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

ID#: NCT07284849

Age: 18 years - 66+

Gender: All

Healthy Subjects: No

Study Phase: Phase 3

Recruitment Status: Recruiting

Start Date: February 16, 2026

End Date: September 28, 2029

Contact Information:
Incyte Corporation Call Center (US)
1.855.463.3463
Incyte Corporation Call Center (ex-US)
+800 00027423
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 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.