NCT07422779Recruiting
Immunotherapy Efficacy and PD-L1 as a Predictive Biomarker in 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
Source: ClinicalTrials.gov · Last updated 20 Feb 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 100 (estimated)
- First submitted
- 5 Feb 2026
- Start date
- 1 Mar 2022
- Primary completion date
- 31 Mar 2027
- Lead sponsor
- Institute of Oncology Ljubljana
- Diseases
- Melanoma
- NCT number
- NCT07422779
What you commit to
- Study type: Interventional
- Planned participants: 100
- From 1 Mar 2022 to the primary completion date, 31 Mar 2027
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Previous systemic therapy for melanoma
Other illness
- Contraindications to immunotherapy (immune deficiency, active immunosuppressive therapy, or active autoimmune disease requiring systemic treatment)
Age
- Other active malignancy (except cured basal cell carcinoma, squamous cell carcinoma, or other solid tumors without recurrence \>3 years)
Other
- ECOG performance status 3-4
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Institute of Oncology Ljubljana Coordinator of this site? Confirm its status | Ljubljana | Slovenia | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.