Observational Study for Melanoma Adjuvant Treatment With Tafinlar® + Mekinist® (Dabrafenib + Trametinib)
Last updated on July 2021Recruitment
- Recruitment Status
- Not yet recruiting
- Estimated Enrollment
- Same as current
Summary
- Conditions
- Malignant Melanoma
- Type
- Observational
- Design
- Observational Model: CohortTime Perspective: Prospective
Participation Requirements
- Age
- Between 18 years and 100 years
- Gender
- Both males and females
Description
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 w...
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.
Tracking Information
- NCT #
- NCT04547946
- Collaborators
- Not Provided
- Investigators
- Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals