Ongoing, recruitingTherapeutic exploratory (Phase II)Interventional

C5701002/SGN22E-002 - A study of enfortumab vedotin (ASG-22CE) as monotherapy or in combination with other anticancer therapies for the treatment of urothelial cancer

This study is for people with bladder cancer that has either spread to other parts of the body (metastatic) or has grown into the muscle of the bladder (muscle-invasive). Researchers want to find out how safe and effective a new medicine called Padcev is, both on its own and when given with other established cancer treatments like Keytruda. They will be carefully checking for any side effects and how well the treatment shrinks the cancer. This is a Phase II study, meaning it aims to explore how well the treatment works and gather more information before potentially moving to larger studies.

At a glance

Status

Ongoing, recruiting

Phase

Therapeutic exploratory (Phase II)

Sponsor

Seagen Inc.

Enrolment target

Start

28 Sep 2023

Urothelial cancer

What is this study about?

This research study is focused on improving treatments for a type of cancer called urothelial cancer, which most commonly affects the bladder but can also be found in other parts of the urinary system. The study is specifically looking at patients whose cancer has either spread to different parts of the body (known as advanced or metastatic cancer) or has grown deep into the muscle layers of the bladder.

The main aim of the study is to test a medicine called Padcev (also known as enfortumab vedotin). Researchers want to see how well Padcev works when given by itself, and also how it performs when combined with other existing cancer treatments, such as Keytruda. They are particularly interested in understanding if these treatments can shrink the cancer and how long any benefits might last.

Alongside checking how effective the treatments are, a very important part of this study is to closely monitor any side effects. This involves looking at how often side effects occur, how severe they are, and if they are related to the medicines being given. This information helps doctors understand the overall safety of these new treatment approaches.

Key takeaways

This study evaluates Padcev, alone or with other drugs, for urothelial cancer.
It's for people with locally advanced or metastatic bladder cancer.
Researchers will monitor how well the treatment shrinks cancer and its side effects.
Treatments are given as infusions, with regular hospital visits.
Participation involves blood tests, scans, and quality of life questionnaires.
It's a Phase II study, exploring effectiveness and safety in a larger group.

Who may be eligible?

To join this study, generally, you need to be an adult, 18 years old or older. Both men and women are welcome to take part.

Your doctor will need to confirm that you have been diagnosed with urothelial cancer, and specifically that it is either locally advanced (meaning it has grown significantly but hasn't spread far) or metastatic (meaning it has spread to other parts of your body).

There will be other detailed medical checks to make sure the study treatments are right for you and won't cause unnecessary risks. These checks typically involve looking at your overall health, how your kidneys and liver are working, and any other medical conditions you might have. Your specialist will be able to tell you all the specific rules.

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?
Do you have a diagnosis of urothelial cancer?
Has your cancer been described as 'locally advanced' or 'metastatic'?
Are you able to travel for regular hospital visits and treatments?
Do you understand that there will be various medical tests and questionnaires?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you will receive either Padcev on its own or Padcev combined with other cancer treatments. These medicines are given as an infusion into your vein. The treatments will follow a regular schedule, and you'll have frequent visits to the hospital or clinic for these infusions, as well as for various tests and check-ups.

Throughout the study, nurses and doctors will closely monitor your health. This includes having regular blood tests, urine tests, and scans (like CT or MRI scans) to see how your cancer is responding and to spot any side effects early. You'll also be asked to fill out questionnaires about your quality of life and any pain you might be experiencing, which helps the research team understand your experience.

The total length of time you'll be involved in the study can vary. You would continue treatment for as long as it is helping you and you are tolerating it well, or until your doctor decides it's no longer the best option. After treatment finishes, there will be follow-up visits to check on your long-term health and the lasting effects of the treatment.

Potential risks and benefits

Taking part in a clinical trial offers the chance to access new treatments before they are widely available, which could potentially benefit you if standard treatments haven't worked or aren't suitable. However, new treatments can have unexpected side effects, some of which may be serious. There's also no guarantee that the treatment will be effective for your cancer. Your medical team will explain all known risks and benefits, and you always have the right to withdraw from the study at any time, for any reason, without affecting your future 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 urothelial cancer?

Urothelial cancer is a type of cancer that starts in the cells lining the bladder, ureters, or renal pelvis (parts of the urinary system).

What does 'locally advanced' or 'metastatic' mean?

'Locally advanced' means the cancer has grown into nearby tissues but hasn't spread far. 'Metastatic' means the cancer has spread from where it started to other parts of the body.

What is Padcev (enfortumab vedotin)?

Padcev is a targeted cancer drug that aims to deliver chemotherapy directly to cancer cells while limiting harm to healthy cells.

What is Keytruda?

Keytruda is an immunotherapy drug that helps your body's immune system fight cancer cells more effectively.

What does Phase II study mean?

A Phase II study is an early stage of research that looks at how well a new treatment works and checks for side effects in a larger group of people than a Phase I study.