MedTrace Logo

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

NCT07050940 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 35

Last updated 2025-07-03

No results posted yet for this study

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.

Conditions

  • Melanoma Metastatic

Interventions

DIETARY_SUPPLEMENT

Postbiotic

postbiotic food supplement PostbiotiX-HLA 1 capsule (200mg) /day

DRUG

AntiPD1

Antibody to PD1 approved for standard of care

Sponsors & Collaborators

  • Istituto Clinico Humanitas

    collaborator OTHER

  • Azienda Ospedaliera di Perugia

    lead OTHER

Principal Investigators

  • Mario Mandalà, MD · AO perugia-University of perugia

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

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

Countries

  • Italy

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07050940 on ClinicalTrials.gov