Ongoing, recruitingPhase I and Phase II (Integrated)- OtherInterventional

A phase I/II multicenter trial evaluating the association of hypofractionated stereotactic radiation therapy and the anti-PD-L1 Durvalumab (Medi4736) for patients with recurrent glioblastoma

This research study is investigating a new treatment approach for adults whose glioblastoma brain tumour has returned. It combines a special, focused type of radiation called hypofractionated stereotactic radiation therapy with a drug known as Durvalumab, also called Imfinzi. The study is divided into two main parts. The first part, Phase I, is focused on finding a safe dose of the treatment combination. The second part, Phase II, will then look at how well this treatment works, specifically if it helps people live longer after their diagnosis. Researchers will also be checking for side effects and how the treatment affects quality of life, using special questionnaires and tests.

At a glance

Status

Ongoing, recruiting

Phase

Phase I and Phase II (Integrated)- Other

Sponsor

Oncopole Claudius Regaud

Enrolment target

106

Start

14 Aug 2024

Recurrent glioblastoma.

What is this study about?

This study is about finding better ways to treat a type of brain tumour called glioblastoma, especially when it has unfortunately come back after previous treatments. Researchers are trying a new combination of treatments: a very precise type of radiation therapy and a drug called Durvalumab, known commercially as Imfinzi.

Think of the precise radiation therapy like a very targeted laser beam that aims to destroy tumour cells while trying to protect the healthy brain tissue around it. Durvalumab is an immunotherapy, which means it helps your own immune system recognise and fight cancer cells. The idea behind combining these treatments is that the radiation might make the tumour more visible to the immune system, allowing Durvalumab to work even more effectively.

The study has two main steps. The first step, Phase I, is simply to make sure the combination of radiation and Durvalumab is safe for patients. Doctors will carefully monitor for any side effects. Once a safe approach is found, the study moves to Phase II. In this part, the main goal is to see if this combined treatment helps people live longer. They will also look at other things like how well it stops the tumour from growing and how it affects a person's daily life and well-being.

Key takeaways

This study combines targeted radiation with an immunotherapy drug for recurrent glioblastoma.
It aims to find a safe dose and see if this combination helps patients live longer.
The study will also check for side effects and how treatment affects daily life.
Adults 18+ with glioblastoma that has returned are being considered.
Participation involves treatments, regular medical checks, and filling out questionnaires.

Who may be eligible?

To join this study, you need to be an adult, 18 years old or older. The study is open to both men and women.

The most important health requirement is that you have a type of brain tumour called glioblastoma, and that it has come back after you've already had treatment for it. The doctors running the study will need to review your full medical history and current health to make sure this study is the right fit for you and that taking part would be safe.

There might be other specific health conditions or medications that mean you cannot join the study, so your doctor will need to check everything carefully before you can be considered.

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 diagnosed with glioblastoma?
Has your glioblastoma come back or progressed after previous treatment?
Are you able to attend regular hospital appointments for treatment and check-ups?
Are you willing to complete questionnaires about your health and well-being?

Answer every question to see your result.

What does participation involve?

If you join this study, you would first go through a screening process to make sure the treatment is right and safe for you. This would involve medical checks and tests. Once accepted, you would receive the hypofractionated stereotactic radiation therapy and intravenous infusions of the drug Durvalumab. You would have regular visits to the hospital for treatment, check-ups, blood tests, and scans to see how you are doing and if the treatment is working. You would also complete questionnaires about your quality of life and have tests to check your brain function, likely during and after your treatment period. The exact number of visits and the total duration in the study would depend on how your treatment progresses and how long doctors need to follow up on your health.

Potential risks and benefits

Participating in this trial could offer benefits, such as access to a new experimental treatment that might help control your glioblastoma. However, it's also important to understand there are potential risks, including side effects from both the radiation therapy and the Durvalumab. These side effects can vary from person to person and could be mild, such as tiredness, or more serious. The research team will carefully explain all known risks. Remember, you can choose to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (1)

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

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Unverified
France

Common questions

What is Durvalumab (Imfinzi)?

Durvalumab (Imfinzi) is a drug that helps your body's immune system recognise and fight cancer cells more effectively.

What is 'hypofractionated stereotactic radiation therapy'?

This is a very precise type of radiation therapy that delivers high doses of radiation to a specific area, like a tumour, over fewer treatment sessions than traditional radiation.

What does 'recurrent glioblastoma' mean?

This means that the glioblastoma brain tumour has come back, or grown again, after it was previously treated.

Will I definitely get the new treatment if I join?

If you are eligible, you would receive the combined treatment of precise radiation and Durvalumab. This is not a study where some people get a dummy treatment.

How long would I be involved in the study?

The length of your involvement would depend on your response to treatment and how long doctors need to monitor your health, but it could involve ongoing appointments and follow-up.