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

December 5, 2025 updated by: Novartis Pharmaceuticals

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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
39

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

  • Name: Novartis Pharmaceuticals

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

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
12 months

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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).
until end of treatment or permanent treatment discontinuation
Number of patients on treatment
Time Frame: Baseline, up to 12 months
Collection of number of patients on treatment
Baseline, up to 12 months
incidence and severity of Adverse Events (AEs)
Time Frame: 12 months
Collection of incidence and severity of Adverse Events
12 months
procedures of the management of Adverse Events (AEs)
Time Frame: 12 months
Collection of procedures of the management of Adverse Events (AEs)
12 months
Reason for treatment discontinuation
Time Frame: 12 months
death, relapse, AEs, withdrawal of consent, other
12 months
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.
12 months
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
12 months
Reason for dabrafenib and trametinib dose reduction
Time Frame: 12 months
Collection of the reason for dabrafenib and trametinib dose reduction
12 months
Time since surgery
Time Frame: 12 months
Collection of the time since surgery
12 months
Type of relapse
Time Frame: 12 months
Collection of the type of relapse: local, regional or distant
12 months
Rate of permanent study drug discontinuation
Time Frame: 12 months
Rate of permanent study drug discontinuation due to any reason
12 months
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
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Novartis Pharmaceuticals

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Novartis Pharmaceuticals, Novartis Pharmaceuticals

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
December 1, 2021

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 5, 2024

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 5, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
July 5, 2021

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 5, 2021

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
July 14, 2021

Study Record Updates

Last Update Posted (Estimated)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
December 12, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 5, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
December 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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