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

Recruiting now · Not applicable

Conditions studied: Metastatic Melanoma, Skin Cancer

In brief

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.

Key facts

Study ID

NCT07422779

Run by

Institute of Oncology Ljubljana

People needed

100

Starts

2022-03-01

Expected to finish

2028-03-31

Last updated by the study team

2026-02-20

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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)

Where it is running

• Institute of Oncology Ljubljana — Ljubljana, Slovenia (enrolling)

Full record on ClinicalTrials.gov

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