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Botensilimab, Balstilimab, and Liposomal Doxorubicin in Combination with Ultrasound-Mediated Blood Brain Barrier Opening for the Treatment of Patients with Newly Diagnosed Glioblastoma

Trial Status: active

This phase II trial tests how well botensilimab, balstilimab, and liposomal doxorubicin work in combination with ultrasound-mediated blood brain barrier opening, using the SonoCloud-9 device, for the treatment of patients with newly diagnosed glioblastoma. The SonoCloud-9 device is surgically placed in the skull and works by temporarily increasing the permeability of the blood brain barrier, using ultrasound and a medication called Definity, to allow increased uptake of the treatment medications to the tumor cells. Botensilimab and balstilimab are monoclonal antibodies that may interfere with the ability of tumor cells to grow and spread. Doxorubicin is in a class of medications called anthracyclines. Doxorubicin damages the cell’s DNA and may kill cancer cells. It also blocks a certain enzyme needed for cell division and DNA repair. Liposomal doxorubicin is a form of the anticancer drug doxorubicin that is contained inside very tiny, fat-like particles. Liposomal doxorubicin may have fewer side effects and work better than other forms of the drug. It also may enhance the reaction to the immunotherapy medications. Giving botensilimab, balstilimab and liposomal doxorubicin in combination with ultrasound mediated blood brain barrier opening may kill more tumor cells in patients with newly diagnosed glioblastoma.