Mesothelioma Stratified Therapy (MiST)
Research type
Research Study
Full title
Mesothelioma Stratified Therapy (MiST): A stratified multi-arm phase IIa clinical trial to enable accelerated evaluation of targeted therapies for relapsed malignant mesothelioma.
IRAS ID
217815
Contact name
Dean Fennell
Contact email
Sponsor organisation
University of Leicester
Eudract number
2017-003353-41
ISRCTN Number
ISRCTN39816629
Clinicaltrials.gov Identifier
Clinicaltrials.gov Identifier
38247, NIHR Portfolio Adoption number:
Duration of Study in the UK
4 years, 0 months, 0 days
Research summary
Research Summary
Malignant mesothelioma (MM) is an aggressive, frequently drug resistant, and incurable disease that is increasing in incidence in the UK and worldwide. All patients with MM, subsequently relapse and die following first-line therapy, and at present, there is no standard treatment available in the second-line setting or beyond.
It has been recognised that MMs are genetically different, therefore patients with this condition will respond differently to various drugs dependent on their particular MM genetic makeup.
The purpose of this study is to advance personalised therapy for relapsed MM. Targeted drugs to be received will be selected based on the specific genetic changes identified in the patient’s tumour DNA. We will assess how well this treatment works, monitor tumour shrinkage, and learn more about the disease and how it changes over time.
Patients that enrol will have received standard first-line chemotherapy (a drug treatment aimed at killing cancer cells). At the end of first-line therapy, patients whose tumours have started to grow again, and for whom there is no standard therapy will be eligible. If the tumour has not shrunk or has grown, patients may be eligible to enter the trial to receive treatment based on their particular genetic sub-type.
Throughout the trial we will use Computed Tomography (CT) scans to track the size of the tumours and use results from the tumour biopsy taken at the beginning and end (optional) of the treatment to decipher the genetic evolution of those tumours that acquire drug resistance. This will help us to refine predictive biomarkers to support future personalised drug development.
Treatment will continue for the duration of the study protocol or until there is evidence that the MM has grown, the patient or doctor decides to stop it due to side effects or the patient dies.
REC name
East Midlands - Leicester South Research Ethics Committee
REC reference
18/EM/0118
Date of REC Opinion
5 Jul 2018
REC opinion
Further Information Favourable Opinion