Atezolizumab Versus Placebo for the Adjuvant Treatment of Malignant Pleural Mesothelioma (Atezomeso)
- Conditions
- Mesotheliomas Pleural
- Interventions
- Drug: Placebo
- Registration Number
- NCT04996017
- Lead Sponsor
- Gruppo Oncologico Italiano di Ricerca Clinica
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 162
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Arm A Atezolizumab 1200 mg in 20 ML Injection atezolizumab 1200mg every 21 days Arm B Placebo Placebo will be supplied by the sponsor and will be identical in appearance to atezolizumab and will comprise the same excipients but without atezolizumab every 21 days
- Primary Outcome Measures
Name Time Method To evaluate the efficacy of atezolizumab in patients with MPM in terms of DFS 12 weeks DFS, defined as the time from initiation of study treatment to first recurrence of disease or death for any cause, whichever occurs first.
- Secondary Outcome Measures
Name Time Method To evaluate the safety of atezolizumab in patients with MPM 12 months Incidence, nature, frequency, duration, timing and severity of serious adverse events (SAEs) and non-serious adverse events (AEs) related to atezolizumab treatment graded by National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v. 5.
To evaluate the efficacy of atezolizumab in patients with MPM in terms of OS 12 months OS, defined as the time from start of study drug to the date of death from any cause
Trial Locations
- 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
Azienda Ospedaliera Universitaria Policlinico- Vittorio Emanuele Catania
🇮🇹Catania, Italy
Ospedale S. G. Moscati
🇮🇹Taranto, Italy
Ospedale Ss Annunziata
🇮🇹Chieti, Italy
Istituto Tumori Bari
🇮🇹Bari, 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
🇮🇹Napoli, Italy
Istituto Oncologico Veneto
🇮🇹Padova, Italy
A.O.U. San Luigi Gonzaga
🇮🇹Orbassano, Italy
Azienda Ospedaliera Universitaria Di Parma
🇮🇹Parma, Italy
IRCCS Regina Elena
🇮🇹Roma, Italy
Humanitas Cancer Center, IRCCS
🇮🇹Rozzano, Italy
Policlinico San Matteo
🇮🇹Pavia, Italy
AUSL/IRCCS di Reggio Emilia
🇮🇹Reggio Emilia, Italy
Azientda Sanitaria Universitaria Giuliano Isontina
🇮🇹Trieste, Italy