RecruitingNot ApplicableNCT07050940

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:

Sponsor

Azienda Ospedaliera di Perugia

Enrollment

35 participants

Start Date

Feb 1, 2025

Study Type

INTERVENTIONAL

Conditions

Melanoma Metastatic

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.

Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This trial tests whether adding a postbiotic supplement (a product derived from beneficial bacteria) to standard immunotherapy (anti-PD-1 treatment) improves outcomes for people with advanced melanoma (skin cancer) that has spread or cannot be surgically removed. **You may be eligible if:** - You are 18 or older with confirmed unresectable stage IIIC or IV metastatic melanoma - You have not previously received treatment for metastatic melanoma - You are in good functional condition (ECOG 0 or 1) - You have at least one measurable tumor - You have adequate blood counts and organ function - You agree to use effective contraception - You have a life expectancy of at least 3 months **You may NOT be eligible if:** - You have mucosal melanoma or eye (ocular) melanoma - You have brain metastases (active or symptomatic) - You have an active autoimmune disease requiring treatment - You have had another cancer in the past 2 years (excluding certain skin or cervical cancers) Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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