A Phase IB Study of Nivolumab and Ipilimumab Immunotherapy in People with Glioblastoma

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Full Title

A Phase Ib Clinical Trial to Evaluate Early Immunologic Pharmacodynamic Parameters Following Neoadjuvant Anti-PD-1 (Nivolumab), or the Combination of Anti-PD-1 Plus Anti-CTLA-4 (Nivolumab Plus Ipilimumab) in Patients With Surgically Accessible Glioblastoma

Purpose

Researchers are doing this study to assess the safety and effectiveness of giving nivolumab alone or with ipilimumab before and after surgery in people whose glioblastoma came back after prior treatment. Both medications are forms of immunotherapy; they block proteins that inhibit the immune response. By targeting these proteins, nivolumab and ipilimumab boost the ability of the immune system to find and kill cancer cells.

Participants in this study will be randomly assigned to receive nivolumab alone or nivolumab plus ipilimumab before and after glioblastoma surgery. Both medications are given intravenously (by vein).

Eligibility

To be eligible for this study, patients must meet several requirements, including:

  • Participants must have glioblastoma that came back after one or two prior regimens of treatment that included radiation therapy.
  • At least 4 weeks must pass between the completion of prior therapies and receipt of the study treatment.
  • Patients must be physically well enough that they are able to be mobile, take care of themselves, and engage in all but physically strenuous activities. For example, they must be well enough that they could carry out office work or light housework.
  • This study is for people age 18 and older.

For more information and to inquire about eligibility for this study, please contact Dr. Thomas Kaley at 212-639-5122 or the Brain Tumor Hotline at 866-886-9807.

Protocol

21-367

Phase

I

Investigator

Co-Investigators

Ingo Mellinghoff