Testing UCPVax vaccine with or without pembrolizumab and temozolomide in patients with unmethylated MGMT glioblastoma after initial treatment

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What is this study about?

This study is looking at glioblastoma, which is a type of brain cancer. The study will test a treatment combination that includes an experimental vaccine called UCPVax, which may be given alone or together with a medication called pembrolizumab. These treatments will be combined with standard therapy that includes temozolomide, a chemotherapy drug taken as a capsule. The study is specifically for people whose tumor has an unmethylated MGMT promoter status, which is a specific characteristic of the cancer cells. The purpose of the study is to see how many patients are still alive at 18 months after starting the treatment with these different combinations.

Patients taking part in this study will have already completed an initial phase of treatment that combined radiation therapy with temozolomide. After joining the study, they will receive the experimental vaccine UCPVax as an injection, and depending on which treatment group they are in, they may also receive pembrolizumab as an infusion. These treatments will be given alongside the standard maintenance therapy with temozolomide. The study will track patients for several years to measure how well the treatments work and to monitor any side effects that may occur.

During the study, doctors will regularly check how patients are doing through medical examinations, blood tests, and brain scans. They will also assess the quality of life of patients using questionnaires. The study will look at whether the cancer grows or spreads and will measure how long patients live after starting the treatment. Safety will be carefully monitored throughout the study by tracking any unwanted effects from the medications and checking routine laboratory results.

1 Completion of initial treatment phase

Before entering this trial, you will have completed the combined phase of radiotherapy (radiation treatment) plus temozolomide (a chemotherapy medication taken by mouth).

You will be evaluated to confirm that you are eligible to continue with the maintenance treatment phase, which consists of 6 monthly cycles of temozolomide.

2 Randomization and treatment assignment

You will be randomly assigned to one of the treatment groups. This process is called randomization and determines which combination of treatments you will receive.

All treatment groups will include the standard maintenance treatment with temozolomide, which may be combined with NovoTTF-200A (a device that delivers electric fields to the tumor area).

In addition to standard treatment, you will receive the UCPVax vaccine, and you may also receive pembrolizumab, depending on your assigned group.

3 Standard maintenance treatment with temozolomide

You will receive temozolomide for oral use as part of your standard maintenance treatment.

This treatment consists of 6 monthly cycles.

The specific dosage and schedule will be determined by your medical team based on standard treatment protocols.

4 UCPVax vaccine administration

You will receive the UCPVax vaccine as an injection.

The vaccine is provided as a solution for injection in the form of an emulsion (a mixture of liquids).

The standard formulation is 1 mg per 2 ml.

The timing and frequency of vaccine injections will be scheduled according to the trial protocol.

5 Pembrolizumab treatment (if assigned)

If you are assigned to a treatment group that includes pembrolizumab, you will receive this medication as an infusion (administered directly into your vein).

The medication is provided as a solution for infusion.

The infusion will be given at scheduled intervals as determined by the trial protocol.

6 Regular monitoring visits

Throughout the trial, you will have regular visits for monitoring your health and treatment response.

At each visit, your medical team will check for any adverse events (unwanted effects or reactions) and perform routine laboratory tests.

Your Karnofsky Performance Status (a measure of your ability to perform daily activities) will be assessed.

If you are taking corticosteroids (medications that reduce inflammation and swelling), your dose will be monitored to ensure it remains stable.

7 Imaging and disease assessment

You will have regular imaging scans to evaluate your disease status.

These evaluations will be performed according to RANO 2.0 criteria (standardized guidelines for assessing brain tumors).

The scans will help determine if the disease is stable, improving, or progressing.

8 Blood sample collection for immune response

Blood samples will be collected at specified times during the trial.

These samples will be used to assess your immune response to the vaccine through a laboratory test called IFN-γ ELISpot.

This test measures how your immune system is responding to the treatment.

9 Quality of life assessments

You will be asked to complete questionnaires about your quality of life at specific time points.

These questionnaires are called EORTC-QLQ-C30 and BN20.

You will complete them at the time of randomization and at 6 months.

The questionnaires ask about your physical condition, daily activities, and overall well-being.

10 Follow-up period

After completing the treatment phase, you will enter a follow-up period.

During this time, your health status and disease progression will continue to be monitored.

The key assessment point is at 18 months after randomization, when your survival status will be evaluated.

Follow-up will continue as specified in the trial protocol.

Who Can Join the Study?

You must be 18 years of age or older, either male or female, and able to provide your informed consent
You must have a confirmed diagnosis through tissue examination of primary glioblastoma that does not have a mutation in a gene called IDH, which was obtained through surgery or biopsy
Your tumor must have an unmethylated MGMT promoter status, which means a specific part of your tumor DNA does not have a chemical change that affects treatment response
You must have completed the first phase of treatment combining radiation therapy (treatment using high-energy rays) and temozolomide (a chemotherapy medicine), and be eligible to receive six monthly cycles of temozolomide as maintenance treatment
Your Karnofsky Performance Status must be at least 70%, which is a measure of your ability to perform daily activities and care for yourself
Your expected survival time must be at least 3 months
If you are taking corticosteroids (medicines that reduce swelling and inflammation), your dose must be stable for 15 days and not exceed 10 mg of prednisone daily or an equivalent amount of similar medicine
Your blood tests must show that your organs are functioning adequately
If you are a female able to become pregnant, you must use highly effective birth control methods and have a negative pregnancy test before starting the study treatment, or you must be unable to become pregnant due to menopause or surgical removal of reproductive organs
If you are a male with a female partner who can become pregnant, you must be willing to use barrier contraception during the study and for 6 months after stopping the study treatment, and you should not donate sperm during this time
You must be affiliated with or a beneficiary of the French social security system
You must be able to follow the study requirements as determined by the doctor conducting the study
You must sign and date an informed consent form

Who Cannot Join the Study?

The study has not provided specific exclusion criteria in the available information.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name	City	Country	Status
Centr Georges Francois Leclerc	Dijon	France

Other Sites

Site Name	City	Country
Centre Hospitalier Regional Universitaire	Besançon	France
Aapcxojuwq Prejbmqy Hwreenth Dg Ptepm	Paris	France
Aeqoorfitj Ppeumvou Hchowhax Da Mtsnowrtp	Marseille	France

Trial status

Country	Status	Recruitment Start
France	Not yet recruiting	01.10.2025

Trial locations

Investigated drugs:

UCPVax is an investigational vaccine being tested in this study. It is designed to help the body’s immune system fight against glioblastoma, a type of brain cancer. This vaccine is being tested to see if it can help patients live longer when used together with standard treatments.

Pembrolizumab is a medication that helps the immune system recognize and attack cancer cells. It works by blocking a protein that prevents immune cells from doing their job. In this trial, some patients will receive this medication along with the vaccine and standard treatments, while others will not, to compare the results.

Temozolomide is a chemotherapy medication commonly used to treat brain tumors. It works by damaging the DNA of cancer cells, which helps stop them from growing and dividing. This is part of the standard treatment that all patients in the trial will receive.

NovoTTF-200A is a treatment device that uses electric fields to disrupt cancer cell division. Patients wear this portable device on their head, and it delivers tumor treating fields to the area where the brain tumor is located. Some patients in this trial may receive this treatment as part of their standard care.

Investigated diseases:

Glioblastoma

Glioblastoma – Glioblastoma is an aggressive type of cancer that occurs in the brain or spinal cord. It forms from star-shaped cells called astrocytes that support nerve cells. The tumor grows quickly and can spread to other parts of the brain. Patients may experience headaches, nausea, vomiting, and seizures as the disease progresses. Memory problems, personality changes, and difficulty with speech or movement may also develop. The tumor can increase pressure inside the skull, leading to worsening symptoms over time.

Trial ID:

2024-514399-42-00

Trial Phase:

Therapeutic exploratory (Phase II)

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Testing UCPVax vaccine with or without pembrolizumab and temozolomide in patients with unmethylated MGMT glioblastoma after initial treatment

What is this study about?

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