Clinical trial · Observational
pRospective Evaluation of Clinical Outcomes in Patients With metAsTatIс melanOma Treated With dabrafeNib and trAmetinib in reaL practicE
Prospective Evaluation of Clinical Outcomes in Patients With Resectable or Metastatic BRAF+ Melanoma Treated With Dabrafenib and Trametinib in Real Practice
NCT05171374CI-TRIAL-00058821RATIONALEunknownClinicalTrials.gov clinicaltrialsProvenance
- 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)
Prospective evaluation of clinical outcomes in patients with resectable or metastatic BRAF+ melanoma treated with dabrafenib and trametinib in real practice
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Dabrafenib | Drug | Dabrafenib | ALIAS |
| Trametinib | Drug | Trametinib | ALIAS |
Design
Arms and outcomes
Arms (2)
- label
- Adjuvant cohort
- description
- Patients with resectable stage III melanoma, reciveng dabrafenib and trametinib in adjuvant settings
- interventionNames
- Drug: Dabrafenib
- Drug: Trametinib
- label
- Metastatic cohort
- description
- Patients with unresectable stage IIIC/D or stage IV melanoma, reciveng dabrafenib and trametinib in metastatic settings
- interventionNames
- Drug: Dabrafenib
- Drug: Trametinib
Primary outcomes (2)
- measure
- 12-month RFS rate
- timeFrame
- 12 months
- description
- The primary efficacy endpoint of the study is 12-month RFS rate, definded as the time form index date to the date of first documented relapse or death due to any cause
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Male or female patients aged 18 years or older; * Histologically confirmed stage III resectable or stage IV metastatic cutaneous melanoma with confirmed BRAF mutation, for whom the treating physician took the decision to initiate treatment with dabrafenib and trametinib before entering the study; * Treatment with Dabrafenib and Trametinib was initiated no longer than 4 weeks (28 days) prior to written informed consent for this study; * Performance status ≤ 2 by Eastern Cooperative Oncology Group (ECOG) scale; * Patient is willing and able to participate in the study; * Written informed consent for study participation. Exclusion Criteria: * Patients with a life expectancy of less than 3 months at the time of melanoma diagnosis, per the investigator's judgment. * Patients participating in any interventional clinical trial that includes investigational or marketed products at the time of enrollment. (Patients participating in other investigator initiated or other non-interventional study \[NIS\] can be included as long as their standard of care is not altered by the study). * Patients on active treatment for malignancies other than melanoma at the time of enrollment.
References
Publications (0)
Data not yet available
No reference posted for this study.