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

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.

Study Overview

• Status: Completed
• Conditions: Melanoma
• Intervention / Treatment: Drug: dabrafenib; Drug: trametinib

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.

• Study Type: Observational
• Enrollment (Actual): 39

Contacts and Locations

Study Locations

• Turkey (Türkiye)
  • Ankara, Turkey (Türkiye), 06520
    • Novartis Investigative Site
  • Izmir, Turkey (Türkiye), 35100
    • Novartis Investigative Site
  • Kecioren Ankara, Turkey (Türkiye), 06010
    • Novartis Investigative Site
  • Konyaalti
    • Antalya, Konyaalti, Turkey (Türkiye), 07070
      • Novartis Investigative Site
  • Merkez
    • Edirne, Merkez, Turkey (Türkiye), 22030
      • Novartis Investigative Site
  • Nilufer
    • Bursa, Nilufer, Turkey (Türkiye), 16059
      • Novartis Investigative Site
  • Sur
    • Diyarbakır, Sur, Turkey (Türkiye), 21280
      • Novartis Investigative Site
  • Uskudar
    • Istanbul, Uskudar, Turkey (Türkiye), 34668
      • Novartis Investigative Site
  • Yuregir
    • Adana, Yuregir, Turkey (Türkiye), 1230
      • Novartis Investigative Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Completely resected high-risk stage III melanoma patients treated with dabrafenib and trametinib in the adjuvant setting

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
dabrafenib and trametinib; patients on adjuvant treatment with dabrafenib + trametinib	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

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

Collaborators and Investigators

• Sponsor: Novartis Pharmaceuticals
• Investigators: Study Director: Novartis Pharmaceuticals, Novartis Pharmaceuticals

Publications and helpful links

Helpful Links

• Link to study results

Study record dates

Study Major Dates

• Study Start (Actual): December 1, 2021
• Primary Completion (Actual): December 5, 2024
• Study Completion (Actual): December 5, 2024

Study Registration Dates

• First Submitted: July 5, 2021
• First Submitted That Met QC Criteria: July 5, 2021
• First Posted (Actual): July 14, 2021

Study Record Updates

• Last Update Posted (Estimated): December 12, 2025
• Last Update Submitted That Met QC Criteria: December 5, 2025
• Last Verified: December 1, 2025

More Information

Terms related to this study

• Keywords: Melanoma; trametinib; dabrafenib; Turkey; stage III melanoma; BRAF V600E mutation
• Additional Relevant MeSH Terms: Neoplasms by Site; Neoplasms; Neoplasms by Histologic Type; Skin Diseases; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms, Nerve Tissue; Neuroendocrine Tumors; Nevi and Melanomas; Skin Neoplasms; Skin and Connective Tissue Diseases; Melanoma; Antineoplastic Agents; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Protein Kinase Inhibitors; dabrafenib; trametinib
• Other Study ID Numbers: CDRB436BTR01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No