ETOP 13-18 BEAT-meso
Research type
Research Study
Full title
A multicentre randomised phase III trial comparing atezolizumab plus bevacizumab and standard chemotherapy versus bevacizumab and standard chemotherapy as first-line treatment for advanced malignant pleural mesothelioma
IRAS ID
259897
Contact name
Anita Hiltbrunner
Contact email
Sponsor organisation
European Thoracic Oncology Platform (ETOP)
Eudract number
2018-002180-25
Clinicaltrials.gov Identifier
Duration of Study in the UK
5 years, 4 months, 1 days
Research summary
Summary of Research
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. 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.
Chemotherapy (with cisplatin or carboplatin plus pemetrexed) is the standard first-line therapy for patients with malignant pleural mesothelioma who are not suitable for surgery. The effect of the treatment can be improved by combining chemotherapy with bevacizumab. Bevacizumab is an artificially produced immune protein that prevents the development of blood vessels to the tumour. Scientific data also suggest that another protein called atezolizumab that enhances the activity of a type of human immune cells can be a potential anti-tumour therapy.
The aim of this clinical trial is to assess whether the addition of the immunotherapy agent atezolizumab given in combination with standard chemotherapy plus bevacizumab improves the outcome in advanced treatment-naive malignant pleural mesothelioma patients.
Treatment-naive subjects older than 18 years diagnosed with malignant pleural mesothelioma, who are not amenable for radical surgery, have good performance status and adequate haematological, renal and liver functions are eligible to take part in this clinical trial. A total of 320 patients from approximately 30 oncology centres in Europe are expected to be included in this trial.
Trial subjects will receive 4-6 - three weeks long - cycles of chemotherapy and either bevacizumab or bevacizumab and atezolizumab on day 1 of every 3 weeks until worsening of the disease. The condition of the subjects will be assessed every three weeks with blood tests and quality of life questionnaires and every six weeks with radiological examinations (computer tomography/CT of the chest and upper abdomen).
The research project is funded by European Thoracic Oncology Platform
REC name
London - Central Research Ethics Committee
REC reference
19/LO/0989
Date of REC Opinion
4 Jul 2019
REC opinion
Favourable Opinion