Effectiveness of Immunotherapy in First-line Treatment of Disseminated Melanoma and Identification of Predictive Biomarkers from Tumor, Stool, and Body Fluids

What this Trial Is About

Researchers are evaluating biomarkers from the gastrointestinal microbiome (including bacteria and viruses) and exosomal mRNA expression of PD-L1 and IFNb3 to predict how patients with metastatic melanoma respond to immune checkpoint inhibitor treatments. This study focuses on patients receiving first-line immunotherapy for advanced melanoma, aiming to better understand factors influencing treatment response and immune-related side effects. It is led by the Institute of Oncology Ljubljana and follows patients treated with PD-1 and CTLA-4 inhibitors. Participants provide stool samples before treatment begins, then again around 12 and 28 weeks after starting immunotherapy, as well as at any significant events such as disease progression or immune-related adverse effects. Blood samples are collected at the same times for additional molecular and cytologic testing. Tumor tissue samples are obtained before treatment to analyze relevant biomarkers. The study tracks changes over time in these biological markers to correlate with radiological responses assessed by imaging according to irRECIST criteria. During the study, participants undergo regular imaging scans to evaluate tumor response and provide samples for laboratory analysis. Researchers monitor the composition of the microbiome and expression of specific genes in exosomes to see how they relate to treatment outcomes and side effects. The primary outcome is to assess whether these biomarkers can predict response to immune checkpoint inhibitors over a three-year period. The total participation time depends on treatment and follow-up schedules, with ongoing assessments of safety and disease status.

Biomarkers in Immunotherapy of Melanoma