Clinical trial NCT04045691: Binimetinib Plus Encorafenib Real Life Investigation of Next Generation Melanoma Treatment
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
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Melanoma Stage IV
Melanoma Stage III
Keywords: BERING
Encorafenib
Binimetinib
Lead sponsor: Pierre Fabre Pharma GmbH
Sponsor class: INDUSTRY
Collaborators: name: Pierre Fabre Pharma Austria
name: Pierre Fabre Pharma AG
First posted: 2019-08-05
Enrollment: 750
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adult patients with unresectable advanced or metastatic BRAFV600-mutant malignant melanoma, with a decision to receive targeted treatment with Encorafenib/Binimetinib according to the current SmPC.

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 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 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).

Primary outcomes:
measure: Progression-free survival
timeFrame: At 12 months after start of treatment
Secondary outcomes:
measure: Patient and disease profiles at start of treatment with encorafenib plus binimetinib
timeFrame: Baseline
measure: Type of treatments before and after encorafenib plus binimetinib
timeFrame: Complete observation time-frame (the total observation period of this study will amount to 90 months).
measure: Sequence of treatments before and after encorafenib plus binimetinib
timeFrame: Complete observation time-frame (the total observation period of this study will amount to 90 months).
measure: Characteristics of treatment with encorafenib plus binimetinib
timeFrame: From start to end of treatment (anticipated median treatment duration ca. 12 months)
measure: Effectiveness of treatment with encorafenib plus binimetinib
timeFrame: From start to end of treatment (anticipated median treatment duration ca. 12 months)
measure: Effectiveness of treatment with encorafenib plus binimetinib
timeFrame: From start to end of treatment (anticipated median treatment duration ca. 12 months)
measure: Effectiveness of treatment with encorafenib plus binimetinib
timeFrame: From start to end of treatment (anticipated median treatment duration ca. 12 months)
measure: Effectiveness of treatment with encorafenib plus binimetinib
timeFrame: From start to end of treatment (anticipated median treatment duration ca. 12 months)
measure: Effectiveness of treatment with encorafenib plus binimetinib
timeFrame: From start to end of treatment (anticipated median treatment duration ca. 12 months)
measure: Effectiveness of treatment with encorafenib plus binimetinib
timeFrame: From start to end of treatment (anticipated median treatment duration ca. 12 months)
measure: Effectiveness of treatment with encorafenib plus binimetinib
timeFrame: From start to end of treatment (anticipated median treatment duration ca. 12 months)
measure: Effectiveness of treatment with encorafenib plus binimetinib
timeFrame: Complete observation time-frame (the total observation period of this study will amount to 90 months).
measure: Patient reported outcomes during treatment with encorafenib plus binimetinib - evaluated with EORTC QLQ C-30
timeFrame: From start to end of treatment (anticipated median treatment duration ca. 12 months)
measure: Patient reported outcomes during treatment with encorafenib plus binimetinib evaluated with WPAI
timeFrame: From start to end of treatment (anticipated median treatment duration ca. 12 months)
measure: Patient reported outcomes during treatment with encorafenib plus binimetinib evaluated with CTSQ
timeFrame: From start to end of treatment (anticipated median treatment duration ca. 12 months)
measure: Physicians' satisfaction with regard the treatment with encorafenib plus binimetinib
timeFrame: From start to end of treatment (anticipated median treatment duration ca. 12 months)
measure: Safety and tolerability of treatment with encorafenib plus binimetinib - Adverse events and adverse reactions including time to onset and time to resolution
timeFrame: Complete observation time-frame (the total observation period of this study will amount to 90 months).
measure: Prognostic factors
timeFrame: Complete observation time-frame (the total observation period of this study will amount to 90 months).
measure: Prognostic factors
timeFrame: Complete observation time-frame (the total observation period of this study will amount to 90 months).
measure: Prognostic factors
timeFrame: Complete observation time-frame (the total observation period of this study will amount to 90 months).
measure: Treatment duration
timeFrame: From start to end of treatment (anticipated median treatment duration ca. 12 months)
measure: Treatment dose intensity
timeFrame: From start to end of treatment (anticipated median treatment duration ca. 12 months)
measure: Number of treatment interruptions
timeFrame: From start to end of treatment (anticipated median treatment duration ca. 12 months)
measure: Duration of treatment interruptions
timeFrame: From start to end of treatment (anticipated median treatment duration ca. 12 months)
Other outcomes:
Locations:
city: Graz
country: Austria
facility: 11
city: Innsbruck
country: Austria
facility: 13
city: Klagenfurt
country: Austria
facility: 14
city: Linz
country: Austria
facility: 10
city: Linz
country: Austria
facility: 3
city: Salzburg
country: Austria
facility: 12
city: Wiener Neustadt
country: Austria
facility: 23
city: Wien
country: Austria
facility: 22
city: Wien
country: Austria
facility: 53
city: Ahaus
country: Germany
facility: 45
city: Aschaffenburg
country: Germany
facility: 8
city: Augsburg
country: Germany
facility: 56
city: Berlin
country: Germany
facility: 51
city: Bremerhaven
country: Germany
facility: 27
city: Buxtehude
country: Germany
facility: 1
city: Chemnitz
country: Germany
facility: 43
city: Donauwörth
country: Germany
facility: 34
city: Dresden
country: Germany
facility: 49
city: Duisburg
country: Germany
facility: 47
city: Erfurt
country: Germany
facility: 40
city: Essen
country: Germany
facility: 20
city: Gera
country: Germany
facility: 9
city: Gießen
country: Germany
facility: 28
city: Goslar
country: Germany
facility: 42
city: Göttingen
country: Germany
facility: 59
city: Hamburg
country: Germany
facility: 19
city: Hannover
country: Germany
facility: 21
city: Heidelberg
country: Germany
facility: 2
city: Karlsruhe
country: Germany
facility: 33
city: Kiel
country: Germany
facility: 39
city: Landshut
country: Germany
facility: 29
city: Leipzig
country: Germany
facility: 44
city: Ludwigshafen
country: Germany
facility: 30
city: Lübeck
country: Germany
facility: 4
city: Magdeburg
country: Germany
facility: 46
city: Mainz
country: Germany
facility: 15
city: Mannheim
country: Germany
facility: 5
city: Marburg
country: Germany
facility: 57
city: Minden
country: Germany
facility: 6
city: München
country: Germany
facility: 31
city: München
country: Germany
facility: 7
city: Münster
country: Germany
facility: 16
city: Münster
country: Germany
facility: 35
city: Nürnberg
country: Germany
facility: 18
city: Regensburg
country: Germany
facility: 50
city: Schorndorf
country: Germany
facility: 41
city: Schwerin
country: Germany
facility: 17
city: Stolberg
country: Germany
facility: 48
city: Trier
country: Germany
facility: 55
city: Tübingen
country: Germany
facility: 54
city: Zwickau
country: Germany
facility: 32
city: Bellinzona
country: Switzerland
facility: 52
state: Tessin
city: Aarau
country: Switzerland
facility: 38
city: Bern
country: Switzerland
facility: 37
city: Chur
country: Switzerland
facility: 24
city: Lausanne
country: Switzerland
facility: 36
city: Luzern
country: Switzerland
facility: 58
city: Winterthur
country: Switzerland
facility: 26
city: Zürich
country: Switzerland
facility: 25
Study officials:
References: