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Biomarkers in Immunotherapy of Melanoma

RecruitingNAAges 18 Years - anyAllInstitute of Oncology Ljubljana
NCT05878977 on ClinicalTrials.gov โ†—
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In plain words

What the trial is, and whether it could suit you

Background: Immunotherapy has been successful in treating advanced melanoma, but a large proportion of patients do not respond to the treatment with immune checkpoint inhibitors (ICIs). Preclinical and small cohort studies suggest biomarkers from the primary tumor, stool and body fluids as markers of response. This prospective study will evaluate gastrointestinal microbiome (bacterial spices and virome) composition and exosomal mRNA expression of PD-L1 and IFNฮณ correlation with radiological response rates to ICIs treatment of advanced melanoma patients. Methods: Patients treated with immune checkpoint inhibitors as a first line treatment for metastatic melanoma are recruted to the study. Stool samples are submitted before the start of treatment, at the 12 (+/-2) week and 28 (+/-4) week, and at the event ( such as, suspected disease progression/hyperprogressio, immune related adverse even

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๐Ÿ“‹ Eligibility rules (as published)
Inclusion Criteria: * Age over 18 years * Cytologically or histologically verified malignant melanoma * Stage IIID unresectable/IV according to AJCC classification (8th edition, 2018) * Performance status according to WHO 0 - 2 (ECOG criteria) * 1st line of systemic treatment with immunotherapy (nivolumab, ipi/nivo, pembrolizumab) * Triple CT/PET CT done within 4 weeks before the first application * Signed consent to participate in clinical research Exclusion Criteria: * Previously treated melanoma with systemic therapy * Capacity status according to WHO 3 - 4 (ECOG criteria) * Contraindications for immunotherapy treatment (known deficiency of the immune system or active immunosuppressive treatment or active autoimmune disease requiring treatment) * Other malignant diseases (except cured basal cell carcinoma and squamous cell carcinoma)
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What it tests

  • Immune checkpoint inhibitor
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Where

1 site
Institute of Oncology Ljubljana
Ljubljana, Slovenia
๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
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