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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

NCT ID: NCT06948448

Last Updated: 2026-01-21

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE2

Total Enrollment

144 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-11-18

Study Completion Date

2028-10-01

Brief Summary

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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.

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Detailed Description

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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

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Colorectal Cancer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Arm A ONO-4578 dose 1 + Opdivo® + SOC (mFOLFOX6 + bevacizumab)

Group Type EXPERIMENTAL

ONO-4578

Intervention Type DRUG

ONO-4578 tablets once a day

Opdivo®

Intervention Type DRUG

Specified dose on specified days

Oxaliplatin

Intervention Type DRUG

Specified dose on specified days

5-Fluorouracil

Intervention Type DRUG

Specified dose on specified days

Bevacizumab

Intervention Type DRUG

Specified dose on specified days

Leucovorin

Intervention Type DRUG

Specified dose on specified days

Arm B ONO-4578 dose 2 + Opdivo® + SOC (mFOLFOX6 + bevacizumab)

Group Type EXPERIMENTAL

ONO-4578

Intervention Type DRUG

ONO-4578 tablets once a day

Opdivo®

Intervention Type DRUG

Specified dose on specified days

Oxaliplatin

Intervention Type DRUG

Specified dose on specified days

5-Fluorouracil

Intervention Type DRUG

Specified dose on specified days

Bevacizumab

Intervention Type DRUG

Specified dose on specified days

Leucovorin

Intervention Type DRUG

Specified dose on specified days

Arm C SOC (mFOLFOX6+bevacizumab)

Group Type ACTIVE_COMPARATOR

Oxaliplatin

Intervention Type DRUG

Specified dose on specified days

5-Fluorouracil

Intervention Type DRUG

Specified dose on specified days

Bevacizumab

Intervention Type DRUG

Specified dose on specified days

Leucovorin

Intervention Type DRUG

Specified dose on specified days

Interventions

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ONO-4578

ONO-4578 tablets once a day

Intervention Type DRUG

Opdivo®

Specified dose on specified days

Intervention Type DRUG

Oxaliplatin

Specified dose on specified days

Intervention Type DRUG

5-Fluorouracil

Specified dose on specified days

Intervention Type DRUG

Bevacizumab

Specified dose on specified days

Intervention Type DRUG

Leucovorin

Specified dose on specified days

Intervention Type DRUG

Other Intervention Names

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Nivolumab

Eligibility Criteria

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Inclusion Criteria

* 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

Exclusion Criteria

* Participants with high microsatellite instability (MSI-High), or mismatch repair deficient (dMMR) tumor
* Participants with BRAF V600E mutation
* Unable to swallow tablets.
* Participants with complication or history of interstitial lung disease, pneumonitis or pulmonary fibrosis
* Participants with an active, known or suspected autoimmune disease.
* Prior treatment with an anti-PD-1, anti-PD-L1, anti-PD-L2, or anti-CTLA-4 antibody, or any other antibody or drug specifically targeting T-cell co-stimulation or immune checkpoint pathways.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Ono Pharmaceutical Co. Ltd

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Project Leader

Role: STUDY_DIRECTOR

Ono Pharmaceutical Co. Ltd

Locations

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Mayo Clinic Arizona

Phoenix, Arizona, United States

Site Status RECRUITING

USC Norris Comprehensive Cancer Center

Los Angeles, California, United States

Site Status RECRUITING

Rocky Mountain Cancer Centers, LLP

Lone Tree, Colorado, United States

Site Status RECRUITING

Mayo Clinic Florida

Jacksonville, Florida, United States

Site Status RECRUITING

The Ohio State University Comprehensive Cancer Center

Columbus, Ohio, United States

Site Status RECRUITING

Baylor Scott & White Medical Center

Temple, Texas, United States

Site Status RECRUITING

Blue Ridge Cancer Care

Salem, Virginia, United States

Site Status RECRUITING

Princess Margaret Cancer Centre- University Health Network

Toronto, Ontario, Canada

Site Status RECRUITING

CHU Bordeaux - Hôpital Haut-Lévêque

Pessac, Gironde, France

Site Status RECRUITING

Hôpital de la Timone

Marseille, Marseille, France

Site Status RECRUITING

Hôpital Européen Georges Pompidou

Paris, Paris, France

Site Status RECRUITING

Hôpital Saint-Antoine

Paris, Paris, France

Site Status RECRUITING

Kobe City Medical Center General Hospital

Hyōgo, Kobe-shi, Japan

Site Status RECRUITING

National Hospital Organization Osaka National Hospital

Osaka, Osaka-shi, Japan

Site Status RECRUITING

Osaka General Medical Center

Osaka, Osaka-shi, Japan

Site Status RECRUITING

Osaka International Cancer Institute

Osaka, Osaka-shi, Japan

Site Status RECRUITING

Hospital Universitario Virgen del Rocio

Seville, Sevilla, Spain

Site Status RECRUITING

Countries

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United States Canada France Japan Spain

Central Contacts

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North America Clinical Trial Support Desk

Role: CONTACT

[email protected]
+18665877745(Toll-Free)

International Clinical Trial Support Desk

Role: CONTACT

[email protected]
+17162141777(Standard)

Other Identifiers

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ONO-4578-10

Identifier Type: -

Identifier Source: org_study_id

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