PredictID
Research type
Research Study
Full title
Study of the predictive value of immune profiles on response to the immune checkpoint inhibitors; A non-interventional study in metastatic melanoma
IRAS ID
199898
Contact name
Olly G Donnelly
Contact email
Sponsor organisation
University of Leeds
Duration of Study in the UK
0 years, 11 months, 28 days
Research summary
Immunotherapy with Ipilimumab or Pembrolizumab has given new hope to patients with metastatic melanoma - when the drugs successfully stimulate the immune system the benefits can be dramatic. Unfortunately the treatments only work in a minority of people, but there is a significant risk of serious, sometimes life-threatening, side-effects.
Preliminary data suggests that the breadth of someone’s immune ‘repertoire’ may predict their chance of responding to immunotherapies - i.e. patients with a restricted immune repertoire are unlikely to benefit and if identified beforehand they could be spared a futile treatment and the risks of toxicity.
This study will assess the validity of the ImmunTraCkeR assay - which quantifies the breadth of a patient’s T cell receptors - as a predictive test to identify non-responders. Using a standard blood sample the ImmunTraCkeR assay extracts genomic DNA from white cells in the peripheral blood and sequences the genes encoding a component of the T-cell receptor. Each T-cell’s DNA is examined separately and with computer-modelling the degree of variability amongst the T-cells can be quantified.
In this study we take blood from 40 patients before and during immunotherapy and compare ImmunTraCkeR assay results with each individual’s response to treatment.
It is important to emphasize that at this stage the results of the ImmunTraCkeR assay will not be used to change treatment - this study is purely observational and principally designed to check how reliably the test performs.
REC name
South West - Frenchay Research Ethics Committee
REC reference
16/SW/0092
Date of REC Opinion
4 Apr 2016
REC opinion
Further Information Favourable Opinion