Binimetinib Plus Encorafenib Real Life Investigation of Next Generation Melanoma Treatment
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorPierre Fabre Pharma GmbH
About this trial
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
This trial does not accept healthy volunteersQualifiers
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;
Disqualifiers
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;
Trial 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.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Encorafenib
DrugObservation of real-life treatment with encorafenib and binimetinib
Binimetinib
DrugObservation of real-life treatment with encorafenib and binimetinib
Treatment groups
No treatment groups listed
Trial outcomes
Primary outcomes
1
Progression-free survival
Progression-free survival rate
Time frame
At 12 months after start of treatmentSecondary outcomes
1
Patient and disease profiles at start of treatment with encorafenib plus binimetinib
Demographic and disease characteristics
Time frame
Baseline2
Type of treatments before and after encorafenib plus binimetinib
Treatment sequence prior to and after encorafenib plus binimetinib; by documenting pre-treatments with adjuvant therapy and systemic therapy in palliative setting; and by documenting subsequent systemic treatment lines after administration of encorafenib plus binimetinib
Time frame
Complete observation time-frame (the total observation period of this study will amount to 90 months).3
Sequence of treatments before and after encorafenib plus binimetinib
Treatment sequence prior to and after encorafenib plus binimetinib; by documenting pre-treatments with adjuvant therapy and systemic therapy in palliative setting; and by documenting subsequent systemic treatment lines after administration of encorafenib plus binimetinib
Time frame
Complete observation time-frame (the total observation period of this study will amount to 90 months).4
Characteristics of treatment with encorafenib plus binimetinib
Evaluation of reason for treatment selection (efficacy, safety profile, quality of life, patients preference, physician's preference, comorbidities, other)
Time frame
From start to end of treatment (anticipated median treatment duration ca. 12 months)Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Pierre Fabre Pharma GmbH
Lead sponsor
Pierre Fabre Pharma Austria
Collaborator
Pierre Fabre Pharma AG
Collaborator
Source ClinicalTrials.gov