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
Status: Recruiting
Location: See all (12) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2
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.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:
• 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
Locations
United States
Arizona
Mayo Clinic Arizona
RECRUITING
Phoenix
California
USC Norris Comprehensive Cancer Center
RECRUITING
Los Angeles
Florida
Mayo Clinic Florida
RECRUITING
Jacksonville
Ohio
The Ohio State University Comprehensive Cancer Center
RECRUITING
Columbus
Other Locations
Canada
Princess Margaret Cancer Centre- University Health Network
RECRUITING
Toronto
France
Hôpital Européen Georges Pompidou
RECRUITING
Paris
Hôpital Saint-Antoine
RECRUITING
Paris
CHU Bordeaux - Hôpital Haut-Lévêque
RECRUITING
Pessac
Japan
Kobe City Medical Center General Hospital
RECRUITING
Hyōgo
National Hospital Organization Osaka National Hospital
RECRUITING
Osaka
Osaka General Medical Center
RECRUITING
Osaka
Osaka International Cancer Institute
RECRUITING
Osaka
Contact Information
Primary
North America Clinical Trial Support Desk
clinical_trial@ono-pharma.com
+18665877745(Toll-Free)
Backup
International Clinical Trial Support Desk
clinical_trial@ono-pharma.com
+17162141777(Standard)
Time Frame
Start Date: 2025-11-18
Estimated Completion Date: 2028-10-01
Participants
Target number of participants: 144
Treatments
Experimental: Arm A ONO-4578 dose 1 + Opdivo® + SOC (mFOLFOX6 + bevacizumab)
Experimental: Arm B ONO-4578 dose 2 + Opdivo® + SOC (mFOLFOX6 + bevacizumab)
Active_comparator: Arm C SOC (mFOLFOX6+bevacizumab)
Related Therapeutic Areas
Sponsors
Leads: Ono Pharmaceutical Co. Ltd