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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
Sponsor: Ono Pharmaceutical Co. Ltd
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.
Official title: 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
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
144
Start Date
2025-11-18
Completion Date
2028-10-01
Last Updated
2026-03-27
Healthy Volunteers
No
Conditions
Interventions
ONO-4578
ONO-4578 tablets once a day
Opdivo®
Specified dose on specified days
Oxaliplatin
Specified dose on specified days
5-Fluorouracil
Specified dose on specified days
Bevacizumab
Specified dose on specified days
Leucovorin
Specified dose on specified days
Locations (28)
Mayo Clinic Arizona
Phoenix, Arizona, United States
USC Norris Comprehensive Cancer Center
Los Angeles, California, United States
Rocky Mountain Cancer Centers, LLP
Lone Tree, Colorado, United States
Mayo Clinic Florida
Jacksonville, Florida, United States
The Ohio State University Comprehensive Cancer Center
Columbus, Ohio, United States
Thomas Jefferson University, Sidney Kimmel Cancer Center
Philadelphia, Pennsylvania, United States
Baylor Scott & White Medical Center
Temple, Texas, United States
Virginia Oncology Associates
Norfolk, Virginia, United States
Blue Ridge Cancer Care
Salem, Virginia, United States
Princess Margaret Cancer Centre- University Health Network
Toronto, Ontario, 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
Istituto Clinico Humanitas
Milan, Italy, Italy
Istituto Europeo di Oncologia
Milan, Italy, 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
Hospital Universitario Reina Sofia
Córdoba, Córdoba, Spain
Hospital Universitario 12 de Octubre
Madrid, Madrid, Spain
Hospital Universitario Virgen del Rocio
Seville, Sevilla, Spain
Hospital General Universitario de Valencia
Valencia, Valencia, Spain