MelanomaLEAD MelanomaNCT04961619
Adjuvant Dabrafenib and Trametinib Treatment in Patients With Completely Resected High-risk Stage III Melanoma.
An observational study of Melanoma, run by Novartis Pharmaceuticals at 9 sites in Turkey (Türkiye).
Trial summary
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)… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Melanoma
- What is being tested?
- dabrafenib and trametinib
- How many people
- 39 participants
- Where
- 9 sitesTurkey (Türkiye)
- Study dates
- 1 Dec 2021to 5 Dec 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Completely resected high-risk stage III melanoma patients treated with dabrafenib and trametinib in the adjuvant setting
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
9 sites in 1 country.
9 sites in 1 country
Turkey (Türkiye)9 sites
Novartis Investigative Site
Adana, Yuregir, 1230
Novartis Investigative Site
Ankara, 06520
Novartis Investigative Site
Antalya, Konyaalti, 07070
Novartis Investigative Site
Bursa, Nilufer, 16059
Novartis Investigative Site
Diyarbakır, Sur, 21280
Novartis Investigative Site
Edirne, Merkez, 22030
Novartis Investigative Site
Istanbul, Uskudar, 34668
Novartis Investigative Site
Izmir, 35100
Novartis Investigative Site
Kecioren Ankara, 06010
About this study
Official 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
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.
Read the 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.
- Conditions
- Melanoma
- Being tested
- dabrafenib, trametinib
- Keywords
- Melanoma, stage III melanoma, BRAF V600E mutation, dabrafenib, trametinib, Turkey
- Medical subject headings
- Melanoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
dabrafenibDrug
There was no treatment allocation. Patients administered dabrafenib by prescription that started before inclusion of the patient into the study were enrolled.
trametinibDrug
There was no treatment allocation. Patients administered trametinib by prescription that started before inclusion of the patient into the study were enrolled.
| Study group | Role | What they receive |
|---|---|---|
| dabrafenib and trametinib | patients on adjuvant treatment with dabrafenib + trametinib Receives: Drug: dabrafenib; Drug: trametinib |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 12 months
Secondary outcomes (12)
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).
Measured: until end of treatment or permanent treatment discontinuation
Number of patients on treatment
Collection of number of patients on treatment
Measured: Baseline, up to 12 months
Rate of permanent study drug discontinuation
Rate of permanent study drug discontinuation due to any reason
Measured: 12 months
Rate of permanent drug discontinuation due to pyrexia and other AEs
Rate of permanent drug discontinuation due to pyrexia and other AEs
Measured: 12 months
incidence and severity of Adverse Events (AEs)
Collection of incidence and severity of Adverse Events
Measured: 12 months
procedures of the management of Adverse Events (AEs)
Collection of procedures of the management of Adverse Events (AEs)
Measured: 12 months
Reason for treatment discontinuation
death, relapse, AEs, withdrawal of consent, other
Measured: 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.
Measured: 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
Measured: 12 months
Reason for dabrafenib and trametinib dose reduction
Collection of the reason for dabrafenib and trametinib dose reduction
Measured: 12 months
Time since surgery
Collection of the time since surgery
Measured: 12 months
Type of relapse
Collection of the type of relapse: local, regional or distant
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jul 2021
- Study start1 Dec 2021
- Primary completion5 Dec 2024
- Study completion5 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MelanomaStudies of the same condition, open and under way.
- More trials run by Novartis PharmaceuticalsThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 39 participants (actual)
Sponsor and investigators
- Lead sponsor
- Novartis Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Novartis Pharmaceuticals, Study director, Novartis Pharmaceuticals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04961619
- Sponsor's protocol ID
- CDRB436BTR01
- Acronym
- LEAD Melanoma
- Status last verified
- Dec 2025
- First submitted
- 5 Jul 2021
- Last updated
- 12 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT04961619
- Acronym / sponsor ID
- LEAD Melanoma / CDRB436BTR01
- Conditions
- Melanoma
- Keywords
- Melanoma, stage III melanoma, BRAF V600E mutation, dabrafenib, trametinib, Turkey
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 39 participants (actual)
- Lead sponsor
- Novartis PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- 1 Dec 2021 (actual)
- Primary completion
- 5 Dec 2024 (actual)
- Study completion
- 5 Dec 2024 (actual)
- First posted
- 14 Jul 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| dabrafenib and trametinib | – | Drug: dabrafenib, Drug: trametinibpatients on adjuvant treatment with dabrafenib + trametinib |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Completely resected high-risk stage III melanoma patients treated with dabrafenib and trametinib in the adjuvant setting
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| dabrafenibThere was no treatment allocation. Patients administered dabrafenib by prescription that started before inclusion of the patient into the study were enrolled. | Drug | dabrafenib and trametinib |
| trametinibThere was no treatment allocation. Patients administered trametinib by prescription that started before inclusion of the patient into the study were enrolled. | Drug | dabrafenib and trametinib |
Primary outcome
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 secondary outcomes
Total duration of treatment
Time frame: until end of treatment or permanent treatment discontinuation
Number of patients on treatment
Time frame: Baseline, up to 12 months
Rate of permanent study drug discontinuation
Time frame: 12 months
Rate of permanent drug discontinuation due to pyrexia and other AEs
Time frame: 12 months
incidence and severity of Adverse Events (AEs)
Time frame: 12 months
procedures of the management of Adverse Events (AEs)
Time frame: 12 months
Reason for treatment discontinuation
Time frame: 12 months
Average dose of dabrafenib and trametinib used during the treatment
Time frame: 12 months
Proportion of patients with dabrafenib and trametinib dose reduction during treatment
Time frame: 12 months
Reason for dabrafenib and trametinib dose reduction
Time frame: 12 months
Time since surgery
Time frame: 12 months
Type of relapse
Time frame: 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Dec 2025.
- Link to study resultsLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Novartis Pharmaceuticals study director
Novartis Pharmaceuticals
9 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Melanoma, run by Novartis Pharmaceuticals at 9 sites in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 sites in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Relapse-free survival (RFS) rate (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Dec 2025; AzTrials last refreshed its copy on 8 Nov 2026.