NCT06948448 · Ono Pharmaceutical Co., Ltd.
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
What this study is about
The purpose of this study is to evaluate the safety and effectiveness of two dose levels of ONO-4578 with Opdivo® when added to mFOLFOX6 and bevacizumab versus SOC as first-line treatment for advanced CRC.
View original scientific description
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.
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
Primary outcome measures
Overall Response Rate (ORR) per Blinded Independent Central Review (BICR)
Time frame: 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)
Time frame: 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)
Time frame: 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.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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. Other protocol-defined inclusion/exclusion criteria apply
Where
- Phoenix, Arizona
- Los Angeles, California
- Lone Tree, Colorado
- Jacksonville, Florida
- Orlando, Florida
- Rochester, Minnesota
- Columbus, Ohio
- Philadelphia, Pennsylvania
- Temple, Texas
- Norfolk, Virginia
- Salem, Virginia
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Jul 16, 2026 · Source of record for eligibility and locations