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.
Signed informed Consent Form
Age ≥ 18 years on day of signing informed consent
Histologically confirmed malignant pleural mesothelioma
Surgical resection (P/D), without macroscopic residual. For stage I patient without visceral involvement a total pleurectomy is allowed
Patient with macroscopic residual disease after surgery, evaluated with CT scan
after surgery or adjuvant therapy
Subjects with active, known or suspected autoimmune disease. Subjects with vitiligo, type I diabetes mellitus, residual hypothyroidism due to autoimmune condition only requiring hormone replacement, psoriasis not requiring systemic treatment, or conditions not expected to recur in the absence of an external trigger are permitted to enroll
Additional malignancy in the last 5 years. Exceptions include basal cell carcinoma of the skin, squamous cell carcinoma of the skin, or in situ cervical cancer that has undergone potentially curative therapy