The Assessment of Immune Response in Newly Diagnosed Glioblastoma Patients Treated With Pembrolizumab
A Single Center, Open-Label, Randomized Study to Evaluate the Safety and Efficacy of Neoadjuvant and Adjuvant Pembrolizumab on Top of Standard Chemo-Radiotherapy (Stupp Protocol) in Treatment of Patients With Newly Diagnosed Glioblastoma Multiforme (GBM).
Medical University of Silesia
36 participants
Mar 1, 2022
INTERVENTIONAL
Conditions
Summary
To evaluate the short-term and longer-term safety, tolerability, and effectiveness of neoadjuvant and adjuvant Pembrolizumab on top of standard therapy (Stupp protocol) in patients with Glioblastoma Multiforme (GBM). Randomized comparison of safety, tolerability, and clinical efficacy of (1) neoadjuvant and adjuvant Pembrolizumab (on top of Stupp protocol, n=12 patients), (2) neoadjuvant Pembrolizumab (on top of Stupp protocol, n=12 patients), and (3) standard of care (Stupp protocol only, n=12 patients). Immuno-PET examination will be performed before and after surgery in all patients.
Eligibility
Plain Language Summary
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Interventions
Adding Pembrolizumab as a neoadjuvant and adjuvant therapy to the standard of care protocol
Adding Pembrolizumab as a neoadjuvant therapy to the standard of care protocol
Locations(1)
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NCT05235737