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

NCT04996017 | Recruiting Phase 3

• 1 other identifier: GOIRC -03-2019
• Study Type: interventional
• Target: 162
• Locations: 1 country
• Sites: 19

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.

Conditions

Mesotheliomas Pleural

Keywords

mesothelioma; Adjuvant therapy; immunotherapy

Outcome Measures

Primary Outcomes (1)

• 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.

  12 weeks

Secondary Outcomes (2)

• To evaluate the safety of atezolizumab in patients with MPM

  12 months

• To evaluate the efficacy of atezolizumab in patients with MPM in terms of OS

  12 months

Study Arms (2)

Arm A

EXPERIMENTAL

atezolizumab 1200mg every 21 days

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

Drug: Placebo

Interventions

Atezolizumab 1200 mg in 20 ML Injection DRUG

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.

Arm A

Placebo DRUG

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

Arm B

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• 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:

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• Gruppo Oncologico Italiano di Ricerca Clinica: lead

Study Sites (19)

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

Meldola, ITAòY, 47017, Italy

NOT YET RECRUITING

Ospedaliera SS Antonio e Biagio e Cesare Arrigo di Alessandria

Alessandria, 15121, Italy

NOT YET RECRUITING

Istituto Tumori Bari

Bari, 70121, Italy

NOT YET RECRUITING

Azienda Ospedaliera Universitaria Policlinico- Vittorio Emanuele Catania

Catania, 95123, Italy

NOT YET RECRUITING

Ospedale Ss Annunziata

Chieti, 66100, Italy

NOT YET RECRUITING

Azienda Ospedaliero Universitaria di Ferrara

Ferrara, 44121, Italy

NOT YET RECRUITING

Villa Scassi

Genova, 16121, Italy

NOT YET RECRUITING

Ospedale Dell'Angelo

Mestre, 30174, Italy

NOT YET RECRUITING

Azienda Ospedaliera Universitaria Di Modena

Modena, 41100, Italy

NOT YET RECRUITING

Aorn Ospedale Dei Colli

Napoli, 80131, Italy

RECRUITING

A.O.U. San Luigi Gonzaga

Orbassano, 10043, Italy

NOT YET RECRUITING

Istituto Oncologico Veneto

Padua, 35128, Italy

NOT YET RECRUITING

Azienda Ospedaliera Universitaria Di Parma

Parma, 43126, Italy

NOT YET RECRUITING

Policlinico San Matteo

Pavia, 27100, Italy

NOT YET RECRUITING

AUSL/IRCCS di Reggio Emilia

Reggio Emilia, Italy

NOT YET RECRUITING

IRCCS Regina Elena

Roma, 00144, Italy

RECRUITING

Humanitas Cancer Center, IRCCS

Rozzano, 20089, Italy

NOT YET RECRUITING

Ospedale S. G. Moscati

Taranto, 74121, Italy

NOT YET RECRUITING

Azientda Sanitaria Universitaria Giuliano Isontina

Trieste, 34100, Italy

NOT YET RECRUITING

MeSH Terms

Conditions

Mesothelioma, Malignant; Mesothelioma

Interventions

atezolizumab; Injections

Condition Hierarchy (Ancestors)

Adenoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Mesothelial; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Pleural Neoplasms; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Drug Administration Routes; Drug Therapy; Therapeutics

Central Study Contacts

Carmine Pinto, MD

CONTACT

0522296614; carmine.pinto@ausl.re.it

Erika Gervasi, BS

CONTACT

0522296858; erika.gervasi@ausl.re.it

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: CARE PROVIDER
• Masking Details: This is a randomized, placebo-controlled, double-blind study. Patients will be randomized to one of the following treatment arms in a 2:1 ratio (experimental to control arm): * Arm A (experimental arm): atezolizumab * Arm B (control arm): placebo Randomization will be stratified by the following factors: * Histology (epithelioid vs non epithelioid) * Stage (I vs \>I) Blinding Investigators and patients will remain blinded to treatment assignment until the final analysis of OS, except in the event unblinding is necessary for a medical emergency or to help guide decisions on subsequent treatment. If the investigator wishes to know the identity of the study drug for any reason other than a medical emergency, he or she should contact the Scientific Responsible. In case of unblinding, patient will be withdrawn by the study.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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).

Study Record Dates

• First Submitted: May 25, 2021
• First Posted: August 9, 2021
• Study Start: December 14, 2021
• Primary Completion (Estimated): July 30, 2027
• Study Completion (Estimated): June 30, 2029
• Last Updated: March 13, 2025

Record last verified: 2025-03

Locations

IT (19)