BEAT-meso/ETOP 13-18: 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
Indication :

Mésothéliome pleural malin


Sponsor :

ETOP


Phase :

III


Traitement :

Carboplatin, Pemetrexed, Bevacizumab, +/- Atezolizumab


Site :

CHUV


Contact(s) :
Prof. Solange Peters
Investigateur Principal

CHUV
Oncologie

Rue du Bugnon 46
Lausanne
1011

+41213144462
solange.peters@chuv.ch

Primary objective :

The aim of this clinical trial is to assess the effect of treatment with a monoclonal antibody called atezolizumab in patients diagnosed with a type of lung cancer called malignant pleural mesothelioma. The efficacy (whether the treatment works), safety and tolerability (side effects of treatment) of atezolizumab plus bevacizumab in combination with standard chemotherapy versus bevacizumab in combination with standard chemotherapy will be investigated.+41


Inclusion criteria :

Histologically confirmed advanced malignant pleural mesothelioma (all histological subtypes are eligible)
Not amenable for radical surgery based on local standards
Evaluable disease or measurable disease as assessed according to the modified response evaluation criteria for solid tumours for mesothelioma (mRECIST) v1.1
Availability of tumour tissue for translational research
Age >18 years
Performance Status 0-1
Life expectancy >3 months
Adequate haematological, renal and liver function
Completed baseline quality of life (QoL) questionnaire
Women of childbearing potential and sexually active men must agree to use highly effective contraception
Able to understand and give written informed consent and comply with trial procedures


Exclusion criteria :

Prior treatment for malignant pleural mesothelioma
Treatment with systemic immune-stimulatory agents within 4 weeks or five half-lives of the drug prior to randomisation and during protocol treatment.
Treatment with systemic immunosuppressive medications within 2 weeks prior to randomisation and during protocol treatment.
Previous allogeneic tissue/solid organ transplant
Live vaccines within 4 weeks prior to first dose of protocol treatment
Inadequately controlled hypertension
Prior history of hypertensive crisis or hypertensive encephalopathy
Significant vascular disease within 6 months prior to randomisation
History of haemoptysis