Actively Recruiting

Age: 18Years +
All Genders
ID04045691

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

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

750

Participants Needed

59

Research Sites

39 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

Researchers are investigating the real-world use of encorafenib plus binimetinib for patients with unresectable advanced or metastatic melanoma that has a BRAF V600 mutation. This observational study focuses on documenting treatment effects, quality of life, safety, and tolerability after these drugs became commercially available in Germany, Austria, and Switzerland. The study specifically looks at patients treated in the first and second line settings after prior checkpoint inhibitor therapy. The study observes patients who are treated with encorafenib plus binimetinib according to the approved product guidelines. Participants may have started this treatment up to six months before joining the study or may begin treatment soon after enrollment. The study tracks treatment details, effectiveness, side effects, and patient-reported outcomes over a median treatment duration of about 12 months, with a total observation period of up to 90 months. Participants will be followed through regular documentation of their disease and treatment progress, including patient and disease profiles, treatment sequences, adverse events, and quality of life assessments using questionnaires. The main outcome measured is progression-free survival at 12 months after treatment start. Researchers will also evaluate treatment duration, interruptions, dose intensity, and physician satisfaction. Long-term safety and prognostic factors will be monitored throughout the observation period until study completion in September 2027.

CONDITIONS

Brief 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...

  • Patient provides written informed consent for pseudonymized data documentation and transfer
  • Male or female patient aged 18 years or older with legal capacity
  • Decision to treat with encorafenib plus binimetinib made independently before study inclusion
  • Treatment with encorafenib plus binimetinib started within 6 months before consent or planned to start soon
  • Diagnosed with unresectable advanced or metastatic malignant melanoma with BRAF V600 mutation
  • Treatment-naive or after one prior line of checkpoint inhibitor therapy in advanced or metastatic setting
Not Eligible

You will not qualify if you...

  • Prior treatment with BRAF and/or MEK inhibitors except adjuvant therapy ended over 6 months before start of encorafenib/binimetinib
  • More than one prior line of checkpoint inhibitor treatment in advanced or metastatic setting
  • Previous chemotherapy for melanoma
  • Any contraindication to encorafenib-binimetinib treatment per product guidelines
  • Current or planned participation in an interventional clinical trial
  • Current or planned systemic treatment for any tumor other than melanoma
  • Prisoners or involuntarily incarcerated persons

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Treatment

Duration - Approximately 12 months or until treatment ends

Participants receive treatment with encorafenib plus binimetinib and are observed for treatment characteristics, effectiveness, safety, and patient-reported outcomes.

Visits scheduled as per treating physician's routine care during treatment

Long-term Monitoring

Duration - Up to 90 months total observation period

Participants are followed up over an extended period to observe treatment outcomes and safety for up to 90 months.

Follow-up visits as per routine clinical practice

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

A

Andrea Schmidt, MSc

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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