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AuthorisedHuman Pharmacology (Phase I)- OtherInterventional

A Phase I Study using Oncolytic AdenoVirus Immunotherapy with Repeat Administrations in Recurrent GliOblastoma (VIRAGO)

Glioblastoma is an aggressive type of brain cancer that often comes back after standard treatment like surgery, radiotherapy, or chemotherapy. When it returns, finding effective new treatments can be very difficult. The VIRAGO trial is testing a new approach called oncolytic viral immunotherapy. Doctors use a harmlessly modified virus that seeks out and destroys cancer cells while leaving healthy brain tissue alone. This virus also helps train the body's natural immune system to recognise and attack the tumour. Because VIRAGO is a Phase I trial, the primary aim is safety. Doctors want to understand how the human body handles repeated doses of this viral therapy and find the most suitable dose. While this trial may not cure the cancer, it provides vital information that could help doctors develop more effective brain tumour treatments in the future.

At a glance

Status
Authorised
Phase
Human Pharmacology (Phase I)- Other
Sponsor
Erasmus Universitair Medisch Centrum Rotterdam (Erasmus MC)
Enrolment target
18
Start
21 Aug 2026

What is this study about?

Glioblastoma is the most common type of primary brain tumour in adults. Even after successful initial treatment with surgery, radiotherapy, and chemotherapy, small cancer cells can remain hidden and cause the tumour to grow back. When this happens, it is called recurrent glioblastoma, and doctors have limited treatment options available on the NHS.

The VIRAGO trial is exploring an innovative therapy using a virus. In everyday life, viruses make us unwell, but scientists can re-engineer them in a laboratory so they cannot cause regular illness. Instead, these 'oncolytic' viruses are programmed to infect brain tumour cells, multiply inside them, and break them apart. As the cancer cells break open, they release signals that help the body's immune system fight the remaining tumour.

This study is a Phase I trial, which means it is one of the first times this specific treatment is being tested in people. The researchers want to discover if giving repeated doses is safe, what side effects occur, and how the immune system responds. It is an important stepping stone towards finding gentler, more targeted ways to manage recurrent brain tumours.

Key takeaways

  • VIRAGO is a Phase I clinical trial testing a modified virus for recurrent glioblastoma.
  • The therapy aims to destroy cancer cells and train the immune system to fight the tumour.
  • The primary focus of this study is to test the safety of repeated doses and check for side effects.
  • Open to adults aged 18 and older whose brain tumour has returned after prior treatment.
  • Taking part is completely voluntary and you can stop at any time without losing your standard NHS care.

Who may be eligible?

This trial is open to adults aged 18 and over who have been diagnosed with glioblastoma that has grown back or progressed after previous treatment. Men and women can both take part.

To be eligible, patients usually need to be well enough to carry out daily tasks and travel to the hospital for regular visits. Doctors will also check blood tests, kidney and liver function, and general heart health to ensure taking part is as safe as possible.

People with severe active infections, certain autoimmune conditions, or other serious health problems may not be able to join. Your hospital care team will look closely at your past medical records and brain scans to confirm whether this trial is suitable 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.

  1. I am aged 18 or over.
  2. I have been diagnosed with glioblastoma.
  3. My tumour has returned or grown following earlier treatments.
  4. I am well enough to travel to hospital appointments and manage everyday activities.
  5. I do not have a serious active infection or unstable medical condition.
Answer every question to see your result.

What does participation involve?

If you take part in the VIRAGO study, you will need to attend a specialist hospital regularly. First, you will have screening tests, which may include physical examinations, blood samples, and an MRI scan of your brain. The trial treatment involves receiving the modified virus directly, which may be given during a planned procedure or through a special line into the tumour area, repeated over a set schedule. After each dose, the medical team will monitor you closely to check for any reactions or side effects. You will have regular check-ups, ongoing scans to see how the tumour responds, and routine blood tests. The total time on the study can range from several months to over a year, depending on how your body responds to the treatment.

Potential risks and benefits

Taking part in an early trial may not improve your cancer directly, though it could help advance treatments for people facing glioblastoma in the future. Because this is a Phase I trial, there are risks of side effects. Common reactions to viral therapies include mild flu-like symptoms, fatigue, chills, or headache. There is also a risk of inflammation or swelling in the brain, which the medical team will watch for carefully and treat promptly if needed. Taking part is entirely voluntary, and you are free to leave the trial at any time without your regular NHS medical care being affected.

Locations (1)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.
  • —
    Unverified
    Netherlands

Common questions

What is an oncolytic virus?

It is a virus that has been modified in a lab so that it targets and destroys cancer cells without harming normal, healthy cells.

Can the virus give me a cold or the flu?

No. The virus has been altered so it cannot cause its usual illness, though your immune system may react with temporary flu-like symptoms like a mild fever or tiredness.

Will this treatment cure my brain tumour?

Phase I trials are designed to test safety and find the right dose rather than cure the illness. While doctors hope it may slow down tumour growth, a cure cannot be promised.

Do I have to pay to be part of the VIRAGO trial?

No. Clinical trials in the UK do not charge you for the study medication or tests. You may also be able to get help with travel costs to the hospital.

Can I leave the trial if I feel unwell?

Yes. You can withdraw from the trial at any point, for any reason. Your medical team will continue to support you with standard treatment options.

How to find out more

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

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