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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| dabrafenib and trametinib | patients on adjuvant treatment with dabrafenib + trametinib |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| dabrafenib | Drug | There was no treatment allocation. Patients administered dabrafenib by prescription that started before inclusion of the patient into the study were enrolled. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| 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). | until end of treatment or permanent treatment discontinuation |
| Number of patients on treatment |
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Inclusion Criteria:
Exclusion Criteria:
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Completely resected high-risk stage III melanoma patients treated with dabrafenib and trametinib in the adjuvant setting
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| Name | Affiliation | Role |
|---|---|---|
| Novartis Pharmaceuticals | Novartis Pharmaceuticals | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Novartis Investigative Site | Antalya | Konyaalti | 07070 | Turkey (Türkiye) | ||
| Novartis Investigative Site |
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| Label | URL |
|---|---|
| Link to study results | View source |
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| trametinib | Drug | There was no treatment allocation. Patients administered trametinib by prescription that started before inclusion of the patient into the study were enrolled. |
|
Collection of number of patients on treatment |
| Baseline, up to 12 months |
| Rate of permanent study drug discontinuation | Rate of permanent study drug discontinuation due to any reason | 12 months |
| Rate of permanent drug discontinuation due to pyrexia and other AEs | Rate of permanent drug discontinuation due to pyrexia and other AEs | 12 months |
| incidence and severity of Adverse Events (AEs) | Collection of incidence and severity of Adverse Events | 12 months |
| procedures of the management of Adverse Events (AEs) | Collection of procedures of the management of Adverse Events (AEs) | 12 months |
| Reason for treatment discontinuation | death, relapse, AEs, withdrawal of consent, other | 12 months |
| Average dose of dabrafenib and trametinib used during the treatment | Average dose of dabrafenib and trametinib used during the treatment including dose reductions. | 12 months |
| Proportion of patients with dabrafenib and trametinib dose reduction during treatment | collection of the proportion of patients with dabrafenib and trametinib dose reduction during treatment | 12 months |
| Reason for dabrafenib and trametinib dose reduction | Collection of the reason for dabrafenib and trametinib dose reduction | 12 months |
| Time since surgery | Collection of the time since surgery | 12 months |
| Type of relapse | Collection of the type of relapse: local, regional or distant | 12 months |
| Edirne |
| Merkez |
| 22030 |
| Turkey (Türkiye) |
| Novartis Investigative Site | Bursa | Nilufer | 16059 | Turkey (Türkiye) |
| Novartis Investigative Site | Diyarbakır | Sur | 21280 | Turkey (Türkiye) |
| Novartis Investigative Site | Istanbul | Uskudar | 34668 | Turkey (Türkiye) |
| Novartis Investigative Site | Adana | Yuregir | 1230 | Turkey (Türkiye) |
| Novartis Investigative Site | Ankara | 06520 | Turkey (Türkiye) |
| Novartis Investigative Site | Izmir | 35100 | Turkey (Türkiye) |
| Novartis Investigative Site | Kecioren Ankara | 06010 | Turkey (Türkiye) |
| ID | Term |
|---|---|
| D008545 | Melanoma |
| ID | Term |
|---|---|
| D018358 | Neuroendocrine Tumors |
| D017599 | Neuroectodermal Tumors |
| D009373 | Neoplasms, Germ Cell and Embryonal |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D009380 | Neoplasms, Nerve Tissue |
| D018326 | Nevi and Melanomas |
| D012878 | Skin Neoplasms |
| D009371 | Neoplasms by Site |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
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| ID | Term |
|---|---|
| C561627 | dabrafenib |
| C560077 | trametinib |
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