Condition: Mesotheliomas Pleural · Sponsor: Gruppo Oncologico Italiano di Ricerca Clinica
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.
This description comes directly from the study's public registry record.
Carmine Pinto, MD · 0522296614 · carmine.pinto@ausl.re.it
Erika Gervasi, BS · 0522296858 · erika.gervasi@ausl.re.it
Always discuss trial participation with your own doctor first.
| Istituto Scientifico Romagnolo Per Lo Studio E La Cura Dei Tumori - Irccs | Meldola, ITAòY, Italy | Not Yet Recruiting |
| Ospedaliera SS Antonio e Biagio e Cesare Arrigo di Alessandria | Alessandria, Italy | Not Yet Recruiting |
| Istituto Tumori Bari | Bari, Italy | Not Yet Recruiting |
| Azienda Ospedaliera Universitaria Policlinico- Vittorio Emanuele Catania | Catania, Italy | Not Yet Recruiting |
| Ospedale Ss Annunziata | Chieti, Italy | Not Yet Recruiting |
| Azienda Ospedaliero Universitaria di Ferrara | Ferrara, Italy | Not Yet Recruiting |
| Villa Scassi | Genova, Italy | Not Yet Recruiting |
| Ospedale Dell'Angelo | Mestre, Italy | Not Yet Recruiting |
| Azienda Ospedaliera Universitaria Di Modena | Modena, Italy | Not Yet Recruiting |
| Aorn Ospedale Dei Colli | Naples, Italy | Recruiting |
| A.O.U. San Luigi Gonzaga | Orbassano, Italy | Not Yet Recruiting |
| Istituto Oncologico Veneto | Padova, Italy | Not Yet Recruiting |
+ 7 more locations — full list on the registry record.
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Source record: clinicaltrials.gov/study/NCT04996017