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A Study of ONO-4578 with Opdivo® for Advanced Colorectal Cancer

This study is looking at two different doses of ONO-4578, given along with Opdivo®, mFOLFOX6 (a chemotherapy combination of Oxaliplatin, 5-Fluorouracil, and Leucovorin), and Bevacizumab. This combination is compared to the standard treatment for advanced colorectal cancer. You may be able to join if you have advanced colorectal cancer that has not spread to other parts of your body, or has spread (metastatic), and your tumor shows a specific biomarker called PD-L1. The study aims to see how well the treatment shrinks tumors (Overall Response Rate) and to track any side effects. The current status of this study is unclear.

Study design
This is an interventional study with an unclear phase, planning to enroll 144 participants. Participants will be randomly assigned to one of three treatment groups.
What's involved
Eligible participants will receive treatment in 28-day cycles. Treatment continues until the disease gets worse, side effects are too severe, or you decide to stop.
Compensation
Not stated in the trial record.
Follow-up
The study will track how well the treatment works until the end of treatment (up to 39 months). Side effects will be monitored from the first dose until 28 days after the last dose.

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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

Recruiting
PHASE2Ages 18+InterventionalTreatment
Ono Pharmaceutical Co., Ltd.
~144 participants
Updated 2026-07-16 on ClinicalTrials.gov
What's tested:ONO-4578Opdivo®Oxaliplatin5-FluorouracilBevacizumabLeucovorin

At a glance

Recruiting sites
39 of 39 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Overall Response Rate (ORR) per Blinded Independent Central Review (BICR)
Measured over From randomization to the end of treatment (Up to 39 months)
+2 more outcomes measured

Conditions

Colorectal Cancer

Explore related trials

Colorectal Carcinoma

Where it's being run

39 sites across 29 states
Italy3
Osaka-shi3
Florida2
Virginia2
Ontario2
Paris2
Napoli2
Barcelona2

Study leadership

  • Project Leader · STUDY_DIRECTOR · Ono Pharmaceutical Co., Ltd.

Who to contact

North America Clinical Trial Support Desk
[email protected]
+18665877745(Toll-Free)
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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

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.

What this trial measures

  • Overall Response Rate (ORR) per Blinded Independent Central Review (BICR)From randomization to the end of treatment (Up to 39 months)

    ORR (assessed by BICR per RECIST v1.1) is defined as the proportion of participants with a BOR of confirmed CR or PR. The ORR will be estimated as the number of participants achieving BOR of CR or PR assessed by BICR per RECIST v1.1 divided by the total number of participants.

  • Number of participants with Adverse Events (AEs)From first dose to 28 days post last dose

    An AE is any untoward medical occurrence in a patient or clinical study patient, temporally associated with the use of a study intervention, whether or not considered related to the study intervention.

  • Number of participants with Serious Adverse Events (SAEs)From first dose to 28 days post last dose

    SAE is defined as any untoward medical occurrence that, at any dose results in death, is life-threatening, requires inpatient hospitalization or causes prolongation of existing hospitalization, results in significant disability/incapacity.