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First-line treatment with standard chemotherapy and bevacizumab, with or without INCA33890, for metastatic microsatellite-stable colorectal cancer

A Randomized, Double-Blind, Phase 3 Study of Standard-of-Care Chemotherapy and Bevacizumab With or Without INCA33890 in the First-Line Treatment of Metastatic Microsatellite Stable Colorectal Cancer

Phase 3 Interventional Incyte Corporation · NCT07284849

This trial will test whether adding a new drug, INCA33890, to standard chemotherapy and bevacizumab helps people with metastatic microsatellite-stable colorectal cancer respond better or live longer.

Quick facts

PhasePhase 3
Study typeInterventional
Enrollment700 (estimated)
Ages18 Years and up
SexAll
SponsorIncyte Corporation Industry-sponsored
Drugs / interventionsbevacizumab, chemotherapy
Locations273 sites (Chandler, Arizona and 272 other locations)
Trial IDNCT07284849 on ClinicalTrials.gov

What this trial studies

This Phase 3 randomized trial compares standard first-line chemotherapy (FOLFOX) plus bevacizumab with either INCA33890 or placebo in patients with unresectable stage IV microsatellite-stable colorectal adenocarcinoma. Eligible participants must have measurable disease, ECOG 0–1, adequate organ function, and no prior systemic therapy for metastatic disease. The study measures efficacy (tumor response, progression, and survival) and safety outcomes while monitoring adverse events. Treatments and follow-up are delivered at participating clinical sites in Arizona.

Who should consider this trial

Good fit: People with unresectable stage IV microsatellite-stable colorectal adenocarcinoma who have not received prior systemic therapy for metastatic disease, have measurable disease, ECOG 0–1, and adequate organ function are the intended candidates.

Not a fit: Patients with MSI-H/dMMR tumors, BRAF V600E mutation, untreated or progressing CNS metastases, recent immune checkpoint therapy, recent other malignancies, active autoimmune disease requiring recent systemic treatment, significant uncontrolled medical conditions, or a history of organ transplant are excluded and unlikely to benefit.

Why it matters

Potential benefit: If successful, adding INCA33890 could improve tumor response rates and delay disease progression compared with standard chemotherapy plus bevacizumab.

How similar studies have performed: Previous trials combining novel agents with chemotherapy and bevacizumab in microsatellite-stable colorectal cancer have shown mixed results, so this approach builds on some encouraging signals but is not yet proven.

Eligibility criteria

Show full inclusion / exclusion 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.

Where this trial is running

Chandler, Arizona and 272 other locations

+223 more sites — see ClinicalTrials.gov for the full list.

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions CRCMetastatic Colorectal CancerColon CancerINCA33890
Last reviewed 2026-06-13 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.