Immune checkpoint inhibitors (ICIs) have become paradigm-shifting therapies for a variety of cancers. However, these agents are associated with various toxicities that affect the skin, GI tract, liver, lungs, endocrine system, and nervous system. Immune-mediated colitis (IMC) is among the most encountered severe toxicities that can lead to ICI discontinuation. The development of IMC indicates that a tumor is responding to the treatment because of the boosted immune reaction. Current treatment for severe IMC is to stop ICI therapy and give corticosteroids and other immunosuppressing agents; however, some patients stop responding to these treatments. Thus, it is crucial to find a new treatment approach to IMC so ICI treatment can be continued. The investigators hypothesize that healthy stool microbiome, restored via fecal microbiota transplantation (FMT), can reverse the inflammatory process in the colon resolving IMC. This phase I study will assess if FMT conducted via colonoscopy is safe in patients on an ICI with treatment-refractory IMC. If successful, this will be a groundbreaking milestone for the management of IMC and could be used first-line prior to immunosuppressive therapy to remove complications associated with immunosuppression.
Trial Registration: ClinicalTrials.gov Identifier: NCT03819296