Preventing Toxicity in Renal Cancer Patients Treated With Immunotherapy Using Fecal Microbiota Transplantation
Status:
Recruiting
Trial end date:
2028-11-01
Target enrollment:
Participant gender:
Summary
Cancer immunotherapy has been largely adopted in oncology patient management in the last
decade. The deep and long responses to immunotherapy have accelerated the approval of these
drugs across multiple disease sites. However, these agents can also be toxic to patients,
meaning, the patient will have to discontinue treatment and outcomes could be negatively
affected. Recently, a combination of two immunotherapy drugs, ipilimumab and nivolumab
(ipi/nivo), has been approved for the treatment of intermediate and poor-risk renal cell
carcinoma (RCC) patients. This powerful combination provides survival benefit, however, it
can also be highly toxic leading to discontinuation of this treatment.
There has been some evidence that these otherwise toxic drugs can be better tolerated by
altering the composition of the patients gut bacteria to create a more diverse and healthy
microbiome. The current study will involve Fecal Microbiota Transplantation (FMT) before the
start of the immunotherapy combination, and during the first two cycles of ipilimumab
treatment (the more toxic agent) as supportive therapy to prevent toxicity associated with
the ipi/nivo combination.
The goal of this project is to study the safety of such FMT combination treatment and reduce
occurrence of immune-related toxicities in patients, allowing them to continue their cancer
treatments in the hopes of a better outcome. The investigators will also be looking at
changes in the immune populations, microbiome profile of patients, response to treatment, and
patient survival as secondary objectives.
Phase:
Phase 1
Details
Lead Sponsor:
Lawson Health Research Institute
Collaborator:
Academic Medical Organization of Southwestern Ontario