NCT07050940

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

Anti PD-1 Plus Postbiotic Versus Anti PD-1 Alone in Locally Advanced or Metastatic, Treatment naïve, Cutaneous Melanoma: a Phase II Randomized Study With Correlative Biomarkers' Analysis:

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 35 (estimated)
• Sponsor: Azienda Ospedaliera di Perugia · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

The study is designed for the primary endpoint as a non-comparative calibrated phase II clinical trial. Patients assigned to the anti PD-1 alone arm will be considered as the calibration group. . Results obtained in the calibration arm will be used to judge the results obtained in the experimental arm. This is a study protocol settled up on a biological primary endpoint To evaluate the activity of the combination of anti PD-1 plus postbiotic in terms of upregulation of MHC class I APM component expression and/or function in advanced, treatment naïve, cutaneous melanoma patients. The Clinical Objectives is to evaluate the activity of the combination of anti PD-1 plus postbiotic compared to anti PD-1 alone in terms of overall response rate (ORR). To evaluate the efficacy of the combination of anti PD-1 plus postbiotic compared to anti PD-1 alone in terms of PFS.

Conditions

• Melanoma Metastatic

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	Postbiotic	postbiotic food supplement PostbiotiX-HLA 1 capsule (200mg) /day
DRUG	AntiPD1	Antibody to PD1 approved for standard of care

Timeline

• Start date: 2025-02-01
• Primary completion: 2026-08-01
• Completion: 2026-08-01
• First posted: 2025-07-03
• Last updated: 2025-07-03

Locations

5 sites across 1 country: Italy