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:
NCT04961619
Novartis Reference Number:CDRB436BTR01
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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.

Novartis Investigative Site

Recruiting

Ankara,06520,Turkey

Novartis Investigative Site

Recruiting

Izmir,35040,Turkey

Novartis Investigative Site

Recruiting

Ankara,06680,Turkey

Novartis Investigative Site

Recruiting

Kecioren Ankara,06010,Turkey

Novartis Investigative Site

Recruiting

Antalya,07059,Turkey

Novartis Investigative Site

Recruiting

Diyarbakir,21000,Turkey

Novartis Investigative Site

Recruiting

Edirne,22030,Turkey

Novartis Investigative Site

Recruiting

Istanbul,34668,Turkey

Novartis Investigative Site

Recruiting

Bursa,Gorukle,16059,Turkey

Novartis Investigative Site

Recruiting

Istanbul,Turkey

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