BRAF-/MEK-Inhibition With Dabrafenib and Trametinib in Melanoma Patients
Combi-EU
1 other identifier
observational
232
1 country
36
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Jul 2019
Longer than P75 for all trials
36 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 26, 2019
CompletedFirst Posted
Study publicly available on registry
May 9, 2019
CompletedStudy Start
First participant enrolled
July 1, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
October 8, 2024
CompletedMarch 12, 2025
March 1, 2025
4.5 years
April 26, 2019
March 10, 2025
Conditions
Outcome Measures
Primary Outcomes (1)
Median time on treatment
Median time on adjuvant dabrafenib + trametinib treatment defined as the interval between start of treatment and permanent discontinuation of treatment.
Date of first dose up to 12 months
Secondary Outcomes (12)
Permanent study drug discontinuation due to any reason
From date of first treatment until the date of treatment end, assessed up to 12 months
Permanent study drug discontinuation due to adverse drug reactions
From date of first treatment until the date of treatment end, assessed up to 12 months
Pyrexia and related symptoms
From date of first treatment until the date of treatment end, assessed up to 12 months
Adverse drug reaction management: pyrexia
From date of first treatment until the date of treatment end, assessed up to 12 months
Adverse drug reactions in Follow-up
From date of first treatment until the date of treatment end plus 3 months of follow-up, assessed up to 15 months
- +7 more secondary outcomes
Interventions
Dabrafenib and trametinib treatment under routine conditions according to the applying SmPC.
Eligibility Criteria
Adult patients with complete surgical resection of histologically confirmed AJCC (8th edition) clinical stage III (IIIA, IIIB, IIIC, IIID) BRAF V600-mutated cutaneous melanoma who are planned to be treated or who already started treatment no longer than 4 weeks prior to study inclusion with dabrafenib and trametinib under routine conditions according to the applying SmPC.
You may qualify if:
- 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
- Age ≥ 18 years
- Signed written informed consent
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- EuMelaReg gGmbHlead
Study Sites (36)
Elbe Kliniken Stade - Buxtehude GmbH
Buxtehude, Lower Saxony, 21614, Germany
Universitätsklinikum Essen, Klinik und Poliklinik für Dermatologie, Venerologie und Allergologie
Essen, North Rhine-Westphalia, 45147, Germany
Universitätsklinik Kiel, Klinik für Dermatologie, Venerologie und Allergologie
Kiel, Schleswig-Holstein, 24105, Germany
Katholisches Klinikum Bochum
Bochum, 44791, Germany
Klinikum Bremen Mitte gGmbH
Bremen, 28177, Germany
Klinikum Bremerhaven Reinkenheide gGmbH
Bremerhaven, Germany
DRK Krankenhaus Chemnitz Rabenstein
Chemnitz, 09117, Germany
Klinikum Darmstadt GmbH
Darmstadt, 64297, Germany
Klinikum Dortmund gGmbH
Dortmund, 44137, Germany
Krankenhaus Dresden-Friedrichstadt
Dresden, 01067, Germany
Universitätsklinik Dresden
Dresden, Germany
HELIOS St. Johannes Klinik Duisburg
Duisburg, 47166, Germany
HELIOS Klinikum Erfurt
Erfurt, 99089, Germany
Universitätsklinikum Erlangen
Erlangen, Germany
Universitätsklinikum Freiburg
Freiburg im Breisgau, Germany
SRH Wald-Klinikum Gera GmbH
Gera, 07548, Germany
Universitätsklinikum Greifswald
Greifswald, 17475, Germany
Universitätsklinik Halle
Halle, 06120, Germany
Universitätsklinikum Hamburg-Eppendorf
Hamburg, Germany
Medizinische Hochschule Hannover
Hanover, 30625, Germany
Universitätsklinikum Heidelberg
Heidelberg, 69120, Germany
Staedtisches Klinikum Karlsruhe
Karlsruhe, 76133, Germany
Universitätsklinikum Leipzig
Leipzig, 04103, Germany
Klinikum Ludwigshafen gGmbH
Ludwigshafen, 67063, Germany
Universitätsklinikum Schleswig-Holstein
Lübeck, 23568, Germany
Universitätsklinik Magdeburg
Magdeburg, 39120, Germany
Universitaetsklinikum Mannheim
Mannheim, 68167, Germany
Johannes Wesling Klinikum Minden
Minden, 32429, Germany
Klinikum der Universität München
München, 80337, Germany
Fachklinik Hornheide
Münster, 48157, Germany
Klinikum Nürnberg Nord
Nuremberg, 90419, Germany
Harzklinikum Dorothea Christiane Erxleben GmbH
Quedlinburg, 06484, Germany
Universitätsklinikum Regensburg
Regensburg, 93053, Germany
HELIOS Kliniken Schwerin
Schwerin, 19049, Germany
Universitätsklinikum Tübingen
Tübingen, 72076, Germany
Universitätsklinikum Ulm
Ulm, Germany
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- observational
- Observational Model
- CASE ONLY
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 26, 2019
First Posted
May 9, 2019
Study Start
July 1, 2019
Primary Completion
December 31, 2023
Study Completion
October 8, 2024
Last Updated
March 12, 2025
Record last verified: 2025-03