Encorafenib: Observation of real-life treatment with encorafenib and binimetinib
Binimetinib: Observation of real-life treatment with encorafenib and binimetinib
Study 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).
Eligibility
Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
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).
Primary outcome measure(s)
Progression-free survival — At 12 months after start of treatment Progression-free survival rate
Trial sites (59)
Facility
City
Region
Status
11
Graz
Austria
Recruiting
13
Innsbruck
Austria
Recruiting
14
Klagenfurt
Austria
Recruiting
10
Linz
Austria
Recruiting
3
Linz
Austria
Recruiting
12
Salzburg
Austria
Recruiting
22
Vienna
Austria
Recruiting
53
Vienna
Austria
Recruiting
23
Wiener Neustadt
Austria
Recruiting
45
Ahaus
Germany
Recruiting
8
Aschaffenburg
Germany
Recruiting
56
Augsburg
Germany
Recruiting
51
Berlin
Germany
Recruiting
27
Bremerhaven
Germany
Recruiting
1
Buxtehude
Germany
Recruiting
43
Chemnitz
Germany
Recruiting
34
Donauwörth
Germany
Recruiting
49
Dresden
Germany
Recruiting
47
Duisburg
Germany
Recruiting
40
Erfurt
Germany
Recruiting
20
Essen
Germany
Recruiting
9
Gera
Germany
Recruiting
28
Giessen
Germany
Recruiting
42
Goslar
Germany
Recruiting
59
Göttingen
Germany
Recruiting
19
Hamburg
Germany
Recruiting
21
Hanover
Germany
Recruiting
2
Heidelberg
Germany
Recruiting
33
Karlsruhe
Germany
Recruiting
39
Kiel
Germany
Recruiting
29
Landshut
Germany
Recruiting
44
Leipzig
Germany
Recruiting
30
Ludwigshafen
Germany
Recruiting
4
Lübeck
Germany
Recruiting
46
Magdeburg
Germany
Recruiting
15
Mainz
Germany
Recruiting
5
Mannheim
Germany
Recruiting
57
Marburg
Germany
Recruiting
6
Minden
Germany
Recruiting
31
München
Germany
Recruiting
+ 19 more sites — see the full list on the official registry below.
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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