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NCT07284849phase 3recruiting
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
700
Enrollment · estimated
21
Countries · 254 sites
2028-12
Primary completion
1 mo ago
Record updated
Commercial relevance
Trial record references molecular eligibility required.
Molecular eligibility required
Change timeline
Signals from this trial
- New trial53/100Opportunity
New phase 3 trial NCT07284849 posted by Incyte Corporation: "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".
Eligibility — raw, for validation
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.