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

NCT07422779 | Recruiting

• 1 other identifier: OI-693-MEL-PDL1-2022
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Metastatic Melanoma; Skin Cancer

Keywords

Immunotherapy; Immune Checkpoint Inhibitors

Outcome Measures

Primary Outcomes (1)

• 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).

  Baseline; Week 12 (±2 weeks); Week 28 (±2 weeks)

Secondary Outcomes (1)

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

  Baseline

Study Arms (2)

PD-1 inhibitor therapy

OTHER

Participants with metastatic malignant melanoma treated in the first-line setting with PD-1 inhibitor therapy (pembrolizumab or nivolumab) according to standard clinical practice.

Drug: Pembrolizumab; Drug: Nivolumab

Combination PD-1 and CTLA-4 inhibitor therapy

OTHER

Participants with metastatic malignant melanoma treated in the first-line setting with combination immune checkpoint inhibitor therapy (ipilimumab plus nivolumab) according to standard clinical practice.

Drug: Nivolumab; Drug: Ipilimumab

Interventions

Pembrolizumab DRUG

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

PD-1 inhibitor therapy

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.

Combination PD-1 and CTLA-4 inhibitor therapy; PD-1 inhibitor therapy

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.

Combination PD-1 and CTLA-4 inhibitor therapy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Institute of Oncology Ljubljana: lead

Study Sites (1)

Institute of Oncology Ljubljana

Ljubljana, 1000, Slovenia

RECRUITING

MeSH Terms

Conditions

Melanoma; Skin Neoplasms

Interventions

pembrolizumab; Nivolumab; Ipilimumab

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Central Study Contacts

Tanja Mesti, MD

CONTACT

+386 1 587 9000; tmesti@onko-i.si

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Non-randomized comparative study evaluating response to immune checkpoint inhibitors in first-line treatment of metastatic melanoma and association with PD-L1 expression in tumor tissue and blood.

Study Record Dates

• First Submitted: February 5, 2026
• First Posted: February 20, 2026
• Study Start: March 1, 2022
• Primary Completion (Estimated): March 31, 2027
• Study Completion (Estimated): March 31, 2028
• Last Updated: February 20, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

SL (1)