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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04961619
Recruitment Status : Recruiting
First Posted : July 14, 2021
Last Update Posted : March 2, 2022
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )

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
Melanoma 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 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.

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Study Type : Observational
Estimated 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 : December 1, 2021
Estimated Primary Completion Date : October 20, 2023
Estimated Study Completion Date : October 20, 2023

Resource links provided by the National Library of Medicine

MedlinePlus Genetics related topics: Melanoma
MedlinePlus related topics: Melanoma

Group/Cohort 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.




Primary Outcome Measures :
  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 Outcome Measures :
  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 will be collected

  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 will be collected

  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



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04961619


Contacts
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Contact: Novartis Pharmaceuticals +41613241111 novartis.email@novartis.com
Contact: Novartis Pharmaceuticals

Locations
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Turkey
Novartis Investigative Site Recruiting
Bursa, Gorukle, Turkey, 16059
Novartis Investigative Site Recruiting
Ankara, Turkey, 06520
Novartis Investigative Site Recruiting
Ankara, Turkey, 06680
Novartis Investigative Site Recruiting
Antalya, Turkey, 07059
Novartis Investigative Site Recruiting
Diyarbakir, Turkey, 21000
Novartis Investigative Site Recruiting
Edirne, Turkey, 22030
Novartis Investigative Site Recruiting
Istanbul, Turkey, 34668
Novartis Investigative Site Recruiting
Istanbul, Turkey
Novartis Investigative Site Recruiting
Izmir, Turkey, 35040
Novartis Investigative Site Recruiting
Kecioren Ankara, Turkey, 06010
Sponsors and Collaborators
Novartis Pharmaceuticals
Investigators
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Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals
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Responsible Party: Novartis Pharmaceuticals
ClinicalTrials.gov Identifier: NCT04961619    
Other Study ID Numbers: CDRB436BTR01
First Posted: July 14, 2021    Key Record Dates
Last Update Posted: March 2, 2022
Last Verified: February 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Novartis ( Novartis Pharmaceuticals ):
Melanoma
stage III melanoma
BRAF V600E mutation
dabrafenib
trametinib
Turkey
Additional relevant MeSH terms:
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Melanoma
Neuroendocrine Tumors
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Nerve Tissue
Nevi and Melanomas
Trametinib
Dabrafenib
Antineoplastic Agents
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action