Clinical trial · Observational
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
NCT03944356CI-TRIAL-00087106Combi-EUcompletedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Melanoma | Melanoma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Dabrafenib and Trametinib | Drug | Dabrafenib/Trametinib Regimen | ALIAS |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- Median time on treatment
- timeFrame
- Date of first dose up to 12 months
- description
- Median time on adjuvant dabrafenib + trametinib treatment defined as the interval between start of treatment and permanent discontinuation of treatment.
Secondary outcomes (12)
- measure
- Permanent study drug discontinuation due to any reason
- timeFrame
- From date of first treatment until the date of treatment end, assessed up to 12 months
- description
- Rate of permanent study drug discontinuation due to any reason.
- measure
- Permanent study drug discontinuation due to adverse drug reactions
- timeFrame
- From date of first treatment until the date of treatment end, assessed up to 12 months
- description
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.