RecruitingPHASE1INTERVENTIONAL

A Study Assessing if it is Safe and Possible to Treat Brain Cancer Patients With Immunotherapy Before They Receive the Standard Treatment.

This research, called WinGlio, is a first-step study (Phase 1) looking into a new way to treat brain cancer (glioblastoma) with a medicine called ipilimumab. This drug is a type of immunotherapy, which helps your body's immune system fight cancer. Participants will receive up to two doses of ipilimumab before they have their standard treatments, such as surgery or chemotherapy and radiotherapy. The main goals are to see how safe this treatment approach is and if giving ipilimumab early can help manage the disease. This study is for adults newly diagnosed with glioblastoma. It helps doctors understand if this new timing for the drug could be beneficial in the future.

At a glance

Status

Recruiting

Phase

PHASE1

Sponsor

University College, London

Enrolment target

Start

10 Jul 2025

Estimated completion

01 Jan 2028

Glioblastoma Gliosarcoma, Adult Glioblastoma - Category

What is this study about?

This study is called WinGlio, and it's looking into a new way to treat a serious type of brain cancer called glioblastoma. Normally, people with glioblastoma have surgery, followed by treatments like chemotherapy and radiotherapy, which are designed to kill cancer cells.

However, this study is trying something different. It's giving a special type of medicine called ipilimumab *before* these standard treatments. Ipilimumab is an immunotherapy drug, which means it works by boosting your body's own immune system to fight the cancer. The main idea is to see if giving this drug early, before surgery and other common treatments, is safe for patients and if it can help reduce or control the cancer from the start. This is a "Phase 1" study, which means it's one of the first times this approach is being tested in people, so doctors are mainly checking for safety and the right dose.

By adding ipilimumab to the treatment plan *before* other treatments, doctors hope to learn if this earlier use of the drug could make future treatments more effective or improve outcomes for people with glioblastoma. This research is a really important step in trying to find better ways to care for patients with this challenging condition.

Key takeaways

This study explores a new timing for an immunotherapy drug (ipilimumab) for brain cancer.
The drug is given before standard treatments like surgery, chemotherapy, and radiotherapy.
It's a Phase 1 study, mainly focused on checking the safety of this new approach.
Participants will have regular check-ups and scans to monitor their health and treatment effects.
This research hopes to find better ways to treat glioblastoma in the future.

Who may be eligible?

To join this study, you would need to be an adult (18 years or older) who has recently been diagnosed with glioblastoma, a type of brain cancer. This diagnosis would need to be confirmed by scans or a small sample (biopsy) of the tumour. You should also be generally well enough to manage the treatment, as judged by your doctor, and have a good enough health outlook.

Your body's organs, such as your kidneys, liver, and blood, need to be working properly, as shown by standard blood tests. You should also be able to attend all the appointments and follow the study's plan. It's important that you haven't received any treatment for glioblastoma before, except for a biopsy or a small surgery that didn’t remove all the cancer.

There are also some reasons why you might not be able to join. For example, if the cancer has spread outside your brain, or if you're taking high doses of certain medications like steroids (dexamethasone) at the start of the study. Active autoimmune diseases (where your immune system attacks your own body) or a recent need for antibiotics could also prevent you from participating, unless they are specific types that are allowed.

Quick self-check

Are you 18 years old or older?
Have you recently been diagnosed with glioblastoma brain cancer?
Are you generally well and able to manage daily activities?
Do your doctors believe you are healthy enough for this study, including your organ function?
Have you not had other treatments for glioblastoma yet, besides a biopsy or small surgery?
Are you able to attend all required hospital visits and commit to the study plan?

This is a guide only — the research team will confirm whether you can take part.

What does participation involve?

If you decide to join the WinGlio study, you would first have a full check-up to make sure you meet all the requirements. Once confirmed, you would receive up to two doses of the study drug, ipilimumab. This will happen before you start your usual treatments for glioblastoma, such as surgery and chemotherapy or radiotherapy. Each dose of ipilimumab is given into your vein over a period of time, similar to a drip.

Throughout the study, you'll have regular appointments at the hospital. These visits will include physical examinations, blood tests, and scans (like MRI scans) to see how you are responding to the treatment and to check for any side effects. After receiving the study drug, you will then proceed with the standard care treatments for your condition, and the study team will continue to follow your progress.

The overall duration of your active participation in receiving the study drug will be relatively short (up to two doses), but you will be monitored and followed up by the study team for a longer period to understand the long-term effects of the treatment. The exact schedule of visits and tests will be explained in detail by the study team.

Potential risks and benefits

Taking part in a clinical trial can have potential benefits, like getting access to a new treatment that isn’t widely available yet, which might help your condition. However, there are also potential risks involved. The study drug, ipilimumab, can have side effects, and while doctors will monitor you closely, some side effects could be serious. It’s also possible the treatment might not help your cancer, or it could even cause unexpected problems. You have the right to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (1)

University College London Hospital
London, United Kingdom· Recruiting

Common questions

What is glioblastoma?

Glioblastoma is a serious type of brain cancer that starts in the brain's supporting cells. It can grow quickly.

What is immunotherapy?

Immunotherapy is a type of cancer treatment that helps your body's own immune system find and fight cancer cells more effectively.

What does 'Phase 1 study' mean?

A Phase 1 study is the first step in testing a new treatment in people. Its main goals are to check if the new treatment is safe and to find the right dose. It's not primarily designed to see if it cures the disease, but rather to understand how it works and what side effects it might cause.

Will I still get my standard treatment?

Yes, after receiving the study drug (ipilimumab), you will then have the usual treatments for glioblastoma, such as surgery and chemotherapy with radiotherapy.

What is 'neoadjuvant' treatment?

Neoadjuvant means giving a treatment, like chemotherapy or immunotherapy, before the main treatment, such as surgery. In this study, ipilimumab is given before surgery and other standard care.

How to find out more

WinGlio Trial Manager

ctc.winglio@ucl.ac.uk Official trial record

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