MEDALLION-Pilot (Version 1.1)
Research type
Research Study
Full title
Feasibility study to establish sample collection and processing for “MEDALLION” - The 'Monitoring immunE DysregulAtion foLLowing Immune checkpOint-inhibitioN' Study
IRAS ID
252992
Contact name
Elizabeth R Plummer
Contact email
Sponsor organisation
The Newcastle upon Tyne Hospitals NHS Foundation Trust
Duration of Study in the UK
2 years, 0 months, 0 days
Research summary
This study is looking at a new class of drugs used to treat cancers called immune checkpoint inhibitors (CPIs) that interfere with the body’s immune system so that cancer cells are recognised and attacked by the immune system. However, over 30% of CPI-treated patients develop severe side effects where normal cells are attacked by the immune system, called immune-related adverse events (irAEs), which usually occur within the first 10 weeks of treatment. These adverse events look like Immune Mediated Inflammatory Diseases (IMIDs) such as inflammatory bowel disease and rheumatoid arthritis. The study aims to try and identify why these side-effects occur. This may also help towards our understanding of spontaneous IMIDs that occur in the general population and are poorly understood.
This is a pilot project aiming to recruit up to 15 participants with melanoma (to include 5 patients who develop immune related adverse events), to generate pilot data and explore the feasibility of conducting a larger similar study of 150 participants. The pilot study will involve taking a blood samples and skin swabs at 8 different time-points (over 38 weeks of their treatment), at the same time as standard of care bloods are taken, to explore biological systems that may be associated with the development of immune related side effects. Participants will also be asked to complete a questionnaire about any symptoms they develop during treatment with the CPI drug. Patients who develop clinically significant colitis (inflammation of the inner lining of the gut) will undergo a standard endoscopy to obtain biopsies during which 'optional' additional study biopsies will be taken to identify immune cells in the gut that may be associated with the colitis.
Participants may also provide an ‘optional’ stool sample (to look for microorganisms), with a questionnaire relating to bowel movement, diet and antibiotic use.
REC name
East of England - Essex Research Ethics Committee
REC reference
18/EE/0400
Date of REC Opinion
17 Jan 2019
REC opinion
Further Information Favourable Opinion