Montreal Immune-Related Adverse Events (MIRAE) Study

Recruiting now

Conditions studied: Cancer, Immune System Disorder, Inflammatory Reaction, Autoimmune Diseases

In brief

Immune checkpoint inhibitors (ICI) are among the most promising approaches to fighting cancer. However, a substantial percentage of patients experience off-target adverse effects in the form of mild to severe inflammation in different organs, commonly called immune-related adverse events (irAEs). irAEs can lead to treatment discontinuation, or can be life-threatening in extreme cases. The causes of irAEs are largely unknown and there are no reliable predictive biomarkers. The Montreal Immune-Related Adverse Events (MIRAE) study collects clinical information and biospecimens (blood, tissue, stool) from cancer patients treated with ICI to facilitate research on the identification of predictive biomarkers of irAEs, their causes, and the design of effective management strategies.

Key facts

Study ID

NCT05139706

Run by

Sir Mortimer B. Davis - Jewish General Hospital

People needed

1000

Starts

2020-01-21

Expected to finish

2030-01-01

Last updated by the study team

2026-02-03

Who can join

Age: 18 and older, up to 100. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• >= 18 years of age
• cancer patients treated with ICI therapy (e.g., anti-CTLA-4, anti-PD-1, anti-PD-L1, and combinations)
• patients with primary autoimmune or autoinflammatory diseases that resemble immune-related adverse events (irAEs)
• healthy volunteers with non-inflammatory disorders, and without any history of cancer

You may not qualify if…

• Participants not able to provide informed consent

Where it is running

• Jewish General Hospital — Montreal, Quebec, Canada (enrolling)

Full record on ClinicalTrials.gov

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