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RECRUITING
NCT05235737
PHASE4

The Assessment of Immune Response in Newly Diagnosed Glioblastoma Patients Treated With Pembrolizumab

Sponsor: Medical University of Silesia

View on ClinicalTrials.gov

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.

Official title: 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).

Key Details

Gender

All

Age Range

18 Years - 70 Years

Study Type

INTERVENTIONAL

Enrollment

36

Start Date

2022-03-01

Completion Date

2026-05-30

Last Updated

2023-08-31

Healthy Volunteers

No

Interventions

DRUG

Pembrolizumab

Adding Pembrolizumab as a neoadjuvant and adjuvant therapy to the standard of care protocol

DRUG

Pembrolizumab

Adding Pembrolizumab as a neoadjuvant therapy to the standard of care protocol

Locations (1)

Wojciech Kaspera

Sosnowiec, Silesian, Poland