Active not recruitingPHASE3INTERVENTIONAL

Treatment Combination of Durvalumab, Tremelimumab and Enfortumab Vedotin or Durvalumab and Enfortumab Vedotin in Patients With Muscle Invasive Bladder Cancer Ineligible to Cisplatin or Who Refuse Cisplatin

This research study is for people with bladder cancer that has grown into the bladder muscle. It's for those who can't have or prefer not to have a common chemotherapy called cisplatin before surgery to remove their bladder. The study is testing new combinations of anti-cancer drugs: Durvalumab and Enfortumab Vedotin, sometimes with an additional drug called Tremelimumab. These new combinations are given before and after surgery. The main aim is to see if these new treatments are more effective and safer than the current standard care. If you join, you have a two-out-of-three chance of receiving one of the new drug combinations, assigned randomly by computer.

At a glance

Status

Active not recruiting

Phase

PHASE3

Sponsor

AstraZeneca

Enrolment target

712

Start

05 Aug 2021

Estimated completion

08 Sep 2028

Muscle Invasive Bladder Cancer

What is this study about?

This study is investigating new ways to treat a type of bladder cancer called 'muscle-invasive bladder cancer'. This means the cancer has grown into the muscle layer of the bladder wall. For many people, a chemotherapy drug called cisplatin is often given before surgery to help shrink the cancer. However, some people can't take cisplatin due to other health issues, or they may choose not to have it.

This study is for those individuals. It’s a 'Phase 3' trial, which means it's testing new treatments that have already shown promise in earlier studies, to see if they are better than the standard treatments currently available. The goal is to improve how we treat this type of bladder cancer by exploring new drug combinations.

The trial is looking at two new combinations. One combination uses two drugs, Durvalumab and Enfortumab Vedotin. The other uses these two drugs plus a third one called Tremelimumab. These drugs are given both before the surgery to remove the bladder (called a 'radical cystectomy') and again afterwards. Researchers want to compare how well these new combinations work, and what side effects they might cause, to the standard treatment people would normally receive.

Key takeaways

New drug combinations are being tested for muscle-invasive bladder cancer (MIBC).
It's for people who can't have or don't want cisplatin chemotherapy.
Treatments are given before and after bladder removal surgery.
The study compares new combinations to standard care.
Participation involves random assignment to a treatment group.

Who may be eligible?

To join this study, you must have bladder cancer that has spread into the muscle. This includes certain stages of the disease, and you should not have received other cancer treatments (like chemotherapy or immunotherapy) for this bladder cancer before.

You also need to be well enough to have surgery to remove your bladder and to receive the medicines involved in the study. Importantly, you must either not be able to have cisplatin chemotherapy (due to specific medical reasons) or you must have decided that you do not want to receive cisplatin chemotherapy. The study is open to both men and women, aged 18 and over.

You wouldn't be able to join if your cancer has already spread to distant parts of your body (beyond nearby lymph nodes). Also, if you have an active infection, an uncontrolled illness, or have previously had similar types of immune-boosting cancer treatments (except for BCG), you would not be eligible.

Quick self-check

Do I have bladder cancer that has grown into the muscle layer?
Am I unable to receive cisplatin chemotherapy, or have I decided against it?
Have I not had previous chemotherapy or immunotherapy for this bladder cancer?
Am I generally well enough to have surgery to remove my bladder?

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'll first have some tests to make sure you're suitable. The study plans to include about 677 patients in total. Once you're in, a computer will randomly assign you to one of three groups. Two groups will receive one of the new drug combinations, and one group will receive the standard treatment. This means you have a two-out-of-three chance of being on one of the new treatment arms.

If you're in one of the new treatment groups, you'll receive several cycles of study drugs before your bladder removal surgery. After the surgery, you'll receive more cycles of study drugs to help prevent the cancer from coming back. The specific drugs and timing will vary slightly depending on which treatment group you're in. Throughout your time in the study, you'll have regular hospital visits, blood tests, and scans to monitor your health and how the treatment is working. The study team will explain the exact schedule and duration of your treatment and follow-up.

Potential risks and benefits

Potential benefits of joining this study include receiving new, potentially more effective treatments for your bladder cancer, which might improve your chances of a better outcome. You would also be contributing valuable information that could help future patients. However, there are also potential risks, as all medications can have side effects. The new drugs being tested might cause side effects that are not fully known, or that are more severe than standard treatments. The study team will closely monitor you for any side effects and provide care, but there's no guarantee the new treatments will work better for you. You have the right to withdraw from the study at any time, for any reason, without it affecting your medical care.

Locations (196)

Research Site
Orange, United States
Research Site
Santa Monica, United States
Research Site
New Haven, United States
Research Site
Washington D.C., United States
Research Site
Fort Myers, United States
Research Site
Coeur d'Alene, United States
Research Site
Maywood, United States
Research Site
Indianapolis, United States
Research Site
Iowa City, United States
Research Site
Louisville, United States
Research Site
Scarborough, United States
Research Site
Boston, United States

+184 more sites — see the official record for the full list.

Common questions

What is 'muscle-invasive bladder cancer'?

This is a type of bladder cancer where the cancer cells have grown into the muscle layer of the bladder wall.

What is 'cisplatin-ineligible'?

This means you have other health conditions that make it unsafe for you to receive cisplatin, a common chemotherapy drug for bladder cancer.

What does 'randomized' mean?

It means a computer will decide which treatment group you are in, like flipping a coin, so it's fair and unbiased.

What is a 'radical cystectomy'?

This is a surgery to remove your entire bladder.

Are the study drugs chemotherapy?

The study drugs are a combination of immunotherapy (drugs that help your own immune system fight cancer) and a targeted therapy, which is different from traditional chemotherapy.