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A Study on Preventing Toxicity in Kidney Cancer Patients Using Fecal Transplantation (PERFORM)

Trial ID: NCT04163289
Kidney Cancer Type: Any


Background:

The term “microbiome” refers to all of the microorganisms (including bacteria, fungi, and other living things) that live inside and on the surface of the human body. There is growing evidence that suggests the microbiome plays a large role in our overall health and wellbeing. However, the relationship between the microbiome and its effect on cancer treatment is not yet known.

Recently, a combination of two immunotherapy drugs, Ipilimumab (Yervoy®). and Nivolumab (Opdivo®), has been approved for the treatment of Advanced Kidney Cancer in Canada. This powerful combination significantly improves the long term survival and qualify of life among patients, however, it can also be highly toxic –  which may lead some to discontinue treatment.

There is evidence to suggest that these drugs could be better tolerated by creating a more diverse and healthy gut microbiome. This can be achieved using a “Fecal Microbiota Transplant”, which involves transferring some of the gut microbes from one individual to another.


The Trial:

This study will involve patients receiving Fecal Microbiota Transplantation before they start receiving their immunotherapy treatment, as well as during their first two treatments.

The goal of this project is to study the safety of Fecal Microbiota Transplantation and to determine whether it can reduce the occurrence of immune-related toxicities in patients.

This is a single-group study, so there is no randomization, no placebo, and all patients will receive treatment.


Basic Eligibility:

  • All subtypes eligible
  • Cancer has spread or cannot be removed by surgery
  • Must not have received any drug therapies for their kidney cancer

Additional eligibility criteria will apply. Please speak to your doctor.

 

Find out more about this study.
Hospital / Cancer CentrePrincipal InvestigatorLocationTrial Status
Hospital / Cancer CentreLondon Regional Cancer Program of the Lawson Health Research Institute Principal InvestigatorDr. Ricardo Fernandes LocationLondon, ON Trial StatusRecruiting
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