RecruitingPhase 4NCT05235737

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).


Sponsor

Medical University of Silesia

Enrollment

36 participants

Start Date

Mar 1, 2022

Study Type

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

Min Age: 18 YearsMax Age: 70 Years

Plain Language Summary

Simplified for easier understanding

This study looks at how the immune system responds in patients with newly diagnosed glioblastoma (a serious brain tumor) who receive pembrolizumab — an immunotherapy drug — alongside standard treatment including surgery, chemotherapy, and radiation. **You may be eligible if...** - You are between 18 and 70 years old with a new diagnosis of glioblastoma - Your tumor can be surgically removed and is not in a critical brain area - You are physically active and functioning well (Karnofsky score ≥80) - You have not received any prior cancer treatment - Your blood counts, kidney, and liver function are within normal ranges **You may NOT be eligible if...** - You have another active cancer (with some exceptions for low-risk skin cancers) - You have an active autoimmune disease or immunodeficiency - You have had a prior allergic reaction to pembrolizumab or similar drugs - You are pregnant or planning to become pregnant - Your BMI is 35 or above Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGPembrolizumab

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

DRUGPembrolizumab

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


Locations(1)

Wojciech Kaspera

Sosnowiec, Silesian, Poland

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NCT05235737


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