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

PHASE2Not yet recruitingINTERVENTIONAL
Enrollment

144

Participants

Timeline

Start Date

July 31, 2025

Primary Completion Date

February 15, 2028

Study Completion Date

October 1, 2028

Conditions
Colorectal Cancer
Interventions
DRUG

ONO-4578

ONO-4578 tablets once a day

DRUG

Opdivo®

Specified dose on specified days

DRUG

Oxaliplatin

Specified dose on specified days

DRUG

5-Fluorouracil

Specified dose on specified days

DRUG

Bevacizumab

Specified dose on specified days

DRUG

Leucovorin

Specified dose on specified days

Sponsors
All Listed Sponsors
lead

Ono Pharmaceutical Co. Ltd

INDUSTRY

NCT06948448 - 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 | Biotech Hunter | Biotech Hunter