Mesotheliomas PleuralPhase 3AtezoMesoNCT04996017
Atezolizumab Versus Placebo for the Adjuvant Treatment of Malignant Pleural Mesothelioma (Atezomeso)
A Phase 3 study testing Atezolizumab 1200 mg in 20 ML Injection in people with Mesotheliomas Pleural, run by Gruppo Oncologico Italiano di Ricerca Clinica at 19 sites in Italy.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Mesotheliomas Pleural
- What is being tested?
- Atezolizumab 1200 mg in 20 ML Injection
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 162 participants
- Where
- 19 sitesItaly
- Study dates
- 14 Dec 2021to 30 Jun 2029
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Signed informed Consent Form
- Age ≥ 18 years on day of signing informed consent
- Histologically confirmed malignant pleural mesothelioma
- Surgical resection (P/D), without macroscopic residual. For stage I patient without visceral involvement a total pleurectomy is allowed
- Absence of measurable or non-measurable disease assessed with CT scan after surgery
- Patients must have received at least no 4 cycles of platinum/pemetrexed
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- perioperative chemotherapy as per local practice (neoadjuvant or adjuvant or both). Less than 4 cycles of chemotherapy are allowed for clinical decisions
- In patients previously treated with neoadjuvant chemotherapy, randomization
- should occur within 50 days from surgical resection.
- In patients treated with adjuvant chemotherapy, randomization should occur
- within 30 ±7 days from last dose of adjuvant treatment.
- Performance status of 0-1 on the ECOG Performance Scale
- Availability of a representative tumor specimen for exploratory biomarker research (see Section 4.5.6 for information on tumor specimens) A formalin-fixed paraffin-embedded (FFPE) tumor specimen in a paraffin block (preferred) or at least 10 slides containing unstained, freshly cut, serial sections must be submitted along with an associated pathology report prior to study enrollment.
- Adequate hematologic and end-organ function, defined by the following laboratory test results, obtained within 14 days prior to initiation of study treatment: ANC ³ 1.5 ´ 109/L (1500/mL) without granulocyte colony-stimulating factor support Lymphocyte count ³ 0.5 ´ 109/L (500/mL) Platelet count ³ 100 ´ 109/L (100,000/mL) without transfusion Hemoglobin 9 g/dL Patients may be transfused to meet this criterion. AST, ALT, and alkaline phosphatase (ALP) £ 2.5 ´ upper limit of normal (ULN)
- Bilirubin £ 1.5 ´ ULN with the following exception:
- Patients with known Gilbert disease: bilirubin level £ 3 ´ ULN. Creatinine £ 1.5 ´ ULN Albumin ³ 25 g/L (2.5 g/dL) For patients not receiving therapeutic anticoagulation: INR or aPTT £ 1.5 ´ ULN
- For women of childbearing potential: agreement to remain abstinent (refrain from heterosexual intercourse) or use contraception, as defined below: Women must remain abstinent or use contraceptive methods with a failure rate of < 1% per year during the treatment period and for 5 months after the final dose of atezolizumab. Women must refrain from donating eggs during this same period.
- A woman is considered to be of childbearing potential if she is postmenarcheal, hasnot reached a postmenopausal state (³12 continuous months of amenorrhea with no identified cause other than menopause), and is not permanently infertile due to surgery (i.e., removal of ovaries, fallopian tubes, and/or uterus) or another cause as determined by the investigator (e.g., Müllerian agenesis). Examples of contraceptive methods with a failure rate of <1% per year include bilateral tubal ligation, male sterilization, hormonal contraceptives that inhibit ovulation, hormone-releasing intrauterine devices, and copper intrauterine devices.
- The reliability of sexual abstinence should be evaluated in relation to the duration of the clinical trial and the preferred and usual lifestyle of the patient. Periodic abstinence (e.g., calendar, ovulation, symptothermal, or postovulation methods) andn withdrawal are not acceptable methods of contraception. If required per local guidelines or regulations, locally recognized acceptable methods of contraception and information about the reliability of abstinence will be described in the local Informed Consent Form.
- Women with a positive pregnancy test at enrollment or prior to administration of study medication will be excluded.
Who cannot join
- Patient with macroscopic residual disease after surgery, evaluated with CT scan
- after surgery or adjuvant therapy
- Subjects with active, known or suspected autoimmune disease. Subjects with vitiligo, type I diabetes mellitus, residual hypothyroidism due to autoimmune condition only requiring hormone replacement, psoriasis not requiring systemic treatment, or conditions not expected to recur in the absence of an external trigger are permitted to enroll
- Additional malignancy in the last 5 years. Exceptions include basal cell carcinoma of the skin, squamous cell carcinoma of the skin, or in situ cervical cancer that has undergone potentially curative therapy
- Active infection requiring systemic therapy
- Patient with positive result to Human Immunodeficiency Virus (HIV) (HIV 1/2
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- antibodies) test
- Active Hepatitis B (e.g., HBsAg reactive) or Hepatitis C (e.g., HCV RNA [qualitative] is detected) 7. History of idiopathic pulmonary fibrosis, organizing pneumonia (e.g., bronchiolitis
- obliterans), drug-induced pneumonitis, or idiopathic pneumonitis, or evidence of
- active pneumonitis on screening chest computed tomography (CT) scan. NOTE:
- History of radiation pneumonitis in the radiation field (fibrosis) is permitted
- Known active tuberculosis
- Significant cardiovascular disease (such as New York Heart Association Class II or
- greater cardiac disease, myocardial infarction, or cerebrovascular accident) within 3 months prior to initiation of study treatment, unstable arrhythmia, or unstable
- angina
- Major surgical procedure, other than for diagnosis, within 4 weeks prior to initiation of
- study treatment, or anticipation of need for a major surgical procedure during the
- study
- Severe infection within 4 weeks prior to initiation of study treatment, including, but
- not limited to, hospitalization for complications of infection, bacteremia, or severe
- pneumonia
- Prior allogeneic stem cell or solid organ transplantation
- Any other disease, metabolic dysfunction, physical examination finding, or clinical laboratory finding that contraindicates the use of an investigational drug, may affect the interpretation of the results, or may render the patient at high risk from treatment complications
- Treatment with a live, attenuated vaccine within 4 weeks prior to initiation of study treatment, or anticipation of need for such a vaccine during atezolizumab treatment or within 5 months after the final dose of atezolizumab15. Current treatment with anti-viral therapy for HBV
- Treatment with investigational therapy within 28 days prior to initiation of study
- treatment
- Prior treatment with CD137 agonists or immune checkpoint blockade therapies, including anti-CTLA-4, anti-PD-1, and anti-PD-L1 therapeutic antibodies
- Treatment with systemic immunostimulatory agents (including, but not limited to, interferon and interleukin 2 [IL-2]) within 4 weeks or 5 drug elimination half-lives (whichever is longer) prior to initiation of study treatment
- Treatment with systemic immunosuppressive medication (including, but not limited to, corticosteroids, cyclophosphamide, azathioprine, methotrexate, thalidomide, and anti-TNF-a agents) within 2 weeks prior to initiation of study treatment, or anticipation of need for systemic immunosuppressive medication during study treatment, with the following exceptions:
- Patients who received acute, low-dose systemic immunosuppressant medication or a one-time pulse dose of systemic immunosuppressant medication (e.g., 48 hours of corticosteroids for a contrast allergy) are eligible for the study after Scientific Responsible approval has been obtained
- Patients who received mineralocorticoids (e.g., fludrocortisone), corticosteroids for chronic obstructive pulmonary disease (COPD) or asthma, or low-dose corticosteroids for orthostatic hypotension or adrenal insufficiency are eligible for the study
- History of severe allergic anaphylactic reactions to chimeric or humanized antibodies or fusion proteins
- Known hypersensitivity to Chinese hamster ovary cell products or to any component of the atezolizumab formulation
- Pregnancy or breastfeeding, or intention of becoming pregnant during study treatment or within 5 months after the final dose of study treatment
- Women of childbearing potential must have a negative serum pregnancy test result within 14 days prior to initiation of study treatment.
Trial locations and contacts
19 sites in 1 country. Contact the study team or a site near you to ask about taking part.
19 sites in 1 country
Italy19 sites, 19 recruiting
- Not yet recruiting
Ospedaliera SS Antonio e Biagio e Cesare Arrigo di Alessandria
Alessandria, 15121
FEDERICA GROSSO, MD, 0131206183, fgrosso@ospedale.al.it
- Not yet recruiting
Istituto Tumori Bari
Bari, 70121
ANNAMARIA CATINO, MD, 080/5555442
- Not yet recruiting
Azienda Ospedaliera Universitaria Policlinico- Vittorio Emanuele Catania
Catania, 95123
HECTOR SOTO PARRA, MD, 3472603703, hsotoparra@yahoo.it
- Not yet recruiting
Ospedale Ss Annunziata
Chieti, 66100
MICHELE DE TURSI, MD, 0871358243, michele.detursi@unich.it
- Not yet recruiting
Azienda Ospedaliero Universitaria di Ferrara
Ferrara, 44121
ANTONIO FRASSOLDATI, MD, a.frassoldati@ospfe.it
- Not yet recruiting
Villa Scassi
Genova, 16121
MANILO MENCOBONI, MD
- Not yet recruiting
Istituto Scientifico Romagnolo Per Lo Studio E La Cura Dei Tumori - Irccs
Meldola, ITAòY, 47017
ANGELO DELMONTE, MD, 0543 739100, angelodelmonte@irst.emr.it
- Not yet recruiting
Ospedale Dell'Angelo
Mestre, 30174
ALBERTO PAVAN, MD, 041 9657111
- Not yet recruiting
Azienda Ospedaliera Universitaria Di Modena
Modena, 41100
FAUSTO BARBIERI, MD, barbieri.fausto@policlinico.mo.it
- Recruiting
Aorn Ospedale Dei Colli
Naples, 80131
VINCENZO MOTESARCHIO, MD, 0817065298, vincenzo.montesarchio@ospedalideicolli.it
VINCENZO MONTESARCHIO, MD
- Not yet recruiting
A.O.U. San Luigi Gonzaga
Orbassano, 10043
SILVIA NOVELLO, MD, silvia.novello@unito.it
- Not yet recruiting
Istituto Oncologico Veneto
Padova, 35128
GIULIA PASELLO, MD, 0498215608, giulia.pasello@ioveneto.it
- Not yet recruiting
Azienda Ospedaliera Universitaria Di Parma
Parma, 43126
MARCELLO TISEO, MD, 0521 702807, MTISEO@AO.PR.IT
- Not yet recruiting
Policlinico San Matteo
Pavia, 27100
PAOLO PEDRAZZOLI, MD, p.pedrazzoli@smatteo.pv.it
- Not yet recruiting
AUSL/IRCCS di Reggio Emilia
Reggio Emilia
Carmine Pinto, MD
- Recruiting
IRCCS Regina Elena
Roma, 00144
FEDERICO CAPUZZO, MD, 06-52665698, federico.cappuzzo@ifo.gov.it
- Not yet recruiting
Humanitas Cancer Center, IRCCS
Rozzano, 20089
ARMANDO SANTORO, MD, 02/8224.4080, armando.santoro@cancercenter.humanitas.it
- Not yet recruiting
Ospedale S. G. Moscati
Taranto, 74121
SALVATORE PISCONTI, MD
- Not yet recruiting
Azientda Sanitaria Universitaria Giuliano Isontina
Trieste, 34100
ALESSANDRA GUGLIELMI, MD, 0403992423, alessandra.guglielmi@asugi.sanita.fvg.it
About this study
Official title: PHASE III STUDY WITH ATEZOLIZUMAB VERSUS PLACEBO IN MALIGNANT PLEURAL MESOTHELIOMA PATIENTS AFTER PLEURECTOMY/DECORTICATION
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
- Mesotheliomas Pleural
- Being tested
- Atezolizumab 1200 mg in 20 ML Injection, Placebo
- Keywords
- mesothelioma, Adjuvant therapy, immunotherapy
- Medical subject headings
- Mesothelioma, Malignant, Mesothelioma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Atezolizumab 1200 mg in 20 ML InjectionDrug
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.
PlaceboDrug
Placebo will be supplied as sterile liquid in 20ml vials. the vial is designed
| Study group | Role | What they receive |
|---|---|---|
| Arm A | Experimental | atezolizumab 1200mg every 21 days Receives: Drug: Atezolizumab 1200 mg in 20 ML Injection |
| Arm B | Placebo comparator | 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 Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
To evaluate the efficacy of atezolizumab in patients with MPM in terms of DFS
DFS, defined as the time from initiation of study treatment to first recurrence of disease or death for any cause, whichever occurs first.
Measured: 12 weeks
Secondary outcomes (2)
To evaluate the safety of atezolizumab in patients with MPM
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.
Measured: 12 months
To evaluate the efficacy of atezolizumab in patients with MPM in terms of OS
OS, defined as the time from start of study drug to the date of death from any cause
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Aug 2021
- Study start14 Dec 2021
- Primary completion30 Jul 2027 (estimated)
- Study completion30 Jun 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mesotheliomas PleuralStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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).
- Masking
- Single blind
- Who is masked
- Care provider
- Enrolment
- 162 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Gruppo Oncologico Italiano di Ricerca Clinica
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04996017
- Sponsor's protocol ID
- GOIRC -03-2019
- Acronym
- AtezoMeso
- Status last verified
- Mar 2025
- First submitted
- 25 May 2021
- Last updated
- 13 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- PHASE III STUDY WITH ATEZOLIZUMAB VERSUS PLACEBO IN MALIGNANT PLEURAL MESOTHELIOMA PATIENTS AFTER PLEURECTOMY/DECORTICATION
- ClinicalTrials.gov ID
- NCT04996017
- Acronym / sponsor ID
- AtezoMeso / GOIRC -03-2019
- Conditions
- Mesotheliomas Pleural
- Keywords
- mesothelioma, Adjuvant therapy, immunotherapy
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 162 participants (estimated)
- Lead sponsor
- Gruppo Oncologico Italiano di Ricerca ClinicaUniversity, hospital or other
- Study start
- 14 Dec 2021 (actual)
- Primary completion
- 30 Jul 2027 (estimated)
- Study completion
- 30 Jun 2029 (estimated)
- First posted
- 9 Aug 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (care provider)
- Number of arms
- 2
- Model description
- 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).
| Arm | Type | Receives |
|---|---|---|
| Arm A | Experimental | Drug: Atezolizumab 1200 mg in 20 ML Injectionatezolizumab 1200mg every 21 days |
| Arm B | Placebo comparator | Drug: PlaceboPlacebo 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (20 listed)
- Signed informed Consent Form
- Age ≥ 18 years on day of signing informed consent
- Histologically confirmed malignant pleural mesothelioma
- Surgical resection (P/D), without macroscopic residual. For stage I patient without visceral involvement a total pleurectomy is allowed
- Absence of measurable or non-measurable disease assessed with CT scan after surgery
Key exclusion criteria (35 listed)
- Patient with macroscopic residual disease after surgery, evaluated with CT scan
- after surgery or adjuvant therapy
- Subjects with active, known or suspected autoimmune disease. Subjects with vitiligo, type I diabetes mellitus, residual hypothyroidism due to autoimmune condition only requiring hormone replacement, psoriasis not requiring systemic treatment, or conditions not expected to recur in the absence of an external trigger are permitted to enroll
- Additional malignancy in the last 5 years. Exceptions include basal cell carcinoma of the skin, squamous cell carcinoma of the skin, or in situ cervical cancer that has undergone potentially curative therapy
- Active infection requiring systemic therapy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Atezolizumab 1200 mg in 20 ML InjectionAtezolizumab 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. | Drug | Arm A |
| PlaceboPlacebo will be supplied as sterile liquid in 20ml vials. the vial is designed | Drug | Arm B |
Primary outcome
To evaluate the efficacy of atezolizumab in patients with MPM in terms of DFS
Time frame: 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.
2 secondary outcomes
To evaluate the safety of atezolizumab in patients with MPM
Time frame: 12 months
To evaluate the efficacy of atezolizumab in patients with MPM in terms of OS
Time frame: 12 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Mar 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
19 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Atezolizumab 1200 mg in 20 ML Injection in people with Mesotheliomas Pleural, run by Gruppo Oncologico Italiano di Ricerca Clinica at 19 sites in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 20 inclusion and 35 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 13 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 19 sites in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Carmine Pinto, MD (0522296614, carmine.pinto@ausl.re.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To evaluate the efficacy of atezolizumab in patients with MPM in terms of DFS (time frame: 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Mar 2025.