BEAT-meso: Bevacizumab and Atezolizumab in Malignant Pleural Mesothelioma

• Status: Recruiting
• Trial end date: 2024-01-31
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: European Thoracic Oncology Platform
• Collaborator: Hoffmann-La Roche
• Treatments: Antibodies, Monoclonal; Atezolizumab; Bevacizumab; Carboplatin; Pemetrexed

Criteria

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. Prior radiotherapy for symptom control is allowed, but the irradiated lesion cannot be used as target lesion. If the patient has another target lesion, the patient is eligible.

• 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

• Evidence of bleeding diathesis or coagulopathy

• Active autoimmune disease that has required systemic treatment in past 2 years

• History of active diverticulitis

• Previous treatment with atezolizumab and/or bevacizumab or parallel participation in other interventional clinical trial with atezolizumab and/or bevacizumab.