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| Name | Class |
|---|---|
| Pierre Fabre Pharma Austria | UNKNOWN |
| Pierre Fabre Pharma AG | INDUSTRY |
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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).
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Encorafenib | Drug | Observation of real-life treatment with encorafenib and binimetinib | ||
| Binimetinib | Drug | Observation of real-life treatment with encorafenib and binimetinib |
| Measure | Description | Time Frame |
|---|---|---|
| Progression-free survival | Progression-free survival rate | At 12 months after start of treatment |
| Measure | Description | Time Frame |
|---|---|---|
| Patient and disease profiles at start of treatment with encorafenib plus binimetinib | Demographic and disease characteristics | Baseline |
| Type of treatments before and after encorafenib plus binimetinib |
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Inclusion Criteria:
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).
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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.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Christian A Rosé, MD | Contact | +49 761 45261 | 0 | bering_de@pierre-fabre.com |
| Andrea Schmidt, MSc | Contact | +49 641 94436 | 0 | ansc@alcedis.de |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| 11 | Recruiting | Graz | Austria | |||
| 13 |
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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
| 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 | 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 | Complete observation time-frame (the total observation period of this study will amount to 90 months). |
| 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) | From start to end of treatment (anticipated median treatment duration ca. 12 months) |
| Effectiveness of treatment with encorafenib plus binimetinib | Further progression-free survival parameters | From start to end of treatment (anticipated median treatment duration ca. 12 months) |
| Effectiveness of treatment with encorafenib plus binimetinib | Time-to-progression | From start to end of treatment (anticipated median treatment duration ca. 12 months) |
| Effectiveness of treatment with encorafenib plus binimetinib | Best observed tumor response | From start to end of treatment (anticipated median treatment duration ca. 12 months) |
| Effectiveness of treatment with encorafenib plus binimetinib | Overall response rate | From start to end of treatment (anticipated median treatment duration ca. 12 months) |
| Effectiveness of treatment with encorafenib plus binimetinib | Duration of response | From start to end of treatment (anticipated median treatment duration ca. 12 months) |
| Effectiveness of treatment with encorafenib plus binimetinib | Disease control rate | From start to end of treatment (anticipated median treatment duration ca. 12 months) |
| Effectiveness of treatment with encorafenib plus binimetinib | Duration of disease control | From start to end of treatment (anticipated median treatment duration ca. 12 months) |
| Effectiveness of treatment with encorafenib plus binimetinib | Overall survival | Complete observation time-frame (the total observation period of this study will amount to 90 months). |
| Patient reported outcomes during treatment with encorafenib plus binimetinib - evaluated with EORTC QLQ C-30 | EORTC QLQ C-30 questionnaires (European Organisation for Research and Treatment of Cancer Quality of Life C-30 questionnaires) to assess quality of life of cancer patients; comprises 30 items, 24 of which are aggregated into nine multi-item scales, that is, five functioning scales (physical, role, cognitive, emotional and social), three symptom scales (fatigue, pain and nausea/vomiting) and one global health status scale. The remaining six single-item (dyspnoea, appetite loss, sleep disturbance, constipation, diarrhoea and the financial impact) scales assess symptoms. | From start to end of treatment (anticipated median treatment duration ca. 12 months) |
| Patient reported outcomes during treatment with encorafenib plus binimetinib evaluated with WPAI | WPAI questionnaires (Work Productivity and Activity Impairment questionnaires). The following questions ask about the effect of patients melanoma on the ability to work and perform regular activities.
| From start to end of treatment (anticipated median treatment duration ca. 12 months) |
| Patient reported outcomes during treatment with encorafenib plus binimetinib evaluated with CTSQ | CTSQ questionnaires (Cancer Therapy Satisfaction Questionnaire) to assess patients' opinions and feelings concerning their cancer therapy and associated adverse events:
| From start to end of treatment (anticipated median treatment duration ca. 12 months) |
| Physicians' satisfaction with regard the treatment with encorafenib plus binimetinib | Physicians' satisfaction questionnaires (measuring Physician's Satisfaction with regard to Effictiveness and Safety, as well as Physician's Overall Treatment Satisfaction) using the following scale construct:
Scale:
| From start to end of treatment (anticipated median treatment duration ca. 12 months) |
| Safety and tolerability of treatment with encorafenib plus binimetinib - Adverse events and adverse reactions including time to onset and time to resolution | Number of patients with Adverse Events and maximum grade per patient, Adverse Drug Reactions, Adverse Drug Reactions grade 3/4, Serious Adverse Events, Serious Adverse Drug Reactions. | Complete observation time-frame (the total observation period of this study will amount to 90 months). |
| Prognostic factors | Influence of prognostic factors on quality of life outcome parameters | Complete observation time-frame (the total observation period of this study will amount to 90 months). |
| Prognostic factors | Influence of prognostic factors on effectiveness | Complete observation time-frame (the total observation period of this study will amount to 90 months). |
| Prognostic factors | Influence of prognostic factors on safety | Complete observation time-frame (the total observation period of this study will amount to 90 months). |
| Treatment duration | From date of first treatment (encorafenib or binimetinib, whichever occurs first) until date of last treatment (encorafenib or binimetinib, whichever occurs last) | From start to end of treatment (anticipated median treatment duration ca. 12 months) |
| Treatment dose intensity | From date of first treatment (encorafenib or binimetinib, whichever occurs first) until date of last treatment (encorafenib or binimetinib, whichever occurs last) | From start to end of treatment (anticipated median treatment duration ca. 12 months) |
| Number of treatment interruptions | From date of first treatment (encorafenib or binimetinib, whichever occurs first) until date of last treatment (encorafenib or binimetinib, whichever occurs last) | From start to end of treatment (anticipated median treatment duration ca. 12 months) |
| Duration of treatment interruptions | From date of first treatment (encorafenib or binimetinib, whichever occurs first) until date of last treatment (encorafenib or binimetinib, whichever occurs last) | From start to end of treatment (anticipated median treatment duration ca. 12 months) |
| Recruiting |
| Innsbruck |
| Austria |
| 14 | Recruiting | Klagenfurt | Austria |
| 10 | Recruiting | Linz | Austria |
| 3 | Recruiting | Linz | Austria |
| 12 | Recruiting | Salzburg | Austria |
| 22 | Recruiting | Vienna | Austria |
| 53 | Recruiting | Vienna | Austria |
| 23 | Recruiting | Wiener Neustadt | Austria |
| 45 | Recruiting | Ahaus | Germany |
| 8 | Recruiting | Aschaffenburg | Germany |
| 56 | Recruiting | Augsburg | Germany |
| 51 | Recruiting | Berlin | Germany |
| 27 | Recruiting | Bremerhaven | Germany |
| 1 | Recruiting | Buxtehude | Germany |
| 43 | Recruiting | Chemnitz | Germany |
| 34 | Recruiting | Donauwörth | Germany |
| 49 | Recruiting | Dresden | Germany |
| 47 | Recruiting | Duisburg | Germany |
| 40 | Recruiting | Erfurt | Germany |
| 20 | Recruiting | Essen | Germany |
| 9 | Recruiting | Gera | Germany |
| 28 | Recruiting | Giessen | Germany |
| 42 | Recruiting | Goslar | Germany |
| 59 | Recruiting | Göttingen | Germany |
| 19 | Recruiting | Hamburg | Germany |
| 21 | Recruiting | Hanover | Germany |
| 2 | Recruiting | Heidelberg | Germany |
| 33 | Recruiting | Karlsruhe | Germany |
| 39 | Recruiting | Kiel | Germany |
| 29 | Recruiting | Landshut | Germany |
| 44 | Recruiting | Leipzig | Germany |
| 30 | Recruiting | Ludwigshafen | Germany |
| 4 | Recruiting | Lübeck | Germany |
| 46 | Recruiting | Magdeburg | Germany |
| 15 | Recruiting | Mainz | Germany |
| 5 | Recruiting | Mannheim | Germany |
| 57 | Recruiting | Marburg | Germany |
| 6 | Recruiting | Minden | Germany |
| 31 | Recruiting | München | Germany |
| 7 | Recruiting | München | Germany |
| 16 | Recruiting | Münster | Germany |
| 35 | Recruiting | Münster | Germany |
| 18 | Recruiting | Nuremberg | Germany |
| 50 | Recruiting | Regensburg | Germany |
| 41 | Recruiting | Schorndorf | Germany |
| 17 | Recruiting | Schwerin | Germany |
| 48 | Recruiting | Stolberg | Germany |
| 55 | Recruiting | Trier | Germany |
| 54 | Recruiting | Tübingen | Germany |
| 32 | Recruiting | Zwickau | Germany |
| 52 | Recruiting | Bellinzona | Canton Ticino | 6500 | Switzerland |
| 38 | Recruiting | Aarau | Switzerland |
| 37 | Recruiting | Bern | 3010 | Switzerland |
| 24 | Recruiting | Chur | Switzerland |
| 36 | Recruiting | Lausanne | Switzerland |
| 58 | Recruiting | Lucerne | 6000 | Switzerland |
| 26 | Recruiting | Winterthur | Switzerland |
| 25 | Recruiting | Zurich | Switzerland |
| ID | Term |
|---|---|
| D008545 | Melanoma |
| ID | Term |
|---|---|
| D018358 | Neuroendocrine Tumors |
| D017599 | Neuroectodermal Tumors |
| D009373 | Neoplasms, Germ Cell and Embryonal |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D009380 | Neoplasms, Nerve Tissue |
| D018326 | Nevi and Melanomas |
| D012878 | Skin Neoplasms |
| D009371 | Neoplasms by Site |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
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| ID | Term |
|---|---|
| C000601108 | encorafenib |
| C581313 | binimetinib |
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