Window Studies in Glioblastoma A Phase I Trial Investigating Neoadjuvant Ipilimumab in Newly Diagnosed Glioblastoma

What this Trial Is About

Researchers are evaluating neoadjuvant ipilimumab, a type of immunotherapy drug, in patients newly diagnosed with glioblastoma, a form of brain cancer. This phase I study aims to determine if it is safe to treat these patients with ipilimumab before they receive the standard treatments, which may include surgery and chemoradiation. The study is designed to assess safety, feasibility, and whether the drug can help control the disease. All participants will receive up to two cycles of ipilimumab at a dose of 3 mgkg, with each cycle lasting 21 days. The ipilimumab treatment is given before the standard care treatments such as debulking surgery and chemoradiation. This neoadjuvant approach will be followed by the usual care for glioblastoma patients. Participants will undergo regular assessments including monitoring for treatment-related side effects up to three months after ipilimumab administration. Researchers will also evaluate overall survival at 12 months, feasibility of the treatment, objective response rates, and other secondary outcomes such as progression-free survival, surgical complications, and quality of life measures. The total study duration includes follow-up of up to 24 months after registration.

A Study Assessing if it is Safe and Possible to Treat Brain Cancer Patients With Immunotherapy Before They Receive the Standard Treatment.