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
Sponsor: Incyte Corporation
ClinicalTrials ID:NCT07284849
This study assesses the efficacy and safety of adding INCA33890 to standard chemotherapy and bevacizumab in treating metastatic microsatellite stable colorectal cancer. Eligible participants have Stage IV disease, measurable per RECIST v1.1, and ECOG 0-1. Interventions include INCA33890, placebo, bevacizumab, and FOLFOX, all administered at protocol-defined doses.
Patient Parameters
| Parameter | Options |
|---|
Program Overview
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 Criteria
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 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.
Locations
| FACILITY | ZIP | CITY | STATE |
|---|---|---|---|
| Ironwood Cancer & Research Centers | 85224-5665 | Chandler | Arizona |
| The University of Arizona Cancer Center | 85719 | Tucson | Arizona |
| Roche Tissue Diagnostics, Companion Diagnostics | 85755 | Tucson | Arizona |
| Los Angeles Cancer Network | 92801 | Anaheim | California |
| Toi Clinical Research | 90703 | Cerritos | California |
| Memorial Care Orange Coast Medical Center | 92708 | Fountain Valley | California |
| Providence Medical Foundation | 92835 | Fullerton | California |
| University of California Los Angeles Health | 90095 | Los Angeles | California |
| Sarah Cannon Research Institute Scri Oncology Partners | 80012 | Aurora | Colorado |
| Hartford Hospital | 06102 | Hartford | Connecticut |
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