BRAF-/MEK-Inhibition With Dabrafenib and Trametinib in Melanoma Patients
- Sponsor
- EuMelaReg gGmbH
- Study ID
- NCT03944356
- Status
- Completed
Conditions
Eligibility Criteria
- Sex
- ALL
- Age
- 18 Years - N/A
- Healthy Volunteers
- Not accepted
Interventions
- Dabrafenib and Trametinib — DRUGDabrafenib and trametinib treatment under routine conditions according to the applying SmPC.
Study Details
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.
Key Dates
- Start date
- Jul 1, 2019
- Status verified
- Mar 2025
- Primary completion
- Dec 31, 2023
- Completion
- Oct 8, 2024
Study Design
- Enrollment
- 232 participants (actual)
Primary Outcome Measure
Median time on treatment [ Time Frame: Date of first dose up to 12 months ]
Related Studies
- Evaluation for NCI Surgery Branch Clinical Research ProtocolsRecruiting · National Cancer Institute (NCI) · Bethesda, Maryland
- Clinical, Laboratory, and Epidemiologic Characterization of Individuals and Families at High Risk of MelanomaRecruiting · National Cancer Institute (NCI) · Bethesda, Maryland
- Harvesting Cells for Experimental Cancer TreatmentsEnrolling By Invitation · National Cancer Institute (NCI) · Bethesda, Maryland
- Follow Up Protocol for Subjects Previously Enrolled on NCI Surgery Branch StudiesEnrolling By Invitation · National Cancer Institute (NCI) · Bethesda, Maryland