Immune related adverse events with PD-1 Inhibitors
Research type
Research Study
Full title
The population based incidence and severity of immune related adverse events with PD-1 inhibitors Nivolumab and Pembrolizumab within Oncology in NHS Tayside and how this compares to clinical trial data to allow comparison with the experience of other centres in order to provide a basis to plan future service provision.
IRAS ID
265302
Contact name
Karen Brown
Contact email
Sponsor organisation
NHS - Tayside Health Board
Duration of Study in the UK
0 years, 8 months, 31 days
Research summary
The adverse event profile of immunotherapy is very different to that of traditional chemotherapy. There is a risk of developing immune related adverse events which can be severe and even life threatening.
Within oncology in NHS Tayside, to date, we have treated approximately 60-70 patients with nivolumab and approximately 60-70 patients with pembrolizumab. We have therefore gained some experience recognising and managing immune related adverse events but our experience is very much still limited. However we have not collated any data about the incidence and severity of immune related adverse events among our patients so do not have any knowledge about how our local incidence of adverse reactions compare to that reported in the literature for nivolumab or pembrolizumab. There is very little population level data about the incidence of immune related adverse effects. There is some speculation that incidence of some immune related adverse events may be higher than those reported in the initial trials which led to approval of their use. It would therefore be very beneficial to collate accurate data about our incidence of immune related adverse events and compare this to that found in clinical trials and determine if there are any differences. We can also then compare our population level data with the experience of other centres to ensure we are managing our patients appropriately and provide a basis to plan future service provision.
The study will be a retrospective non-experimental analysis of patient data looking at all patients who have received nivolumab or pembrolizumab, for a licensed indication, approved by the Scottish Medicines Consortium (SMC), within oncology in NHS Tayside to determine the incidence and severity of immune related adverse events. Local data will then be compared to that reported in the literature to determine if there is any statically significant differences.REC name
North East - Tyne & Wear South Research Ethics Committee
REC reference
19/NE/0159
Date of REC Opinion
20 May 2019
REC opinion
Favourable Opinion