Binimetinib Plus Encorafenib Real Life Investigation of Next Generation Melanoma Treatment
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorPierre Fabre Pharma GmbH
About this trial
BERING-MELANOMA - designed as a prospective, longitudinal, non-interventional study - investigates real-world effectiveness, quality of life, safety and tolerability of encorafenib plus binimetinib in unresectable advanced or metastatic BRAF(Rapidly Accelerated Fibrosarcoma isoform B)-V600-mutant malignant melanoma after commercial availability of these two products in Germany, Austria and Switzerland. The study focusses on the documentation of the first and second line setting (i.e. after one line of prior checkpoint inhibition) by documenting patients treated according to the SmPC (Summary of Product Characteristics).
Eligibility criteria
Qualifiers
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;
Disqualifiers
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;
Trial design
Treatments tested in this trial
- Encorafenib
- Binimetinib
Treatment groups
No treatment groups listed
Sponsors and collaborators
Pierre Fabre Pharma GmbH
Lead sponsor
Pierre Fabre Pharma Austria
Collaborator
Pierre Fabre Pharma AG
Collaborator
Source ClinicalTrials.gov