Binimetinib Plus Encorafenib Real Life Investigation of Next Generation Melanoma Treatment

Официальное название

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

Обзор

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).

Вмешательства

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

Первичные конечные точки

• Progression-free survival [Срок оценки: At 12 months after start of treatment]

Вторичные конечные точки (12)

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

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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).

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения

Когортное

Центры проведения

Германия · 42 центра

• 45 — Ahaus
• 8 — Aschaffenburg
• 56 — Augsburg
• 51 — Berlin
• 27 — Bremerhaven
• 1 — Buxtehude
• 43 — Chemnitz
• 34 — Donauwörth
• … и ещё 34 центра

Австрия · 9 центров

• 11 — Graz
• 13 — Innsbruck
• 14 — Klagenfurt
• 10 — Linz
• 3 — Linz
• 12 — Salzburg
• 22 — Vienna
• 53 — Vienna
• … и ещё 1 центр

Швейцария · 8 центров

• 52 — Bellinzona
• 38 — Aarau
• 37 — Bern
• 24 — Chur
• 36 — Lausanne
• 58 — Lucerne
• 26 — Winterthur
• 25 — Zurich

Идентификаторы

NCT: NCT04045691 · NIS-PFO-2019-1921

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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