Phase I Study of Combined Intravenous and Brain Immunotherapy with Ipilimumab and Nivolumab for Recurrent Glioblastoma

What this Trial Is About

Researchers are studying a new treatment approach for patients with recurrent glioblastoma that can be surgically removed. This phase I trial aims to assess the safety and feasibility of combining intravenous and direct brain immunotherapy around the time of surgery. The investigational treatment involves giving immune-boosting drugs before and after tumor removal to evaluate their potential in managing glioblastoma recurrence. Participants will first receive intravenous immunotherapy with the drugs ipilimumab and nivolumab on day 1 and day 22. Then they will undergo a maximal safe brain surgery to remove the tumor, followed by direct injection of the same immunotherapy drugs into the brain tissue and placement of an Ommaya reservoir to allow continued drug delivery. After surgery, participants will continue to receive intravenous nivolumab along with intracavitary injections of ipilimumab and nivolumab every two weeks. During the study, participants will be closely monitored with regular visits, laboratory tests, and imaging scans such as MRI and PETCT to assess tumor status and treatment safety. Researchers will track immune responses and side effects over one year, with longer follow-up planned to estimate anti-tumor effects. Overall, the trial involves multiple stages of treatment and assessments to carefully evaluate this combined immunotherapy approach for recurrent glioblastoma.

A Clinical Trial on Combined (Neo-)Adjuvant Intravenous Plus Intracranial Administration of Ipilimumab and Nivolumab in Recurrent Glioblastoma