Fecal Microbial Transplantation in Combination With Immunotherapy in Melanoma Patients (MIMic)
Status:
Recruiting
Trial end date:
2023-12-01
Target enrollment:
Participant gender:
Summary
Immunotherapy has helped many cancer patients in the last 5 years by enhancing a patient's
immune system to fight cancer. Anti-Programmed Death (PD-1) immunotherapy drugs such as
pembrolizumab and nivolumab remove the breaks from cancer-fighting immune cells and have been
effective in treating some melanoma patients. Despite the major breakthrough of immunotherapy
in oncology treatment, many patients do not respond to this new class of anti-cancer drugs.
Recently, evidence suggests that the microorganisms living in a patient's intestines play a
major role in modifying the response to anti-PD-1drugs. Patients who respond to these drugs
have a unique and healthy group of microorganisms in their gut. Therefore, positive
modification of a cancer patient's gut microorganisms to create a more diverse and healthy
microbiome may improve the response to immunotherapy. One method of modifying the microbiome
is Fecal Microbial Transplantation (FMT) that is already being successfully used in the
clinic to treat non-cancer patients with persistent bacterial infections.
In this study, the investigators will combine FMT with the approved immunotherapy drugs
pembrolizumab or nivolumab that are the standard of care for the treatment of advanced
melanoma. The purpose of this study is to examine the safety of combining these two therapies
in melanoma patients. The investigator will use fecal material from a healthy donor selected
via our stringent protocol that is Health Canada approved. In addition to assessing the
safety of the combination, the investigator will also study the effect of FMT on the immune
system and microbial ecosystem of the gut.