A Randomized, Double-Blind, Phase 3 Study of Standard-of-Care Chemotherapy and Bevacizumab With or Without INCA33890 in the First-Line Treatment of Metastatic Microsatellite Stable Colorectal Cancer
Incyte Corporation
Summary
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.
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: * 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. * Adequate organ function determined by laboratory results. Exclusion Criteria: * MSI-H/dMMR per historical data in the medical record. * BRAF V600E mutation per historical data in the medical record. * Untreated and/or p…
Interventions
- DrugINCA33890
INCA33890 will be administered at protocol defined dose.
- DrugPlacebo
Placebo will be administered at protocol defined dose.
- DrugBevacizumab
Bevacizumab will be administered at protocol defined dose.
- DrugFOLFOX
FOLFOX will be administered at protocol defined dose.
Locations (273)
- Ironwood Cancer & Research CentersChandler, Arizona
- The University of Arizona Cancer CenterTucson, Arizona
- Roche Tissue Diagnostics, Companion DiagnosticsTucson, Arizona
- Los Angeles Cancer NetworkAnaheim, California
- Toi Clinical ResearchCerritos, California
- Memorial Care Orange Coast Medical CenterFountain Valley, California