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

Novartis Pharmaceuticals39 enrolled

Overview

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 was based on collaboration with centers of excellence on melanoma patients treatment. Pre-identified centers considered as the most advanced according to their knowledge and experience, took part in the patients recruitment.

Study Type

OBSERVATIONAL

Enrollment

Conditions

Melanoma

Interventions

dabrafenibDRUG

There was no treatment allocation. Patients administered dabrafenib by prescription that started before inclusion of the patient into the study were enrolled.

trametinibDRUG

There was no treatment allocation. Patients administered trametinib by prescription that started before inclusion of the patient into the study were enrolled.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Locations (9)

Novartis Investigative Site

Antalya, Konyaalti, Turkey (Türkiye)

Novartis Investigative Site

Edirne, Merkez, Turkey (Türkiye)

Novartis Investigative Site

Bursa, Nilufer, Turkey (Türkiye)

Novartis Investigative Site

Outcomes

Primary Outcomes

Relapse-free survival (RFS) rate

RFS is the length of time after primary treatment for a cancer ends that the patient survives without any signs or symptoms of that cancer.

Time frame: 12 months

Secondary Outcomes

Total duration of treatment

Total duration of treatment defined as median time on adjuvant dabrafenib + trametinib treatment (from start to end of treatment/permanent treatment discontinuation).

Time frame: until end of treatment or permanent treatment discontinuation

Number of patients on treatment

Collection of number of patients on treatment

Time frame: Baseline, up to 12 months

Rate of permanent study drug discontinuation

Rate of permanent study drug discontinuation due to any reason

Time frame: 12 months

Rate of permanent drug discontinuation due to pyrexia and other AEs

Time frame: 12 months

incidence and severity of Adverse Events (AEs)

Collection of incidence and severity of Adverse Events

Time frame: 12 months

procedures of the management of Adverse Events (AEs)

Collection of procedures of the management of Adverse Events (AEs)

Time frame: 12 months

Reason for treatment discontinuation

Data from ClinicalTrials.gov

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