Active not recruitingPHASE1INTERVENTIONAL

A MultIceNTER Phase I Peptide VaCcine Trial for the Treatment of H3-Mutated Gliomas

This study is looking into a new treatment for adults recently diagnosed with a specific type of brain tumour called H3-mutated glioma. This tumour has a particular change in its genetic code. The treatment involves a vaccine designed to help your body's immune system recognise and fight the cancer cells. You'll receive this vaccine along with standard radiation therapy and another medication called Tecentriq, which is given as an injection. Researchers want to find out how safe this new combination is, what side effects it might cause, and if it helps your body build a defence against the tumour. This is a very early-stage study, meaning it's one of the first times this treatment combination is being tested in people.

At a glance

Status

Active not recruiting

Phase

PHASE1

Sponsor

German Cancer Research Center

Enrolment target

Start

15 Feb 2023

Estimated completion

01 Nov 2026

Newly Diagnosed H3-mutated Glioma

What is this study about?

This study is exploring a new way to treat certain brain tumours called H3-mutated gliomas. These specific tumours have a particular change, or 'mutation', in a gene called H3. This mutation makes the cancer cells slightly different from healthy cells. The idea behind this study is to use a special vaccine that can train your body's immune system – its natural defence force – to recognise these unique changes in the cancer cells and attack them.

In this trial, adult patients who have been newly diagnosed with this type of glioma will receive standard radiation therapy. Alongside this, they will get the new H3K27M peptide vaccine, which is given as an injection under the skin. Later, another medication called Tecentriq will be added. Tecentriq is designed to help your immune system work even better at fighting cancer. The main goal of this early-stage study is to check if this combination of treatments is safe for patients and how well their immune system responds to the vaccine.

Brain tumours with the H3K27M mutation can be serious and often affect children and young adults, but they can also occur in adults. Currently, the main treatment after diagnosis is radiation therapy. Doctors are continually looking for new and more effective treatments. This study represents an important step in trying to find better ways to manage this challenging type of cancer by harnessing the power of the body's own immune system.

Key takeaways

This is a Phase 1 study testing a new vaccine and drug combination for H3-mutated glioma.
It aims to train your immune system to fight the cancer cells.
The treatment involves a vaccine, radiation therapy, and Tecentriq injections.
The main goals are to check for safety and how the immune system responds.
Only adults newly diagnosed with specific H3-mutated gliomas are eligible.

Who may be eligible?

To be considered for this study, you must be 18 years or older and have been recently diagnosed with a specific type of brain tumour called an H3.1K27M or H3.3K27M-mutated diffuse midline glioma. This diagnosis needs to be confirmed by lab tests showing the specific gene change. You shouldn't have received any previous treatment for your glioma, apart from surgery or a biopsy.

You also need to be well enough to take part. This means your kidneys should be working properly, and you shouldn't have any serious problems with your immune system, such as having very low levels of certain blood cells. If you're taking steroids, they need to be at a low, stable dose. We will also need a sample of your tumour tissue from your biopsy or surgery for further testing.

It's important that you are scheduled to receive standard radiation therapy as part of your treatment. Women who are pregnant or breastfeeding cannot take part. If you are a woman of childbearing potential, you will need to have a negative pregnancy test before starting the study treatment.

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 newly diagnosed with an H3.1K27M or H3.3K27M glioma?
Have you had no prior treatment for your glioma, except surgery or biopsy?
Are you scheduled to receive standard radiation therapy?
Are you generally well and able to consent to participate?

Answer every question to see your result.

What does participation involve?

If you join this study, you will receive 11 doses of the H3K27M peptide vaccine. The first three doses will be given every two weeks while you're also having standard radiation therapy. An additional dose will be given just after your radiation therapy finishes. After this, you'll receive the remaining seven doses of the vaccine every six weeks. You will also receive 14 doses of Tecentriq, given as an injection every three weeks, starting about four weeks after your radiation therapy ends and continuing alongside some of your vaccine doses.

The first three patients in the study will be monitored very closely at the start to ensure the treatment is safe. After your last study medication, you will be followed up for 24 weeks (about six months) to check on your safety and how your immune system has reacted. This follow-up will involve visits to the clinic for checks and tests. The total duration of your active participation, including treatment and follow-up, will be around a year.

Potential risks and benefits

The potential benefit of taking part is that this new vaccine and drug combination might help your body fight your type of brain tumour more effectively than current standard treatments alone. However, as this is an early-stage study, it's not yet known if this new therapy will be effective. There are potential risks, as with any medical treatment. The treatments could cause side effects, and some may be serious. We don't know exactly what all the side effects might be yet. Your doctors will explain all known risks to you. You have the right to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (8)

Department of Neurology and Polyclinic, Universitiy Clinic Heidelberg
Verified postcode
Heidelberg, Germany
University Medical Center Mannheim, Department of Neurology
Verified postcode
Mannheim, Germany
University Clinic Tuebingen, Neurological Clinic, Department of Neurology
Verified postcode
Tübingen, Germany
Dr. Senckenberg Institute for Neurooncology, University Hospital Frankfurt
Verified postcode
Frankfurt am Main, Germany
Clinical Neuro-Oncology Section, University Hospital Bonn (UKB)
Verified postcode
Bonn, Germany
Neurooncology Department, University Hospital Essen
Verified postcode
Essen, Germany
Clinic and Polyclinic for Neurosurgery, University Hospital Carl Gustav Carus Dresden
Verified postcode
Dresden, Germany
Department of Neurosurgery with Pediatric Neurosurgery
Verified postcode
Berlin, Germany

Common questions

What does 'H3-mutated glioma' mean?

It's a specific type of brain tumour that has a particular change (mutation) in one of its genes, called H3.

What is a 'peptide vaccine'?

It's a type of vaccine that uses small pieces of protein (peptides) from the cancer cells to teach your immune system to recognise and attack them.

What is 'Tecentriq'?

Tecentriq is a drug that helps your body's immune system work better at finding and fighting cancer cells.

Is this a new treatment?

Yes, this is an early-stage study (Phase 1), meaning it's one of the first times this combination of treatments is being tested in people to check its safety.

Will this cure my cancer?

This study is early research to see if the treatment is safe and if it helps the body fight the cancer. It's too soon to say if it will lead to a cure.