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Clinical Trials in Germany / NCT04045691
Recruiting Observational

Binimetinib Plus Encorafenib Real Life Investigation of Next Generation Melanoma Treatment

NCT04045691 · tracked via the Priya Life Science Germany tracker
Sponsor
Pierre Fabre Pharma GmbH
Phase
Observational
Started
2019-10-17
Last updated
2021-01-19

Condition(s) studied

Melanoma Stage IVMelanoma Stage III

Investigational drug(s) / intervention(s)

Encorafenib →Binimetinib →

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)

Trial sites (59)

FacilityCityRegionStatus
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.

More Pierre Fabre Pharma GmbH trials in Germany

Other trials for the same condition

Official registry record

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.

View NCT04045691 on ClinicalTrials.gov ↗ ← All trials in Germany