NCT04961619

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
39

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Dec 2021

Typical duration for all trials

Geographic Reach
1 country

9 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 5, 2021

Completed
9 days until next milestone

First Posted

Study publicly available on registry

July 14, 2021

Completed
5 months until next milestone

Study Start

First participant enrolled

December 1, 2021

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 5, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 5, 2024

Completed
Last Updated

December 12, 2025

Status Verified

December 1, 2025

Enrollment Period

3 years

First QC Date

July 5, 2021

Last Update Submit

December 5, 2025

Conditions

Melanoma

Keywords

Melanomastage III melanomaBRAF V600E mutationdabrafenibtrametinibTurkey

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (12)

  • Total duration of treatment

    until end of treatment or permanent treatment discontinuation

  • Number of patients on treatment

    Baseline, up to 12 months

  • Rate of permanent study drug discontinuation

    12 months

  • Rate of permanent drug discontinuation due to pyrexia and other AEs

    12 months

  • incidence and severity of Adverse Events (AEs)

    12 months

  • +7 more secondary outcomes

Study Arms (1)

dabrafenib and trametinib

patients on adjuvant treatment with dabrafenib + trametinib

Drug: dabrafenibDrug: trametinib

Interventions

dabrafenibDRUG

There was no treatment allocation. Patients administered dabrafenib by prescription that started before inclusion of the patient into the study were enrolled.

dabrafenib and trametinib
trametinibDRUG

There was no treatment allocation. Patients administered trametinib by prescription that started before inclusion of the patient into the study were enrolled.

dabrafenib and trametinib

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (9)

Novartis Investigative Site

Antalya, Konyaalti, 07070, Turkey (Türkiye)

Location

Novartis Investigative Site

Edirne, Merkez, 22030, Turkey (Türkiye)

Location

Novartis Investigative Site

Bursa, Nilufer, 16059, Turkey (Türkiye)

Location

Novartis Investigative Site

Diyarbakır, Sur, 21280, Turkey (Türkiye)

Location

Novartis Investigative Site

Istanbul, Uskudar, 34668, Turkey (Türkiye)

Location

Novartis Investigative Site

Adana, Yuregir, 1230, Turkey (Türkiye)

Location

Novartis Investigative Site

Ankara, 06520, Turkey (Türkiye)

Location

Novartis Investigative Site

Izmir, 35100, Turkey (Türkiye)

Location

Novartis Investigative Site

Kecioren Ankara, 06010, Turkey (Türkiye)

Location

Related Links

MeSH Terms

Conditions

Melanoma

Interventions

dabrafenibtrametinib

Condition Hierarchy (Ancestors)

Neuroendocrine TumorsNeuroectodermal TumorsNeoplasms, Germ Cell and EmbryonalNeoplasms by Histologic TypeNeoplasmsNeoplasms, Nerve TissueNevi and MelanomasSkin NeoplasmsNeoplasms by SiteSkin DiseasesSkin and Connective Tissue Diseases

Study Officials

  • Novartis Pharmaceuticals

    Novartis Pharmaceuticals

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 5, 2021

First Posted

July 14, 2021

Study Start

December 1, 2021

Primary Completion

December 5, 2024

Study Completion

December 5, 2024

Last Updated

December 12, 2025

Record last verified: 2025-12

Data Sharing

IPD Sharing
Will not share

Locations

TU(9)