Adjuvant Dabrafenib and Trametinib Treatment in Patients With Completely Resected High-risk Stage III Melanoma.

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: NCT04961619

Novartis Reference Number: CDRB436BTR01

Last Update: Mar 02, 2022

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.

Condition

Melanoma

Phase

Not Given

Overall status

Recruiting

Start date

Dec 01, 2021

Completion date

Oct 20, 2023

Gender

All

Age(s)

18 Years and older (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.