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

European Thoracic Oncology Platform (ETOP)0 个研究点目标入组 320 人开始时间: 2019年7月31日最近更新: 2020年2月1日

试验速览

暂无简介。

•- Histologically confirmed advanced malignant pleural mesothelioma (all histological subtypes are eligible)
•- Able to understand and give written informed consent and comply with trial procedures
•- Age >18 years
•- Performance Status 0-1
•- Not amenable for radical surgery based on local standards
•- Availability of tumour tissue for translational research
•- Evaluable disease or measurable disease as assessed according to the mRECIST v1.1
•- Life expectancy >3 months
•- Adequate haematological, renal and liver function (CrCl >45)
•- Completed baseline QoL questionnaire
•- Men and women of childbearing potential must agree to use adequate contraception
•Are the trial subjects under 18? no
•Number of subjects for this age range:
•F.1.2 Adults (18-64 years) yes
•F.1.2.1 Number of subjects for this age range 160
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 160

•- Prior treatment for malignant pleural mesothelioma
•- Active autoimmune disease that has required systemic treatment in past 2 years
•- Previous history of significant haemoptysis (defined as at least 2.5mL emission of red blood) in the 3 months prior to inclusion.
•- Recent surgery:
•1. Major surgery or significant traumatic injury within 28 days prior to inclusion.
•2. Minor surgical procedure within 7 days, or placement of a vascular access device within 2 days of randomisation.
•- HIV or active hepatitis B or hepatitis C

发起方

European Thoracic Oncology Platform (ETOP)