Comparison of atezolizumab and bevacizumab with standard chemotherapy versus bevacizumab with standard chemotherapy in treatment of the cancer called malignant pleural mesothelioma.

Phase 1

• Conditions: advanced malignant pleural mesothelioma; MedDRA version: 21.0 Level: LLT Classification code 10035605 Term: Pleural mesothelioma malignant advanced System Organ Class: 100000004864; Therapeutic area: Diseases [C] - Cancer [C04]

• Registration Number: EUCTR2018-002180-25-FR
• Lead Sponsor: European Thoracic Oncology Platform (ETOP)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2019-07-31
• Last Update Posted: 1 February 2020

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: Not specified
• Target Recruitment: 320

Inclusion Criteria

- 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

Exclusion Criteria

- 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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified