Study on Glioblastoma Treatment with Olaptesed Pegol and Radiation, with Bevacizumab or Pembrolizumab, for Patients with Unmethylated MGMT Promoter

1 1 1 1

What is this study about?

This clinical trial is focused on studying a type of brain cancer called glioblastoma. The study is investigating the use of a treatment called olaptesed pegol, also known by its code name NOX-A12, in combination with radiation therapy. In some cases, the study will also include additional treatments with either bevacizumab or pembrolizumab. The main goal of the study is to explore the safety of these treatment combinations in patients who have been newly diagnosed with glioblastoma that has a specific genetic feature known as an unmethylated MGMT promoter.

Participants in the study will receive the treatment through an infusion, which is a way of delivering medication directly into the bloodstream. The study will be conducted in different phases, starting with a dose-escalation phase to determine the safest and most effective dose of olaptesed pegol. Following this, there will be an expansion phase where more patients will receive the treatment to further assess its safety and effects. Throughout the study, patients will undergo regular monitoring, including MRI scans, to evaluate the treatment’s impact on the tumor and overall health.

The study aims to provide valuable information on the potential benefits and risks of using olaptesed pegol in combination with radiation therapy, and possibly with bevacizumab or pembrolizumab, for treating glioblastoma. This research could lead to new treatment options for patients with this challenging form of brain cancer. The study is expected to continue until the end of 2029, allowing researchers to gather comprehensive data on the long-term effects of the treatment.

1 initial treatment phase

Begin with the administration of olaptesed pegol through an intravenous injection. This is combined with radiation therapy.

The goal is to assess the safety of this combination in treating newly diagnosed glioblastoma.

2 combination therapy phase

Receive bevacizumab or pembrolizumab through intravenous infusion, in addition to the ongoing treatment with olaptesed pegol and radiation therapy.

This phase aims to further evaluate the safety and effectiveness of the combined treatments.

3 oral medication phase

Take temozolomide capsules orally. The dosage varies: 5 mg, 20 mg, 100 mg, 140 mg, 180 mg, or 250 mg, depending on the specific treatment plan.

The frequency and duration of this medication will be determined by the healthcare provider.

4 monitoring and assessment phase

Undergo regular MRI scans to monitor tumor vascularization and assess the topography of any recurrence.

Participate in assessments to determine the maximum tolerated dose and the recommended Phase 2 dose of olaptesed pegol.

5 quality of life evaluation

Participate in evaluations to assess the impact of the treatment on quality of life.

This includes regular check-ins and assessments to ensure the treatment is not adversely affecting daily living.

Who Can Join the Study?

Provide written informed consent, which means you agree to participate in the study after understanding all the details.
Be at least 18 years old.
Agree to have a diagnostic and scientific work-up of glioblastoma tissue from a previous surgery or biopsy. This involves analyzing the tissue for specific markers.
Agree to have a subcutaneous port implantation, which is a small device placed under the skin to help deliver medication.
Have a newly diagnosed glioblastoma, which is a type of brain tumor, confirmed by a tissue test.
Have an unmethylated MGMT promoter status, which is a specific genetic feature of the tumor.
Have a maximum ECOG score of 2, which is a measure of your ability to perform daily activities. A score of 2 means you are up and about more than half the day but cannot work.
Have an estimated minimum life expectancy of 3 months.
Be on a stable or decreasing dose of corticosteroids during the week before joining the study. Corticosteroids are medications that reduce inflammation.
Have certain laboratory test results within specified ranges, including tests for liver and kidney function.
If you are a female of child-bearing potential, you must have a negative pregnancy test and agree to use a highly effective method of birth control during and for a period after the study.
If you are a male, you must use an effective barrier method of contraception during the study and for a period after the study if you are sexually active with a female of child-bearing potential.

Who Cannot Join the Study?

Patients who have a different type of brain tumor other than glioblastoma cannot participate. Glioblastoma is a specific type of brain cancer.
Patients who have not been newly diagnosed with glioblastoma are excluded. This means the diagnosis should be recent.
Patients with a methylated MGMT promoter status are not eligible. This refers to a specific genetic characteristic of the tumor.
Patients who are not within the specified age range cannot join. The study is open to certain age groups only.
Patients who are part of a vulnerable population are not allowed to participate. This includes groups that may need special protection.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

No sites found in this category

Other Sites

Site Name	City	Country
Universitaetsklinikum Tuebingen AöR	Tuebingen	Germany
Universitaetsklinikum Mannheim GmbH	Mannheim	Germany
Rheinische Friedrich-Wilhelms-Universitaet Bonn	Bonn	Germany
Universitaetsklinikum Leipzig AöR	Leipzig	Germany
Ukzpyntqsflgzgklmzsup Ebfmf Amt	Essen	Germany
Ufyvupfaonnocyvtgkzvr Mrwhmmtw Afa	Munster	Germany

Trial status

Country	Status	Recruitment Start
Germany	Recruiting	01.04.2019

Trial locations

Investigated drugs:

Olaptesed pegol (NOX-A12) is an experimental medication being studied for its potential to enhance the effects of radiation therapy in patients with glioblastoma, a type of brain cancer. It is being tested to see if it can improve treatment outcomes when combined with radiation therapy.

Radiation therapy is a standard treatment for glioblastoma that uses high-energy rays to target and kill cancer cells. In this trial, it is used in combination with other therapies to assess if the combination can improve patient outcomes.

Bevacizumab is a medication that works by inhibiting the growth of blood vessels that supply nutrients to tumors. It is being tested in combination with olaptesed pegol and radiation therapy to see if it can further enhance the treatment of glioblastoma.

Pembrolizumab is an immunotherapy drug that helps the immune system recognize and attack cancer cells. In this trial, it is combined with olaptesed pegol and radiation therapy to evaluate its effectiveness in treating glioblastoma.

Investigated diseases:

Glioblastoma

Glioblastoma – Glioblastoma is a type of brain cancer that originates from glial cells, which support nerve cells in the brain. It is known for its aggressive nature and rapid growth, often infiltrating surrounding brain tissue. The disease typically presents with symptoms such as headaches, seizures, and neurological deficits, depending on the tumor’s location. Glioblastomas are characterized by their heterogeneous appearance and tendency to form new blood vessels, which support their growth. As the tumor progresses, it can cause increased pressure within the skull, leading to further neurological complications. Despite its challenging nature, research continues to explore new treatment options to manage its progression.

Trial ID:

2024-510964-21-00

Protocol code:

SNOXA12C401

NCT ID:

NCT04121455

Trial Phase:

Human Pharmacology (Phase I) – Other

Other Trials to Consider

#1 Clinical Trials Search in Europe

Study on Glioblastoma Treatment with Olaptesed Pegol and Radiation, with Bevacizumab or Pembrolizumab, for Patients with Unmethylated MGMT Promoter

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?