Binimetinib Plus Encorafenib Real Life Investigation of Next Generation Melanoma Treatment

Prior treatment

• 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;

Other

• 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).

• 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.