RecruitingNot ApplicableNCT07407166

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

Sponsor

Institute of Oncology Ljubljana

Enrollment

40 participants

Start Date

May 1, 2021

Study Type

INTERVENTIONAL

Conditions

Melanoma Metastatic Melanoma

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

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is collecting real-world data from Slovenia on how well first-line immunotherapy works in people with metastatic melanoma (skin cancer that has spread). Researchers also want to identify biological markers (biomarkers) in the blood or tissue that might predict who responds better to these treatments. **You may be eligible if...** - You are 18 years or older - You have been diagnosed with metastatic (stage IV) melanoma - You are about to start your first course of immunotherapy treatment - You are willing to sign an informed consent form **You may NOT be eligible if...** - You are under 18 years old - You are unable to provide informed consent - Your doctor determines that there is any condition that prevents participation or sample collection Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

Interested in this trial?

Get notified about updates and connect with the research team.

Interventions

DRUGImmunotherapy

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.