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

Sponsor
Novartis Pharmaceuticals (Industry)
Overall Status
Recruiting
CT.gov ID
NCT04961619
Collaborator
(none)
84
10
22.6
8.4
0.4

Study Details

Study Description

Brief 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) melanoma in Turkey.

Condition or Disease Intervention/Treatment Phase

Detailed Description

The prospective registration of completely resected high-risk stage III melanoma patients treated with dabrafenib and trametinib in the adjuvant setting will be based on collaboration with centers of excellence on melanoma patients treatment. Pre-identified centers (up to 12) considered as the most advanced according to their knowledge and experience, will take part in the patients recruitment.

Study Design

Study Type:
Observational
Anticipated Enrollment :
84 participants
Observational Model:
Cohort
Time Perspective:
Prospective
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
Actual Study Start Date :
Dec 1, 2021
Anticipated Primary Completion Date :
Oct 20, 2023
Anticipated Study Completion Date :
Oct 20, 2023

Arms and Interventions

Arm Intervention/Treatment
dabrafenib and trametinib

patients on adjuvant treatment with dabrafenib + trametinib

Drug: dabrafenib
There is no treatment allocation. Patients administered dabrafenib by prescription that have started before inclusion of the patient into the study will be enrolled.

Drug: trametinib
There is no treatment allocation. Patients administered trametinib by prescription that have started before inclusion of the patient into the study will be enrolled.

Outcome Measures

Primary Outcome Measures

  1. Relapse-free survival (RFS) rate [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 Outcome Measures

  1. Total duration of treatment [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 [Baseline, up to 12 months]

    Collection of number of patients on treatment

  3. Rate of permanent study drug discontinuation [12 months]

    Rate of permanent study drug discontinuation due to any reason will be collected

  4. Rate of permanent drug discontinuation due to pyrexia and other AEs [12 months]

    Rate of permanent drug discontinuation due to pyrexia and other AEs will be collected

  5. incidence and severity of Adverse Events (AEs) [12 months]

    Collection of incidence and severity of Adverse Events

  6. procedures of the management of Adverse Events (AEs) [12 months]

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

  7. Reason for treatment discontinuation [12 months]

    death, relapse, AEs, withdrawal of consent, other

  8. Average dose of dabrafenib and trametinib used during the treatment [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 [12 months]

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

  10. Reason for dabrafenib and trametinib dose reduction [12 months]

    Collection of the reason for dabrafenib and trametinib dose reduction

  11. Time since surgery [12 months]

    Collection of the time since surgery

  12. Type of relapse [12 months]

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

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Novartis Investigative Site Bursa Gorukle Turkey 16059
2 Novartis Investigative Site Ankara Turkey 06520
3 Novartis Investigative Site Ankara Turkey 06680
4 Novartis Investigative Site Antalya Turkey 07059
5 Novartis Investigative Site Diyarbakir Turkey 21000
6 Novartis Investigative Site Edirne Turkey 22030
7 Novartis Investigative Site Istanbul Turkey 34668
8 Novartis Investigative Site Istanbul Turkey
9 Novartis Investigative Site Izmir Turkey 35040
10 Novartis Investigative Site Kecioren Ankara Turkey 06010

Sponsors and Collaborators

  • Novartis Pharmaceuticals

Investigators

  • Study Director: Novartis Pharmaceuticals, Novartis Pharmaceuticals

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Novartis Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT04961619
Other Study ID Numbers:
  • CDRB436BTR01
First Posted:
Jul 14, 2021
Last Update Posted:
Mar 2, 2022
Last Verified:
Feb 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Novartis Pharmaceuticals
Additional relevant MeSH terms:

Study Results

No Results Posted as of Mar 2, 2022