Binimetinib Plus Encorafenib Real Life Investigation of Next Generation Melanoma Treatment (BERING)

  • STATUS
    Recruiting
  • End date
    Sep 30, 2027
  • participants needed
    750
  • sponsor
    Pierre Fabre Pharma GmbH
Updated on 17 February 2022
cancer
BRAF

Summary

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).

Details
Condition Melanoma Stage IV, Melanoma Stage III
Treatment Binimetinib, Encorafenib
Clinical Study IdentifierNCT04045691
SponsorPierre Fabre Pharma GmbH
Last Modified on17 February 2022

Eligibility

Yes No Not Sure

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)
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