Clinical trial NCT04961619: Adjuvant Dabrafenib and Trametinib Treatment in Patients With Completely Resected High-risk Stage III Melanoma.
Official title: 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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Melanoma
Keywords: Melanoma
stage III melanoma
BRAF V600E mutation
dabrafenib
trametinib
Turkey
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2021-07-14
Enrollment: 39
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Completely resected high-risk stage III melanoma patients treated with dabrafenib and trametinib in the adjuvant setting

Brief summary: 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.

Detailed 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.

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.

Primary outcomes:
measure: Relapse-free survival (RFS) rate
timeFrame: 12 months
Secondary outcomes:
measure: Total duration of treatment
timeFrame: until end of treatment or permanent treatment discontinuation
measure: Number of patients on treatment
timeFrame: Baseline, up to 12 months
measure: Rate of permanent study drug discontinuation
timeFrame: 12 months
measure: Rate of permanent drug discontinuation due to pyrexia and other AEs
timeFrame: 12 months
measure: incidence and severity of Adverse Events (AEs)
timeFrame: 12 months
measure: procedures of the management of Adverse Events (AEs)
timeFrame: 12 months
measure: Reason for treatment discontinuation
timeFrame: 12 months
measure: Average dose of dabrafenib and trametinib used during the treatment
timeFrame: 12 months
measure: Proportion of patients with dabrafenib and trametinib dose reduction during treatment
timeFrame: 12 months
measure: Reason for dabrafenib and trametinib dose reduction
timeFrame: 12 months
measure: Time since surgery
timeFrame: 12 months
measure: Type of relapse
timeFrame: 12 months
Other outcomes:
Locations:
city: Bursa
country: Turkey
facility: Novartis Investigative Site
state: Gorukle
city: Adana
country: Turkey
facility: Novartis Investigative Site
city: Ankara
country: Turkey
facility: Novartis Investigative Site
city: Antalya
country: Turkey
facility: Novartis Investigative Site
city: Diyarbakir
country: Turkey
facility: Novartis Investigative Site
city: Edirne
country: Turkey
facility: Novartis Investigative Site
city: Istanbul
country: Turkey
facility: Novartis Investigative Site
city: Izmir
country: Turkey
facility: Novartis Investigative Site
city: Kecioren Ankara
country: Turkey
facility: Novartis Investigative Site
Study officials:
affiliation: Novartis Pharmaceuticals
name: Novartis Pharmaceuticals
role: STUDY_DIRECTOR
References: