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

Institute of Oncology Ljubljana100 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

OTHER

Masking

NONE

Enrollment

100

Conditions

Metastatic Melanoma Skin Cancer

Interventions

PembrolizumabDRUG

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

NivolumabDRUG

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.

IpilimumabDRUG

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.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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)

Outcomes

Primary Outcomes

Objective Response Rate (ORR) According to irRECIST

Objective response will be assessed using CT or PET/CT imaging and evaluated according to irRECIST criteria. The outcome will be reported as the proportion (%) of participants achieving complete response (CR) or partial response (PR).

Time frame: Baseline; Week 12 (±2 weeks); Week 28 (±2 weeks)

Secondary Outcomes

PD-L1 Expression in Tumor Tissue (Immunohistochemistry, H-score or % Positive Cells)

PD-L1 expression in tumor tissue will be assessed using immunohistochemistry (IHC). The outcome will be reported as PD-L1 expression level (H-score and/or percentage of PD-L1 positive tumor cells) and correlated with objective response according to irRECIST.

Time frame: Baseline