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

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• The University of Arizona Cancer Center
  Tucson, Arizona, United States Recruiting
• Roche Tissue Diagnostics, Companion Diagnostics
  Tucson, Arizona, United States Recruiting
• Memorial Care Orange Coast Medical Center
  Fountain Valley, California, United States Recruiting
• Providence Medical Foundation
  Fullerton, California, United States Recruiting
• Cancer & Blood Research Center
  Los Alamitos, California, United States Recruiting
• Oncura Health
  Sacramento, California, United States Recruiting

+247 more sites. See ClinicalTrials.gov for the full list.

Study contacts

• Study coordinator: Incyte Corporation Call Center (US)
• Email: medinfo@incyte.com
• Phone: 1.855.463.3463

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.