First-line immunotherapy and PD-L1 testing for metastatic melanoma in Slovenia
Efficacy of Immunotherapy in the First-Line Treatment of Metastatic Melanoma in Slovenia and Predictive Value of PD-L1 Expression in Tumor and Blood
This study will see if first-line immunotherapy (pembrolizumab, nivolumab, or ipilimumab plus nivolumab) works for adults in Slovenia with metastatic melanoma and whether PD-L1 measurements predict who responds.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 100 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Institute of Oncology Ljubljana Academic / other |
| Drugs / interventions | pembrolizumab, nivolumab, ipilimumab, immunotherapy |
| Locations | 1 site (Ljubljana) |
| Trial ID | NCT07422779 on ClinicalTrials.gov |
What this trial studies
This single-center study at the Institute of Oncology Ljubljana enrolls adults with unresectable stage IIID or stage IV metastatic melanoma who are starting first-line systemic immunotherapy (pembrolizumab, nivolumab, or ipilimumab plus nivolumab). Researchers will collect tumor tissue and blood samples to measure PD-L1 expression in tumor cells, PD-L1 on immune-cell surfaces, and exosomal PD-L1 miRNA, and will correlate these biomarkers with radiographic response and survival. Baseline imaging (CT or PET-CT within 4 weeks) and regular clinical follow-up will track treatment response and immune-related adverse events. The study excludes patients with prior systemic melanoma therapy, significant immune suppression, active autoimmune disease requiring systemic treatment, or poor performance status.
Who should consider this trial
Good fit: Adults (≥18) with cytologically or histologically confirmed unresectable stage IIID or stage IV metastatic melanoma, ECOG 0–2, who are starting first-line pembrolizumab, nivolumab, or ipilimumab plus nivolumab are ideal candidates.
Not a fit: Patients with prior systemic therapy for melanoma, ECOG 3–4, active autoimmune disease requiring systemic treatment, ongoing immunosuppression, or another active malignancy are unlikely to benefit or are excluded.
Why it matters
Potential benefit: If successful, the study could help tailor immunotherapy by identifying PD-L1–related biomarkers that predict which patients are more likely to benefit.
How similar studies have performed: Immune checkpoint inhibitors are established treatments for metastatic melanoma, but PD-L1 as a predictive biomarker has shown mixed results and exosomal PD-L1 miRNA remains exploratory.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
Ljubljana
- Institute of Oncology Ljubljana — Ljubljana, Slovenia (Recruiting)
Study contacts
- Study coordinator: Tanja Mesti, MD
- Email: tmesti@onko-i.si
- Phone: +386 1 587 9000
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.