Immunotherapy Efficacy and PD-L1 as a Predictive Biomarker in Metastatic Melanoma in Slovenia
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorInstitute of Oncology Ljubljana
About this trial
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 criteria
This trial does not accept healthy volunteersQualifiers
Age ≥18 years
Cytologically or histologically confirmed metastatic malignant melanoma
Stage IIID unresectable or stage IV (AJCC 8th edition)
ECOG performance status 0-2
Disqualifiers
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)
Trial design
Design model
Parallel
Treatments tested in this trial
Pembrolizumab
DrugPD-1 immune checkpoint inhibitor administered as first-line therapy according to standard clinical practice.
Nivolumab
DrugNivolumab 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
DrugIpilimumab 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.
Treatment groups
100 Participants
are divided into 2 treatment groupsGroup A: PD-1 inhibitor therapyOther 2 interventions
Group B: Combination PD-1 and CTLA-4 inhibitor therapyOther 2 interventions
Trial outcomes
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).
Time frame
Baseline; Week 12 (±2 weeks); Week 28 (±2 weeks)Secondary outcomes
1
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
BaselineSponsors and contacts
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Source ClinicalTrials.gov