Immune Checkpoint Inhibitors for Cancer
(MIRAE Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial aims to understand why some cancer patients experience side effects, known as immune-related adverse events (irAEs), from treatments called immune checkpoint inhibitors (ICI). These side effects can cause inflammation in different organs and may lead to stopping the treatment. Researchers collect samples like blood and tissue to identify the causes of these side effects and improve management strategies. Suitable participants include cancer patients already receiving ICI therapy, patients with autoimmune diseases, and healthy individuals without cancer.
As a Phase 2 trial, this research measures the treatment's effectiveness in an initial, smaller group of people, offering participants a chance to contribute to the development of better management strategies for irAEs.
Is there any evidence suggesting that immune checkpoint inhibitors are likely to be safe for humans?
Research has shown that some patients taking immune checkpoint inhibitors (ICIs) experience side effects due to unwanted inflammation in the body, often affecting organs. These side effects, known as immune-related adverse events (irAEs), are common, particularly in the gut. About 14.7% of patients may experience these effects 6 to 12 months after starting treatment, and 10.8% might notice them after a year. While these side effects can be serious, they do not occur in everyone and can vary in severity. Understanding these risks helps prospective participants make informed decisions about joining a trial.12345
Why are researchers excited about this trial?
Researchers are excited about the Montreal Immune-Related Adverse Events (MIRAE) Study because it aims to better understand and manage the immune-related side effects that can result from cancer immunotherapy. Unlike traditional cancer treatments, which often focus on directly attacking cancer cells, immunotherapy harnesses the body's immune system to fight cancer. The MIRAE study is unique in that it seeks to identify and potentially mitigate the adverse reactions that can arise when the immune system is activated in this way. By focusing on the underlying immune responses, researchers hope to improve the safety and effectiveness of immunotherapy, making it a more viable option for a broader range of patients.
What evidence suggests that immune checkpoint inhibitors could be effective for cancer?
Research shows that certain cancer treatments, known as immune checkpoint inhibitors (ICIs), have greatly benefited patients. Studies have found that these treatments can extend life and delay the need for additional treatment in cancers such as lung cancer and melanoma. ICIs enhance the body's natural defenses to better combat cancer cells. However, they can also cause side effects, including inflammation in various parts of the body. Despite these potential side effects, many patients experience longer lives and improved quality of life with ICIs.678910
Who Is on the Research Team?
Marie Hudson, MD
Principal Investigator
Jewish General Hospital, McGill University
Are You a Good Fit for This Trial?
Inclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive immune checkpoint inhibitors (ICI) and are monitored for immune-related adverse events (irAEs)
Follow-up
Participants are monitored for safety and effectiveness after treatment, with a focus on identifying biomarkers predictive of irAEs
What Are the Treatments Tested in This Trial?
Find a Clinic Near You
Who Is Running the Clinical Trial?
Sir Mortimer B. Davis - Jewish General Hospital
Lead Sponsor