Studieninformationen
Kurztitel:
BERING MELANOMA
Beschreibung:
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
Studiendesign:
Anwendungsbeobachtung, , Monozentrisch, National
Alter:
>= 18 Jahre
Erkrankungen:
Ein-/Ausschlusskriterien:
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).
NCT-Nummer:
Studienaktive Standorte
common:study_status_active
MVZ am Klinikum Aschaffenburg-Alzenau
MVZ Klinikum Aschaffenburg-Alzenau, Onkologie Aschaffenburg
Herr Dr. Manfred Welslau
m.welslau@onkologie-ab.de