Active not recruitingPHASE1, PHASE2INTERVENTIONAL

Glioblastoma Treatment With Irradiation and Olaptesed Pegol (NOX-A12) in MGMT Unmethylated Patients

This research is testing new treatments for a type of brain cancer called glioblastoma, specifically in patients where a usual chemotherapy drug (temozolomide) might be less effective. The study combines a new drug, olaptesed pegol, with radiation therapy and sometimes other medications like bevacizumab. Its main goals are to check if these new combinations are safe and if they can help patients. The study is also comparing these new approaches to the standard treatment to see which works best. This is an early-stage study, meaning it's one of the first times these combinations are being tested in people to find the right doses and understand their effects.

At a glance

Status

Active not recruiting

Phase

PHASE1, PHASE2

Sponsor

TME Pharma AG

Enrolment target

117

Start

12 Sep 2019

Estimated completion

01 Dec 2028

Glioblastoma

What is this study about?

This study is investigating new treatments for a serious type of brain cancer known as glioblastoma. Glioblastoma can be very challenging to treat, and doctors are always looking for better options. This particular study focuses on patients whose glioblastoma has a specific genetic feature (called 'unmethylated MGMT promoter status'). This feature means that a common chemotherapy drug, temozolomide, might not work as well for them. Because of this, researchers are exploring different treatment combinations that could be more effective.

The main idea behind this study is to combine a new drug called olaptesed pegol with familiar treatments like radiation therapy. In some parts of the study, another drug called bevacizumab is also included. The first step is to make sure these new combinations are safe for patients. Once safety is understood, the study will then look at whether these new treatments can help patients live longer or keep their cancer from growing. They will also compare these new treatments to the usual care to see which approach works best.

This is a 'Phase 1/2' study, which means it's an early step in testing a new treatment. Phase 1 focuses on finding the safest dose and understanding side effects, while Phase 2 looks at whether the treatment shows promise in treating the disease. By carefully studying these new combinations, researchers hope to find better and more effective ways to treat glioblastoma for patients who currently have limited options.

Key takeaways

This study explores new treatments for a type of brain cancer called glioblastoma.
It focuses on patients where standard chemotherapy might be less effective.
The study combines a new drug (olaptesed pegol) with radiation and other medicines.
It aims to find out if these new combinations are safe and can help patients.
This is an early-stage study, carefully checking how the drugs work in people.

Who may be eligible?

To join this study, you would need to be at least 18 years old and have been recently diagnosed with a specific type of brain cancer called glioblastoma. This diagnosis needs to be confirmed by a biopsy or surgery, and your doctor would need to find a particular genetic marker (called 'unmethylated MGMT promoter status') on your tumour. This marker helps doctors understand if standard chemotherapy might be less effective for you. You would also need to be able to give your written consent to take part.

The study is for patients who have had either a biopsy (where a small piece of tissue is removed for testing) or surgery that didn't remove all of the tumour. Your general health would need to be good enough to take part, meaning you couldn't have severe health problems that would make the treatment too risky. This includes having good kidney and liver function, and a good level of physical activity in your daily life, as assessed by your doctor.

Also, if you are a woman who could become pregnant, you would need to have a negative pregnancy test and agree to use effective contraception during the study and for three months after your last dose. Men would also need to use contraception if they are sexually active with a partner who could become pregnant. All patients would need to agree to have a special port (a small device inserted under the skin) to help with treatments or blood tests.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

Are you 18 years old or older?
Have you been diagnosed with glioblastoma that has 'unmethylated MGMT status'?
Have you recently had a biopsy or surgery, but the tumour wasn't fully removed?
Is your general health reasonably good (e.g., no severe kidney/liver problems)?
Are you able to use contraception if necessary?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you will receive a combination of treatments, which will likely include radiation therapy and the study drug, olaptesed pegol. Depending on which part of the study you join, you might also receive other medications like bevacizumab. These treatments involve regular visits to the hospital for doctors to give you your medication and check on how you're doing. This will include blood tests, scans (like MRI scans of your brain), and discussions about any side effects you might be experiencing.

Initially, there will be more frequent visits to establish your reaction to the drugs and find the right dose. You will also need to have a small device called a 'subcutaneous port' placed under your skin, which helps with giving medicines. The total duration of your participation in the treatment part of the study will vary, but you will be monitored closely throughout and for some time after your last treatment dose. The study team will explain your specific schedule in detail.

Potential risks and benefits

Taking part in any medical study carries both potential benefits and risks. You might benefit from receiving new treatments that are not yet widely available, and these treatments could potentially help control your cancer. However, there's no guarantee that the new treatments will work for you, and you might experience side effects, some of which could be serious. The study team will carefully monitor you for any problems. You have the right to withdraw from the study at any time, for any reason, without it affecting your usual medical care, and the study doctors will stop the treatment if it is not helping or if the side effects are too severe.

Locations (6)

Klinik und Poliklinik für Neurologie Schwerpunkt Klinische Neuroonkologie
Verified postcode
Bonn, Germany
Klinik für Neurologie
Verified postcode
Essen, Germany
Klinik für Strahlentherapie und Radioonkologie
Verified postcode
Leipzig, Germany
Klinik für Strahlentherapie und Radioonkologie
Verified postcode
Mannheim, Germany
Klinik für Neurologie mit Institut für Translationale Neurologie
Verified postcode
Münster, Germany
Abteilung Neurologie mit interdisziplinärem Schwerpunkt Neuroonkologie
Verified postcode
Tübingen, Germany

Common questions

What is glioblastoma?

Glioblastoma is a serious and fast-growing type of brain tumour that starts in brain cells called astrocytes.

What does 'unmethylated MGMT promoter status' mean?

This is a feature of the tumour's genes that tells doctors that a common chemotherapy drug, temozolomide, might not work as well for you.

What is olaptesed pegol?

Olaptesed pegol is a new drug being tested in this study to see if it can help treat glioblastoma when combined with other therapies.

Is this a new treatment?

Yes, this study is testing new combinations of drugs to see if they are safe and effective for treating glioblastoma.

Can I stop participating in the study at any time?

Yes, you are free to leave the study at any point, and your decision will not affect your ongoing medical care.