The purpose of this study is to evaluate the efficacy and safety of standard-of-care chemotherapy and bevacizumab with or without INCA33890 in the first-line treatment of metastatic microsatellite stable colorectal cancer.
Stage IV colorectal adenocarcinoma not amenable to curative resection.
No prior systemic treatment for unresectable or metastatic disease. Participants who received adjuvant or neoadjuvant therapy may enroll if there was no recurrence within 12 months of the end of treatment.
Measurable disease per RECIST v1.1.
ECOG performance status of 0 or 1.
MSI-H/dMMR per historical data in the medical record.
BRAF V600E mutation per historical data in the medical record.
Untreated and/or progressing CNS metastases.
History of other malignancy within 2 years.
Parallel
INCA33890
DrugINCA33890 will be administered at protocol defined dose.
Placebo
DrugPlacebo will be administered at protocol defined dose.
Bevacizumab
DrugBevacizumab will be administered at protocol defined dose.
FOLFOX
DrugFOLFOX will be administered at protocol defined dose.
Progression-Free Survival (PFS)
Defined as the time from the date of randomization to the date of the first documented progression as determined by the investigator per Response Evaluation Criteria in Solid Tumours (RECIST) v1.1 or death due to any cause.
Overall Survival (OS)
Defined as the time from the date of randomization to the date of death due to any cause.
Objective response
Defined as complete response (CR) or partial response (PR) as determined by the investigator per RECIST v1.1.
Duration of Response (DOR)
Defined as the time from the earliest date of documented response until the earliest date of disease progression as determined by the investigator per RECIST v1.1 or death due to any cause, whichever occurs first.
Treatment Emergent Adverse Events (TEAEs)
Adverse events reported for the first time or worsening of a pre-existing event after first dose of study treatment, up to 90 days after the last dose INCA33890/placebo (or 30 days after the last dose of any FOLFOX component or bevacizumab if later) or the start of new anticancer therapy, whichever comes first.
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