First-line immunotherapy and PD-L1 testing for metastatic melanoma in Slovenia
Official title: Efficacy of Immunotherapy in the First-Line Treatment of Metastatic Melanoma in Slovenia and Predictive Value of PD-L1 Expression in Tumor and Blood
Run by Institute of Oncology Ljubljana · NCT07422779 · Data updated 2026-11-12
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
| Study type | Interventional |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 100 (estimated) |
| Sponsor | Institute of Oncology Ljubljana Academic / other |
| Drugs / interventions | pembrolizumab, nivolumab, ipilimumab, immunotherapy |
| Locations | 1 site (Ljubljana) |
| Status | Recruiting |
| Started | March 1, 2022 |
| Main results expected | March 31, 2027 |
| Study ends | March 31, 2028 |
| Registry record updated | February 20, 2026 |
| Trial ID | NCT07422779 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a 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.
✕Probably 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.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
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.
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 gone: 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.
Who can join: the full rules
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 it's running
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Institute of Oncology Ljubljana
Ljubljana, Slovenia Recruiting
Study contacts
- Study coordinator: Tanja Mesti, MD
- Email: tmesti@onko-i.si
- Phone: +386 1 587 9000
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.