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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

NCT06948448 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 144

Last updated 2026-05-18

No results posted yet for this study

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.

Conditions

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 & Collaborators

Principal Investigators

  • Project Leader · Ono Pharmaceutical Co., Ltd.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-11-18
Primary Completion
2028-02-15
Completion
2028-10-01
FDA Drug
Yes

Countries

  • United States
  • Canada
  • France
  • Italy
  • Japan
  • Spain

Study Locations

More Related Trials

Entities

Drugs
Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06948448 on ClinicalTrials.gov