Last Update: Jan 05, 2024
A Real-life Study to Evaluate the Use of Adjuvant Treatment With Dabrafenib and Trametinib in Routine Practice in Patients With Completely Resected High-risk Stage III Melanoma
ClinicalTrials.gov Identifier:
Novartis Reference Number:CDRB436BTR01
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

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.

Melanoma
Recruiting
84
Dec 01, 2021
Dec 30, 2024
All
18 Years - (Adult, Older Adult)

Interventions

Drug

dabrafenib

There is no treatment allocation. Patients administered dabrafenib by prescription that have started before inclusion of the patient into the study will be enrolled.
Drug

trametinib

There is no treatment allocation. Patients administered trametinib 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 (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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