Study of Pembrolizumab Combined with Standard Chemo-Radiotherapy for Newly Diagnosed Glioblastoma Multiforme Patients

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What is this study about?

This study focuses on patients with newly diagnosed Glioblastoma Multiforme (GBM), which is an aggressive type of brain tumor. The research examines a treatment approach that combines standard therapy (known as the Stupp protocol) with a medication called Pembrolizumab (also known as Keytruda). The standard therapy includes both chemotherapy and radiation treatment.

The purpose of this research is to evaluate how safe and effective it is to add Pembrolizumab treatment both before and after the standard therapy for patients with Glioblastoma Multiforme. Pembrolizumab is given through intravenous infusion, which means it is delivered directly into the bloodstream through a vein. The medication dose is 200 milligrams per treatment session.

During the study, participants will receive Pembrolizumab along with the standard combination of chemotherapy and radiation therapy. The treatment period may continue for up to 48 months. Throughout the study, doctors will monitor participants’ health status and measure how well they are responding to the treatment. They will also track any side effects that may occur and assess the overall impact on patients’ quality of life.

1 Initial treatment phase

You will receive pembrolizumab through an intravenous infusion (directly into your vein). The medication is called KEYTRUDA, with a concentration of 25 mg/mL.

This treatment will be given before the standard brain tumor treatment (called neoadjuvant therapy).

2 Standard treatment protocol

You will undergo the standard treatment known as the Stupp protocol, which includes:

Surgery to remove the brain tumor where possible

Radiation therapy to the brain

Chemotherapy treatment

3 Continued treatment phase

After completing the standard treatment, you will continue receiving pembrolizumab infusions (called adjuvant therapy)

Regular health assessments will monitor your condition throughout the treatment period

4 Monitoring and evaluation

Your health status will be regularly assessed using various questionnaires that measure quality of life

Brain scans will be performed to evaluate your response to treatment

Blood tests will be conducted to monitor your organ function

Any side effects will be recorded and monitored

5 Study duration

The study is scheduled to continue until January 2026

Your participation will require maintaining the prescribed treatment schedule and attending all planned medical visits

Who Can Join the Study?

Patient must sign an informed consent form to participate in the study
Age requirements: must be between 18 and 70 years old
Women who can become pregnant must agree to either:
- Remain abstinent, or
- Use double barrier contraception methods during treatment and for 120 days after the last imaging scan
Men must agree to either:
- Remain abstinent, or
- Use double barrier contraception methods during treatment and for 120 days after the last imaging scan
Must be able to follow study protocol requirements
Must have confirmed Glioblastoma Multiforme diagnosis through brain scans (CT and MRI)
Tumor must be in a location where surgery is possible
Must have good physical performance (Karnofsky score of 80 or higher, meaning able to carry out normal activities with minimal symptoms)
Life expectancy of at least 3 months
Must have adequate organ function, including:
- Acceptable blood counts (hemoglobin, white blood cells, platelets)
- Normal liver function
- Normal kidney function
- Normal blood clotting measures

Who Cannot Join the Study?

History of autoimmune disease requiring systemic treatment in the past 2 years (a condition where the body’s immune system attacks healthy cells)
Active hepatitis B or C infection (liver infections)
Known HIV infection or AIDS
Previous treatment with immune checkpoint inhibitors (a type of cancer immunotherapy)
Uncontrolled high blood pressure (above 150/90 mmHg)
Serious heart conditions, including:
- Heart attack within last 6 months
- Unstable chest pain
- Severe heart rhythm problems
Active infection requiring systemic therapy (treatment that affects the whole body)
Other active cancers requiring treatment (except for non-melanoma skin cancer or cervical cancer in situ)
Pregnancy or breastfeeding
Known allergy or sensitivity to study medications
Participation in other clinical trials within 30 days before this study
Mental conditions that could interfere with study compliance
Life expectancy less than 3 months

Where you can join this trial?

Verified and Recommended Sites

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Verified Sites

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Other Sites

Site Name	City	Country	Status
Wvayzkvrho Syubueo Sooznjcnwypzdop np 5 ipu śmt Bpfxpng w Sthrrhhl	Sosnowiec	Poland
Nxespbqi Ioscmgpa Obovbeagg Ibm Mhshv Suzhdanrycpguvppkcrntwyrxowd Itmwthml Bsxkrhuq	Cracow	Poland

Trial status

Country	Status	Recruitment Start
Poland	Recruiting	31.08.2022

Trial locations

Investigated drugs:

Pembrolizumab

Pembrolizumab is a medication that helps your immune system fight cancer cells. It belongs to a group of drugs called immunotherapy. In this trial, it’s being tested as an additional treatment before and after standard therapy for brain cancer (glioblastoma).

Temozolomide is a chemotherapy medication that is part of the standard treatment (Stupp protocol) for glioblastoma. It works by stopping cancer cells from growing and dividing.

Radiation therapy is also part of the standard treatment (Stupp protocol). While not a medication, it uses high-energy rays to target and destroy cancer cells in the brain.

Note: The Stupp protocol mentioned in the trial refers to the combination of radiation therapy and temozolomide, which is the current standard treatment for glioblastoma.

Glioblastoma Multiforme – A primary brain tumor that develops from glial cells in the brain. This aggressive tumor forms in the supportive tissue of the brain and typically appears in the cerebral hemispheres. The tumor grows rapidly and can spread throughout brain tissue, creating pressure within the skull. Glioblastoma can cause symptoms such as headaches, nausea, seizures, and changes in behavior or memory. The condition may also affect physical function, depending on which part of the brain is involved.

Trial ID:

2024-517535-52-00

Protocol code:

2019/ABM/01/00062

NCT ID:

NCT05235737

Trial Phase:

Therapeutic confirmatory (Phase III)

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Study of Pembrolizumab Combined with Standard Chemo-Radiotherapy for Newly Diagnosed Glioblastoma Multiforme Patients

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?