Pembrolizumab versus standard therapy in mesothelioma (PROMISE-meso)
Research type
Research Study
Full title
A multicentre randomised phase III trial comparing pembrolizumab versus standard chemotherapy for advanced pre-treated malignant pleural mesothelioma
IRAS ID
221097
Contact name
Sanjay Popat
Contact email
Sponsor organisation
ETOP (European Thoracic Oncology Platform)
Eudract number
2016-002062-31
Clinicaltrials.gov Identifier
Duration of Study in the UK
3 years, 7 months, 0 days
Research summary
The aim of the study is to assess if pembrolizumab therapy is superior to standard chemotherapy as day unit care for adult pre-treated patients who have advanced malignant pleural mesothelioma and are capable of all self-care and whose condition has worsened after or during their first treatment.
Pleural mesothelioma is a type of malignant tumour that develops from the cells of the thin layer that covers the surface of the lung and the internal chest wall called the mesothelium. It is a rare but aggressive cancer almost always caused by asbestos exposure with a usual lag-time of 30 years between exposure and presentation.
Outcomes for most patients are fatal and the median survival from presentation is 9-12 months. This is because complete surgical resection of the tumour is difficult and the available chemotherapies are minimally effective.
A potential new treatment for the disease is pembrolizumab which is an immunotherapy drug that helps the immune system detect and kill mesothelioma cells. It is already used for the treatment of some skin and lung cancers. According to previous trial results 76 % of patients with relapsed mesothelioma showed disease control with pembrolizumab and 61% of the patients with evidence of the tumour shrinkage.
71 subjects are planned to be treated in this open label, randomised phase III clinical trial in the UK, who will be recruited from 8 cancer centers. Patients will be treated either with pembrolizumab or with standard, institutional-choice chemotherapy (gemcitabine or vinorelbine). In case of tumour progression patients on standard therapy can be switched to pembrolizumab as well. Therapy will be continued until progression or for a maximum of 2 years if benefitting.
The research project is funded by an academic group called the European Thoracic Oncology Platform.
REC name
South Central - Oxford C Research Ethics Committee
REC reference
17/SC/0231
Date of REC Opinion
12 May 2017
REC opinion
Favourable Opinion