Investigation of encorafenib and binimetinib for advanced melanoma treatment

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 examines the real-world effectiveness, safety, and quality of life for patients with unresectable advanced or metastatic melanoma who are treated with encorafenib and binimetinib. It focuses on patients with BRAF V600 mutations and documents their treatment experiences after prior checkpoint inhibition. The study collects data on patients treated according to the Summary of Product Characteristics in Germany, Austria, and Switzerland, aiming to provide insights into the outcomes of this combination therapy 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 as well as the transfer and processing of his/her data within the study and the ADOREG \[Cancer Registry of German Working Group of Dermato-Oncology\] registry (data transfer to ADOREG registry only for patients from German sites);
* Legally capable male or female patient ≥ 18 years of age (no upper limit);
* Decision was taken to treat the patient with encorafenib plus binimetinib in accordance with the current SmPC \[Summary of Product Characteristics\] and by prescription; this decision was taken prior to and independent from the inclusion into the study;
* Treatment with encorafenib plus binimetinib has been started ≤ 6 months prior to providing written informed consent for this study or is planned to be started in the near future;
* Unresectable advanced or metastatic malignant melanoma with BRAF \[Rapidly Accelerated Fibrosarcoma isoform B\] V600 mutation;
* Treatment-naive or after one prior line of checkpoint inhibitor treatment (anti-CTLA4 \[Cytotoxic T-Lymphocyte Antigen-4\] and/or anti-PD(L)1 \[Programmed cell Death protein 1\]) in the unresectable advanced or metastatic setting.

Exclusion Criteria:

* Previous treatment with a BRAF- and/or MEK \[Mitogen-Activated Protein/Extracellular-signal Regulated Kinase\]- inhibitor except for:

  \-- prior adjuvant treatment with BRAF+MEK-inhibitor combination therapy that ended \> 6 months prior start of Encorafenib/Binimetinib treatment;
* More than one prior line of checkpoint inhibitor treatment in the unresectable advanced or metastatic setting;
* Any previous chemotherapeutic treatment of the melanoma disease;
* Presence of any contraindication with regard to the encorafenib-binimetinib-treatment 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 melanoma;
* Prisoners or persons who are compulsorily detained (involuntarily incarcerated).

Where it's running

• 11
  Graz, Austria Recruiting
• 13
  Innsbruck, Austria Recruiting
• 14
  Klagenfurt, Austria Recruiting
• 10
  Linz, Austria Recruiting
• 3
  Linz, Austria Recruiting
• 12
  Salzburg, Austria Recruiting

+9 more sites. See ClinicalTrials.gov for the full list.

Study contacts

• Study coordinator: Christian A Rosé, MD
• Email: bering_de@pierre-fabre.com
• Phone: +49 761 45261

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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.