NCT07422779

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

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 100 (estimated)
• Sponsor: Institute of Oncology Ljubljana · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

This study evaluates the efficacy of immunotherapy in the first-line treatment of metastatic melanoma in Slovenia and investigates the predictive value of PD-L1 expression in tumor tissue and blood. The aim is to assess the association 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 treatment with immune checkpoint inhibitors. In addition, the study evaluates the association between the occurrence of immune-related adverse events and survival.

Conditions

• Metastatic Melanoma
• Skin Cancer

Interventions

Type	Name	Description
DRUG	Pembrolizumab	PD-1 immune checkpoint inhibitor administered as first-line therapy according to standard clinical practice.
DRUG	Nivolumab	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.
DRUG	Ipilimumab	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.

Timeline

• Start date: 2022-03-01
• Primary completion: 2027-03-31
• Completion: 2028-03-31
• First posted: 2026-02-20
• Last updated: 2026-02-20

Locations

1 site across 1 country: Slovenia