A Study 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
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
700 participants
Mar 5, 2026
INTERVENTIONAL
Conditions
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
Inclusion Criteria5
- 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 Criteria8
- 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.
- Treatment with an anti-PD-(L)1 or other immune checkpoint inhibitor for any indication within the last 3 years.
- Active autoimmune disease that has required systemic treatment in the past 2 years.
- Significant concurrent and/or uncontrolled medical condition.
- History of organ transplant, including allogeneic stem cell transplantation.
Interventions
INCA33890 will be administered at protocol defined dose.
Placebo will be administered at protocol defined dose.
Bevacizumab will be administered at protocol defined dose.
FOLFOX will be administered at protocol defined dose.
Locations(240)
View Full Details on ClinicalTrials.gov
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NCT07284849