FMT With Nivolumab in Patients With Advanced Solid Cancers Who Have Progressed During Anti-PD-(L)1 Therapy
Trial Parameters
Brief Summary
This is a single-center, open-label, Phase 2 study to evaluate the efficacy and safety of FMT with nivolumab in patients with advanced, unresectable, or metastatic solid cancer who have progressed during anti-PD-(L)1 therapy.
Eligibility Criteria
Donor inclusion criteria Having provided written consent before participation in the study, all donor candidates must fulfil all of the following criteria to be eligible for a donor in this study. 1. Sex: Male or female 2. Age (at the time of informed consent): 19 years and older 3. Subjects with histologically- or cytologically-confirmed solid cancer In case of hepatocellular carcinoma, clinically confirmed diagnosis as per the American Association for the Study of Liver Diseases (AASLD) is allowed.1 4. Patients who currently maintain a CR, PR or SD per RECIST v1.12 for at least 6 months with anti-PD-(L)1 monotherapy for solid cancer Donor exclusion criteria The subject who meets any of the following criteria will be excluded from a donor candidate. If an enrolled donor candidate is found to meet any of the following criteria anytime during the study, the donated stool obtained when those exclusion criteria are met will not be used for FMT. 1. Having taken antimicrobials (antibiotics,