NCT04045691Recruiting
Binimetinib Plus Encorafenib Real Life Investigation of Next Generation Melanoma Treatment
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).
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).
Contacts
The trial team's contact details are shown on request.
See the official trial record- Status
- Recruiting
- Phase
- —
- Study type
- Observational
- Countries
- Switzerland, Germany, Austria
- Sponsor
- Pierre Fabre Pharma GmbH(Industry)
- Protocol no.
- NIS-PFO-2019-1921
- Conditions
- Melanoma Stage IV, Melanoma Stage III
- Interventions
- Drug
Treatments studied
- Encorafenib
- Binimetinib
Collaborators
Pierre Fabre Pharma Austria, Pierre Fabre Pharma AG
Locations · 59
- Bellinzona, Switzerland52Recruiting at this site
- Aarau, Switzerland38Recruiting at this site
- Bern, Switzerland37Recruiting at this site
- Chur, Switzerland24Recruiting at this site
- Lausanne, Switzerland36Recruiting at this site
- Lucerne, Switzerland58Recruiting at this site
- Winterthur, Switzerland26Recruiting at this site
- Zurich, Switzerland25Recruiting at this site
- Ahaus, Germany45Recruiting at this site
- Aschaffenburg, Germany8Recruiting at this site
- Augsburg, Germany56Recruiting at this site
- Berlin, Germany51Recruiting at this site
- Bremerhaven, Germany27Recruiting at this site
- Buxtehude, Germany1Recruiting at this site
- Chemnitz, Germany43Recruiting at this site
- Donauwörth, Germany34Recruiting at this site
- Dresden, Germany49Recruiting at this site
- Duisburg, Germany47Recruiting at this site
- Erfurt, Germany40Recruiting at this site
- Essen, Germany20Recruiting at this site
- Gera, Germany9Recruiting at this site
- Giessen, Germany28Recruiting at this site
- Goslar, Germany42Recruiting at this site
- Göttingen, Germany59Recruiting at this site
- Hamburg, Germany19Recruiting at this site
- Hanover, Germany21Recruiting at this site
- Heidelberg, Germany2Recruiting at this site
- Karlsruhe, Germany33Recruiting at this site
- Kiel, Germany39Recruiting at this site
- Landshut, Germany29Recruiting at this site
In total, worldwide, all 59 sites listed in the registry are recruiting.
Site status per the ClinicalTrials.gov registry (last update posted: January 19, 2021).
This status may have changed and says nothing about your eligibility: before taking any step, check with your oncologist or the site.
+ 29 more locations
See also
Other versions
These results are indicative and do not replace medical advice — discuss them with your doctor.