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NCT Number: NCT04961619

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

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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Key information

Conditions

Melanoma Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Germ Cell and Embryonal Neoplasms, Nerve Tissue Neuroectodermal Tumors Neuroendocrine Tumors Nevi and Melanomas Skin Diseases Skin Neoplasms Skin and Connective Tissue Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Novartis Investigative Site, Antalya, Konyaalti, Turkey (Türkiye)

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Primary outcomes

  1. Relapse-free survival (RFS) rate

    Time frame: 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 outcomes

  1. Total duration of treatment

    Time frame: 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).

  2. Number of patients on treatment

    Time frame: Baseline, up to 12 months

    Collection of number of patients on treatment

  3. Rate of permanent study drug discontinuation

    Time frame: 12 months

    Rate of permanent study drug discontinuation due to any reason

  4. Rate of permanent drug discontinuation due to pyrexia and other AEs

    Time frame: 12 months

    Rate of permanent drug discontinuation due to pyrexia and other AEs

  5. incidence and severity of Adverse Events (AEs)

    Time frame: 12 months

    Collection of incidence and severity of Adverse Events

  6. procedures of the management of Adverse Events (AEs)

    Time frame: 12 months

    Collection of procedures of the management of Adverse Events (AEs)

  7. Reason for treatment discontinuation

    Time frame: 12 months

    death, relapse, AEs, withdrawal of consent, other

  8. Average dose of dabrafenib and trametinib used during the treatment

    Time frame: 12 months

    Average dose of dabrafenib and trametinib used during the treatment including dose reductions.

  9. Proportion of patients with dabrafenib and trametinib dose reduction during treatment

    Time frame: 12 months

    collection of the proportion of patients with dabrafenib and trametinib dose reduction during treatment

  10. Reason for dabrafenib and trametinib dose reduction

    Time frame: 12 months

    Collection of the reason for dabrafenib and trametinib dose reduction

  11. Time since surgery

    Time frame: 12 months

    Collection of the time since surgery

  12. Type of relapse

    Time frame: 12 months

    Collection of the type of relapse: local, regional or distant

Sponsors and collaborators

Lead sponsor

Novartis Pharmaceuticals

Industry

Registry information

Official study 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

Acronym: LEAD Melanoma

Important dates

Study start
2021
Primary completion
2024
Study completion
2024
First posted
Jul 14, 2021
Registry last updated
Dec 12, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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