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
Qualifiers
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
Treatments tested in this trial
- Pembrolizumab
- Nivolumab
- Ipilimumab
Treatment groups
100 Participants
are divided into 2 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov