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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

39 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-12-01

Study Completion Date

2024-12-05

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.

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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 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

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Melanoma

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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dabrafenib and trametinib

patients on adjuvant treatment with dabrafenib + trametinib

dabrafenib

Intervention Type DRUG

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

trametinib

Intervention Type DRUG

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

Interventions

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dabrafenib

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

Intervention Type DRUG

trametinib

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

Intervention Type DRUG

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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No