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
- 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
- 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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1
11
Graz, Austria
2
13
Innsbruck, Austria
3
14
Klagenfurt, Austria
4
10
Linz, Austria