Status:

RECRUITING

Binimetinib Plus Encorafenib Real Life Investigation of Next Generation Melanoma Treatment

Lead Sponsor:

Pierre Fabre Pharma GmbH

Collaborating Sponsors:

Pierre Fabre Pharma Austria

Pierre Fabre Pharma AG

Conditions:

Melanoma Stage IV

Melanoma Stage III

Eligibility:

All Genders

18+ years

Brief 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...

Eligibility Criteria

Inclusion Criteria:

  • Written informed consent of the patient with regard to the pseudonymized documentation as 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 transfer to 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 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:

  • Previous treatment with a BRAF- and/or MEK [Mitogen-Activated Protein/Extracellular-signal Regulated Kinase]- inhibitor except for:

    -- 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).

Key Trial Info

Start Date :

October 17 2019

Trial Type :

OBSERVATIONAL

Allocation :

ESTIMATED

End Date :

September 1 2027

Estimated Enrollment :

750 Patients enrolled

Trial Details

Trial ID

NCT04045691

Start Date

October 17 2019

End Date

September 1 2027

Last Update

January 19 2021

Active Locations (59)

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Page 1 of 15 (59 locations)

1

11

Graz, Austria

2

13

Innsbruck, Austria

3

14

Klagenfurt, Austria

4

10

Linz, Austria