A Phase 2 interventional study of ONO-4578 and Opdivo® in Colorectal Cancer, sponsored by Ono Pharmaceutical Co., Ltd.. Recruiting at 39 sites in 6 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-07-16.
Sponsored by Ono Pharmaceutical Co., Ltd. · Phase 2, Interventional, and Treatment
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.
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.
5,599 studies on the registry are indexed under Colorectal Neoplasms; 1,459 are open to participants now.
This study's planned enrollment of 144 is above the median of 77 across 4,123 interventional studies indexed under Colorectal Neoplasms.
Browse Colorectal Neoplasms studies →Ono Pharmaceutical Co., Ltd. is the lead sponsor of 43 studies on the registry; 17 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Other protocol-defined inclusion/exclusion criteria apply
Drug: ONO-4578 · Drug: Opdivo® · Drug: Oxaliplatin · Drug: 5-Fluorouracil · Drug: Bevacizumab · Drug: Leucovorin
Drug: ONO-4578 · Drug: Opdivo® · Drug: Oxaliplatin · Drug: 5-Fluorouracil · Drug: Bevacizumab · Drug: Leucovorin
Drug: Oxaliplatin · Drug: 5-Fluorouracil · Drug: Bevacizumab · Drug: Leucovorin
ONO-4578 tablets once a day
Specified dose on specified days
Also known as: Nivolumab
Specified dose on specified days
Specified dose on specified days
Specified dose on specified days
Specified dose on specified days
Overall Response Rate (ORR) per Blinded Independent Central Review (BICR)
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.
Time frame: From randomization to the end of treatment (Up to 39 months)
Number of participants with Adverse Events (AEs)
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.
Time frame: From first dose to 28 days post last dose
Number of participants with Serious Adverse Events (SAEs)
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.
Time frame: From first dose to 28 days post last dose
Overall Response Rate (ORR) per Investigator assessment
ORR (assessed by site Investigator 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 site Investigator per RECIST v1.1 divided by the total number of participants.
Time frame: From randomization to the end of treatment (Up to 39 months)
Overall Survival (OS)
OS is defined as the time between the date of randomization and the date of death due to any cause.
Time frame: From randomization to the end of treatment (Up to 39 months)
Progression-Free Survival (PFS) by BICR
PFS by BICR is defined as the time from date of randomization to the date of the first documented progressive disease (PD) as determined by BICR per RECIST version 1.1, or the date of death due to any cause, whichever occurs first.
Time frame: From randomization to the end of treatment (Up to 39 months)
Progression-Free Survival (PFS) by Investigator assessment
PFS by Investigator assessment is defined as the time from date of randomization to the date of the first documented progressive disease (PD) as determined by site Investigator per RECIST version 1.1, or the date of death due to any cause, whichever occurs first.
Time frame: From randomization to the end of treatment (Up to 39 months)
Best overall response (BOR) by BICR
BOR is defined as the best response designation, recorded between the start of the study intervention and the date of the initial objectively documented PD per RECIST v1.1 or the date of subsequent anti-cancer therapy, whichever occurs first.
Time frame: From randomization to the end of treatment (Up to 39 months)
Best overall response (BOR) by Investigator assessment
BOR is defined as the best response designation, recorded between the start of the study intervention and the date of the initial objectively documented PD per RECIST v1.1 or the date of subsequent anti-cancer therapy, whichever occurs first.
Time frame: From randomization to the end of treatment (Up to 39 months)
Duration of response (DOR) by BICR
DOR is defined as the time between the date of first confirmed CR or PR to the date of the first documented PD per RECIST v1.1 or death due to any cause, whichever occurs first.
Time frame: From randomization to the end of treatment (Up to 39 months)
Duration of response (DOR) by Investigator assessment
DOR is defined as the time between the date of first confirmed CR or PR to the date of the first documented PD per RECIST v1.1 or death due to any cause, whichever occurs first.
Time frame: From randomization to the end of treatment (Up to 39 months)
Disease Control Rate (DCR) by BICR
DCR is defined as the percentage of participants whose BOR is determined to be CR, PR, or stable disease (SD).
Time frame: From randomization to the end of treatment (Up to 39 months)
Disease Control Rate (DCR) by Investigator assessment
DCR is defined as the percentage of participants whose BOR is determined to be CR, PR, or stable disease (SD).
Time frame: From randomization to the end of treatment (Up to 39 months)
Time to Response (TTR) by BICR
TTR is defined as the time from the date of randomization to the date of first confirmed CR or PR.
Time frame: From randomization to the end of treatment (Up to 39 months)
Time to Response (TTR) by Investigator assessment
TTR is defined as the time from the date of randomization to the date of first confirmed CR or PR.
Time frame: From randomization to the end of treatment (Up to 39 months)
Maximum percent change in the sum of the diameters of the target lesions by BICR
In participants who have target lesions at baseline and at least 1 post-baseline imaging evaluation, the maximum percent change in the sum of diameters of target lesions is the percent change at the point of the minimum sum of diameters of the target lesions.
Time frame: From randomization to the end of treatment (Up to 39 months)
Maximum percent change in the sum of the diameters of the target lesions by Investigator assessment
In participants who have target lesions at baseline and at least 1 post-baseline imaging evaluation, the maximum percent change in the sum of diameters of target lesions is the percent change at the point of the minimum sum of diameters of the target lesions.
Time frame: From randomization to the end of treatment (Up to 39 months)
Progression-Free Survival of second line therapy (PFS2) by Investigator assessment
PFS2 is defined as the time from date of randomization to the date of an overall response of PD after subsequent anti-cancer therapy, initiating date of a second subsequent anti-cancer therapy, or date of death from any cause, whichever occurs first.
Time frame: From randomization to the end of treatment (Up to 39 months)
Plan to share: No
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Ono Pharmaceutical Co., Ltd.