First-line immunotherapy for metastatic melanoma in Slovenia with biomarker identification
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
This study will try first-line immunotherapy in adults with metastatic melanoma in Slovenia and collect blood, stool, and fluid samples to find markers linked to treatment response.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 40 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Institute of Oncology Ljubljana Academic / other |
| Drugs / interventions | immunotherapy |
| Locations | 1 site (Ljubljana) |
| Trial ID | NCT07407166 on ClinicalTrials.gov |
What this trial studies
This prospective, single-center study at the Institute of Oncology Ljubljana will enroll adults with metastatic melanoma who are starting first-line immunotherapy. Participants will undergo baseline and scheduled imaging (CT or PET/CT at baseline, week 4, week 12, and week 28) to measure response, and primary clinical outcomes include overall response rate, progression-free survival, and safety. Peripheral blood, stool, and available pleural or peritoneal effusion samples will be collected at predefined time points and analyzed for molecular tumor markers. Biomarker data will be correlated with imaging and clinical outcomes to identify prognostic and predictive markers that could support more personalized treatment decisions.
Who should consider this trial
Good fit: Adults (age ≥18) with metastatic melanoma in Slovenia who are planning to start first-line immunotherapy and can give informed consent are ideal candidates.
Not a fit: Patients who have already received prior systemic therapy for metastatic melanoma, cannot provide informed consent, or cannot attend the Ljubljana site or provide required samples are unlikely to qualify or receive benefit from this protocol.
Why it matters
Potential benefit: If successful, the study could help identify which patients are likely to benefit from first-line immunotherapy and direct others to alternative treatments.
How similar studies have performed: Large trials of first-line immune checkpoint inhibitors have produced substantial survival benefits in metastatic melanoma, though robust predictive biomarkers for routine clinical use remain limited.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Ljubljana
- Institute of Oncology Ljubljana — Ljubljana, Slovenia (Recruiting)
Study contacts
- Study coordinator: Tanja Mesti, MD
- Email: tmesti@onko-i.si
- Phone: 015879287
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.