Ongoing, recruitingTherapeutic confirmatory (Phase III)Interventional

A Phase 3 Study of Erdafitinib Compared with Vinflunine or Docetaxel or Pembrolizumab in Subjects with Advanced Urothelial Cancer and Selected FGFR Gene Aberrations

Researchers are conducting a Phase 3 study to investigate a new medication called erdafitinib for individuals diagnosed with advanced urothelial cancer, which is a type of bladder cancer. This study specifically focuses on patients whose cancer cells show certain genetic changes known as FGFR gene aberrations. The main goal is to see if erdafitinib is more effective at helping people live longer compared to existing treatments like pembrolizumab, vinflunine, or docetaxel. By comparing these treatments, doctors hope to find better ways to manage this challenging cancer, offering new hope to patients who might benefit from this targeted approach. It aims to confirm whether this new drug can provide a significant improvement in patient outcomes.

At a glance

Status

Ongoing, recruiting

Phase

Therapeutic confirmatory (Phase III)

Sponsor

Janssen Cilag International

Enrolment target

179

Start

08 Apr 2024

Advanced Urothelial Cancer

What is this study about?

This important study is searching for better treatments for a type of cancer called urothelial cancer, which often starts in the bladder but can also be found in other parts of the urinary system. When this cancer is advanced, it means it has spread and is harder to treat with standard methods. This particular study is interested in patients whose cancer has a specific change, or 'aberration,' in a gene called FGFR. This genetic change can sometimes make the cancer grow in a particular way.

The study is in 'Phase 3,' which means it's a major step in testing new medicines. Doctors are looking to see if a new drug called erdafitinib can help people with this specific type of advanced urothelial cancer live longer than they might with other common treatments. They are comparing erdafitinib to medications that are already approved and used, such as pembrolizumab (also known as KEYTRUDA), vinflunine (Javlor), and docetaxel. This comparison is crucial because it helps doctors understand if the new drug offers a real advantage.

The main thing researchers will measure is how long people taking the different treatments live. This is called 'overall survival.' By carefully tracking this for everyone in the study, they can determine if erdafitinib is a more effective option for people with advanced urothelial cancer that has the FGFR gene change. The results of this study could potentially lead to a new treatment choice for these patients.

Key takeaways

This study is for advanced urothelial (bladder) cancer with specific gene changes.
It compares a new drug, erdafitinib, to existing standard treatments.
The main goal is to see if erdafitinib helps people live longer.
You would receive treatment via infusion and have regular hospital visits.
You are free to leave the study at any time.
Taking part means helping doctors learn more about cancer treatment.

Who may be eligible?

To join this study, you would generally need to be an adult, 18 years old or older, with advanced urothelial cancer. This means your cancer has spread beyond its original location.

A key requirement is that your cancer cells must have a specific change in their genes, called an FGFR gene aberration. Doctors will need to do tests to confirm if your cancer has this particular genetic change. Your medical team will help determine if your specific situation matches all the detailed requirements for participation.

Because this is a carefully designed study, there will be other medical criteria that your doctors will check, such as your general health, how well your organs are working, and any other medical conditions or treatments you might be having. These checks are important to make sure the study is safe for you and that the results are clear.

Quick self-check

Are you 18 years old or older?
Do you have advanced urothelial cancer?
Has your cancer been tested for specific FGFR gene changes?
Are you able to travel for regular hospital visits and treatments?
Are you willing to potentially receive a new drug or a standard treatment?
Are you able to commit to the study's follow-up schedule?

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

What does participation involve?

If you decide to take part in this study, you would first undergo a series of medical tests to confirm you meet all the requirements. Once confirmed, you would start receiving one of the study medications. These medications are given as an infusion, which means they are put into your bloodstream through a drip, and you would typically receive this in a clinic.

Throughout the study, you would have regular visits to the hospital or clinic. During these visits, doctors and nurses would perform various checks. This includes physical examinations, blood tests, urine tests, and scans (like CT scans or MRI scans) to see how your cancer is responding and to monitor your general health. You would also be asked about any side effects you might be experiencing.

Treatment would continue for as long as it is helping you and as long as you are not experiencing severe side effects. After treatment, there would be a follow-up period where your health status would continue to be monitored, even if you are no longer receiving the study medication. The total length of your involvement in the study could vary depending on how you respond to treatment and the follow-up schedule, potentially lasting for several years.

Potential risks and benefits

Taking part in a study like this could potentially offer benefits, such as access to a new treatment (erdafitinib) that isn't yet widely available, and close monitoring by a specialist medical team. However, there are also potential risks involved; the study drugs, both the new one and the standard ones, can have side effects, which your doctor will discuss with you. These side effects can range from mild to severe, and they vary from person to person. It's important to remember that you are free to withdraw from the study at any time and for any reason, without it affecting your medical care.

Locations (3)

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France
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Spain
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Belgium

Common questions

What is urothelial cancer?

Urothelial cancer is a type of cancer that typically starts in the cells lining the bladder, but it can also be found in other parts of the urinary system.

What does 'advanced' cancer mean?

Advanced cancer means that the cancer has grown and spread from where it started to other parts of the body.

What is an FGFR gene aberration?

This is a specific change in one of the genes within your cancer cells. For some cancers, these changes can be important in choosing the best treatments.

What is 'overall survival'?

Overall survival is a way for doctors to measure how long people live after starting a particular treatment. It's an important measure of how effective a treatment is.

Will I definitely get the new drug, erdafitinib?

This is a comparison study, so you would be randomly assigned to receive either the new drug (erdafitinib) or one of the standard treatments for advanced urothelial cancer.