This clinical trial is focused on studying a type of brain cancer called glioblastoma, which is a newly diagnosed condition in the patients participating. The study is testing the effectiveness of a treatment method that combines a medical device called Optune with medications temozolomide and pembrolizumab. Optune is a portable device that uses electric fields, known as Tumor Treating Fields, to target and kill cancer cells in the brain. Temozolomide is a chemotherapy drug taken orally, while pembrolizumab is an immunotherapy drug given through an intravenous infusion. Some participants will receive a placebo instead of pembrolizumab to compare the outcomes.
The purpose of the study is to compare the overall survival of patients receiving the combination of Optune, temozolomide, and pembrolizumab with those receiving Optune, temozolomide, and a placebo. Participants will be randomly assigned to one of these two groups. The study will be conducted over a period of time, with regular monitoring and assessments to track the progress and effects of the treatment. The trial aims to provide valuable information on whether the addition of pembrolizumab to the existing treatment can improve survival rates for patients with newly diagnosed glioblastoma.
Throughout the study, participants will undergo various evaluations to ensure their safety and to gather data on the treatment’s effectiveness. The trial will help determine if this combination of treatments can offer a better outcome for patients facing this aggressive form of brain cancer. The study is expected to continue until 2028, with the goal of advancing the understanding and management of glioblastoma.



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