Actively Recruiting
Atezolizumab Versus Placebo for the Adjuvant Treatment of Malignant Pleural Mesothelioma (Atezomeso)
Led by Gruppo Oncologico Italiano di Ricerca Clinica · Updated on 2025-03-13
162
Participants Needed
19
Research Sites
393 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Atezolizumab Versus Placebo for the Adjuvant Treatment of Malignant Pleural Mesothelioma (Atezomeso)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Signed informed consent form
- Age 18 years or older at consent
- Histologically confirmed malignant pleural mesothelioma
- Surgical resection (pleurectomy/decortication) without visible remaining disease
- For stage I without visceral involvement, total pleurectomy allowed
- No measurable disease on CT scan after surgery
- Received at least 4 cycles of platinum/pemetrexed chemotherapy perioperatively
- Randomization within 50 days after surgery if neoadjuvant chemotherapy received
- Randomization within 30 ±7 days after last adjuvant chemotherapy dose
- ECOG performance status of 0 or 1
- Availability of tumor specimen for biomarker research
- Adequate blood counts and organ function within 14 days before treatment
- Women of childbearing potential agree to abstain or use effective contraception during treatment and for 5 months after last dose
- Negative pregnancy test for women of childbearing potential
You will not qualify if you...
- Visible remaining disease after surgery on CT scan
- Active or suspected autoimmune disease, except certain controlled conditions
- Other cancer within last 5 years except some skin cancers and treated cervical cancer
- Active infection needing systemic treatment
- Positive HIV test
- Active Hepatitis B or C infection
- History or signs of certain lung diseases or active pneumonitis
- Active tuberculosis
- Significant heart disease within 3 months
- Major surgery within 4 weeks before treatment
- Recent severe infection requiring hospitalization
- Prior allogeneic stem cell or solid organ transplant
- Other health issues that increase risk or interfere with study
- Live vaccine within 4 weeks before treatment or planned during treatment and 5 months after
- Current antiviral treatment for hepatitis B
- Investigational therapy within 28 days before treatment
- Prior treatment with certain immune therapies
- Recent systemic immunostimulatory or immunosuppressive medication use with some exceptions
- Severe allergic reactions to similar antibodies
- Known allergy to components of atezolizumab
- Pregnancy, breastfeeding, or intent to become pregnant during treatment and 5 months after
- Positive pregnancy test within 14 days before treatment start
AI-Screening
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Trial Site Locations
Total: 19 locations
1
Istituto Scientifico Romagnolo Per Lo Studio E La Cura Dei Tumori - Irccs
Meldola, ITAòY, Italy, 47017
Not Yet Recruiting
2
Ospedaliera SS Antonio e Biagio e Cesare Arrigo di Alessandria
Alessandria, Italy, 15121
Not Yet Recruiting
3
Istituto Tumori Bari
Bari, Italy, 70121
Not Yet Recruiting
4
Azienda Ospedaliera Universitaria Policlinico- Vittorio Emanuele Catania
Catania, Italy, 95123
Not Yet Recruiting
5
Ospedale Ss Annunziata
Chieti, Italy, 66100
Not Yet Recruiting
6
Azienda Ospedaliero Universitaria di Ferrara
Ferrara, Italy, 44121
Not Yet Recruiting
7
Villa Scassi
Genova, Italy, 16121
Not Yet Recruiting
8
Ospedale Dell'Angelo
Mestre, Italy, 30174
Not Yet Recruiting
9
Azienda Ospedaliera Universitaria Di Modena
Modena, Italy, 41100
Not Yet Recruiting
10
Aorn Ospedale Dei Colli
Naples, Italy, 80131
Actively Recruiting
11
A.O.U. San Luigi Gonzaga
Orbassano, Italy, 10043
Not Yet Recruiting
12
Istituto Oncologico Veneto
Padova, Italy, 35128
Not Yet Recruiting
13
Azienda Ospedaliera Universitaria Di Parma
Parma, Italy, 43126
Not Yet Recruiting
14
Policlinico San Matteo
Pavia, Italy, 27100
Not Yet Recruiting
15
AUSL/IRCCS di Reggio Emilia
Reggio Emilia, Italy
Not Yet Recruiting
16
IRCCS Regina Elena
Roma, Italy, 00144
Actively Recruiting
17
Humanitas Cancer Center, IRCCS
Rozzano, Italy, 20089
Not Yet Recruiting
18
Ospedale S. G. Moscati
Taranto, Italy, 74121
Not Yet Recruiting
19
Azientda Sanitaria Universitaria Giuliano Isontina
Trieste, Italy, 34100
Not Yet Recruiting
Research Team
C
Carmine Pinto, MD
CONTACT
E
Erika Gervasi, BS
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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