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
Start Date
11/18/2025
Completion Date
10/1/2028
Summary
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.
Detailed Description
Potential participants will be consented and screened for study eligibility. Eligible participants will be randomized in a 1:1:1 ratio to one of the three study intervention arms. Study intervention will be administered in 28-day treatment cycles and continued until disease progression, intolerable toxicity, Investigator decision or withdrawal of consent by the participant, or termination of the study by the Sponsor.
Eligibility Criteria
Age Range: 18 years to No maximum
Interventions
ONO-4578
Opdivo®
Oxaliplatin
5-Fluorouracil
Bevacizumab
Leucovorin
Conditions
Locations
Mayo Clinic Arizona
Phoenix, Arizona 85054
United States
USC Norris Comprehensive Cancer Center
Los Angeles, California 90033
United States
Rocky Mountain Cancer Centers, LLP
Lone Tree, Colorado 80124
United States
Mayo Clinic Florida
Jacksonville, Florida 32224
United States
Advent Health
Orlando, Florida 32803
United States
May Clinic Rochester
Rochester, Minnesota 55905
United States
The Ohio State University Comprehensive Cancer Center
Columbus, Ohio 43221
United States
Thomas Jefferson University, Sidney Kimmel Cancer Center
Philadelphia, Pennsylvania 19107
United States
Baylor Scott & White Medical Center
Temple, Texas 76508
United States
Virginia Oncology Associates
Norfolk, Virginia 23502
United States
Blue Ridge Cancer Care
Salem, Virginia 24153
United States
The Ottawa Hospital Cancer Centre
Ottawa, Ontario
Canada
Princess Margaret Cancer Centre- University Health Network
Toronto, Ontario M5G 2M9
Canada
Jewish General Hospital
Montreal, Quebec
Canada
CHU Besançon - Hôpital Jean Minjoz
Besançon, Doubs
France
CHU Bordeaux - Hôpital Haut-Lévêque
Pessac, Gironde
France
Chru De Nantes Hotel-Dieu
Nantes, Loire Atlantique
France
Hôpital de la Timone
Marseille, Marseille
France
Hôpital Européen Georges Pompidou
Paris, Paris
France
Hôpital Saint-Antoine
Paris, Paris
France
Centre Leon Berard
Lyon, Rhone
France
CHU Poitiers - Hôpital la Milétrie
Poitiers, Vienne
France
Azienda Socio Sanitaria Territoriale Niguarda
Milan, Italy
Italy
Istituto Clinico Humanitas
Milan, Italy
Italy
Istituto Europeo di Oncologia
Milan, Italy
Italy
AOU Uni degli Studi Della Campania Lugi Vanvitelli
Naples, Napoli
Italy
Istituto Nazionale Tumori Fondazione G. Pascale
Naples, Napoli
Italy
IOV-Istituto Oncologico
Padova, Padova
Italy
Kobe City Medical Center General Hospital
Hyōgo, Kobe-shi
Japan
National Hospital Organization Osaka National Hospital
Osaka, Osaka-shi
Japan
Osaka General Medical Center
Osaka, Osaka-shi
Japan
Osaka International Cancer Institute
Osaka, Osaka-shi
Japan
Institut Catala d'Oncologia (H. Germans Trias I Pujol, ICO-Barcelona)
Badalona, Barcelona
Spain
Hosptial Universitari Vall d'Hebron
Barcelona, Barcelona
Spain
Hospital Universitario Reina Sofia
Córdoba, Córdoba
Spain
Hospital Universitario 12 de Octubre
Madrid, Madrid
Spain
Hospital Universitario Virgen del Rocio
Seville, Sevilla
Spain
Hospital Regional Universitario de Malaga
Málaga, Spain
Spain
Hospital General Universitario de Valencia
Valencia, Valencia
Spain