NCT05765084 Integration of the PD-L1 Inhibitor Atezolizumab and WT1/DC Vaccination Into Platinum/Pemetrexed-based First-line Treatment for Epithelioid Malignant Pleural Mesothelioma

Trial Parameters

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Brief Summary

In this multicenter phase I/II trial, the programmed death-ligand 1 (PD-L1) inhibitor atezolizumab and dendritic cells (DCs) loaded with the mesothelioma-associated tumor antigen WT1 will be integrated into platinum/pemetrexed-based first-line chemotherapy for the treatment of epitheloid malignant pleural mesothelioma (MPM). The general objective is to provide the first-in-human experimental demonstration that the combination of platinum/pemetrexed-based chemotherapy with atezolizumab and WT1/DC vaccination is feasible and safe, has clinical activity and enables the induction of mesothelioma-specific immune responses in patients with MPM.

Eligibility Criteria

Inclusion Criteria: Subjects must meet all the following criteria to be eligible to participate in the study: * Signed informed consent * Diagnosis with histologically proven epithelioid unresectable MPM (stage I-IV) * Age ≥ 18 years at the time of signing informed consent * World Health Organization (WHO) performance status 0-1 * Adequate hematologic and end-organ function, defined by the following laboratory test results, obtained at the time of screening: * Absolute neutrophil count (ANC) ≥ 1.5 x 10\^9/L (1500/μL) without granulocyte colony- stimulating factor support * Lymphocyte count ≥ 0.5 x 10\^9/L (500/μL) * Platelet count ≥ 100 x 10\^9/L (100,000/μL) without transfusion * Hemoglobin ≥ 90 g/L (9 g/dL) Patients may be transfused to meet this criterion * Aspartate aminotransferase (AST), alanine aminotransferase (ALT), and alkaline phosphatase (ALP) ≤ 2.5 x upper limit of normal (ULN), with the following exceptions: * Patients with documented liver metastases: AST and ALT ≤ 5 x U

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