Atezolizumab Versus Placebo for the Adjuvant Treatment of Malignant Pleural Mesothelioma (Atezomeso)
Trial Parameters
Brief 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.
Eligibility Criteria
Inclusion Criteria * 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 * Absence of measurable or non-measurable disease assessed with CT scan after surgery * Patients must have received at least no 4 cycles of platinum/pemetrexed * perioperative chemotherapy as per local practice (neoadjuvant or adjuvant or both). Less than 4 cycles of chemotherapy are allowed for clinical decisions \- In patients previously treated with neoadjuvant chemotherapy, randomization * should occur within 50 days from surgical resection. \- In patients treated with adjuvant chemotherapy, randomization should occur * within 30 ±7 days from last dose of adjuvant treatment. * Performance status of 0-1 on the ECOG Performance Scale * Availability of a representative tumor specimen for expl