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NCT07428252
Gastrointestinal Microbiome and Response to Immunotherapy in Metastatic Malignant Melanoma
NA trial testing PD-1 inhibitors in Metastatic Malignant Melanoma in 150 participants. Participants enrolled and being followed up; not accepting new ones.
31 March 2024
Quick facts
| Lead sponsor | Institute of Oncology Ljubljana |
|---|---|
| Phase | NA |
| Status | Active, enrolled |
| Study type | INTERVENTIONAL |
| Allocation | non randomized |
| Design | parallel |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 150 |
| Start date | 1 March 2022 |
| Primary completion | 31 March 2024 |
| Estimated completion | 31 March 2026 |
| Sites | 1 location across Slovenia |
Drugs / interventions tested
- PD-1 inhibitors — full drug profile →
- PD-1 and CTLA-4 inhibitors — full drug profile →
Conditions studied
- Metastatic Malignant Melanoma — all drugs for Metastatic Malignant Melanoma →
Sponsor
Institute of Oncology Ljubljana
Who can join
18 and older, any sex, with Metastatic Malignant Melanoma. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
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.
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
Verify or expand the search:
- PubMed search for NCT07428252
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT07428252 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Institute of Oncology Ljubljana
- Last refreshed: 25 February 2026
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT07428252.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing