Adjuvant Dabrafenib and Trametinib Treatment in Patients With Completely Resected High-risk Stage III Melanoma.

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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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

Conditions
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Melanoma

Intervention / Treatment
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* Drug: dabrafenib
* Drug: trametinib


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| dabrafenib and trametinib<br>patients on adjuvant treatment with dabrafenib + trametinib | Drug: dabrafenib<br>* There is no treatment allocation. Patients administered dabrafenib by prescription that have started before inclusion of the patient into the study will be enrolled.<br>Drug: trametinib<br>* There is no treatment allocation. Patients administered trametinib by prescription that have started before inclusion of the patient into the study will be enrolled.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 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 will be collected | 12 months | 
| Rate of permanent drug discontinuation due to pyrexia and other AEs | Rate of permanent drug discontinuation due to pyrexia and other AEs will be collected | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Melanoma, stage III melanoma, BRAF V600E mutation, dabrafenib, trametinib, Turkey