RecruitingPHASE1, PHASE2INTERVENTIONAL

DURvalumab in Combination With S-488210/S-488211 vAccine in Non-muscle Invasive Bladder CancEr

The DURANCE study is for people with bladder cancer that is high-risk but hasn't grown into the bladder muscle (non-muscle invasive bladder cancer, NMIBC). This trial is for those who have not responded to or cannot have the standard treatment called BCG. Researchers want to see if combining a new vaccine (S-488210/S-488211) with an existing immunotherapy drug called durvalumab is safe and helps to control the cancer. You'd receive treatments over several weeks, including infusions and injections, and doctors would closely monitor your health and progress. The study is split into two parts: first checking safety, then checking how well it works to keep the cancer away.

At a glance

Status

Recruiting

Phase

PHASE1, PHASE2

Sponsor

University College, London

Enrolment target

Start

25 Mar 2022

Estimated completion

31 May 2029

Bladder Cancer

What is this study about?

The DURANCE study is looking into a new way to treat bladder cancer that's considered high-risk but hasn't spread deep into the bladder muscle. This type of cancer is called non-muscle invasive bladder cancer (NMIBC). Many people with NMIBC are treated with a therapy called BCG, but sometimes it doesn't work, or people can't tolerate it. This study is specifically for those individuals.

The trial is testing a combination of two different types of treatment: a cancer vaccine (known as S-488210/S-488211) and an immunotherapy drug called durvalumab. Immunotherapy drugs like durvalumab help your body's own immune system find and fight cancer cells. The vaccine is designed to specially target these cancer cells. By combining them, doctors hope to achieve a stronger effect in treating the cancer and preventing it from returning.

The study has two main parts. The first part (Phase 1b) focuses on making sure the combination treatment is safe and finding the right dose. Once safety is confirmed, the study moves to the second part (Phase 2), where a larger group of patients will receive the treatment. In this part, doctors will closely watch to see how effective the treatment is, particularly how long people remain free of cancer after starting the treatment.

Key takeaways

The DURANCE study combines a vaccine and an immunotherapy drug for bladder cancer.
It's for high-risk bladder cancer that hasn't spread into the muscle and hasn't responded to standard treatment (BCG).
Treatment involves regular infusions and injections over several weeks.
Doctors will closely monitor your health and how the cancer responds.
The study aims to check the safety and effectiveness of this new combination.

Who may be eligible?

To be considered for the DURANCE study, you would need to meet certain requirements. This study is for adults aged 18 or older who have high-risk non-muscle invasive bladder cancer that has been confirmed by a doctor. Importantly, your cancer should not have responded to, or you should be unable to have, previous BCG treatment, and you must not be a suitable candidate for, or have refused, surgery to remove your bladder.

Before joining, you'll need to have had a recent procedure to remove any visible tumours from your bladder and undergone some scans like a CT scan of your chest and abdomen. Doctors will also check your general health, including blood tests, to make sure your heart, lungs, liver, and kidneys are working well enough for you to safely receive the study treatments. Your overall physical health should be good.

You'll also need to have some tissue samples available from your cancer, taken in the last six months, for the study doctors to review. This helps confirm the type of cancer you have. Finally, you must be willing and able to understand and give your consent to take part in the study.

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 of age or older?
Do you have high-risk bladder cancer that has not invaded the muscle?
Has your bladder cancer not responded to or can you not have BCG treatment?
Have you had recent surgery to remove visible bladder tumours?
Have you been told that bladder removal surgery is not suitable or you've refused it?
Are you generally in good health with normal organ function?

Answer every question to see your result.

What does participation involve?

If you join the DURANCE study, you would receive treatment over several weeks. The durvalumab drug is given through a vein (like a drip) every four weeks, for up to seven doses. In total, this part of the treatment could last about 24 weeks. The vaccine (S-488210/S-488211) is given as two shots under the skin. You'd get the first shots the day after your first durvalumab drip, then weekly for six doses, followed by doses every two weeks for an additional nine doses, up to a total of 16 vaccine doses.

Throughout the study, doctors and nurses will regularly check your health, likely through blood tests, physical exams, and discussions about how you're feeling. About 12 weeks after starting treatment, you'll have a special examination called a cystoscopy, where a thin tube with a camera is used to look inside your bladder. This is to see how well the treatment is working. If the cystoscopy shows that your cancer is completely gone, you may continue receiving treatment for up to 24 weeks.

If the cancer hasn't completely cleared, or if you experience significant side effects, you would stop the study treatment. The total length of your active treatment would be up to 24 weeks, with follow-up appointments after that to monitor your long-term health and cancer status.

Potential risks and benefits

Participating in a clinical trial like DURANCE comes with potential benefits and risks. A potential benefit is that you could receive a new treatment combination that might help control your bladder cancer, especially if standard treatments haven't worked or aren't suitable for you. However, there's no guarantee the treatment will work for everyone, and it might not improve your condition. There are also potential risks, as these are new treatments used together. You might experience side effects from the durvalumab, the vaccine, or the combination. These side effects can vary from mild to serious, and the research team will explain these to you in detail. Throughout the study, your well-being is a priority, and you have the right to withdraw from the study at any time, for any reason, without affecting your future medical care.

Locations (5)

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

Guy's and St Thomas' NHS Foundation Trust
Verified postcode
London, United Kingdom· Recruiting
The Royal Marsden NHS Foundation Trust
Verified postcode
London, United Kingdom· Recruiting
University College London Hospital NHS Foundation Trust
Verified postcode
London, United Kingdom· Recruiting
The Christie NHS Foundation Trust
Verified postcode
Manchester, United Kingdom· Recruiting
University Hospital Southampton NHS Foundation Trust
Verified postcode
Southampton, United Kingdom· Recruiting

Common questions

What is non-muscle invasive bladder cancer (NMIBC)?

NMIBC is bladder cancer that is found on the inside lining of the bladder but hasn't spread into the deeper muscle wall.

What is BCG treatment?

BCG (Bacillus Calmette-Guérin) is a common treatment for NMIBC where a medicine is put directly into the bladder to help the immune system fight cancer cells.

What is durvalumab?

Durvalumab is a type of immunotherapy drug that helps your body's immune system recognise and attack cancer cells.

What is a cancer vaccine in this context?

In this study, the S-488210/S-488211 vaccine is designed to stimulate your immune system to specifically target and fight your bladder cancer cells.

What is a cystoscopy?

A cystoscopy is a procedure where a thin, flexible tube with a camera on the end is inserted into your bladder to allow doctors to examine its lining.

How to find out more

Madison Williams

ctc.durance@ucl.ac.uk 02076799514 Official trial record

Always speak to your GP or specialist before deciding to take part in a study.