Phase II Study Comparing Anti PD-1 With and Without Postbiotic in Treatment-Naive Advanced or Metastatic Cutaneous Melanoma Patients

What this Trial Is About

Researchers are studying advanced or metastatic cutaneous melanoma patients who have not received prior treatment for metastatic disease. The trial aims to evaluate whether combining an anti PD-1 antibody with a postbiotic food supplement can better increase the expression and function of MHC class I antigen processing machinery in cancer cells compared to anti PD-1 alone. This study is a phase II randomized clinical trial designed to assess biological and clinical responses to these treatments. Participants will be randomly assigned to receive either the combination of anti PD-1 therapy plus a daily postbiotic supplement or anti PD-1 therapy alone, following standard clinical practice. The postbiotic is given as one capsule 200mg daily. The study uses the anti PD-1 alone group as a calibration arm to compare biological activity and overall response rate between the two treatment groups. During the study, participants will undergo tumor biopsies or provide archival tumor tissue to assess treatment effects on MHC class I expression. Researchers will measure biological response rates at 18 months as the primary outcome, along with overall response rate and progression-free survival. Patients will be monitored for safety and treatment efficacy throughout the trial, which involves regular clinical evaluations and laboratory assessments.

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