Observational Study for Melanoma Adjuvant Treatment With Tafinlar® + Mekinist® (Dabrafenib + Trametinib)

Sponsor
Novartis Pharmaceuticals
Study ID
NCT04547946
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 100 Years
Healthy Volunteers
Not accepted

Interventions

  • dabrafenib + trametinib — DRUG
    There was no treatment allocation. Patients administered adjuvant treatment with combination therapy of Dabrafenib (Tafinlar®) and Trametinib (Mekinist®) by prescription that had started before inclusion of the patient into the study could be enrolled.

Study Details

The primary objective for this non-interventional study was to assess the quality of life of melanoma patients under adjuvant treatment with dabrafenib and trametinib in real world setting in Portugal through disease specific FACT-M questionnaire and generic EQ-5D-3L questionnaire. The secondary study objectives were to assess the usage of adjuvant dabrafenib and trametinib in clinical practice and to evaluate clinical outcomes in patients that started adjuvant treatment with dabrafenib and trametinib. In addition, this study aimed to explore if treatment discontinuation affects clinical outcomes in real-world practice.

Key Dates

Start date
Oct 15, 2021
Status verified
May 2023
Primary completion
Jun 7, 2022
Completion
Jun 7, 2022

Study Design

Enrollment
3 participants (actual)

Arms

  • Arm: dabrafenib + trametinib
    Patients administered dabrafenib and trametinib

Primary Outcome Measure

Change from baseline in FACT-M score [ Time Frame: Baseline, months 3-4, months 6-8, months 9-12, months 12, months 15-16 ]

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