Study Description
Non-interventional (observational) cohort prospective real life study with primary and
secondary data collection from patients on adjuvant treatment with dabrafenib +
trametinib in patients with completely resected high-risk stage III (stage IIIA [lymph
node > 1mm], IIIB, IIIC and IIID according to AJCC 8th edition) melanoma in Turkey. 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 centers of excellence on melanoma patients treatment. Pre-identified
centers (up to 12) considered as the most advanced according to their knowledge and
experience, will take part in the patients recruitment.
Interventions
dabrafenib
trametinib
Eligibility Criteria
Inclusion Criteria:
- Patients with complete surgical resection of histologically confirmed AJCC (8th
edition) clinical stage III (stage IIIA [lymph node > 1mm],, IIIB, IIIC, IIID)
melanoma, in whom a decision for adjuvant treatment with dabrafenib and trametinib
has been made before entering the study;
- V600E mutation-positive cutaneous melanoma;
- ≥ 18 years of age;
- Written informed consent signed.
Exclusion Criteria:
- Lack of basic demographic and staging data.
- Current active participation in an interventional clinical trial for treatment of
melanoma.
- Pregnancy or breastfeeding women.
- Current primary diagnosis of a cancer other than melanoma, that requires systemic or
other treatment.
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