NCT04961619

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

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

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 39 (actual)
• Sponsor: Novartis Pharmaceuticals · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Melanoma

Interventions

Type	Name	Description
DRUG	dabrafenib	There was no treatment allocation. Patients administered dabrafenib by prescription that started before inclusion of the patient into the study were enrolled.
DRUG	trametinib	There was no treatment allocation. Patients administered trametinib by prescription that started before inclusion of the patient into the study were enrolled.

Timeline

• Start date: 2021-12-01
• Primary completion: 2024-12-05
• Completion: 2024-12-05
• First posted: 2021-07-14
• Last updated: 2025-12-12

Locations

9 sites across 1 country: Turkey (Türkiye)