Immunotherapy Efficacy and PD-L1 as a Predictive Biomarker in Metastatic Melanoma in Slovenia
Recruiting · NCT07422779 · Interventional (participants receive a specific treatment) · Lead sponsor: Institute of Oncology Ljubljana
View the official record on ClinicalTrials.gov →Interventions studied
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.
Who can take part
Age range
18 Years and older
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Not applicable (e.g. observational or device study)
Study type
Interventional (participants receive a specific treatment)
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)
Where it is running
1 location listed.
- Institute of Oncology Ljubljana - Ljubljana, Slovenia