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

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.

Trial Details

NCT ID
NCT07050940
Phase
NA
Sponsor
Azienda Ospedaliera di Perugia
Status
RECRUITING
Cancer Type
Melanoma
Interventions
  • Postbiotic
  • AntiPD1
Locations (sample)
  • Bari, BA, Italy|41.12066,16.86982
  • Torino, TO, Italy|44.88856,11.99138
  • Bari, Italy|41.12066,16.86982
  • Milan, Italy|42.78235,12.59836
  • Perugia, Italy|43.1122,12.38878

Key Eligibility Criteria

  • Patients 18 years or older
  • Histologically confirmed, unresectable stage IIIC or IV metastatic melanoma;
  • Eastern Cooperative Oncology Group performance status of 0 or 1;
  • The patient must treatment naïve for metastatic disease

For full eligibility, visit ClinicalTrials.gov.

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