Efficacy of First-Line Immunotherapy in Metastatic Melanoma in Slovenia and Identification of Predictive Biomarkers
Efficacy of Immunotherapy in the First Line of Treatment of Diffuse Melanoma in Slovenia and Recognition of Prognostic and Predictive Biomarkers From Primary Tumor, Faeces and Body Fluids
Institute of Oncology Ljubljana
40 participants
May 1, 2021
INTERVENTIONAL
Conditions
Summary
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.
Eligibility
Inclusion Criteria4
- Age ≥ 18 years
- Metastatic (diffuse) melanoma
- Planned first-line immunotherapy treatment
- Signed informed consent for participation in the study
Exclusion Criteria3
- Age \< 18 years
- Inability to provide informed consent
- Any condition preventing participation or sample collection according to investigator judgment
Interventions
Standard-of-care first-line immunotherapy for metastatic melanoma, including immune checkpoint inhibitors (anti-PD-1 with or without anti-CTLA-4), administered according to institutional practice.
Locations(1)
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NCT07407166