Status:
RECRUITING
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
Lead Sponsor:
Incyte Corporation
Conditions:
CRC (Colorectal Cancer)
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief 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 sta...
Eligibility Criteria
Inclusion
- 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
- 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.
- Other protocol-defined inclusion/exclusion criteria apply.
Key Trial Info
Start Date :
March 5 2026
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
September 28 2029
Estimated Enrollment :
700 Patients enrolled
Trial Details
Trial ID
NCT07284849
Start Date
March 5 2026
End Date
September 28 2029
Last Update
March 10 2026
Active Locations (234)
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1
Ironwood Cancer & Research Centers
Chandler, Arizona, United States, 85224-5665
2
The University of Arizona Cancer Center
Tucson, Arizona, United States, 85719
3
Roche Tissue Diagnostics, Companion Diagnostics
Tucson, Arizona, United States, 85755
4
Providence Medical Foundation
Fullerton, California, United States, 92835