source)
- July 16, 2026
- Sex
- No restrictions
Therapies / drugs in trial
Locations (39)
Mayo Clinic Arizona
Phoenix, United States
USC Norris Comprehensive Cancer Center
Los Angeles, United States
Rocky Mountain Cancer Centers, LLP
Lone Tree, United States
Mayo Clinic Florida
Jacksonville, United States
Advent Health
Orlando, United States
May Clinic Rochester
Rochester, United States
The Ohio State University Comprehensive Cancer Center
Columbus, United States
Thomas Jefferson University, Sidney Kimmel Cancer Center
Philadelphia, United States
Baylor Scott & White Medical Center
Temple, United States
Virginia Oncology Associates
Norfolk, United States
Blue Ridge Cancer Care
Salem, United States
The Ottawa Hospital Cancer Centre
Ottawa, Canada
Princess Margaret Cancer Centre- University Health Network
Toronto, Canada
Jewish General Hospital
Montreal, Canada
CHU Besançon - Hôpital Jean Minjoz
Besançon, France
CHU Bordeaux - Hôpital Haut-Lévêque
Pessac, France
Chru De Nantes Hotel-Dieu
Nantes, France
Hôpital de la Timone
Marseille, France
Hôpital Européen Georges Pompidou
Paris, France
Hôpital Saint-Antoine
Paris, France
Centre Leon Berard
Lyon, France
CHU Poitiers - Hôpital la Milétrie
Poitiers, France
Azienda Socio Sanitaria Territoriale Niguarda
Milan, Italy
Istituto Clinico Humanitas
Milan, Italy
Istituto Europeo di Oncologia
Milan, Italy
AOU Uni degli Studi Della Campania Lugi Vanvitelli
Naples, Italy
Istituto Nazionale Tumori Fondazione G. Pascale
Naples, Italy
IOV-Istituto Oncologico
Padova, Italy
Kobe City Medical Center General Hospital
Hyōgo, Japan
National Hospital Organization Osaka National Hospital
Osaka, Japan
Osaka General Medical Center
Osaka, Japan
Osaka International Cancer Institute
Osaka, Japan
Institut Catala d'Oncologia (H. Germans Trias I Pujol, ICO-Barcelona)
Badalona, Spain
Hosptial Universitari Vall d'Hebron
Barcelona, Spain
Hospital Universitario Reina Sofia
Córdoba, Spain
Hospital Universitario 12 de Octubre
Madrid, Spain
Hospital Universitario Virgen del Rocio
Seville, Spain
Hospital Regional Universitario de Malaga
Málaga, Spain
Hospital General Universitario de Valencia
Valencia, Spain
Trial contact
North America Clinical Trial Support Desk
International Clinical Trial Support Desk
Contact information from ClinicalTrials.gov. Contact in English.
Share this trial
Data from ClinicalTrials.gov. AI-assisted translation, last sync: 7/17/2026.
You can help another person
We fund the Radar, this site, and the development of our Grosz dla Życia fundraising platform from donations and our own resources. Every contribution, even a small one, really helps.