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

See if I qualify

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 Identifier	NCT04045691
Sponsor	Pierre Fabre Pharma GmbH
Last Modified on	17 February 2022

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