Immunotherapy for mesothelioma

Offentlig prosjektsammendrag

Phase II study – Mesothelioma (NIPU) UV1 will be investigated in a randomized, multi-center phase II trial in advanced malignant pleural mesothelioma (MPM). The trial, named NIPU, investigates UV1 in combination with the checkpoint inhibitors nivolumab and ipilimumab as second-line treatment in mesothelioma. Oslo University Hospital (‘OUS’) is the sponsor of the study. Bristol-Myers Squibb (‘BMS’) and Ultimovacs have entered into agreements with OUS to support the preparations and execution of the trial. A total of 118 patients will be included in the study. Half of the patients will be treated with the combination of UV1, nivolumab, and ipilimumab, whereas the other half will receive nivolumab and ipilimumab only. The study is planned to be conducted at 7 hospitals in five countries (Norway, Sweden, Denmark, Spain, and Australia). The primary endpoint of the trial is progression-free survival (PFS). The necessary approvals from the Norwegian Medicinal Agency and the ethics committee in Norway are in place to initiate the trial. MPM is a rare malignant tumor originating from the cells lining the mesothelial surface in the lungs. MPM is the most common type of mesothelioma and is a disease with a high unmet medical need with a median overall survival of approximately one year. Most patients are treated with palliative chemotherapy. Patients with disease progression after first-line therapy have few therapeutic options. Asbestos exposure is heavily linked to the development of the disease. It may take 10 – 50 years for symptoms of mesothelioma to manifest after initial asbestos exposure. Even though the use of asbestos to a large extent is banned today, new incidences of mesothelioma will continue to be a medical challenge for decades.