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Recruiting NCT07284849

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

Conditions: CRC (Colorectal Cancer)

Sex: All
Ages: 18 Years – N/A
Healthy volunteers: No
Phase: PHASE3
Enrollment: 700
Sponsor: Incyte Corporation

Location: Mitchell Cancer Institute Mobile Alabama

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 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.

Interested in this study? View the official listing for contact and enrollment details.

View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT07284849). StuddyBuddy aggregates publicly available trial information.