LEAD Melanoma: Adjuvant Dabrafenib and Trametinib Treatment in Patients With Completely Resected High-risk Stage III Melanoma.
Study Details
Study Description
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.
Condition or Disease | Intervention/Treatment | Phase |
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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.
Study Design
Arms and Interventions
Arm | Intervention/Treatment |
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dabrafenib and trametinib patients on adjuvant treatment with dabrafenib + trametinib |
Drug: dabrafenib
There is no treatment allocation. Patients administered dabrafenib by prescription that have started before inclusion of the patient into the study will be enrolled.
Drug: trametinib
There is no treatment allocation. Patients administered trametinib by prescription that have started before inclusion of the patient into the study will be enrolled.
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Outcome Measures
Primary Outcome Measures
- 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
- 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).
- 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
- procedures of the management of Adverse Events (AEs) [12 months]
Collection of procedures of the management of Adverse Events (AEs)
- Reason for treatment discontinuation [12 months]
death, relapse, AEs, withdrawal of consent, other
- 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
Eligibility Criteria
Criteria
Inclusion Criteria:
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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;
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V600E mutation-positive cutaneous melanoma;
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≥ 18 years of age;
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Written informed consent signed.
Exclusion Criteria:
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Lack of basic demographic and staging data.
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Current active participation in an interventional clinical trial for treatment of melanoma.
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Pregnancy or breastfeeding women.
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Current primary diagnosis of a cancer other than melanoma, that requires systemic or other treatment.
Contacts and Locations
Locations
Site | City | State | Country | Postal Code | |
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1 | Novartis Investigative Site | Bursa | Gorukle | Turkey | 16059 |
2 | Novartis Investigative Site | Ankara | Turkey | 06520 | |
3 | Novartis Investigative Site | Ankara | Turkey | 06680 | |
4 | Novartis Investigative Site | Antalya | Turkey | 07059 | |
5 | Novartis Investigative Site | Diyarbakir | Turkey | 21000 | |
6 | Novartis Investigative Site | Edirne | Turkey | 22030 | |
7 | Novartis Investigative Site | Istanbul | Turkey | 34668 | |
8 | Novartis Investigative Site | Istanbul | Turkey | ||
9 | Novartis Investigative Site | Izmir | Turkey | 35040 | |
10 | Novartis Investigative Site | Kecioren Ankara | Turkey | 06010 |
Sponsors and Collaborators
- Novartis Pharmaceuticals
Investigators
- Study Director: Novartis Pharmaceuticals, Novartis Pharmaceuticals
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- CDRB436BTR01