Investigating the Role of the Intestinal Microbiome and Autoimmune Panels as Predictors of Toxicity in Patients Receiving Immunotherapy

Trial ID: NCT04107311
Kidney Cancer Type: All Types Eligible


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.

The Trial:

This purpose of this study is to investigate the composition of the intestinal microbiome among patients who are receiving immunotherapy treatment for their kidney cancer (i.e. Nivolumab (Opdivo®).

Specifically, the researchers will be focussing on the relationship between a patient’s microbiome and their risk of developing treatment side effects called irAE’s (immune-related adverse events).

Patients in this study will be asked to provide fecal samples at multiple time points during their immunotherapy treatment to evaluate the composition of their intestinal microbiome. No additional visits to the hospital will be needed, as samples will be collected at the time of treatment.

Basic Eligibility:

  • All subtypes eligible
  • Advanced kidney cancer – no curative treatments available
  • Must be treated at Princess Margaret Cancer Centre in Toronto

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


Find out more about this study.
Hospital / Cancer CentrePrincipal InvestigatorLocationTrial Status
Hospital / Cancer CentrePrincess Margaret Cancer Centre Principal InvestigatorDr. Anna Spreafico LocationToronto, ON Trial StatusRecruiting
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