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

Impact of Melanoma Adjuvant Treatment With Tafinlar® + Mekinist® (Dabrafenib + Trametinib) on Patients Quality of Life (QoL) and Clinical Outcomes in Portuguese Real World Setting

ClinicalTrials.gov Identifier: NCT04547946

Novartis Reference Number: CTMT212APT02

Last Update: Nov 29, 2021

All compounds are either investigational or being studied for (a) new use(s). Efficacy and safety have not been established. There is no guarantee that they will become commercially available for the use(s) under investigation.

Study Description

The primary objective for this non-interventional study is 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 are to assess the usage of adjuvant dabrafenib and trametinib in clinical practice and to evaluate clinical outcomes in patients that start adjuvant treatment with dabrafenib and trametinib. In addition, this study aims to explore if treatment discontinuation affects clinical outcomes in real-world practice.

Condition

Malignant Melanoma

Phase

Not Given

Overall status

Recruiting

Start date

Oct 15, 2021

Completion date

Oct 02, 2023

Gender

All

Age(s)

18 Years - 100 Years (Adult, Older Adult)

Interventions

Drug

dabrafenib + trametinib

There is no treatment allocation. Patients administered adjuvant treatment with combination therapy of Dabrafenib (Tafinlar®) and Trametinib (Mekinist®) by prescription that have started before inclusion of the patient into the study will be enrolled.

Eligibility Criteria

Inclusion Criteria:

Patients with complete surgical resection of histologically confirmed AJCC (8th edition) clinical stage III (IIIA, IIIB, IIIC, IIID) melanoma, in 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 and by prescription, that has been started before inclusion of the patient into the study;
≥ 18 years of age
Written informed consent signed.

Exclusion Criteria:

Lack of basic demographic (gender, age, age at diagnosis) and staging data (Stage at diagnosis; Breslow index; Clark level; BRAF mutation; BRAF test date; Surgery date).