Actively Recruiting

Age: 18Years +
All Genders
NCT04045691

Binimetinib Plus Encorafenib Real Life Investigation of Next Generation Melanoma Treatment

Led by Pierre Fabre Pharma GmbH · Updated on 2021-01-19

750

Participants Needed

59

Research Sites

410 weeks

Total Duration

On this page

Sponsors

P

Pierre Fabre Pharma GmbH

Lead Sponsor

P

Pierre Fabre Pharma Austria

Collaborating Sponsor

AI-Summary

What this Trial Is About

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).

CONDITIONS

Official Title

Binimetinib Plus Encorafenib Real Life Investigation of Next Generation Melanoma Treatment

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Written informed consent for study documentation and data processing
  • Male or female patients aged 18 years or older
  • Decision to treat with encorafenib plus binimetinib made before study inclusion
  • Treatment with encorafenib plus binimetinib started within 6 months prior to consent or planned soon
  • Unresectable advanced or metastatic melanoma with BRAF V600 mutation
  • Treatment-naive or after one prior checkpoint inhibitor line in advanced/metastatic setting
Not Eligible

You will not qualify if you...

  • Previous treatment with BRAF and/or MEK inhibitors except adjuvant therapy ended more than 6 months before study treatment
  • More than one prior checkpoint inhibitor treatment line in advanced/metastatic setting
  • Any previous chemotherapy for melanoma
  • Any contraindication to encorafenib-binimetinib treatment per prescribing information
  • Current or planned participation in an interventional clinical trial
  • Current or planned systemic treatment for tumors other than melanoma
  • Prisoners or involuntarily incarcerated persons

AI-Screening

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Trial Site Locations

Total: 59 locations

1

11

Graz, Austria

Actively Recruiting

2

13

Innsbruck, Austria

Actively Recruiting

3

14

Klagenfurt, Austria

Actively Recruiting

4

10

Linz, Austria

Actively Recruiting

5

3

Linz, Austria

Actively Recruiting

6

12

Salzburg, Austria

Actively Recruiting

7

22

Vienna, Austria

Actively Recruiting

8

53

Vienna, Austria

Actively Recruiting

9

23

Wiener Neustadt, Austria

Actively Recruiting

10

45

Ahaus, Germany

Actively Recruiting

11

8

Aschaffenburg, Germany

Actively Recruiting

12

56

Augsburg, Germany

Actively Recruiting

13

51

Berlin, Germany

Actively Recruiting

14

27

Bremerhaven, Germany

Actively Recruiting

15

1

Buxtehude, Germany

Actively Recruiting

16

43

Chemnitz, Germany

Actively Recruiting

17

34

Donauwörth, Germany

Actively Recruiting

18

49

Dresden, Germany

Actively Recruiting

19

47

Duisburg, Germany

Actively Recruiting

20

40

Erfurt, Germany

Actively Recruiting

21

20

Essen, Germany

Actively Recruiting

22

9

Gera, Germany

Actively Recruiting

23

28

Giessen, Germany

Actively Recruiting

24

42

Goslar, Germany

Actively Recruiting

25

59

Göttingen, Germany

Actively Recruiting

26

19

Hamburg, Germany

Actively Recruiting

27

21

Hanover, Germany

Actively Recruiting

28

2

Heidelberg, Germany

Actively Recruiting

29

33

Karlsruhe, Germany

Actively Recruiting

30

39

Kiel, Germany

Actively Recruiting

31

29

Landshut, Germany

Actively Recruiting

32

44

Leipzig, Germany

Actively Recruiting

33

30

Ludwigshafen, Germany

Actively Recruiting

34

4

Lübeck, Germany

Actively Recruiting

35

46

Magdeburg, Germany

Actively Recruiting

36

15

Mainz, Germany

Actively Recruiting

37

5

Mannheim, Germany

Actively Recruiting

38

57

Marburg, Germany

Actively Recruiting

39

6

Minden, Germany

Actively Recruiting

40

31

München, Germany

Actively Recruiting

41

7

München, Germany

Actively Recruiting

42

16

Münster, Germany

Actively Recruiting

43

35

Münster, Germany

Actively Recruiting

44

18

Nuremberg, Germany

Actively Recruiting

45

50

Regensburg, Germany

Actively Recruiting

46

41

Schorndorf, Germany

Actively Recruiting

47

17

Schwerin, Germany

Actively Recruiting

48

48

Stolberg, Germany

Actively Recruiting

49

55

Trier, Germany

Actively Recruiting

50

54

Tübingen, Germany

Actively Recruiting

51

32

Zwickau, Germany

Actively Recruiting

52

52

Bellinzona, Canton Ticino, Switzerland, 6500

Actively Recruiting

53

38

Aarau, Switzerland

Actively Recruiting

54

37

Bern, Switzerland, 3010

Actively Recruiting

55

24

Chur, Switzerland

Actively Recruiting

56

36

Lausanne, Switzerland

Actively Recruiting

57

58

Lucerne, Switzerland, 6000

Actively Recruiting

58

26

Winterthur, Switzerland

Actively Recruiting

59

25

Zurich, Switzerland

Actively Recruiting

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Research Team

C

Christian A Rosé, MD

CONTACT

A

Andrea Schmidt, MSc

CONTACT

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

0

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