BERING-MELANOMA - a prospective, longitudinal, non-interventional study - is investigating the real-world efficacy, quality of life, safety and tolerability of encorafenib plus binimetinib in unresectable advanced or metastatic BRAF (Rapidly Accelerated Fibrosarcoma isoform B) V600-mutated malignant melanoma following the launch of these two products in Germany, Austria and Switzerland.
Aim of the study
The aim of this project is to investigate the effect of treatment with Braftovi® hard capsules (active ingredient: encorafenib) and Mektovi® tablets (active ingredient: binimetinib) in the treatment of melanoma. The data obtained in this project will be used to gain experience with authorized medicinal products under conditions of normal use.
Who can take part?
Adult patients with unresectable advanced or metastatic BRAFV600-mutated malignant melanoma for whom a decision for targeted treatment with encorafenib/binimetinib has been made according to the current prescribing information.
Procedure
As part of the observational study, no further examinations will be carried out outside of the routine treatments. The duration of your participation is a minimum of 12 months and a maximum of 84 months (= total observation period of the project). The study is expected to be completed in 2026. Appointments will take place approximately every 3 months during the first year and every 6 months thereafter, in line with the usual clinical routine. During the routine appointment, data on your medical history and your occupation and employment status will be recorded. A doctor will also ask you to complete questionnaires about your quality of life, your satisfaction with your treatment and, if you work, the impact of your illness on your work. This takes about 20-25 minutes per appointment.
Compensation
None
Original study name
Encorafenib plus binimetinib in patients with locally advanced, unresectable or metastatic BRAFV600-mutated melanoma: a multicenter, multinational, prospective, longitudinal, non-interventional study in Germany, Austria and Switzerland
BASEC number
2020-00339
Financial support from
Pierre Fabre Medicament