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

  • End date
    Oct 2, 2023
  • participants needed
  • sponsor
    Novartis Pharmaceuticals
Updated on 29 June 2022
immunologic adjuvant
malignant melanoma of skin


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.


The prospective registration of completely resected high-risk stage III melanoma patients treated with dabrafenib and trametinib in the adjuvant setting will be based on collaboration with 8 centers of excellence on melanoma patients treatment, according to their expertise and experience.

Patients will be recruited from participating centers in the routine setting. This will be done only if the decision about starting treatment with dabrafenib and trametinib has already been made. All patients that comply with the inclusion criteria and that start treatment with dabrafenib+ trametinib during the recruitment period will be considered to participate in the study, at investigator discretion.

Health related quality of life will be assessed by FACT-M and EQ-5D-3L questionnaire after treatment initiation in a quarterly base, according to clinical practice, including the first visit after treatment completion.

Condition Malignant Melanoma
Treatment dabrafenib + trametinib
Clinical Study IdentifierNCT04547946
SponsorNovartis Pharmaceuticals
Last Modified on29 June 2022


Yes No Not Sure

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)
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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