Binimetinib Plus Encorafenib Real Life Investigation of Next Generation Melanoma Treatment

Last updated: January 15, 2021
Sponsor: Pierre Fabre Pharma GmbH
Overall Status: Active - Recruiting

Phase

N/A

Condition

Melanoma

Treatment

N/A

Clinical Study ID

NCT04045691
NIS-PFO-2019-1921
  • Ages > 18
  • All Genders

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 Criteria

Inclusion

Inclusion Criteria:

  • Written informed consent of the patient with regard to the pseudonymized documentationas 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 transferto 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 inaccordance with the current SmPC [Summary of Product Characteristics] and byprescription; this decision was taken prior to and independent from the inclusion intothe study;
  • Treatment with encorafenib plus binimetinib has been started ≤ 6 months prior toproviding written informed consent for this study or is planned to be started in thenear future;
  • Unresectable advanced or metastatic malignant melanoma with BRAF [Rapidly AcceleratedFibrosarcoma 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

Exclusion Criteria:

  • Previous treatment with a BRAF- and/or MEK [Mitogen-ActivatedProtein/Extracellular-signal Regulated Kinase]- inhibitor except for: -- prior adjuvant treatment with BRAF+MEK-inhibitor combination therapy that ended > 6months prior start of Encorafenib/Binimetinib treatment;
  • More than one prior line of checkpoint inhibitor treatment in the unresectableadvanced or metastatic setting;
  • Any previous chemotherapeutic treatment of the melanoma disease;
  • Presence of any contraindication with regard to the encorafenib-binimetinib-treatmentas 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).

Study Design

Total Participants: 750
Study Start date:
October 17, 2019
Estimated Completion Date:
September 30, 2027

Connect with a study center

  • 11

    Graz,
    Austria

    Active - Recruiting

  • 13

    Innsbruck,
    Austria

    Active - Recruiting

  • 14

    Klagenfurt,
    Austria

    Active - Recruiting

  • 10

    Linz,
    Austria

    Active - Recruiting

  • 3

    Linz,
    Austria

    Active - Recruiting

  • 12

    Salzburg,
    Austria

    Active - Recruiting

  • 22

    Wien,
    Austria

    Active - Recruiting

  • 53

    Wien,
    Austria

    Active - Recruiting

  • 23

    Wiener Neustadt,
    Austria

    Active - Recruiting

  • 45

    Ahaus,
    Germany

    Active - Recruiting

  • 8

    Aschaffenburg,
    Germany

    Active - Recruiting

  • 56

    Augsburg,
    Germany

    Active - Recruiting

  • 51

    Berlin,
    Germany

    Active - Recruiting

  • 27

    Bremerhaven,
    Germany

    Active - Recruiting

  • 1

    Buxtehude,
    Germany

    Active - Recruiting

  • 43

    Chemnitz,
    Germany

    Active - Recruiting

  • 34

    Donauwörth,
    Germany

    Active - Recruiting

  • 49

    Dresden,
    Germany

    Active - Recruiting

  • 47

    Duisburg,
    Germany

    Active - Recruiting

  • 40

    Erfurt,
    Germany

    Active - Recruiting

  • 20

    Essen,
    Germany

    Active - Recruiting

  • 9

    Gera,
    Germany

    Active - Recruiting

  • 28

    Gießen,
    Germany

    Active - Recruiting

  • 42

    Goslar,
    Germany

    Active - Recruiting

  • 59

    Göttingen,
    Germany

    Active - Recruiting

  • 19

    Hamburg,
    Germany

    Active - Recruiting

  • 21

    Hannover,
    Germany

    Active - Recruiting

  • 2

    Heidelberg,
    Germany

    Active - Recruiting

  • 33

    Karlsruhe,
    Germany

    Active - Recruiting

  • 39

    Kiel,
    Germany

    Active - Recruiting

  • 29

    Landshut,
    Germany

    Active - Recruiting

  • 44

    Leipzig,
    Germany

    Active - Recruiting

  • 30

    Ludwigshafen,
    Germany

    Active - Recruiting

  • 4

    Lübeck,
    Germany

    Active - Recruiting

  • 46

    Magdeburg,
    Germany

    Active - Recruiting

  • 15

    Mainz,
    Germany

    Active - Recruiting

  • 5

    Mannheim,
    Germany

    Active - Recruiting

  • 57

    Marburg,
    Germany

    Active - Recruiting

  • 6

    Minden,
    Germany

    Active - Recruiting

  • 31

    München,
    Germany

    Active - Recruiting

  • 7

    München,
    Germany

    Active - Recruiting

  • 16

    Münster,
    Germany

    Active - Recruiting

  • 35

    Münster,
    Germany

    Active - Recruiting

  • 18

    Nürnberg,
    Germany

    Active - Recruiting

  • 50

    Regensburg,
    Germany

    Active - Recruiting

  • 41

    Schorndorf,
    Germany

    Active - Recruiting

  • 17

    Schwerin,
    Germany

    Active - Recruiting

  • 48

    Stolberg,
    Germany

    Active - Recruiting

  • 55

    Trier,
    Germany

    Active - Recruiting

  • 54

    Tübingen,
    Germany

    Active - Recruiting

  • 32

    Zwickau,
    Germany

    Active - Recruiting

  • 52

    Bellinzona, Tessin 6500
    Switzerland

    Active - Recruiting

  • 38

    Aarau,
    Switzerland

    Active - Recruiting

  • 37

    Bern, 3010
    Switzerland

    Active - Recruiting

  • 24

    Chur,
    Switzerland

    Active - Recruiting

  • 36

    Lausanne,
    Switzerland

    Active - Recruiting

  • 58

    Luzern, 6000
    Switzerland

    Active - Recruiting

  • 26

    Winterthur,
    Switzerland

    Active - Recruiting

  • 25

    Zürich,
    Switzerland

    Active - Recruiting

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