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Clinical Trials in the UK / NCT07284849
Recruiting Phase 3

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

NCT07284849 · tracked via the Priya Life Science UK tracker
Sponsor
Incyte Corporation
Phase
Phase 3
Started
2026-03-05
Last updated
2026-09-15

Condition(s) studied

CRC (Colorectal Cancer)

Investigational drug(s) / intervention(s)

INCA33890PlaceboBevacizumabFOLFOX

INCA33890: INCA33890 will be administered at protocol defined dose.

Placebo: Placebo will be administered at protocol defined dose.

Bevacizumab: Bevacizumab will be administered at protocol defined dose.

FOLFOX: FOLFOX will be administered at protocol defined dose.

Study 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

Sex
ALL
Min age
18 Years
Max age
Healthy volunteers
No
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.

Primary outcome measure(s)

Trial sites (280)

FacilityCityRegionStatus
Mitchell Cancer Institute Mobile Alabama Not Yet Recruiting
The University of Arizona Cancer Center Tucson Arizona Not Yet Recruiting
Roche Tissue Diagnostics, Companion Diagnostics Tucson Arizona Recruiting
Memorial Care Orange Coast Medical Center Fountain Valley California Recruiting
Providence Medical Foundation Fullerton California Recruiting
Cancer & Blood Research Center Los Alamitos California Recruiting
University of California Los Angeles Health Los Angeles California Not Yet Recruiting
Sarah Cannon Research Institute Scri Oncology Partners Aurora Colorado Recruiting
Hartford Hospital Hartford Connecticut Not Yet Recruiting
George Washington University Washington D.C. District of Columbia Not Yet Recruiting
Florida Oncology & Hematology Fort Myers Florida Recruiting
University of Florida Health Gainesville Florida Recruiting
Sylvester Comprehensive Cancer Center Miami Florida Recruiting
Advent Health Orlando Florida Not Yet Recruiting
Orlando Health Cancer Institute Downtown Orlando Orlando Florida Not Yet Recruiting
Ascension Sacred Heart Pensacola Pensacola Florida Recruiting
Tampa General Hospital-Cancer Institute Tampa Florida Not Yet Recruiting
Piedmont Cancer Institute Locust Grove Georgia Not Yet Recruiting
University of Hawaii Cancer Center Honolulu Hawaii Not Yet Recruiting
St Lukes Mountain States Tumor Institute Msti Boise Boise Idaho Not Yet Recruiting
Sih Cancer Institute Carterville Illinois Recruiting
University of Illinois Cancer Center Chicago Illinois Recruiting
Alexian Brothers Medical Center Elk Grove Village Illinois Not Yet Recruiting
Endeavor Health Evanston Illinois Not Yet Recruiting
Springfield Clinic Springfield Illinois Recruiting
Community Health Network, Inc. Indianapolis Indiana Recruiting
Hematology Oncology of Indiana Indianapolis Indiana Recruiting
University of Iowa Hospital and Clinics Iowa City Iowa Not Yet Recruiting
Saint Agnes Hospital Baltimore Maryland Recruiting
Cancer Center For Blood Disorders A Division of American Oncology Partners P.A Bethesda Maryland Recruiting
Sarah Cannon Research Institute Scri Oncology Partners Brandywine Maryland Recruiting
Massachusetts General Hospital Boston Massachusetts Not Yet Recruiting
Oncura Health Boston Massachusetts Not Yet Recruiting
Trinity Health St Joseph Mercy Ann Arbor Ann Arbor Michigan Recruiting
Henry Ford Hospital Detroit Michigan Not Yet Recruiting
Missouri Cancer Associates Columbia Missouri Recruiting
Saint Luke'S Hospital of Kansas City Kansas City Missouri Recruiting
Midamerica Cancer Care Kansas City Missouri Recruiting
Oncology Hematology Associates Springfield Missouri Recruiting
Washington University School of Medicine St Louis Missouri Recruiting

+ 240 more sites — see the full list on the official registry below.

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07284849 on ClinicalTrials.gov ↗ ← All trials in the UK