CompletedPhase IInterventional

Assessing the safety of atezolizumab being directly administered to the bladder in bladder cancer patients undergoing radical cystectomy

Bladder cancer is often treated with major surgery to remove the entire bladder. Atezolizumab is an immunotherapy medicine that helps the body's immune system recognize and attack cancer cells. Usually, it is given as a drip into a vein, which can cause side effects throughout the whole body. The INVEST trial is looking at whether doctors can safely put atezolizumab straight into the bladder, either through a thin tube (catheter) or as a direct injection into the tumour. This trial is for adults already booked for bladder removal surgery. Treatment takes place in the weeks before surgery, and your operation will not be delayed. Because this is an early-stage study, the main goal is to check safety, find the best dose, and see how the tumour responds. In the future, this research may help reduce the need for major surgery.

At a glance

Status

Completed

Phase

Phase I

Sponsor

Sheffield Teaching Hospitals NHS Foundation Trust

Enrolment target

Start

04 May 2023

Estimated completion

31 Aug 2026

Urothelial cell carcinoma of the bladder

What is this study about?

Bladder cancer is a common condition that can be challenging to treat. When the cancer is aggressive or deep, patients often need an operation called a radical cystectomy to remove the entire bladder. Before this major operation, doctors are keen to find safe ways to shrink the cancer or stop it from spreading.

Atezolizumab is an immunotherapy drug. Immunotherapies work by 'waking up' your own immune defences so they can spot and destroy cancer cells. Usually, atezolizumab is given into a vein, travelling around the entire bloodstream. While effective, this can sometimes trigger side effects across healthy parts of the body.

The INVEST trial is testing a new approach: placing the drug directly inside the bladder before surgery takes place. Doctors hope that delivering the treatment right where the cancer is will treat the tumour effectively while causing fewer general side effects. They are testing two methods: washing the medicine into the bladder using a catheter, or injecting it directly into the tumour.

This is a Phase I trial, meaning it is one of the earliest steps in testing this new method. It involves a small group of patients to check safety, monitor for unusual side effects, and find the most effective dose. The long-term hope is that treatments like this could one day help patients avoid having their bladder removed altogether.

Key takeaways

INVEST is an early-stage UK trial testing atezolizumab placed directly into the bladder.
It is for adults scheduled to have their bladder removed for bladder cancer.
Treating the bladder directly aims to attack the cancer with fewer body-wide side effects.
Your planned cancer surgery will not be delayed by taking part.
Taking part involves extra monitoring, tests, and a three-month follow-up after your operation.

Who may be eligible?

This trial is for adults aged 18 and over who have been diagnosed with urothelial bladder cancer (the most common type of bladder cancer) and are already scheduled to have their bladder removed. Your operation must be planned for at least six weeks after you are accepted onto the study, ensuring there is enough time for the trial treatment without delaying your surgery.

To be eligible, you should be well enough to carry out everyday activities, and your routine blood, liver, and kidney tests must show that your organs are working well. The trial is designed for people who either cannot have, or have chosen not to have, standard chemotherapy before their surgery.

You will not be able to join if you have an active urinary tract infection or another severe infection that needs treatment. Women who could become pregnant and men with partners who could become pregnant will need to use effective contraception during 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.

I am aged 18 or over.
I have been diagnosed with urothelial bladder cancer.
I am scheduled to have my bladder removed (radical cystectomy) in at least six weeks.
I am not receiving standard chemotherapy before my surgery.
I do not currently have an active urinary tract or bladder infection.
I am generally active and able to look after myself day-to-day.

Answer every question to see your result.

What does participation involve?

If you join the trial, you will receive atezolizumab during the period between your diagnosis and your planned surgery. The medicine will be given either through a soft tube placed into your bladder (a catheter) or via a quick injection straight into the tumour during an examination. You may receive a single treatment or weekly doses for three to six weeks, depending on the group you are in.

Because this is a safety trial, you will have extra blood and urine tests, and possibly extra scans (such as CT or MRI scans). Doctors will also examine tissue already removed during your routine biopsies and from your surgery. Your planned bladder removal will happen on schedule and will not be postponed because of the study.

After your operation, the research team will follow your recovery closely for three months, checking your health and monitoring any side effects. They will then check in on your general health status at the end of the wider study, up to two years later.

Potential risks and benefits

Taking part might not benefit you directly, but you will receive very close monitoring from a specialist medical team throughout your treatment. The information learned may also help future bladder cancer patients. However, all medical treatments carry risks. Because this is a new way of giving atezolizumab, you might experience bladder irritation or side effects that doctors have not seen before. Delivering the drug locally is hoped to reduce whole-body side effects, but it cannot remove all risks. Taking part is completely voluntary, and you are free to leave the trial at any time without your standard NHS care or surgery date being affected.

Locations (1)

Weston Park Hospital
Approximate
Sheffield, England

Common questions

Will taking part delay my cancer surgery?

No. The trial is carefully scheduled to take place during your normal waiting period before surgery. Your bladder removal will go ahead as planned.

How does the medicine get into my bladder?

It is given either as a liquid wash passed through a soft catheter tube, or as a direct injection into the tumour during a standard bladder camera check.

Could this treatment cure my cancer completely?

This is an early-stage safety study, so doctors cannot promise it will cure your cancer or remove the need for your planned surgery.

Are there extra hospital visits?

Yes, you may have some additional visits and longer appointments for monitoring, blood tests, and scans, though researchers try to match these with your routine hospital care.

What happens if I decide to stop the trial?

You can withdraw at any point. Leaving the study will never affect your relationship with your healthcare team or the standard of care you receive.

How to find out more

Jamie Oughton

ctru_invest@leeds.ac.uk +44 (0)113 343 1494 Official trial record

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