Pharmacodynamic Study of Pembrolizumab in Patients with Recurrent Glioblastoma
The goal of this clinical research study is to learn if Keytruda (pembrolizumab) can help to control glioblastoma. The safety of this drug will also be studied.
Treatment Location: N/A
1. Primary Objective The co-primary objectives of this study are to 1) evaluate immune effector function in resected glioblastoma tissue after treatment with intravenously administered pembrolizumab monotherapy in the neoadjuvant setting in patients with recurrent glioblastoma and 2) to correlate the progression free survival at 6 months (PFS6) with objective increases in the immune effector Tcell:Treg ratio in tumor tissue as measured by ex vivo T-cell-specific cytokines profiling. 2. Secondary Objective The secondary objectives include comparison of time to progression of last prior therapy to time to progression on pembrolizumab, median duration of response, overall response rate (ORR), and overall survival (OS) and safety. 3. Exploratory Objective To identify imaging characteristics associated with immunological changes in tumor following treatment with pembrolizumab .
IRB Review and Approval Date: 04/28/2015
Recruitment Status: Closed
Projected Accrual: N/A
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