Melanoma
Conditions
Keywords
Melanoma, stage III melanoma, BRAF V600E mutation, dabrafenib, trametinib, Turkey
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 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.
Interventions
DRUGdabrafenib
There was no treatment allocation. Patients administered dabrafenib by prescription that started before inclusion of the patient into the study were enrolled.
DRUGtrametinib
There was no treatment allocation. Patients administered trametinib by prescription that started before inclusion of the patient into the study were enrolled.
Sponsors
Novartis Pharmaceuticals
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| Rate of permanent drug discontinuation due to pyrexia and other AEs | 12 months | Rate of permanent drug discontinuation due to pyrexia and other AEs |
| incidence and severity of Adverse Events (AEs) | 12 months | Collection of incidence and severity of Adverse Events |
| 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. |
| 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 |
| Reason for dabrafenib and trametinib dose reduction | 12 months | Collection of the reason for dabrafenib and trametinib dose reduction |
| Time since surgery | 12 months | Collection of the time since surgery |
| Type of relapse | 12 months | Collection of the type of relapse: local, regional or distant |
| Reason for treatment discontinuation | 12 months | death, relapse, AEs, withdrawal of consent, other |
Countries
Turkey (Türkiye)
Outcome results
None listed