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

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Observational
Eligible Ages 18 Years and Over
Gender All
More Inclusion & Exclusion 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).

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

NCT04547946
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

Novartis Pharmaceuticals
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

Novartis Pharmaceuticals
Principal Investigator Affiliation Novartis Pharmaceuticals
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Industry
Overall Status Recruiting
Countries Portugal
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

Malignant Melanoma
Additional Details

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.

Arms & Interventions

Arms

: dabrafenib + trametinib

Patients administered dabrafenib and trametinib

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.

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

International Sites

Novartis Investigative Site, Coimbra, Center, Portugal

Status

Recruiting

Address

Novartis Investigative Site

Coimbra, Center, 3000-075

Novartis Investigative Site, Lisbon, Lisbon And Tagus Valley, Portugal

Status

Recruiting

Address

Novartis Investigative Site

Lisbon, Lisbon And Tagus Valley, 1649-035

Novartis Investigative Site, Oporto, North, Portugal

Status

Recruiting

Address

Novartis Investigative Site

Oporto, North, 4200-319

Novartis Investigative Site, Funchal, Região Autónoma Da Madeira, Portugal

Status

Recruiting

Address

Novartis Investigative Site

Funchal, Região Autónoma Da Madeira, 9000-177

Novartis Investigative Site, Setúbal, South, Portugal

Status

Recruiting

Address

Novartis Investigative Site

Setúbal, South, 2900-722

Novartis Investigative Site, Évora, South, Portugal

Status

Recruiting

Address

Novartis Investigative Site

Évora, South, 7000-811

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