Integration of the PD-L1 Inhibitor Atezolizumab and WT1/DC Vaccination Into Platinum/Pemet
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
| Condition(s) | Malignant Pleural Mesothelioma |
|---|---|
| Status | Recruiting |
| Phase | Phase 1, Phase 2 |
| Study type | Interventional |
| 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. |
| Who can participate | 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 (A |
| Ages | 18 Years |
| Sex | All |
| Lead sponsor | University Hospital, Antwerp |
| Locations | Edegem, Antwerp, Belgium; Ghent, Belgium; Sint-Niklaas, Belgium |
| Start date | 2023-02-24 |
| NCT ID | NCT05765084 |
| Official listing | https://clinicaltrials.gov/study/NCT05765084 |