Ongoing, recruitingTherapeutic confirmatory (Phase III)Interventional

A Phase III, Randomized, Open-Label, Controlled, Multi-Center, Global Study of First-Line MEDI4736 Monotherapy and MEDI4736 in Combination with Tremelimumab Versus Standard of Care Chemotherapy in Patients with Unresectable Stage IV Urothelial Cancer

This study is for adults with advanced bladder cancer (urothelial cancer) that has spread and can't be treated with surgery. It's for people who haven't had chemotherapy before. Researchers are testing two new drugs, called MEDI4736 (Imfinzi) and tremelimumab (Imjudo). They want to see if using MEDI4736 alone, or MEDI4736 with tremelimumab, is better than standard chemotherapy. The main goal is to find out if these new treatments help people live longer. They will also check if the treatments stop the cancer from growing, how many people respond to the treatment, and how long the improvements last. It's a large study happening in many hospitals around the world.

At a glance

Status

Ongoing, recruiting

Phase

Therapeutic confirmatory (Phase III)

Sponsor

AstraZeneca AB

Enrolment target

Start

08 Oct 2024

ureters urinary bladder and urethra)unresectable Stage IV and who are chemotherapy-naïve.

What is this study about?

This study is a clinical trial, which means it's a carefully planned research study involving people. The main purpose of this particular study is to find better ways to treat a type of advanced bladder cancer called urothelial cancer. This is cancer that starts in the lining of the urinary system, including the bladder, kidneys, and the tubes that connect them. When the cancer is advanced, it means it has spread and can't be removed through an operation.

The study is comparing two new treatments with the standard chemotherapy currently used. One new treatment involves a medicine called MEDI4736 (also known as Imfinzi) on its own. The other new treatment uses MEDI4736 together with another medicine called tremelimumab (also known as Imjudo). These drugs are a type of treatment called immunotherapy, which helps your body's own immune system fight the cancer. They are being compared against regular chemotherapy, which is a common way to treat cancer using powerful drugs.

The researchers want to see which of these treatments is most effective. The most important thing they're looking at is if the new treatments help patients live longer (this is called 'overall survival'). They will also look at how well the treatments stop the cancer from growing, how many patients see their cancer shrink or disappear, and how long any improvements last. By doing this study, doctors hope to find new and more effective treatment options for people with this type of advanced cancer.

Key takeaways

This study evaluates new immunotherapy drugs for advanced bladder cancer.
It compares new treatments against standard chemotherapy.
The main goal is to find treatments that help people live longer.
Participation involves regular hospital visits for treatment and monitoring.
You have the right to withdraw from the study at any time.
This is a large, worldwide study aiming for better treatment options.

Who may be eligible?

To join this study, you need to be an adult, aged 18 or older. You must have a specific type of bladder cancer, called urothelial cancer. This includes cancer in your kidney, the tubes connecting your kidneys to your bladder, your bladder itself, or the tube that carries urine out of your body.

Your cancer must be advanced, meaning it's at Stage IV and cannot be removed by surgery. Also, it's important that you haven't had chemotherapy for your cancer before. The doctors on the study team will carefully check your medical records and do some tests to make sure you meet all the specific requirements for taking part.

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 urothelial cancer (bladder, kidney, ureter, or urethra)?
Is your cancer advanced (Stage IV) and can't be removed with surgery?
Have you not had chemotherapy for your cancer before?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you would first undergo a series of tests to confirm you are eligible. Once confirmed, you would be randomly assigned to receive one of the study treatments: MEDI4736 on its own, MEDI4736 with tremelimumab, or standard chemotherapy. This means neither you nor your doctor can choose which treatment you get; it's decided by chance to ensure the study is fair.

You would receive your treatment as an infusion, which means it’s given through a drip into your vein. You would have regular hospital visits for these treatments and for check-ups, scans, and blood tests to see how the treatment is working and to monitor for any side effects. The frequency of these visits would vary depending on your treatment schedule. After your main treatment period, there would be follow-up appointments to continue monitoring your health and the cancer's status. The total duration of your participation could be several months or even longer, including the follow-up period.

Potential risks and benefits

Participating in a clinical trial offers potential benefits, such as access to new treatments that aren't yet widely available and close medical monitoring. The new drugs in this study might be more effective than current treatments, potentially helping you live longer or improving your quality of life. However, like all medical treatments, there are potential risks, including side effects from the study drugs that could be mild or severe. Your doctors will explain all known side effects. You are free to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (2)

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

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Unverified
Spain
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Unverified
Greece

Common questions

What is urothelial cancer?

Urothelial cancer is a type of cancer that starts in the lining of your urinary system, including your bladder, kidneys, and the tubes that carry urine.

What does 'unresectable Stage IV' mean?

This means your cancer has spread to other parts of your body and cannot be completely removed through surgery.

What is immunotherapy?

Immunotherapy is a type of treatment that helps your body’s own immune system find and fight cancer cells.

What is chemotherapy?

Chemotherapy uses strong medicines to kill cancer cells, stop them from growing, or slow their growth.

Will I know which treatment I'm getting?

In this study, treatments are assigned randomly, so neither you nor your doctor will know which specific treatment you are receiving until after the study is complete, to ensure fair comparison.