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.
Age ≥ 18 years
Metastatic (diffuse) melanoma
Planned first-line immunotherapy treatment
Signed informed consent for participation in the study
Age < 18 years
Inability to provide informed consent
Any condition preventing participation or sample collection according to investigator judgment
Single group
Immunotherapy
DrugStandard-of-care first-line immunotherapy for metastatic melanoma, including immune checkpoint inhibitors (anti-PD-1 with or without anti-CTLA-4), administered according to institutional practice.
Overall Response Rate (ORR) to First-Line Immunotherapy
Proportion of patients with metastatic melanoma achieving complete response (CR) or partial response (PR) during first-line immunotherapy, assessed by imaging (CT or PET/CT)
Progression-Free Survival (PFS)
Time from initiation of first-line immunotherapy to disease progression or death from any cause.
Time to Disease Progression
Time from initiation of first-line immunotherapy to documented disease progression assessed by imaging.
Safety of First-Line Immunotherapy
Incidence of treatment-related adverse events during first-line immunotherapy.
Predictive and Prognostic Biomarkers in Blood, Stool and Body Fluids
Identification of molecular biomarkers in blood (10 mL), stool, and pleural/peritoneal effusions (if present) associated with response to immunotherapy and survival outcomes.
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