Ongoing, recruitingHuman Pharmacology (Phase I)- OtherInterventional

A study of enfortumab vedotin given in the bladder for treatment of patients with non-muscle invasive bladder cancer (NMIBC).

This research study is about a new treatment for a type of bladder cancer that has stayed in the lining of the bladder and hasn't grown into the muscle layer. This is called non-muscle invasive bladder cancer (NMIBC). The medicine, called enfortumab vedotin, is being given directly into the bladder. The aim is to see how safe it is and if it works for people with this condition. This is an early-stage study, meaning it's one of the first times this treatment is being tested in humans. Researchers want to understand more about how the body reacts to the medicine when it's given this way. It's for adults aged 18 and over, and anyone can take part, regardless of whether they are male or female.

At a glance

Status

Ongoing, recruiting

Phase

Human Pharmacology (Phase I)- Other

Sponsor

Seagen Inc.

Enrolment target

Start

25 Oct 2023

Non-muscle invasive bladder cancer

What is this study about?

This study is investigating a new way to treat a specific type of bladder cancer. This cancer is called "non-muscle invasive bladder cancer" (NMIBC), which means the cancer cells are only in the inner lining of the bladder and haven't spread deeper into the bladder muscle. This is good news, but it still needs careful treatment.

The new treatment being tested is a medicine called enfortumab vedotin. Instead of taking it as a pill or injection elsewhere in the body, this study is exploring giving the medicine directly into your bladder using a small tube. The idea behind this is to deliver the treatment right where the cancer is located, hoping it can be more effective and have fewer side effects on other parts of your body.

This is an early-stage study, sometimes called a "Phase I" study. This means the main goals are to find out if the treatment is safe when given directly into the bladder, and what dose might be best. We also want to learn if it shows any signs of working against the cancer. Studies like this are a really important step in developing new medicines and making sure they are as good and safe as possible for patients in the future.

Key takeaways

This study is for adults with non-muscle invasive bladder cancer.
It tests a new medicine, enfortumab vedotin, given directly into the bladder.
It's an early-stage study to check safety and potential effectiveness.
Participation involves regular clinic visits for treatment and monitoring.
You can withdraw from the study at any time.

Who may be eligible?

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

Crucially, you must have been diagnosed with "non-muscle invasive bladder cancer" (NMIBC). This means your bladder cancer has not spread into the muscle wall of your bladder.

More detailed checks will be done by the study doctors to make sure it's safe and right for you to take part. For example, they will look at your overall health.

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 bladder cancer?
Has your bladder cancer *not* spread into the muscle wall (non-muscle invasive)?
Are you willing to attend regular clinic appointments for the treatment?

Answer every question to see your result.

What does participation involve?

If you decide to take part, you would receive the study medication, enfortumab vedotin, which would be given directly into your bladder. This is typically done by inserting a thin tube (catheter) into your bladder. You would have regular appointments at the hospital or clinic so the study team can monitor your health closely, check for any side effects, and see how you are responding to the treatment.

These visits might involve blood tests, urine tests, and other examinations to keep track of your condition. The full duration of your participation, including how often you receive the medication and how long you are followed up, will be clearly explained by the study team. It's important to know the exact schedule of visits and procedures before you agree to join.

Potential risks and benefits

Taking part in any clinical study comes with potential benefits and risks. You might benefit from receiving a new treatment that isn't widely available yet, which could help your specific type of bladder cancer, though there's no guarantee. However, there are also potential risks; the new medicine could cause side effects, some of which might not be fully known yet, or it might not work for you. The study team will explain all known side effects. Remember, you can choose to leave the study at any time, for any reason, without it affecting your usual medical care.

Locations (3)

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

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Unverified
France
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Unverified
Spain
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Unverified
Germany

Common questions

What is 'non-muscle invasive bladder cancer'?

It's a type of bladder cancer where the cancer cells are only in the inner lining of the bladder and haven't spread into the bladder muscle.

What is enfortumab vedotin?

It's the name of the new medicine being tested in this study for bladder cancer.

How is the medicine given in this study?

It's given directly into your bladder using a thin tube.

What is a 'Phase I' study?

It's an early-stage study, mainly focused on checking if a new treatment is safe and finding the right dose in people.

Can I leave the study if I change my mind?

Yes, you can always choose to stop participating in the study at any time, and it won't affect your future medical care.