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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

RECRUITINGPhase 3Sponsored by Incyte Corporation
Actively Recruiting
PhasePhase 3
SponsorIncyte Corporation
Started2026-03-05
Est. completion2028-12-29
Eligibility
Age18 Years+
Healthy vol.Accepted
Locations67 sites

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: 18 Years+Healthy volunteers accepted
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.

Conditions2

CRC (Colorectal Cancer)Cancer

Interventions3

Locations67 sites

The University of Arizona Cancer Center
Tucson, Arizona, 85719
Roche Tissue Diagnostics, Companion Diagnostics
Tucson, Arizona, 85755
Toi Clinical Research
Cerritos, California, 90703
Los Angeles Cancer Network
Fountain Valley, California, 92708
Providence Medical Foundation
Fullerton, California, 92835

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Trial data from ClinicalTrials.gov. Trial status and eligibility can change — verify directly with the study contact or on ClinicalTrials.gov.

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