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Investigation of encorafenib and binimetinib for advanced melanoma treatment

Encorafenib Plus Binimetinib in Patients With Locally Advanced, Unresectable or Metastatic BRAFV600-mutated Melanoma: a Multi-centric, Multinational, Prospective, Longitudinal, Non-interventional Study in Germany, Austria and Switzerland - BERING MELANOMA

Observational Pierre Fabre Pharma GmbH · NCT04045691

This study looks at how well the combination of encorafenib and binimetinib works for people with advanced melanoma who have a specific genetic mutation and have already tried other treatments.

Quick facts

Study typeObservational
Enrollment750 (estimated)
Ages18 Years and up
SexAll
SponsorPierre Fabre Pharma GmbH Industry-sponsored
Drugs / interventionsbinimetinib
Locations59 sites (Graz and 58 other locations)
Trial IDNCT04045691 on ClinicalTrials.gov

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.

Who should consider this trial

Good fit: Ideal candidates include adults aged 18 and older with unresectable advanced or metastatic melanoma harboring the BRAF V600 mutation who are starting or have recently started treatment with encorafenib and binimetinib.

Not a fit: Patients with melanoma that does not have the BRAF V600 mutation or those who are not eligible for treatment with encorafenib and binimetinib may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide valuable information on the effectiveness and tolerability of encorafenib and binimetinib, potentially improving treatment strategies for advanced melanoma.

How similar studies have performed: Other studies have shown promising results with similar combinations of targeted therapies for melanoma, indicating potential for success in this approach.

Eligibility criteria

Show full inclusion / exclusion criteria 
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 this trial is running

Graz and 58 other locations

+9 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 Melanoma Stage IVMelanoma Stage IIIBERINGEncorafenibBinimetinib
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.