Spots Global Cancer Trial Database for BRAF-/MEK-Inhibition With Dabrafenib and Trametinib in Melanoma Patients
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Trial Identification
Brief Title: BRAF-/MEK-Inhibition With Dabrafenib and Trametinib in Melanoma Patients
Official Title: BRAF-/MEK-Inhibition With Dabrafenib and Trametinib in Melanoma Patients in the Adjuvant Setting: a Non-interventional Observatory Study
Study ID: NCT03944356
Conditions
Interventions
Study Description
Brief Summary: Adjuvant therapy with dabrafenib plus trametinib in melanoma was approved in 2018 by the EMA (EUropean Medicines Agency). The purpose of this non-interventional study is to assess the usage of adjuvant dabrafenib and trametinib in clinical practice, where the patient population may differ from study population.
Detailed Description: Melanoma is a disease of significant metastatic potential if not detected very early. Oncogenic mutations in BRAF (B-Raf proto-oncogene, serine/threonine kinase) are found in approximately 40% of melanomas and result in constitutive activation of the MAPK (Mitogen-Activated Protein Kinase) pathway. Treatment with the BRAF inhibitor dabrafenib plus the MEK (Mitogen-activated protein kinase kinase) inhibitor trametinib showed improved overall survival in patients with unresectable or metastatic BRAF V600E/K-mutant melanoma (COMBI-d and COMBI-v studies). In an adjuvant setting treatment with dabrafenib and trametinib significantly reduced the risk of melanoma recurrence in patients with high-risk, stage III BRAF V600-mutant melanoma, with improvements in OS (Overall Survival), DMFS (Distant Metastasis Free Survival), and FFR (Freedom From Relaps) (COMBI-AD study). Based on these results, adjuvant dabrafenib plus trametinib therapy was approved in 2018 by the EMA. Compared to the metastatic situation, issues of compliance and treatment adherence may be more relevant in adjuvant treatments, as patients are free of disease and potentially cured even without adjuvant treatment. As the routine administration of drugs including dosing, treatment interruptions, and early termination in clinical practice may vary from procedures defined in clinical trials, this study aims to assess the usage of adjuvant dabrafenib and trametinib in the routine clinical setting.
Keywords
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
Elbe Kliniken Stade - Buxtehude GmbH, Buxtehude, Niedersachsen, Germany
Universitätsklinikum Essen, Klinik und Poliklinik für Dermatologie, Venerologie und Allergologie, Essen, Nordrhein-Westfalen, Germany
Universitätsklinik Kiel, Klinik für Dermatologie, Venerologie und Allergologie, Kiel, Schleswig-Holstein, Germany
Katholisches Klinikum Bochum, Bochum, , Germany
Klinikum Bremen Mitte gGmbH, Bremen, , Germany
Klinikum Bremerhaven Reinkenheide gGmbH, Bremerhaven, , Germany
DRK Krankenhaus Chemnitz Rabenstein, Chemnitz, , Germany
Klinikum Darmstadt GmbH, Darmstadt, , Germany
Klinikum Dortmund gGmbH, Dortmund, , Germany
Krankenhaus Dresden-Friedrichstadt, Dresden, , Germany
Universitätsklinik Dresden, Dresden, , Germany
HELIOS St. Johannes Klinik Duisburg, Duisburg, , Germany
HELIOS Klinikum Erfurt, Erfurt, , Germany
Universitätsklinikum Erlangen, Erlangen, , Germany
Universitätsklinikum Freiburg, Freiburg, , Germany
SRH Wald-Klinikum Gera GmbH, Gera, , Germany
Universitätsklinikum Greifswald, Greifswald, , Germany
Universitätsklinik Halle, Halle, , Germany
Universitätsklinikum Hamburg-Eppendorf, Hamburg, , Germany
Medizinische Hochschule Hannover, Hannover, , Germany
Universitätsklinikum Heidelberg, Heidelberg, , Germany
Staedtisches Klinikum Karlsruhe, Karlsruhe, , Germany
Universitätsklinikum Leipzig, Leipzig, , Germany
Klinikum Ludwigshafen gGmbH, Ludwigshafen, , Germany
Universitätsklinikum Schleswig-Holstein, Lübeck, , Germany
Universitätsklinik Magdeburg, Magdeburg, , Germany
Universitaetsklinikum Mannheim, Mannheim, , Germany
Johannes Wesling Klinikum Minden, Minden, , Germany
Klinikum der Universität München, München, , Germany
Fachklinik Hornheide, Münster, , Germany
Klinikum Nürnberg Nord, Nürnberg, , Germany
Harzklinikum Dorothea Christiane Erxleben GmbH, Quedlinburg, , Germany
Universitätsklinikum Regensburg, Regensburg, , Germany
HELIOS Kliniken Schwerin, Schwerin, , Germany
Universitätsklinikum Tübingen, Tübingen, , Germany
Universitätsklinikum Ulm, Ulm, , Germany
Contact Details
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