Clinical trial · Observational
Adjuvant Dabrafenib and Trametinib Treatment in Patients With Completely Resected High-risk Stage III Melanoma.
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
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Melanoma | Melanoma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| dabrafenib | Drug | Dabrafenib | ALIAS |
| trametinib | Drug | Trametinib | ALIAS |
Design
Arms and outcomes
Arms (1)
- label
- dabrafenib and trametinib
- description
- patients on adjuvant treatment with dabrafenib + trametinib
- interventionNames
- Drug: dabrafenib
- Drug: trametinib
Primary outcomes (1)
- measure
- Relapse-free survival (RFS) rate
- timeFrame
- 12 months
- description
- 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 outcomes (12)
- measure
- Total duration of treatment
- timeFrame
- until end of treatment or permanent treatment discontinuation
- description
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available