Active not recruitingPHASE2INTERVENTIONAL

A Study of Durvalumab Alone and Durvalumab+Olaparib in Advanced, Platinum-Ineligible Bladder Cancer (BAYOU)

This study is for people with advanced bladder cancer that has spread (Stage IV) and can't be removed by surgery. It focuses on patients who aren't able to have standard platinum-based chemotherapy. The study is testing a drug called Durvalumab by itself, and Durvalumab combined with another drug called Olaparib. Researchers want to find out if these treatments are safe and if they can help shrink the cancer or stop it from growing. This is a common type of study called a 'Phase II' trial, meaning it's still in relatively early stages of testing these new treatment combinations.

At a glance

Status

Active not recruiting

Phase

PHASE2

Sponsor

AstraZeneca

Enrolment target

154

Start

16 Mar 2018

Estimated completion

31 Dec 2026

Urinary Bladder Neoplasms

Results

Results from this study

Posted October 2022

Results have been published for this study.

Primary outcome

Progression-free Survival (PFS)

Progression-free survival based on investigator assessments according to RECIST 1.1

Full results on the registry

What is this study about?

This study is for individuals facing advanced bladder cancer that has spread to other parts of the body (this is called Stage IV cancer) and cannot be removed with an operation. Importantly, it's designed specifically for patients who, for various health reasons, aren't good candidates for the usual type of chemotherapy that uses platinum-based drugs. Researchers are looking for new and better ways to treat this condition when standard options aren't suitable.

The main goal of this study is to explore two different treatment approaches. One group of patients will receive just Durvalumab, while another group will get Durvalumab combined with a drug called Olaparib. There's also a 'placebo' aspect, meaning some patients will receive a dummy treatment along with Durvalumab instead of Olaparib, so doctors can accurately compare the effects. By doing this, the researchers hope to understand if these new drug combinations are safe to use and how well they work at treating the cancer.

This is a 'Phase II' study, which means it’s an important step in testing new medicines. It helps doctors learn more about the correct dose, potential side effects, and early signs of effectiveness before these treatments can become widely available. The study is also 'randomised' and 'double-blind,' which means participants are put into groups by chance (like flipping a coin) and neither you nor your doctor will know which specific treatment you are receiving until the study is over. This helps ensure the results are fair and unbiased.

Key takeaways

This study is for advanced bladder cancer that has spread.
It's for patients who can't have standard platinum-based chemotherapy.
It tests Durvalumab alone or with Olaparib.
It's a Phase II study, looking at safety and early effectiveness.
Participation involves regular hospital visits, treatments, and checks.
You can withdraw from the study at any time.

Who may be eligible?

To be able to join this study, you need to have bladder cancer that has spread (Stage IV) and cannot be removed by surgery. You also must not be able to receive standard platinum-based chemotherapy due to other health issues. This could be due to kidney problems, hearing loss, nerve damage, heart problems, or feeling very unwell and tired.

Your cancer type needs to be confirmed by lab tests, and you must have at least one spot of cancer that doctors can measure during the study. You'll also need to be able to swallow medicines that are given by mouth. Before you start, doctors will need to know if your cancer has specific changes in its genes (called 'HRR mutation status').

There are also some reasons why you might not be able to join. For instance, if you have certain autoimmune conditions, other types of cancer that have been present recently, serious infections like TB, or if you've had an organ transplant. You also can't have had specific cancer treatments like PARP inhibitors or certain immune-boosting therapies before, and you shouldn't have active brain tumours unless they are stable and you're not taking steroids for them.

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.

Do I have bladder cancer that has spread (Stage IV) and cannot be operated on?
Has my doctor said I cannot receive standard platinum-based chemotherapy?
Do I have any other serious conditions like uncontrolled autoimmune diseases or recent other cancers?
Can I swallow medicines that are given by mouth?
Am I willing to have regular hospital visits for treatment and checks?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you will be randomly assigned to one of two groups. One group will receive Durvalumab on its own, and the other will receive Durvalumab along with Olaparib. Because the study is 'double-blind,' neither you nor your study doctor will know which specific treatment you are getting. Both drugs involve regular visits to the hospital for your treatment and check-ups.

During your time in the study, you will have regular medical appointments. These will include blood tests, scans (like CT scans) to check how your cancer is responding, and general health checks. You will also need to swallow oral medications as prescribed. The doctors and nurses will monitor you closely for any side effects and to see how well the treatment is working. The total duration of your participation, including regular follow-up appointments after treatment, will be discussed with you by the study team. You can stop participating in the study at any time.

Potential risks and benefits

Taking part in a clinical trial may offer potential benefits, such as access to new treatments that are not yet widely available, and close medical monitoring. Your cancer might respond well to the treatments being studied, potentially slowing its growth or shrinking it. However, there are also potential risks; the treatments might not work for you, or you could experience side effects, some of which could be serious. Researchers are carefully studying these drugs to understand both their benefits and risks. Remember, you have the right to withdraw from the study at any time, for any reason, without it affecting your future medical care.

Locations (44)

Research Site
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Birmingham, United States
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Goodyear, United States
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Fort Myers, United States
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St. Petersburg, United States
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Tampa, United States
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Louisville, United States
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New Hyde Park, United States
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New York, United States
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The Bronx, United States
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Philadelphia, United States
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Nashville, United States
Research Site
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Tacoma, United States

Common questions

What is advanced bladder cancer?

Advanced bladder cancer means the cancer has spread from where it started, or has come back and has now spread (Stage IV).

What does 'platinum-ineligible' mean?

This means that for health reasons, you can't have the usual type of chemotherapy for bladder cancer that uses drugs with platinum.

What are Durvalumab and Olaparib?

These are new types of cancer drugs. Durvalumab works with your immune system to fight cancer, and Olaparib targets certain weaknesses in cancer cells.

What is a 'placebo'?

A placebo is a 'dummy' treatment that looks like the real drug but contains no active medicine. It helps researchers fairly compare the active treatment's effects.

Can I stop participating in the study if I want to?

Yes, you can choose to leave the study at any time, for any reason, without it affecting your medical care.