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RECRUITINGINTERVENTIONAL

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

Important: This information is not medical advice. Talk to your doctor about whether a clinical trial is right for you.

About This Trial

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.

Who May Be Eligible (Plain English)

Who May Qualify: - Age ≥ 18 years - Metastatic (diffuse) melanoma - Planned first-line immunotherapy treatment - Signed willing to sign a consent form for participation in the study Who Should NOT Join This Trial: - Age \< 18 years - Inability to provide willing to sign a consent form - Any condition preventing participation or sample collection according to investigator judgment Always talk to your doctor about whether this trial is right for you.

Original Eligibility Criteria

View original clinical language
Inclusion Criteria: * Age ≥ 18 years * Metastatic (diffuse) melanoma * Planned first-line immunotherapy treatment * Signed informed consent for participation in the study Exclusion Criteria: * Age \< 18 years * Inability to provide informed consent * Any condition preventing participation or sample collection according to investigator judgment

Treatments Being Tested

DRUG

Immunotherapy

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)

Institute of Oncology Ljubljana
Ljubljana, Slovenia