RecruitingPHASE1, PHASE2INTERVENTIONAL

New Adjuvant Vaccine in Glioblastoma, a Phase 1/2a Study

This study is looking into a new 'vaccine' for people recently diagnosed with glioblastoma, a serious type of brain cancer. The vaccine is designed to help your body's immune system target specific cancer cells. Researchers want to find out the best and safest dose of this vaccine (Phase 1) and then see how well it helps your immune system (Phase 2a). All patients in the study will receive the usual treatments first, which include surgery, radiotherapy, and chemotherapy. The vaccine would then be given about a month after radiation finishes. This research is a first step, and if successful, it could lead to larger studies to see if the vaccine can improve how long people live and their quality of life.

At a glance

Status

Recruiting

Phase

PHASE1, PHASE2

Sponsor

Assistance Publique - Hôpitaux de Paris

Enrolment target

Start

08 Nov 2024

Estimated completion

08 Mar 2028

Newly Diagnosed Glioblastoma

What is this study about?

This study is exploring a new approach to treating glioblastoma, a serious type of brain cancer. It's like a 'vaccine' that aims to help your body's own immune system recognise and fight the cancer cells. The vaccine targets two specific proteins that are found on glioblastoma cells. The researchers believe this approach could strengthen your body's natural defences against the cancer.

This is a two-part study. In the first part (Phase 1), a small number of people will receive different doses of the vaccine to find the safest and most effective amount to use. Once that dose is chosen, the second part of the study (Phase 2a) will look more closely at how well the vaccine helps your immune system respond to the cancer. All patients in the study will still receive the standard care for glioblastoma, which includes surgery to remove the tumour, followed by radiotherapy and chemotherapy. The vaccine treatment would then start about four weeks after your radiotherapy is complete.

The main goals are to make sure the vaccine is safe and to see if it can activate your immune system to fight the cancer. The study will also track important things like how long people live, how long they stay free from the cancer growing, and their overall quality of life. The information gathered from this study is crucial and will help decide if this new vaccine should be tested in even larger studies in the future, with the hope of developing better treatments for glioblastoma.

Key takeaways

This study is testing a new 'vaccine' for newly diagnosed glioblastoma.
It aims to make your immune system fight cancer cells.
You will still receive standard treatments (surgery, radiotherapy, chemotherapy).
The vaccine is given as a series of injections under the skin over 12 months.
Researchers will check for safety, immune response, and overall health.
This is an early-stage study (Phase 1/2a) to explore potential future treatments.

Who may be eligible?

To be considered for this study, you would generally need to be between 18 and 75 years old and have been recently diagnosed with glioblastoma. You must have already had surgery to remove your tumour and completed your radiotherapy and initial chemotherapy treatment. Your doctors will also check that you are well enough to take part and that your body's organs, like your liver and kidneys, are working properly.

There are also some specific medical requirements. For example, for the first part of the study, your tumour must show certain features, and your blood type must match a specific immune marker (HLA-A2 positive). You would not be able to join if your cancer has spread beyond your brain or has a specific genetic change (IDH mutant Grade 4 astrocytoma). Also, if you have certain autoimmune diseases like lupus or rheumatoid arthritis, or have received specific cancer treatments in the past, you might not be suitable.

It's important that you are able to understand and sign a consent form, agreeing to take part. Women who could become pregnant and men who could father a child would need to use effective contraception during the study and for several months afterwards. Your medical team will thoroughly review your health and medical history to see if this study is right for you.

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 between 18 and 75 years old?
Have you been newly diagnosed with glioblastoma?
Have you completed your surgery, radiotherapy, and initial chemotherapy?
Are you generally well and able to carry out most daily activities?
Do you not have certain other serious health conditions or cancer types?
Are you willing and able to use contraception if required?

Answer every question to see your result.

What does participation involve?

If you join this study, you will first complete your standard glioblastoma treatment, including surgery, radiotherapy, and initial chemotherapy. The vaccine treatment will then begin about four weeks after your radiotherapy is finished.

The vaccine will be given as injections under your skin. You'll receive a series of injections at first (on day 0, then after 2, 4, and 6 weeks). After that, you'll have a booster injection every two months for a total of 12 months. Throughout the study, your medical team will monitor your health closely through clinic visits and blood tests to check for any side effects and to see how your immune system is responding. You will also have regular brain scans (MRI) every other month to check on your tumour. You will also fill out questionnaires about your quality of life.

Your participation involves these regular appointments and assessments over a period of about a year, in addition to your ongoing standard chemotherapy. You can withdraw from the study at any time if you change your mind.

Potential risks and benefits

Being part of this study might offer the benefit of receiving a new experimental treatment that could potentially help your immune system fight your glioblastoma. However, it's important to remember this is a new vaccine, and its full benefits are not yet known. Like all treatments, there are potential risks, including side effects from the injections or effects on your immune system. These will be carefully monitored by the study team. You always have the right to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (5)

Department of Neurology, University Hospital of Besançon
Verified postcode
Besançon, France· Not yet recruiting
Medical Oncology Department, Eugène Marquis Centre
Verified postcode
Rennes, France· Not yet recruiting
Department of Neurology, Hopital de la Salpêtrière
Verified postcode
Paris, France· Recruiting
Neuro-oncology Department, La Timone Hospital
Verified postcode
Marseille, France· Not yet recruiting
Department of Neurology, Hopital Saint louis (APHP)
Verified postcode
Paris, France· Recruiting

Common questions

What is glioblastoma?

Glioblastoma is a serious and fast-growing type of brain tumour that starts in the brain or spinal cord.

What does 'adjuvant' mean?

In this study, 'adjuvant' means the vaccine is given after the main treatment (surgery, radiotherapy, chemotherapy) to help prevent the cancer from coming back.

Is this vaccine approved for general use?

No, this is an experimental vaccine being tested in a clinical trial. It is not yet approved as a standard treatment.

Will I still receive standard treatments if I join?

Yes, all patients in this study will receive the standard treatments for glioblastoma, including surgery, radiotherapy, and chemotherapy, in addition to the vaccine.

What if I experience side effects?

The study team will carefully monitor you for any side effects at each visit, and you should report any concerns you have immediately.

How to find out more

Antoine CARPENTIER, Pr

antoine.carpentier@aphp.fr 0171207466 Official trial record

Always speak to your GP or specialist before deciding to take part in a study.