Immunotherapy and PD-L1 Markers in Metastatic Melanoma Treated in Slovenia
Tests how immunotherapy works against metastatic melanoma and whether PD-L1 predicts response.
Plain-language title generated from the registry record
Registry title: Immunotherapy Efficacy and PD-L1 as a Predictive Biomarker in Metastatic Melanoma in Slovenia
Key facts
- Where
- Ljubljana, SloveniaSee the site
Where in Slovenia
- Institute of Oncology LjubljanaLjubljana, SloveniaTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Institute of Oncology Ljubljana
- Trial code
- NCT07422779
- Record updated
- 20 February 2026
- Original description
The purpose of this study is to evaluate the efficacy of immunotherapy in the first-line treatment of metastatic melanoma in Slovenia and to investigate the association between PD-L1 expression and treatment response. The study aims to determine the relationship between exosomal PD-L1 miRNA expression, PD-L1 expression in tumor tissue, and PD-L1 expression on the surface of immune cells, and response to immunotherapy. The study will also evaluate the association between immune-related adverse events and survival.Read full original descriptionShow less
Efficacy of Immunotherapy in the First-Line Treatment of Metastatic Melanoma in Slovenia and Predictive Value of PD-L1 Expression in Tumor and Blood
The purpose of this study is to evaluate the efficacy of immunotherapy in the first-line treatment of metastatic melanoma in Slovenia and to investigate the association between PD-L1 expression and treatment response. The study aims to determine the relationship between exosomal PD-L1 miRNA expression, PD-L1 expression in tumor tissue, and PD-L1 expression on the surface of immune cells, and response to immunotherapy. The study will also evaluate the association between immune-related adverse events and survival.
Inclusion: Age ≥18 years; Cytologically or histologically confirmed metastatic malignant melanoma; Stage IIID unresectable or stage IV (AJCC 8th edition); ECOG performance status 0-2; First-line systemic immunotherapy (pembrolizumab, nivolumab, or ipilimumab/nivolumab); CT/PET-CT performed within 4 weeks prior to treatment start; Signed informed consent.
Exclusion: Previous systemic therapy for melanoma; Contraindications to immunotherapy (immune deficiency, active immunosuppressive therapy, or active autoimmune disease requiring systemic treatment); Other active malignancy (except cured basal cell carcinoma, squamous cell carcinoma, or other solid tumors without recurrence >3 years); ECOG performance status 3-4.