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

Novartis

Status

Completed

Conditions

Melanoma

Treatments

Drug: trametinib

Drug: dabrafenib

Study type

Observational

Funder types

Industry

Identifiers

NCT04961619

CDRB436BTR01

Details and patient eligibility

About

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.

Full 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 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.

Enrollment

39 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.