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

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
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 144 (estimated)
• Sponsor: Ono Pharmaceutical Co., Ltd. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Colorectal Cancer

Interventions

Type	Name	Description
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

Timeline

• Start date: 2025-11-18
• Primary completion: 2028-02-15
• Completion: 2028-10-01
• First posted: 2025-04-29
• Last updated: 2026-03-27

Locations

28 sites across 6 countries: United States, Canada, France, Italy, Japan, Spain

Regulatory

• FDA-regulated drug study