NCT03944356Completed
BRAF-/MEK-Inhibition With Dabrafenib and Trametinib in Melanoma Patients
BRAF-/MEK-Inhibition With Dabrafenib and Trametinib in Melanoma Patients in the Adjuvant Setting: a Non-interventional Observatory Study
Source: ClinicalTrials.gov · Last updated 12 Mar 2025
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Study type
- Observational
- Enrollment
- 232 (actual)
- First submitted
- 26 Apr 2019
- Start date
- 1 Jul 2019
- Primary completion date
- 31 Dec 2023
- Lead sponsor
- EuMelaReg gGmbH
- Diseases
- Melanoma
- NCT number
- NCT03944356
What you commit to
- Study type: Observational
- Participants enrolled: 232
- From 1 Jul 2019 to the primary completion date, 31 Dec 2023
- 36 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- Current or planned treatment of another tumor disease except keratoacanthoma, squamous cell or basal cell carcinoma of the skin
Other
- 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.
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: All
Sites (36)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Katholisches Klinikum Bochum Coordinator of this site? Confirm its status | Bochum | Germany | Unknown status |
| Klinikum Bremen-Mitte gGmbH Coordinator of this site? Confirm its status | Bremen | Germany | Unknown status |
| Klinikum Bremerhaven Reinkenheide gGmbH Coordinator of this site? Confirm its status | Bremerhaven | Germany | Unknown status |
| Elbe Kliniken Stade - Buxtehude GmbH Coordinator of this site? Confirm its status | Buxtehude | Germany | Unknown status |
| Drk Krankenhaus Chemnitz-Rabenstein Coordinator of this site? Confirm its status | Chemnitz | Germany | Unknown status |
| Klinikum Darmstadt GmbH Coordinator of this site? Confirm its status | Darmstadt | Germany | Unknown status |
| Klinikum Dortmund gGmbH Coordinator of this site? Confirm its status | Dortmund | Germany | Unknown status |
| Krankenhaus Dresden-Friedrichstadt Coordinator of this site? Confirm its status | Dresden | Germany | Unknown status |
| Universitätsklinik Dresden Coordinator of this site? Confirm its status | Dresden | Germany | Unknown status |
| HELIOS St. Johannes Klinik Duisburg Coordinator of this site? Confirm its status | Duisburg | Germany | Unknown status |
| Helios Klinikum Erfurt Coordinator of this site? Confirm its status | Erfurt | Germany | Unknown status |
| Universitätsklinikum Erlangen Coordinator of this site? Confirm its status | Erlangen | Germany | Unknown status |
| Universitätsklinikum Essen, Klinik und Poliklinik für Dermatologie, Venerologie und Allergologie Coordinator of this site? Confirm its status | Essen | Germany | Unknown status |
| Universitätsklinikum Freiburg Coordinator of this site? Confirm its status | Freiburg im Breisgau | Germany | Unknown status |
| SRH Wald-Klinikum Gera GmbH Coordinator of this site? Confirm its status | Gera | Germany | Unknown status |
| Universitätsklinikum Greifswald Coordinator of this site? Confirm its status | Greifswald | Germany | Unknown status |
| Universitätsklinik Halle Coordinator of this site? Confirm its status | Halle | Germany | Unknown status |
| Universitätsklinikum Hamburg-Eppendorf Coordinator of this site? Confirm its status | Hamburg | Germany | Unknown status |
| Medizinische Hochschule Hannover Coordinator of this site? Confirm its status | Hanover | Germany | Unknown status |
| Universitätsklinikum Heidelberg Coordinator of this site? Confirm its status | Heidelberg | Germany | Unknown status |
| Staedtisches Klinikum Karlsruhe Coordinator of this site? Confirm its status | Karlsruhe | Germany | Unknown status |
| Universitätsklinik Kiel, Klinik für Dermatologie, Venerologie und Allergologie Coordinator of this site? Confirm its status | Kiel | Germany | Unknown status |
| Universitatsklinikum Leipzig Coordinator of this site? Confirm its status | Leipzig | Germany | Unknown status |
| Universitätsklinikum Schleswig-Holstein Coordinator of this site? Confirm its status | Lübeck | Germany | Unknown status |
| Klinikum Ludwigshafen gGmbH Coordinator of this site? Confirm its status | Ludwigshafen | Germany | Unknown status |
| Universitätsklinik Magdeburg Coordinator of this site? Confirm its status | Magdeburg | Germany | Unknown status |
| Universitaetsklinikum Mannheim Coordinator of this site? Confirm its status | Mannheim | Germany | Unknown status |
| Johannes Wesling Klinikum Minden Coordinator of this site? Confirm its status | Minden | Germany | Unknown status |
| Klinikum der Universität München Coordinator of this site? Confirm its status | München | Germany | Unknown status |
| Fachklinik Hornheide Coordinator of this site? Confirm its status | Münster | Germany | Unknown status |
| Klinikum Nürnberg Nord Coordinator of this site? Confirm its status | Nuremberg | Germany | Unknown status |
| Harzklinikum Dorothea Christiane Erxleben GmbH Coordinator of this site? Confirm its status | Quedlinburg | Germany | Unknown status |
| Universitätsklinikum Regensburg Coordinator of this site? Confirm its status | Regensburg | Germany | Unknown status |
| Helios Kliniken Schwerin Coordinator of this site? Confirm its status | Schwerin | Germany | Unknown status |
| Universitätsklinikum Tübingen Coordinator of this site? Confirm its status | Tübingen | Germany | Unknown status |
| Universitätsklinikum Ulm Coordinator of this site? Confirm its status | Ulm | Germany | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.