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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
BEAT-meso: BEvacizumab and ATezolizumab in malignant pleural mesothelioma
Chemotherapy with cisplatin plus pemetrexed is the currently approved standard as first-line therapy for patients with malignant pleural mesothelioma. The best survival outcome to date has been achieved by combining standard chemotherapy with bevacizumab. However, new treatment strategies are needed in order to further improve outcome. Immunotherapy has achieved promising results in a subset of patients with PD-L1-positive tumours in the second-line setting.
The aim of the BEAT-meso trial is to address whether the addition of the anti-PD-L1 antibody atezolizumab given in combination with standard chemotherapy plus bevacizumab improves the outcome in advanced treatment-naïve malignant pleural mesothelioma patients.
Trial Scheme
Primary Endpoint: | Progression free survival & Overall survival |
Secondary Endpoints: |
Response rate Disease control rate Time to treatment failure Duration of response Safety and tolerability Patient reported outcome Quality of life |
Target Sample Size: | 320 randomised Patients |
Protocol Release Date: | 7 September 2018 |
Trial Activation Date: | 12 April 2019 |
First Patient In: | 30 April 2019 |
Trial Organisation |
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Trial Chair: | Enriqueta Felip |
Trial Co-Chair: | Sanjay Popat |
Sponsor: | ETOP |
Coordinating Group: | ETOP |
Participating Groups: | SAKK and SLCG |
Participating Countries: |
Belgium, France, Italy, Portugal, Slovenia, Spain, Switzerland and the United Kingdom |
Registrations: |
EudraCT number: 2018-002180-25 ClinicalTrials.gov: NCT03762018 |
Contact
Virginia Rodriguez Martinez (Trial Manager)
Tel: +41 31 511 94 48
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European Thoracic Oncology Platform
c/o IBCSG
Effingerstrasse 40
3008 Bern, Switzerland
Tel: +41 31 511 94 00