Efficacy of First-Line Immunotherapy in Metastatic Melanoma in Slovenia and Identification of Predictive Biomarkers
Recruiting · NCT07407166 · Interventional (participants receive a specific treatment) · Lead sponsor: Institute of Oncology Ljubljana
View the official record on ClinicalTrials.gov →Interventions studied
What this trial is about
This study evaluates the effectiveness of first-line immunotherapy in patients with metastatic melanoma treated at the Institute of Oncology Ljubljana in Slovenia. The main objectives are to assess treatment response rates, progression-free survival, and treatment safety, and to identify prognostic and predictive biomarkers associated with response to immunotherapy. Biological samples including blood, stool, and body fluids (if available) will be collected at predefined time points and analyzed for molecular tumor markers. Imaging assessments (CT or PET/CT) will be performed before treatment initiation and during follow-up to evaluate response. The study aims to improve identification of patient subgroups who benefit from immunotherapy and those who do not, supporting better personalized treatment strategies.
Who can take part
Inclusion criteria
- Age ≥ 18 years
- Metastatic (diffuse) melanoma
- Planned first-line immunotherapy treatment
- Signed informed consent for participation in the study
Exclusion criteria
- Age \< 18 years
- Inability to provide informed consent
- Any condition preventing participation or sample collection according to investigator judgment
Where it is running
1 location listed.
- Institute of Oncology Ljubljana - Ljubljana, Slovenia