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.
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
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
Parallel
ONO-4578
DrugONO-4578 tablets once a day
Opdivo®
DrugSpecified dose on specified days
Oxaliplatin
DrugSpecified dose on specified days
5-Fluorouracil
DrugSpecified dose on specified days
Bevacizumab
DrugSpecified dose on specified days
Leucovorin
DrugSpecified 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.
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.
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.
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.
Overall Survival (OS)
OS is defined as the time between the date of randomization and the date of death due to any cause.
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.
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.
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