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

Sponsor
Novartis Pharmaceuticals
Study ID
NCT04961619
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

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

Study Details

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.

Key Dates

Start date
Dec 1, 2021
Status verified
Dec 2025
Primary completion
Dec 5, 2024
Completion
Dec 5, 2024

Study Design

Enrollment
39 participants (actual)

Arms

  • Arm: dabrafenib and trametinib
    patients on adjuvant treatment with dabrafenib + trametinib

Primary Outcome Measure

Relapse-free survival (RFS) rate [ Time Frame: 12 months ]

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