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
NCT ID: NCT07284849
Last Updated: 2025-12-18
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
NOT_YET_RECRUITING
PHASE3
700 participants
INTERVENTIONAL
2026-02-16
2029-09-28
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Keywords
Explore important study keywords that can help with search, categorization, and topic discovery.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
INCA33890
INCA33890 will be administered in combination with bevacizumab and FOLFOX at the protocol-defined dose.
INCA33890
INCA33890 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.
Placebo
Placebo will be administered in combination with bevacizumab and FOLFOX at the 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.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
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.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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
* 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.
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Incyte Corporation
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Incyte Medical Monitor
Role: STUDY_DIRECTOR
Incyte Corporation
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Related Links
Access external resources that provide additional context or updates about the study.
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
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
2025-523735-19-00
Identifier Type: REGISTRY
Identifier Source: secondary_id
INCA033890-303
Identifier Type: -
Identifier Source: org_study_id