This study aims to investigate the role of the gut microbiota and its derived factors, including bacterial-associated antigens that mimic tumor-associated antigens, in predicting response to immune checkpoint inhibitor immunotherapies in patients with various types of cancer. The aim is to explore whether gut microbiota-mediated immunological modulation is specific to the tumor being treated and whether it can be used to enhance antitumor response.
Histologically or cytologically confirmed disease (see 3.1)
(i) patients with local advanced or metastatic NSCLC candidate to first-line ICB monotherapy or chemo-ICB combination OR (ii) patients with cutaneous melanoma candidate to first-line or adjuvant ICB (iii) patients with primary advanced or first recurrence endometrial or cervical cancer candidate to chemo-ICB combination
Signed Written Informed Consent
Males and Females, ages ≥18 years of age
Previous chemotherapy (< 28 days washout), radiation therapy, immunotherapy, or biologic therapy
Any major surgery within the last 3 weeks
Pregnant or lactating female
Unwillingness or inability to follow the procedures
Single group
sample collection
Biological/VaccineClinical and radiological assessment will be performed at the enrollment and every 3 +/- 1 months. Clinical information and biological samples will be collected also at 2 years from surgery or start of therapy. We plan collection of a maximum of 13 faecal and blood samples per patient (1 baseline + a maximum of 11 during treatment ± 1 disease progression, ± 10%). In addition, we expect to collect fresh stools and tissue biopsies from at least 3-5 patients per group every year, which will be dedicated to our translational studies.
Primary Endopoint
Correlation between Bacterial Antigens Mimicking-Tumor associated antigens (BAM-Ts) and clinical response to Immune Checkpoint Blockade (ICB).
Secondary Endpoints
A. Correlation between circulating immunological factors during ICB and clinical response: Relapse-Free Survival (RFS) or Progression Free Survival (PFS), Overall Response Rate (ORR), Overall Survival (OS);
Exploratory Endpoints
Correlation between, HLA allotypes and microbiota in correlation with clinical response RFS or PFS and OS;
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