drugset / Trial / NCT07050940

Anti PD-1 Plus Postbiotic Versus Anti PD-1 Alone in Locally Advanced or Metastatic, Treatment naïve, Cutaneous Melanoma Study

NCT07050940 ↗

RandomizedParallel-groupOpen-labelOther

Summary

The association between microbiota and response to ICI-based therapy reflects the ability of bacterial metabolites to upregulate MHC class I APM component expression and/or function in cancer cells, leading to their elimination by the host's immune system. Thus, the aim of this project is to evaluate the ability of anti PD-1 combined with postbiotic, that here will be a coadjuvant of a standard immunotherapy to upregulate MHC class I APM component expression and/or function in cancer cells compared to anti PD-1 alone in first line advanced melanoma patients.

Timeline

Start
2025-02-01
Primary completion
2026-08-01
Completion
2026-08-01

Drugs

EvaluationDrugModalityDoseRoute
Subject PostbiotiX-HLA Other / unclassified 200 mg —

Indications