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Immunotherapy Efficacy and PD-L1 as a Predictive Biomarker in Metastatic Melanoma in Slovenia

RecruitingNAAges 18 Years - anyAllInstitute of Oncology Ljubljana
NCT07422779 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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.

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📋 Eligibility rules (as published)
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)
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What it tests

  • Pembrolizumab
  • Nivolumab
  • Ipilimumab
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Where

1 site
Institute of Oncology Ljubljana
Ljubljana, Slovenia
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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