Binimetinib Plus Encorafenib Real Life Investigation of Next Generation Melanoma Treatment
BERING
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
1 other identifier
observational
750
3 countries
59
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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Oct 2019
Longer than P75 for all trials
59 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 25, 2019
CompletedFirst Posted
Study publicly available on registry
August 5, 2019
CompletedStudy Start
First participant enrolled
October 17, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
September 1, 2027
January 19, 2021
January 1, 2021
7.1 years
July 25, 2019
January 15, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Progression-free survival
Progression-free survival rate
At 12 months after start of treatment
Secondary Outcomes (24)
Patient and disease profiles at start of treatment with encorafenib plus binimetinib
Baseline
Type of treatments before and after encorafenib plus binimetinib
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
Complete observation time-frame (the total observation period of this study will amount to 90 months).
Characteristics of treatment with encorafenib plus binimetinib
From start to end of treatment (anticipated median treatment duration ca. 12 months)
Effectiveness of treatment with encorafenib plus binimetinib
From start to end of treatment (anticipated median treatment duration ca. 12 months)
- +19 more secondary outcomes
Interventions
Observation of real-life treatment with encorafenib and binimetinib
Observation of real-life treatment with encorafenib and binimetinib
Eligibility Criteria
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.
You may qualify if:
- 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);
- 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.
You may not qualify if:
- 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).
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Pierre Fabre Pharma GmbHlead
- Pierre Fabre Pharma Austriacollaborator
- Pierre Fabre Pharma AGcollaborator
Study Sites (59)
11
Graz, Austria
13
Innsbruck, Austria
14
Klagenfurt, Austria
10
Linz, Austria
3
Linz, Austria
12
Salzburg, Austria
22
Vienna, Austria
53
Vienna, Austria
23
Wiener Neustadt, Austria
45
Ahaus, Germany
8
Aschaffenburg, Germany
56
Augsburg, Germany
51
Berlin, Germany
27
Bremerhaven, Germany
1
Buxtehude, Germany
43
Chemnitz, Germany
34
Donauwörth, Germany
49
Dresden, Germany
47
Duisburg, Germany
40
Erfurt, Germany
20
Essen, Germany
9
Gera, Germany
28
Giessen, Germany
42
Goslar, Germany
59
Göttingen, Germany
19
Hamburg, Germany
21
Hanover, Germany
2
Heidelberg, Germany
33
Karlsruhe, Germany
39
Kiel, Germany
29
Landshut, Germany
44
Leipzig, Germany
30
Ludwigshafen, Germany
4
Lübeck, Germany
46
Magdeburg, Germany
15
Mainz, Germany
5
Mannheim, Germany
57
Marburg, Germany
6
Minden, Germany
31
München, Germany
7
München, Germany
16
Münster, Germany
35
Münster, Germany
18
Nuremberg, Germany
50
Regensburg, Germany
41
Schorndorf, Germany
17
Schwerin, Germany
48
Stolberg, Germany
55
Trier, Germany
54
Tübingen, Germany
32
Zwickau, Germany
52
Bellinzona, Canton Ticino, 6500, Switzerland
38
Aarau, Switzerland
37
Bern, 3010, Switzerland
24
Chur, Switzerland
36
Lausanne, Switzerland
58
Lucerne, 6000, Switzerland
26
Winterthur, Switzerland
25
Zurich, Switzerland
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 25, 2019
First Posted
August 5, 2019
Study Start
October 17, 2019
Primary Completion (Estimated)
December 1, 2026
Study Completion (Estimated)
September 1, 2027
Last Updated
January 19, 2021
Record last verified: 2021-01
Data Sharing
- IPD Sharing
- Will not share