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NCT Number: NCT07422779

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

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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Key information

Conditions

Metastatic Melanoma Melanoma Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Germ Cell and Embryonal Neoplasms, Nerve Tissue Neuroectodermal Tumors Neuroendocrine Tumors Nevi and Melanomas Skin Cancer Skin Diseases Skin Neoplasms Skin and Connective Tissue Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Pembrolizumab

Drug

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

Nivolumab

Drug

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.

Ipilimumab

Drug

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.

Primary outcomes

  1. Objective Response Rate (ORR) According to irRECIST

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

    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).

Secondary outcomes

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

    Time frame: Baseline

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Tanja Mesti, MD

CONTACT

[email protected]

+386 1 587 9000

Sponsors and collaborators

Lead sponsor

Institute of Oncology Ljubljana

Other

Registry information

Official study title

Efficacy of Immunotherapy in the First-Line Treatment of Metastatic Melanoma in Slovenia and Predictive Value of PD-L1 Expression in Tumor and Blood

Acronym: MAK

Important dates

Study start
2022
Primary completion
2027
Study completion
2028
First posted
Feb 20, 2026
Registry last updated
Feb 20, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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