Adjuvant Dabrafenib and Trametinib Treatment in Patients With Completely Resected High-risk Stage III Melanoma.
- Registration Number
- NCT04961619
- Lead Sponsor
- Novartis Pharmaceuticals
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 39
- 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.
- 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.
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description dabrafenib and trametinib trametinib patients on adjuvant treatment with dabrafenib + trametinib dabrafenib and trametinib dabrafenib patients on adjuvant treatment with dabrafenib + trametinib
- Primary Outcome Measures
Name Time Method Relapse-free survival (RFS) rate 12 months 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.
- Secondary Outcome Measures
Name Time Method Time since surgery 12 months Collection of the time since surgery
procedures of the management of Adverse Events (AEs) 12 months Collection of procedures of the management of Adverse Events (AEs)
Total duration of treatment until end of treatment or permanent treatment discontinuation Total duration of treatment defined as median time on adjuvant dabrafenib + trametinib treatment (from start to end of treatment/permanent treatment discontinuation).
Average dose of dabrafenib and trametinib used during the treatment 12 months Average dose of dabrafenib and trametinib used during the treatment including dose reductions.
Reason for treatment discontinuation 12 months death, relapse, AEs, withdrawal of consent, other
Reason for dabrafenib and trametinib dose reduction 12 months Collection of the reason for dabrafenib and trametinib dose reduction
Number of patients on treatment Baseline, up to 12 months Collection of number of patients on treatment
Rate of permanent study drug discontinuation 12 months Rate of permanent study drug discontinuation due to any reason will be collected
Rate of permanent drug discontinuation due to pyrexia and other AEs 12 months Rate of permanent drug discontinuation due to pyrexia and other AEs will be collected
incidence and severity of Adverse Events (AEs) 12 months Collection of incidence and severity of Adverse Events
Type of relapse 12 months Collection of the type of relapse: local, regional or distant
Proportion of patients with dabrafenib and trametinib dose reduction during treatment 12 months collection of the proportion of patients with dabrafenib and trametinib dose reduction during treatment
Trial Locations
- Locations (1)
Novartis Investigative Site
🇹🇷Kecioren Ankara, Turkey