Clinical trial · Interventional
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
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Metastatic Malignant Melanoma | Melanoma | CURATED_BROADER | 0.78 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| PD-1 and CTLA-4 inhibitors | Drug | — | UNRESOLVED |
| PD-1 inhibitors | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- OTHER
- label
- PD-1 inhibitor therapy
- description
- Patients with metastatic malignant melanoma treated in the first line with PD-1 inhibitors (pembrolizumab or nivolumab).
- interventionNames
- Drug: PD-1 and CTLA-4 inhibitors
- type
- OTHER
- label
- Combination PD-1 and CTLA-4 inhibitor therapy
- description
- Patients with metastatic malignant melanoma treated in the first line with combined immunotherapy with PD-1 and CTLA-4 inhibitors (ipilimumab/nivolumab).
- interventionNames
- Drug: PD-1 inhibitors
Primary outcomes (1)
- measure
- Objective Treatment Response According to irRECIST
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria * 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 Exclusion Criteria * Previous systemic therapy for melanoma * ECOG performance status 3-4 * Contraindications to immunotherapy (e.g., known immunodeficiency, active immunosuppressive treatment, or active autoimmune disease requiring systemic therapy) * 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
References
Publications (0)
Data not yet available