RecruitingPhase 3NCT04996017

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

PHASE III STUDY WITH ATEZOLIZUMAB VERSUS PLACEBO IN MALIGNANT PLEURAL MESOTHELIOMA PATIENTS AFTER PLEURECTOMY/DECORTICATION


Sponsor

Gruppo Oncologico Italiano di Ricerca Clinica

Enrollment

162 participants

Start Date

Dec 14, 2021

Study Type

INTERVENTIONAL

Conditions

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

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study (Atezomeso) tests whether atezolizumab (an immunotherapy drug) given after surgery and chemotherapy reduces the chance of mesothelioma (a cancer of the lining of the lung) coming back in patients whose tumors were completely removed. **You may be eligible if...** - You have confirmed malignant pleural mesothelioma - Your tumor was completely removed by surgery (no visible remaining disease) - You received at least 4 cycles of platinum/pemetrexed chemotherapy around the time of surgery - You are in good overall health (ECOG 0–1) - Your blood counts, liver, kidney, and other organ functions are adequate **You may NOT be eligible if...** - There is visible remaining cancer after surgery - You have an active autoimmune disease (with some exceptions like vitiligo or well-controlled thyroid disease) - You have another active cancer in the last 5 years - You have active HIV, hepatitis B, or hepatitis C - You have had a prior allogeneic stem cell or organ transplant - You have had significant heart problems in the last 3 months - You are pregnant or breastfeeding Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGAtezolizumab 1200 mg in 20 ML Injection

Atezolizumab will be supplied as sterile liquid in 20-mL glass vials. The vial is designed to deliver 20 mL (1200 mg) of atezolizumab solution but may contain more than the stated volume to enable delivery of the entire 20 mL volume. For information on the formulation and handling of atezolizumab, refer to the Atezolizumab Investigator's Brochure.

DRUGPlacebo

Placebo will be supplied as sterile liquid in 20ml vials. the vial is designed


Locations(19)

Istituto Scientifico Romagnolo Per Lo Studio E La Cura Dei Tumori - Irccs

Meldola, ITAòY, Italy

Ospedaliera SS Antonio e Biagio e Cesare Arrigo di Alessandria

Alessandria, Italy

Istituto Tumori Bari

Bari, Italy

Azienda Ospedaliera Universitaria Policlinico- Vittorio Emanuele Catania

Catania, Italy

Ospedale Ss Annunziata

Chieti, Italy

Azienda Ospedaliero Universitaria di Ferrara

Ferrara, Italy

Villa Scassi

Genova, Italy

Ospedale Dell'Angelo

Mestre, Italy

Azienda Ospedaliera Universitaria Di Modena

Modena, Italy

Aorn Ospedale Dei Colli

Naples, Italy

A.O.U. San Luigi Gonzaga

Orbassano, Italy

Istituto Oncologico Veneto

Padova, Italy

Azienda Ospedaliera Universitaria Di Parma

Parma, Italy

Policlinico San Matteo

Pavia, Italy

AUSL/IRCCS di Reggio Emilia

Reggio Emilia, Italy

IRCCS Regina Elena

Roma, Italy

Humanitas Cancer Center, IRCCS

Rozzano, Italy

Ospedale S. G. Moscati

Taranto, Italy

Azientda Sanitaria Universitaria Giuliano Isontina

Trieste, Italy

View Full Details on ClinicalTrials.gov

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NCT04996017


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