Actively Recruiting
Immunotherapy Efficacy and PD-L1 as a Predictive Biomarker in Metastatic Melanoma in Slovenia
Led by Institute of Oncology Ljubljana · Updated on 2026-02-20
100
Participants Needed
1
Research Sites
317 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Immunotherapy Efficacy and PD-L1 as a Predictive Biomarker in Metastatic Melanoma in Slovenia
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 years or older
- Cytologically or histologically confirmed metastatic malignant melanoma
- Stage IIID unresectable or stage IV according to AJCC 8th edition
- ECOG performance status between 0 and 2
- Receiving first-line systemic immunotherapy with pembrolizumab, nivolumab, or ipilimumab/nivolumab
- CT or PET-CT scan done within 4 weeks before starting treatment
- Signed informed consent
You will not qualify if you...
- Previous systemic therapy for melanoma
- ECOG performance status of 3 or 4
- Contraindications to immunotherapy, including immune deficiency, ongoing immunosuppressive therapy, or active autoimmune disease requiring systemic treatment
- Presence of another active cancer except cured basal cell carcinoma, squamous cell carcinoma, or other solid tumors without recurrence for more than 3 years
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Institute of Oncology Ljubljana
Ljubljana, Slovenia, 1000
Actively Recruiting
Research Team
T
Tanja Mesti, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
PARALLEL
Primary Purpose
OTHER
Number of Arms
2
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