Recruiting

Observational Study

Sponsor:

Sir Mortimer B. Davis - Jewish General Hospital

Code:

NCT05139706

Conditions

Cancer

Immune System Disorder

Inflammatory Reaction

Autoimmune Diseases

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Accepted

Study Details

Brief summary:

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.

Conditions

Cancer

Immune System Disorder

Inflammatory Reaction

Autoimmune Diseases

Study ID

NCT05139706

Start date

Jan 21, 2020

Status verified date

May, 2025

Completion date

Jan, 2030

Anticipated

Primary completion date

Jan, 2030

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Accepted

Inclusion Criteria:

  • >= 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

Exclusion Criteria:

  • Participants not able to provide informed consent

Study Design

Enrollment

1000 participants

Anticipated

Interventions and Outcome Measures

Primary outcome measure

  • Incidence of immune-related adverse events [ Time Frame: Up to 5 years ]
  • Biomarkers of irAE [ Time Frame: Up to 5 years ]

Central Contacts and Locations

Locations

Jewish General Hospital

Recruiting

Montreal, Quebec, Canada, H3T 1E2

Contacts

More Information

Sponsor

Sir Mortimer B. Davis - Jewish General Hospital

Last update posted

Feb 3, 2026

Last verified

May, 2025

Keywords

  • irAEs
  • ICI (ICB)
  • CTLA-4
  • PD-1
  • PDL-1
  • Pembrolizumab
  • Nivolumab
  • Ipilimumab
  • Cemiplimab
  • Atezolizumab
  • Avelumab
  • Durvalumab

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Sir Mortimer B. Davis - Jewish General Hospital on 2026-02-03.