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

Melanoma Clinical Trial

— LEAD Melanoma  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04961619
• Other study ID #: CDRB436BTR01
• Status: Recruiting
• Start date: December 1, 2021
• Est. completion date: December 30, 2024

Study information

• Verified date: January 2024
• Source: Novartis
• Contact: Novartis Pharmaceuticals
• Phone: +41613241111
• Email: novartis.email[@]novartis.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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 information / eligibility

• Status: Recruiting
• Enrollment: 84
• Est. completion date: December 30, 2024
• Est. primary completion date: December 30, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Melanoma

Intervention

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.
• 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.

Locations

Country	Name	City	State
Turkey	Novartis Investigative Site	Ankara
Turkey	Novartis Investigative Site	Ankara
Turkey	Novartis Investigative Site	Antalya
Turkey	Novartis Investigative Site	Bursa	Gorukle
Turkey	Novartis Investigative Site	Diyarbakir
Turkey	Novartis Investigative Site	Edirne
Turkey	Novartis Investigative Site	Istanbul
Turkey	Novartis Investigative Site	Istanbul
Turkey	Novartis Investigative Site	Izmir
Turkey	Novartis Investigative Site	Kecioren Ankara

Sponsors (1)

Lead Sponsor	Collaborator
Novartis Pharmaceuticals

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	Number of patients on treatment	Collection of number of patients on treatment	Baseline, up to 12 months
Secondary	Rate of permanent study drug discontinuation	Rate of permanent study drug discontinuation due to any reason will be collected	12 months
Secondary	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
Secondary	incidence and severity of Adverse Events (AEs)	Collection of incidence and severity of Adverse Events	12 months
Secondary	procedures of the management of Adverse Events (AEs)	Collection of procedures of the management of Adverse Events (AEs)	12 months
Secondary	Reason for treatment discontinuation	death, relapse, AEs, withdrawal of consent, other	12 months
Secondary	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
Secondary	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
Secondary	Reason for dabrafenib and trametinib dose reduction	Collection of the reason for dabrafenib and trametinib dose reduction	12 months
Secondary	Time since surgery	Collection of the time since surgery	12 months
Secondary	Type of relapse	Collection of the type of relapse: local, regional or distant	12 months