Immunotherapy Efficacy and PD-L1 as a Predictive Biomarker in Metastatic Melanoma in Slovenia

Summary

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.

Eligibility

Inclusion Criteria:

* 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 Criteria:

* Previous systemic therapy for melanoma
* ECOG performance status 3-4
* 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)

Conditions3

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