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.
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
Patients with mucosal or with a primary ocular melanoma
Active symptomatic or asymptomatic brain metastases
Patients with the following disorders: active, known, or suspected autoimmune disease (except for some non-serious disorders, such as vitiligo and type 1 diabetes mellitus, as specified in the study protocol);
Previous malignancies (exceptions skin basocellular or squamocellular carcinoma radically resected, in situ uterine cervix in situ carcinoma radically resected) in the previous 2 years.
Azienda Ospedaliera di Perugia
Lead sponsor
Istituto Clinico Humanitas
Collaborator