RecruitingNot ApplicableNCT07422779

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

Sponsor

Institute of Oncology Ljubljana

Enrollment

100 participants

Start Date

Mar 1, 2022

Study Type

INTERVENTIONAL

Conditions

Metastatic Melanoma Skin Cancer

Summary

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.

Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study analyzes whether a protein called PD-L1 (found on tumor cells) can predict how well immunotherapy drugs — such as pembrolizumab, nivolumab, or ipilimumab/nivolumab — work in patients with metastatic melanoma (skin cancer that has spread to other parts of the body) in Slovenia. **You may be eligible if...** - You are 18 or older - You have confirmed metastatic malignant melanoma (stage IIID unresectable or stage IV) - You are in reasonably good health (ECOG 0–2) - You are receiving first-line immunotherapy - You had imaging performed within 4 weeks before starting treatment **You may NOT be eligible if...** - You have already received prior immunotherapy - You are in poor health - Your melanoma has not spread Talk to your doctor to see if this trial is right for you.

This is a simplified summary. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGPembrolizumab

PD-1 immune checkpoint inhibitor administered as first-line therapy according to standard clinical practice.

DRUGNivolumab

Nivolumab is a PD-1 immune checkpoint inhibitor administered as first-line systemic immunotherapy for metastatic malignant melanoma according to standard clinical practice, either as monotherapy or in combination with ipilimumab.

DRUGIpilimumab

Ipilimumab is a CTLA-4 immune checkpoint inhibitor administered in combination with nivolumab as first-line systemic immunotherapy for metastatic malignant melanoma according to standard clinical practice.