Gut bacteria may predict immunotherapy success in melanoma patients
NCT ID NCT07428252
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study looks at whether the bacteria in your gut can help predict how well immunotherapy works for advanced melanoma. Researchers collected stool and blood samples from 150 patients before and during treatment. The goal is to find links between gut microbiome patterns and treatment response or side effects.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
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About 150 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Mar 2022
- Expected to finish
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Mar 2026
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
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Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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Institute of Oncology Ljubljana
Ljubljana, 1000, Slovenia
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