Atezolizumab Versus Placebo for the Adjuvant Treatment of Malignant Pleural Mesothelioma (Atezomeso)
Status:
Recruiting
Trial end date:
2023-12-31
Target enrollment:
Participant gender:
Summary
This is a multicentric double-blind, placebo controlled, phase III trial. In this study,
patients who underwent to a surgical resection of pleural mesothelioma and are without signs
of macroscopic residual disease will be randomized 2:1 to receive atezolizumab or placebo.
Patients will be treated for 12 months or until recurrence, unacceptable toxicity or
patient/physician decision, whichever occurs first.
Randomization will be done via a centralized system and patients will be stratified histology
(epithelioid vs non epithelioid) and stage (I vs
>I). Patients will be radiologically evaluated after surgical procedure before starting
therapy and then every 12 weeks for 24 months or until disease progression. At screening
patients should be without macroscopic residual disease. Quality of life questionnaire will
be administered to patient at baseline and every 12 weeks. During the study baseline tumor
blocks will be centrally analyzed to determinate biological characteristics and gene
expression.