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.
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
History of malignancy within 3 years prior to initiation of study treatment, with the exception of the cancer under investigation in this study and malignancies with a negligible risk of metastasis or death (e.g., 5-year OS rate > 90%), such as adequately treated carcinoma in situ of the cervix, non-melanoma skin carcinoma, localized prostate cancer, ductal carcinoma in situ, or Stage I uterine cancer
Measurable disease, per RECIST v1.1, must be present outside the CNS.
The patient has no history of intracranial hemorrhage or spinal cord hemorrhage.
The patient has not undergone stereotactic radiotherapy within 7 days prior to initiation of study treatment, whole-brain radiotherapy within 14 days prior to initiation of study treatment, or neurosurgical resection within 28 days prior to initiation of study treatment.
University Hospital, Antwerp
Lead sponsor
Algemeen Ziekenhuis Maria Middelares
Collaborator
Vitaz
Collaborator
Kom Op Tegen Kanker
Collaborator
Roche Pharma AG
Collaborator