Biomarkers in Immunotherapy of Melanoma

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 IFNγ correlation with radiological response rates to ICIs treatment of advanced melanoma patients. Methods: Patients treated with immune ch

Trial Details

NCT ID
NCT05878977
Phase
NA
Sponsor
Institute of Oncology Ljubljana
Status
RECRUITING
Cancer Type
Melanoma
Interventions
  • Immune checkpoint inhibitor
Locations (sample)
  • Ljubljana, Slovenia|46.05108,14.50513

Key Eligibility 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)

For full eligibility, visit ClinicalTrials.gov.

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