A Phase II Study of Fecal Microbiota Transplantation With Nivolumab in Patients With Advanced Solid Cancers Who Have Progressed During Anti-PD-(L)1 Therapy

A single donor-derived FMT will be administered two times in a 2-week interval (± 5 days), which composes one set of FMT. If clinical benefit (complete response [CR], partial response [PR], or stable disease [SD]) is not observed with the 1st set of FMT in the first evaluation of response, the 2nd set of FMT from another donor will be administered unless rapid progression of disease, rapid clinical deterioration, progressive tumor at critical anatomical sites (e.g., cord compression) requiring urgent alternative medical intervention or medical conditions in which further FMT is not the best patient's interest in the opinion of the investigator. If disease progression occurs after achieving clinical benefit (CR, PR, or SD) with the 1st set of FMT, the 2nd set of FMT can be performed using a stool from the same donor as the 1st set of FMT (preferred) or another donor according to the investigator's discretion.

Nivolumab 3 mg/kg iv will be started on day after FMT and followed by additional nivolumab therapy 3 mg/kg iv every 2 weeks until disease progression, intolerable toxicity, or any other of the criteria for treatment discontinuation is met with a maximum of 2-year total duration. In a cycle when FMT is performed, nivolumab will be administered on day after FMT.