Montreal Immune-Related Adverse Events (MIRAE) Study

NCT ID: NCT05139706

Last Updated: 2024-04-16

Basic Information

• Recruitment Status: RECRUITING
• Total Enrollment: 1000 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2020-01-21
• Study Completion Date: 2030-01-31

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.

Detailed Description

Background:

During cancer development and progression, cancer cells evolve to evade natural anti-tumor immunity. One major pathway of immune evasion involves the engagement of co-inhibitory receptors present on the surface of T cells that modulate their activation status, and therefore their ability to directly or indirectly kill tumor cells. These receptors are known as immune checkpoint inhibitors (ICI). Blockade of ICI using antibodies leads to prolonged T cell activation and unleashes the anti-tumor activity of T cells. ICI treatment for cancer has led to unprecedented advances in cancer treatment by prolonging survival of patients with previously refractory cancers. Among these ICI, CTLA-4, PD-1 and PDL-1 inhibitors have been shown to be effective cancer immunotherapies, and many other ICIs are now in pre-clinical and clinical development.

Although ICI cancer therapy is overall well tolerated, off-target immune reactions targeting healthy cells or tissues called immune-related adverse events (irAEs) develop in a substantial percentage of patients limiting the use of ICI therapy. irAEs target range from mild to severe and fatal. Currently, there are no reliable predictive biomarkers for the wide spectrum of irAEs and their clinical management in severe cases involves discontinuation of ICI therapy.

The Montreal Immune-Related Adverse Events (MIRAE) study is a biobank that collects human biological specimens (e.g., tissue, blood, plasma, PBMCs, saliva, stool) and the associated clinical information from cancer patients treated with ICI with the purpose of promoting research to identify clinical and biological predictors and mechanisms of irAEs, evaluate the effects of immunomodulatory treatment of irAEs on tumor biology, and investigate treatment strategies to minimize irAEs.

Objectives:

1. Identify biomarkers predictive of irAEs, including cellular, immunologic, genetic and microbial biomarkers; and

2. Evaluate the effects of immunomodulatory treatment of irAEs, and investigate treatment strategies that minimize irAEs and maximize ICI efficacy.

Conditions

Cancer; Immune System Disorder; Inflammatory Reaction; Autoimmune Diseases

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 100 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Sir Mortimer B. Davis - Jewish General Hospital

OTHER

Sponsor Role: lead

Responsible Party

Marie Hudson, MD

Marie Hudson, MD MPH FRCPC Principal Investigator, Rheumatologist, Division of Rheumatology and Department of Medicine, Jewish General Hospital and McGill University

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Marie Hudson, MD

Role: PRINCIPAL_INVESTIGATOR

Jewish General Hospital, McGill University

Locations

Jewish General Hospital

Montreal, Quebec, Canada

Site Status: RECRUITING

Countries

Canada

Central Contacts

Marie Hudson, MD

Role: CONTACT

marie.hudson@mcgill.ca, marie.hudson.med@ssss.gouv.qc.ca

1-514-340-8222 ext. 23476

Manuel Flores, PhD

Role: CONTACT

Manuel.Flores.Molina.ccomtl@ssss.gouv.qc.ca

1-514-677-8155

Facility Contacts

Marie Hudson, MD MPH

Role: primary

marie.hudson@mcgill.ca

1-514-340-8222 ext. 23476

Manuel Flores, PhD

Role: backup

Manuel.Flores.Molina.ccomtl@ssss.gouv.qc.ca

1-514-677-8155

Other Identifiers

MP-05-2019-1517

Identifier Type: -

Identifier Source: org_study_id