BRAF-/MEK-Inhibition With Dabrafenib and Trametinib in Melanoma Patients

NCT ID: NCT03944356

Last Updated: 2025-03-12

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 232 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2019-07-01
• Study Completion Date: 2024-10-08

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.

Conditions

Melanoma

Study Design

• Observational Model Type: CASE_ONLY
• Study Time Perspective: PROSPECTIVE

Interventions

Dabrafenib and Trametinib

Dabrafenib and trametinib treatment under routine conditions according to the applying SmPC.

Intervention Type: DRUG

Other Intervention Names

Tafinlar and Mekinist

Eligibility Criteria

Inclusion Criteria

• Patients with complete surgical resection of histologically confirmed AJCC (American Joint Committee on Cancer) (8th edition) clinical stage III (IIIA, IIIB, IIIC, IIID) melanoma, for whom a decision for adjuvant treatment with dabrafenib and trametinib has been made before entering the study.
• V600E/K mutation-positive cutaneous melanoma
• Adjuvant treatment with combination therapy of Dabrafenib (Tafinlar®) and Trametinib (Mekinist®) as indicated in the SmPC (Summary of Product Characteristics) and by prescription, that has been started no longer that 4 weeks before inclusion of the patient into the study or which will be initiated directly after inclusion
• Age ≥ 18 years
• Signed written informed consent

Exclusion Criteria

• Lack of basic demographics and staging information
• Current or planned participation within a clinical trial. The participation in a follow-up phase of a clinical trial without active intervention is allowed.
• Current or planned treatment of another tumor disease except keratoacanthoma, squamous cell or basal cell carcinoma of the skin

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

EuMelaReg gGmbH

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Elbe Kliniken Stade - Buxtehude GmbH

Buxtehude, Lower Saxony, Germany

Universitätsklinikum Essen, Klinik und Poliklinik für Dermatologie, Venerologie und Allergologie

Essen, North Rhine-Westphalia, 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 im Breisgau, , Germany

SRH Wald-Klinikum Gera GmbH

Gera, , Germany

Universitätsklinikum Greifswald

Greifswald, , Germany

Universitätsklinik Halle

Halle, , Germany

Universitätsklinikum Hamburg-Eppendorf

Hamburg, , Germany

Medizinische Hochschule Hannover

Hanover, , 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

Nuremberg, , 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

Countries

Germany

Other Identifiers

EUMR-18001

Identifier Type: -

Identifier Source: org_study_id