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RecruitingNCT04045691

Binimetinib Plus Encorafenib Real Life Investigation of Next Generation Melanoma Treatment

Encorafenib Plus Binimetinib in Patients With Locally Advanced, Unresectable or Metastatic BRAFV600-mutated Melanoma: a Multi-centric, Multinational, Prospective, Longitudinal, Non-interventional Study in Germany, Austria and Switzerland - BERING MELANOMA

Sponsor

Pierre Fabre Pharma GmbH

Enrollment

750 participants

Start Date

Oct 17, 2019

Study Type

OBSERVATIONAL

Conditions

Melanoma Stage IVMelanoma Stage III

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

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This observational study tracks real-world outcomes in patients with advanced melanoma (a type of skin cancer) who carry a specific gene mutation called BRAF V600 and are receiving a drug combination called encorafenib plus binimetinib. It collects data from routine clinical practice to understand how well this treatment works outside of controlled trials. **You may be eligible if...** - You have advanced or metastatic melanoma (skin cancer that has spread) with a BRAF V600 mutation - You are 18 or older - Your doctor has decided to treat you with encorafenib plus binimetinib (either already started or about to start) - You are treatment-naive or have had one prior line of immunotherapy **You may NOT be eligible if...** - Your melanoma does not have a BRAF V600 mutation - You have already received more than one prior line of therapy in the metastatic setting - You are unable to give informed consent Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGEncorafenib

Observation of real-life treatment with encorafenib and binimetinib

DRUGBinimetinib

Observation of real-life treatment with encorafenib and binimetinib

Locations(59)

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

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NCT04045691

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