Efficacy of First-Line Immunotherapy in Metastatic Melanoma in Slovenia and Identification of Predictive Biomarkers

This study evaluates the effectiveness of first-line immunotherapy in patients with metastatic melanoma treated at the Institute of Oncology Ljubljana in Slovenia. The main objectives are to assess treatment response rates, progression-free survival, and treatment safety, and to identify prognostic and predictive biomarkers associated with response to immunotherapy. Biological samples including blood, stool, and body fluids (if available) will be collected at predefined time points and analyzed for molecular tumor markers. Imaging assessments (CT or PET/CT) will be performed before treatment initiation and during follow-up to evaluate response. The study aims to improve identification of patient subgroups who benefit from immunotherapy and those who do not, supporting better personalized treatment strategies.

NCT Number	NCT07407166
Lead Sponsor	Institute of Oncology Ljubljana
Conditions	Metastatic Melanoma, Melanoma
Enrollment	40 participants
Start Date	2021-05-01
Primary Completion	2026-12-31 (estimated)
Study Completion	2027-12-31 (estimated)
Updated on ClinicalTrials.gov	2026-02-17