MIRA-Hep
Research type
Research Study
Full title
Management of Immune Checkpoint Inhibition-related Hepatitis using low-dose Corticosteroids - A prospective registry-based, cohort study
IRAS ID
361133
Contact name
Andreas Schmitt
Contact email
Sponsor organisation
University Hospital Basel
Duration of Study in the UK
1 years, 6 months, 30 days
Research summary
Since the approval of the first immune checkpoint inhibitor for treatment of melanoma in 2011, immunotherapy has revolutionized the treatment of many solid and haematological cancers and is used for many types of cancer. These treatments, called immune checkpoint inhibitors (ICIs), work by helping the body’s immune system to attack cancer cells. However, they can also cause the immune system to attack healthy organs, leading to side effects known as “immune-related adverse events” (irAEs). One of the most common of these side effects is inflammation of the liver, called immune-related hepatitis.
This study aims to better understand how to safely and effectively treat this liver inflammation. Current guidelines often recommend high doses of corticosteroids (a type of anti-inflammatory drug), but these drugs can cause serious side effects such as infections, weight gain, mood changes, and even impact cancer outcomes. Some hospitals have already started using lower doses in select patients, and early results suggest that this may be just as effective, with fewer complications. However, there is little formal research to support this approach.
This study is purely observational. It will collect and analyse information from adult cancer patients being treated at participating hospitals who develop moderate to severe immune-related hepatitis. Patients will receive treatment as decided by their doctors, following the standard practice at their hospital. The study will not interfere with any aspect of a patient’s care, nor will it require extra visits or tests.
The aim is to find out whether starting with a lower dose of corticosteroids leads to good outcomes for patients. The results could help improve future guidelines and patient care.
The study will take place across several large cancer centres and plans to follow participants for 6 months after their liver inflammation is diagnosed.
REC name
HSC REC A
REC reference
25/NI/0128
Date of REC Opinion
3 Sep 2025
REC opinion
Further Information Favourable Opinion