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Phase 3
Age: 18Years +
All Genders
ID04996017

Phase III Trial of Atezolizumab Versus Placebo After Surgery for Malignant Pleural Mesothelioma

Led by Gruppo Oncologico Italiano di Ricerca Clinica · Updated on 2025-03-13

162

Participants Needed

19

Research Sites

100 weeks

Total Duration

AI-Summary

What this Trial Is About

This research evaluates atezolizumab as an additional treatment for patients with malignant pleural mesothelioma who have undergone surgical removal of the tumor and show no visible remaining disease. This phase III trial compares atezolizumab to a placebo to assess how well it works in preventing disease recurrence. Patients are grouped based on tumor type and cancer stage to better understand treatment effects. Participants receive either atezolizumab at 1200 mg or a matching placebo every 21 days for up to 12 months, or until the disease returns, side effects become unacceptable, or the patient or doctor decide to stop treatment. The study uses a centralized system to randomly assign patients to one of these groups, ensuring a balanced comparison. Tumor samples are analyzed to study biological markers and gene expression. During the trial, patients undergo CT scans before starting treatment and then every 12 weeks for two years or until the disease progresses. Quality of life questionnaires are completed at the start and every 12 weeks. Researchers monitor safety, disease-free survival, and overall survival for up to a year. The study lasts several years, with follow-up assessments to understand treatment impact and patient well-being.

CONDITIONS

Brief Title

Atezolizumab Versus Placebo for the Adjuvant Treatment of Malignant Pleural Mesothelioma (Atezomeso)

Research Team

C

Carmine Pinto, MD

E

Erika Gervasi, BS

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