Reducing Immune-Related Adverse Events by Adding Oral FMT to Solid Tumor Cancer Treatment

​Principal Investigator: Dr. Diwakar Davar

Disease: Solid cancer tumor treatment-related side effects

Research Description: Immune checkpoint blockade (ICB) drugs have generally improved outcomes among patients with solid organ cancers. However, research has shown that Black and Hispanic patients have poorer outcomes with ICB drugs than white patients. In addition, approximately 20% of patients with solid organ cancers treated with ICB drugs acquire severe immune-related adverse events (irAEs), including dermatitis and colitis, that do not respond to standard treatments. Oral fecal microbiota transplantation (FMT) is approved to treat recurrent c-difficile infections by changing the gut microbiome, and previous data suggest that microbiome modulation via FMT helps reverse resistance to ICB drugs in advanced cancer and helps treat severe irAEs. This Phase IIA pilot trial will add oral FMT to the standard of care, enrolling Black and Hispanic patients undergoing ICB treatment, to determine if oral FMT is effective in treating and reducing severe irAEs. If successful, oral FMT could potentially improve cancer outcomes, especially for Black and Hispanic patients.

Funding Partners: Burroughs Wellcome Fund, Adtalem Global Education Foundation and others

CWR Funding Role: Participating