NCT07428252Active, not recruiting
Gastrointestinal Microbiome and Response to Immunotherapy in Metastatic Malignant Melanoma
Prognostic and Predictive Value of Gastrointestinal Microbiome in Metastatic Melanoma Treated With Immunotherapy
Source: ClinicalTrials.gov · Last updated 25 Feb 2026
Brief summary (registry, in English)
The aim of this prospective clinical study is to evaluate the prognostic and predictive significance of the gastrointestinal microbiome in patients with metastatic malignant melanoma treated with first-line immunotherapy using immune checkpoint inhibitors (PD-1 inhibitors and CTLA-4 inhibitors). Although immunotherapy has significantly improved survival outcomes, treatment response remains unpredictable and a substantial proportion of patients develop immune-related adverse events, pseudoprogression, or hyperprogression. The gastrointestinal microbiome is an important regulator of immune homeostasis and may influence systemic immune response. This study investigates whether specific microbiome composition is associated with objective treatment response assessed according to iRECIST criteria, progression-free survival (PFS), and the occurrence of immune-related adverse events. Patients treated at the Institute of Oncology Ljubljana between March 2022 and March 2024 were enrolled. In addition to standard-of-care immunotherapy, participants underwent protocol-defined collection of stool and peripheral blood samples at predefined time points for microbiome and immune profiling analyses.
- Status (registry)
- Active, not recruiting
- Study type
- Interventional
- Enrollment
- 150 (estimated)
- First submitted
- 5 Feb 2026
- Start date
- 1 Mar 2022
- Primary completion date
- 31 Mar 2024
- Lead sponsor
- Institute of Oncology Ljubljana
- Diseases
- Melanoma
- NCT number
- NCT07428252
What you commit to
- Study type: Interventional
- Planned participants: 150
- From 1 Mar 2022 to the primary completion date, 31 Mar 2024
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Previous systemic therapy for melanoma
Other illness
- Contraindications to immunotherapy (e.g., known immunodeficiency, active immunosuppressive treatment, or active autoimmune disease requiring systemic therapy)
Age
- Presence of another active malignancy, except adequately treated basal cell carcinoma, squamous cell carcinoma of the skin, or other solid tumors with no evidence of recurrence for ≥3 years
Other
- ECOG performance status 3-4
Who the study is looking for
- Age ≥ 18 years
- Cytologically or histologically confirmed malignant melanoma
- Unresectable stage IIID or stage IV disease according to AJCC (8th edition, 2018)
- ECOG performance status 0-2
- Indication for first-line systemic immunotherapy (nivolumab, combination ipilimumab/nivolumab, or pembrolizumab)
- CT or PET/CT imaging performed within 4 weeks prior to first administration of immunotherapy
- Written informed consent obtained prior to study participation
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Institute of Oncology Ljubljana Coordinator of this site? Confirm its status | Ljubljana | Slovenia | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.