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.
Sex: Male or female
Age (at the time of informed consent): 19 years and older
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
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
Having taken antimicrobials (antibiotics, antivirals antifungals) in the 4 weeks prior to donation
Positive result for any pathogen tests during the screening period (Table 3)
Current gastrointestinal symptoms including diarrhea, nausea, or vomiting
History of chronic gastrointestinal disease including inflammatory bowel disease, celiac disease, or irritable bowel syndrome
Single group
fecal microbiota transplantation with Nivolumab
Other interventionThis 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.
Overall Response Rate
˙ To evaluate the anti-tumor activity (objective response rate \[ORR\]) of fecal microbiota transplantation (FMT) in combination with nivolumab in patients with advanced solid cancers who have progressed on prior anti-PD-(L)1 based therapy (as monotherapy or combination)
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