Binimetinib Plus Encorafenib Real Life Investigation of Next Generation Melanoma Treatment
NCT ID: NCT04045691
Last Updated: 2021-01-19
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
750 participants
OBSERVATIONAL
2019-10-17
2027-09-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Interventions
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Encorafenib
Observation of real-life treatment with encorafenib and binimetinib
Binimetinib
Observation of real-life treatment with encorafenib and binimetinib
Eligibility Criteria
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Inclusion Criteria
* 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
\-- 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).
18 Years
ALL
No
Sponsors
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Pierre Fabre Pharma Austria
UNKNOWN
Pierre Fabre Pharma AG
INDUSTRY
Pierre Fabre Pharma GmbH
INDUSTRY
Responsible Party
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Locations
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11
Graz, , Austria
13
Innsbruck, , Austria
14
Klagenfurt, , Austria
10
Linz, , Austria
3
Linz, , Austria
12
Salzburg, , Austria
22
Vienna, , Austria
53
Vienna, , Austria
23
Wiener Neustadt, , Austria
45
Ahaus, , Germany
8
Aschaffenburg, , Germany
56
Augsburg, , Germany
51
Berlin, , Germany
27
Bremerhaven, , Germany
1
Buxtehude, , Germany
43
Chemnitz, , Germany
34
Donauwörth, , Germany
49
Dresden, , Germany
47
Duisburg, , Germany
40
Erfurt, , Germany
20
Essen, , Germany
9
Gera, , Germany
28
Giessen, , Germany
42
Goslar, , Germany
59
Göttingen, , Germany
19
Hamburg, , Germany
21
Hanover, , Germany
2
Heidelberg, , Germany
33
Karlsruhe, , Germany
39
Kiel, , Germany
29
Landshut, , Germany
44
Leipzig, , Germany
30
Ludwigshafen, , Germany
4
Lübeck, , Germany
46
Magdeburg, , Germany
15
Mainz, , Germany
5
Mannheim, , Germany
57
Marburg, , Germany
6
Minden, , Germany
31
München, , Germany
7
München, , Germany
16
Münster, , Germany
35
Münster, , Germany
18
Nuremberg, , Germany
50
Regensburg, , Germany
41
Schorndorf, , Germany
17
Schwerin, , Germany
48
Stolberg, , Germany
55
Trier, , Germany
54
Tübingen, , Germany
32
Zwickau, , Germany
52
Bellinzona, Canton Ticino, Switzerland
38
Aarau, , Switzerland
37
Bern, , Switzerland
24
Chur, , Switzerland
36
Lausanne, , Switzerland
58
Lucerne, , Switzerland
26
Winterthur, , Switzerland
25
Zurich, , Switzerland
Countries
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Central Contacts
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Other Identifiers
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NIS-PFO-2019-1921
Identifier Type: -
Identifier Source: org_study_id
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