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Recruiting NCT04045691

Binimetinib Plus Encorafenib Real Life Investigation of Next Generation Melanoma Treatment

— Observational Melanoma Stage IV Melanoma Stage III

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Encorafenib, Binimetinib.
Who it may be relevant to
Registry conditions: Melanoma Stage IV, Melanoma Stage III. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Austria, Germany, Switzerland
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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).

Interventions

  • Drug Encorafenib
    Observation of real-life treatment with encorafenib and binimetinib
  • Drug Binimetinib
    Observation of real-life treatment with encorafenib and binimetinib

Primary outcome measures

  • Progression-free survival [Time frame: At 12 months after start of treatment]
Secondary outcome measures (12)
  • Patient and disease profiles at start of treatment with encorafenib plus binimetinib [Time frame: Baseline]
  • Type of treatments before and after encorafenib plus binimetinib [Time frame: Complete observation time-frame (the total observation period of this study will amount to 90 months).]
  • Sequence of treatments before and after encorafenib plus binimetinib [Time frame: Complete observation time-frame (the total observation period of this study will amount to 90 months).]
  • Characteristics of treatment with encorafenib plus binimetinib [Time frame: From start to end of treatment (anticipated median treatment duration ca. 12 months)]
  • Effectiveness of treatment with encorafenib plus binimetinib [Time frame: From start to end of treatment (anticipated median treatment duration ca. 12 months)]
  • Effectiveness of treatment with encorafenib plus binimetinib [Time frame: From start to end of treatment (anticipated median treatment duration ca. 12 months)]
  • Effectiveness of treatment with encorafenib plus binimetinib [Time frame: From start to end of treatment (anticipated median treatment duration ca. 12 months)]
  • Effectiveness of treatment with encorafenib plus binimetinib [Time frame: From start to end of treatment (anticipated median treatment duration ca. 12 months)]
  • Effectiveness of treatment with encorafenib plus binimetinib [Time frame: From start to end of treatment (anticipated median treatment duration ca. 12 months)]
  • Effectiveness of treatment with encorafenib plus binimetinib [Time frame: From start to end of treatment (anticipated median treatment duration ca. 12 months)]
  • Effectiveness of treatment with encorafenib plus binimetinib [Time frame: From start to end of treatment (anticipated median treatment duration ca. 12 months)]
  • Effectiveness of treatment with encorafenib plus binimetinib [Time frame: Complete observation time-frame (the total observation period of this study will amount to 90 months).]

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).

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

Germany · 42 centers
  • 45 — Ahaus
  • 8 — Aschaffenburg
  • 56 — Augsburg
  • 51 — Berlin
  • 27 — Bremerhaven
  • 1 — Buxtehude
  • 43 — Chemnitz
  • 34 — Donauwörth
  • … and 34 more centers
Austria · 9 centers
  • 11 — Graz
  • 13 — Innsbruck
  • 14 — Klagenfurt
  • 10 — Linz
  • 3 — Linz
  • 12 — Salzburg
  • 22 — Vienna
  • 53 — Vienna
  • … and 1 more center
Switzerland · 8 centers
  • 52 — Bellinzona
  • 38 — Aarau
  • 37 — Bern
  • 24 — Chur
  • 36 — Lausanne
  • 58 — Lucerne
  • 26 — Winterthur
  • 25 — Zurich

Identifiers

NCT: NCT04045691 · NIS-PFO-2019-1921

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗