AuthorisedTherapeutic exploratory (Phase II)Interventional

A Phase II, Randomized, Trial of Niraparib Versus Best Supportive Careas Maintenance Treatment In Patients With Locally Advanced Or Metastatic Urothelial Cancer Whose Disease Did Not Progress After Completion Of First-line Platinum-containing Chemotherapy (MEET URO 12)

This research study, called MEET URO 12, is looking into a new medication called Zejula (also known as niraparib). It's for people in the UK who have a type of bladder cancer called urothelial cancer that has spread or is locally advanced. Participants would have already completed their first round of chemotherapy and their cancer hasn't gotten worse. The main goal is to find out if taking Zejula regularly can help stop the cancer from growing or spreading for a longer time compared to just receiving regular supportive care. Researchers will also look at how patients feel, their quality of life, and any side effects from the medication. This is a Phase II study, meaning it's still in the earlier stages of testing new treatments.

At a glance

Status

Authorised

Phase

Therapeutic exploratory (Phase II)

Sponsor

Universita' Degli Studi Di Torino

Enrolment target

Start

15 Jan 2025

urothelial cancer

What is this study about?

This study, called MEET URO 12, is designed for people who have a specific type of cancer called urothelial cancer. This cancer often starts in the bladder but can be found in other parts of the urinary system. In this study, we're focusing on patients whose cancer is either locally advanced (meaning it has grown into nearby tissues) or has spread to other parts of the body (metastatic). You would be considered for this study if you've already had your first course of chemotherapy treatment and your cancer hasn't gotten worse after that.

The main idea behind this study is to see if a medicine called Zejula can help keep the cancer from growing or coming back for longer. After chemotherapy, some people receive 'maintenance treatment' which aims to keep the cancer under control. Zejula is a tablet that you take by mouth. Participants in this study will either receive Zejula or what's called 'best supportive care'. Best supportive care means you'll get the best available advice and care to manage your symptoms and maintain your well-being, but without the study medication.

We want to understand if Zejula helps people live longer without their cancer getting worse. We'll also be looking at other important things, like how the medicine affects your everyday life, how you feel day-to-day (your quality of life), and if the medicine has any side effects. This study is a 'Phase II' trial, which is an early stage of research. It helps us learn more about how well a new medicine works and if it's safe before it can be widely used.

Key takeaways

This study is for adults with advanced urothelial cancer whose cancer is stable after chemotherapy.
It compares a new drug, Zejula, to standard supportive care.
The main aim is to see if Zejula can stop cancer from growing for longer.
Participants will have regular check-ups, scans, and blood tests.
The study also looks at how the treatment affects quality of life and any side effects.

Who may be eligible?

To join this study, you need to be an adult, at least 18 years old. Both men and women can take part.

A really important part of joining is that you must have been diagnosed with urothelial cancer that is either locally advanced (meaning it has started to spread to nearby tissues) or metastatic (meaning it has spread further in the body). You would also need to have recently completed your first course of platinum-based chemotherapy. Crucially, your cancer should not have gotten worse during or after that chemotherapy treatment.

There will be other detailed medical checks to make sure the study is a good and safe fit for you. Your doctor will carefully review your medical history and test results to see if you meet all the specific requirements.

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 advanced or metastatic urothelial cancer?
Have you recently finished your first course of chemotherapy?
Has your cancer not gotten worse since completing your chemotherapy?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you'll be randomly assigned to one of two groups. This is like flipping a coin – you'll either receive the study medicine, Zejula (100 mg tablets), or continue with best supportive care, which focuses on managing your symptoms and general health. You won't know which group you are in, and neither will your doctor, to ensure the results are fair.

You will need to attend regular clinic visits. These visits will involve various tests, such as blood tests, scans (like CT scans or MRI scans) to check on your cancer, and check-ups with the study doctors. You will also be asked to answer questionnaires about how you are feeling and your quality of life. This helps us understand the full impact of the treatment.

Your participation will involve taking the study medication or receiving supportive care for as long as your cancer remains stable or until side effects make it necessary to stop. After this, you will still have follow-up appointments to monitor your health. The total duration of your involvement could be several months or even longer, depending on how you respond to treatment and for follow-up purposes.

Potential risks and benefits

Potential benefits of joining this study include potentially having your cancer kept under control for longer if you receive Zejula, as well as receiving close medical attention and monitoring. However, there's no guarantee that the treatment will work for you, and it might not improve your situation. As with any medication, there are potential risks and side effects, which the study team will explain fully. These could include things like feeling tired, blood count changes, or digestive issues, among others. It's important to remember that participating is completely your choice, and you have the right 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
Italy

Common questions

What is urothelial cancer?

Urothelial cancer is a type of cancer that starts in the lining of the bladder or other parts of the urinary system.

What is Zejula?

Zejula is a medicine (also known by its scientific name, niraparib) that comes in a capsule form. It is being studied to see if it can help keep urothelial cancer from growing.

What does 'maintenance treatment' mean?

Maintenance treatment is given after initial treatment (like chemotherapy) has finished and the cancer is under control. Its goal is to try and keep the cancer from coming back or getting worse.

What is 'best supportive care'?

Best supportive care means you will receive the best medical attention and treatments to manage your symptoms and improve your comfort and quality of life, but it won't include the study medicine.

Will I know if I'm getting Zejula or supportive care?

No, this study uses a 'blinded' approach, meaning neither you nor your doctors will know which treatment you are receiving until the study is over, to make the results as fair as possible.