Investigation of Encorafenib and Cetuximab for BRAF-mutated Metastatic 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 observational study aims to evaluate the real-world effectiveness of the combination therapy of encorafenib and cetuximab in patients with metastatic colorectal carcinoma (mCRC) harboring the BRAFV600E mutation. It focuses on patients who have been pretreated with systemic therapy and have recently started or are about to start this targeted therapy. The study will document treatment outcomes and survival rates in a longitudinal manner, providing insights into the efficacy of this regimen in a real-world setting.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Written informed consent of the patient with regard to the pseudonymized documentation of his/her data in the frame of this non-interventional study
* Legally capable patient ≥ 18 years of age (no upper limit)
* Metastatic colorectal carcinoma with BRAFV600E-mutation, pretreated with systemic therapy
* Decision was taken to treat the patient with the doublet therapy (encorafenib and cetuximab) in accordance with the current SmPC and by prescription; this decision was taken prior to and independent from the inclusion into the study;
* Treatment with the doublet therapy (encorafenib plus cetuximab) has been started ≤ 3 months prior to providing written informed consent for this study or is planned to be started in the near future.

Exclusion Criteria:

* More than 2 prior systemic regimens in the metastatic setting (adjuvant systemic therapy with relapse ≤ 6 months will be counted as metastatic treatment line; maintenance treatment will not be counted as separate metastatic treatment line)
* Prior treatment with any RAF-inhibitor or MEK-inhibitor.
* Presence of any contraindication with regard to the doublet therapy (encorafenib plus cetuximab) as specified in the corresponding SmPCs
* Current or upcoming participation in an interventional clinical trial
* Current or upcoming systemic treatment of any other tumor than metastatic colorectal carcinoma
* Prisoners or persons who are compulsorily detained (involuntarily incarcerated).

Where it's running

• Clinic
  Braunau am Inn, Upper Austria, Austria Recruiting
• Clinic
  Linz, Upper Austria, Austria Recruiting
• Clinic
  Feldkirch, Voralberg, Austria Recruiting
• Clinic
  Vienna, Austria Recruiting
• Practice
  Offenburg, Baden-Wurttemberg, Germany Recruiting
• Medical Care Centre
  Ulm, Baden-Wurttemberg, Germany Recruiting

+20 more sites. See ClinicalTrials.gov for the full list.

Study contacts

• Study coordinator: Marion Schmoll
• Email: marion.schmoll@iomedico.com
• Phone: +4976115242627

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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.