OncoMatch/Clinical Trials/NCT04996017
Atezolizumab Versus Placebo for the Adjuvant Treatment of Malignant Pleural Mesothelioma (Atezomeso)
Is NCT04996017 recruiting? Yes, currently enrolling (May 2026). This Phase 3 trial studies Atezolizumab 1200 mg in 20 ML for mesotheliomas pleural.
Treatment: Atezolizumab 1200 mg in 20 ML — 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.
Check if I qualifyExtracted eligibility criteria
Disease stage
Required: Stage I
Surgical resection (P/D), without macroscopic residual. For stage I patient without visceral involvement a total pleurectomy is allowed
Performance status
ECOG 0–1(Restricted strenuous activity)
Prior therapy
Must have received: platinum-based chemotherapy (platinum, pemetrexed) — perioperative (neoadjuvant or adjuvant or both)
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
Cannot have received: CD137 agonist
Prior treatment with CD137 agonists
Cannot have received: immune checkpoint blockade therapy (anti-CTLA-4, anti-PD-1, anti-PD-L1)
Prior treatment with ... immune checkpoint blockade therapies, including anti-CTLA-4, anti-PD-1, and anti-PD-L1 therapeutic antibodies
Cannot have received: investigational therapy
Treatment with investigational therapy within 28 days prior to initiation of study treatment
Cannot have received: systemic immunostimulatory agent (interferon, interleukin 2)
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
Lab requirements
Blood counts
ANC ≥ 1.5 × 10^9/L (1500/mL) without G-CSF support; Lymphocyte count ≥ 0.5 × 10^9/L (500/mL); Platelet count ≥ 100 × 10^9/L (100,000/mL) without transfusion; Hemoglobin ≥ 9 g/dL (transfusion allowed)
Kidney function
Creatinine ≤ 1.5 × ULN; Albumin ≥ 25 g/L (2.5 g/dL)
Liver function
AST, ALT, and alkaline phosphatase (ALP) ≤ 2.5 × ULN; Bilirubin ≤ 1.5 × ULN (≤ 3 × ULN for Gilbert disease)
Adequate hematologic and end-organ function, defined by the following laboratory test results, obtained within 14 days prior to initiation of study treatment: ANC ≥ 1.5 × 10^9/L (1500/mL) without granulocyte colony-stimulating factor support Lymphocyte count ≥ 0.5 × 10^9/L (500/mL) Platelet count ≥ 100 × 10^9/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 ≥ 25 g/L (2.5 g/dL)
Structured fields extracted by AI. May contain errors — verify against the official protocol.
Could you qualify for this trial?
Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.
Check if I qualify