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

Sponsor
Gruppo Oncologico Italiano di Ricerca Clinica
Study ID
NCT04996017
Phase
PHASE3
Status
Recruiting
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Conditions

  • Mesotheliomas Pleural

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

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

Study 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). 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.

Key Dates

Start date
Dec 14, 2021
Status verified
Mar 2025
Primary completion
Jul 30, 2027
Completion
Jun 30, 2029

Study Design

Enrollment
162 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Arm A
    atezolizumab 1200mg every 21 days
  • Placebo Comparator: Arm B
    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 Measure

To evaluate the efficacy of atezolizumab in patients with MPM in terms of DFS [ Time Frame: 12 weeks ]

Central Contacts

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