RecruitingPhase IIIInterventional

HIVEC® HEAT - the drug mitomycin medac will be warmed to 43°C and administered through a catheter into the bladder via HIVEC® device for patients with nonmuscle-invasive bladder cancer that have previously had no response to BCG treatment

This study, called HIVEC® HEAT, is for people with a type of bladder cancer that hasn't improved after standard BCG treatment. This kind of bladder cancer is called non-muscle-invasive bladder cancer (NMIBC). For these patients, the next step might be surgery to remove the bladder, but this study offers an alternative. It tests a warmed drug, mitomycin medac, delivered into the bladder through a thin tube. The aim is to see if this treatment can be effective and help patients avoid major surgery, while also checking for any potential side effects. Participants will be followed closely for two years.

At a glance

Status

Recruiting

Phase

Phase III

Sponsor

University of Leicester

Enrolment target

238

Start

01 Apr 2025

Estimated completion

01 Apr 2027

Non-Muscle-Invasive Bladder Cancer (NMIBC)

What is this study about?

This study is called HIVEC® HEAT, and it's designed for people in the UK who have a specific type of bladder cancer. This cancer is called 'non-muscle-invasive bladder cancer' (NMIBC). This means the cancer cells are only on the inner lining of the bladder and haven't grown into the bladder muscle. Usually, after this type of cancer is removed, patients receive a treatment called BCG (Bacillus Calmette-Guerin), which is a type of immunotherapy. However, for some people, BCG treatment doesn't work.

When BCG treatment isn't successful, doctors might suggest a cystectomy, which is surgery to remove the bladder. For patients who can't have this surgery or prefer not to, the HIVEC® HEAT study offers a different approach. It aims to see if a warmed drug, mitomycin medac, delivered directly into the bladder, can be a safe and effective treatment. The drug is warmed to 43°C and given through a thin tube (catheter) using a special device called HIVEC®. The study wants to understand if this method can help control the cancer and avoid the need for bladder removal.

The study involves about 238 people. They will receive the mitomycin medac treatment over a year, with frequent check-ups for two years in total. This helps the study team fully understand how well the treatment works and if there are any side effects. The treatment schedule involves weekly sessions at first, then monthly sessions. The study is important because it could provide a new option for people with this challenging type of bladder cancer.

Key takeaways

This study is for adults with a specific type of bladder cancer (NMIBC) that hasn't responded to BCG treatment.
It tests a warmed drug (mitomycin medac) delivered directly into the bladder to try and avoid bladder removal surgery.
The treatment involves 15 sessions over one year, with follow-up for another year.
There will be regular check-ups, scans, and some extra blood tests or biopsies.
Your travel costs for up to 25 study visits can be reimbursed.
You can discuss this study with your doctor to see if it's right for you.

Who may be eligible?

This study is looking for adults aged 18 to 100 in the UK who have non-muscle-invasive bladder cancer (NMIBC). Your cancer must be high-grade, which means the cells look more abnormal under a microscope. It can be a type called papillary (Ta or T1) or flat patches called Carcinoma in Situ (CIS).

Crucially, you must have already received BCG treatment for your bladder cancer, but it hasn't worked. This means your cancer either didn't respond to BCG or came back too soon afterwards. Before joining, any visible bladder tumours must have been completely removed by surgery (called a TURBT) recently. This study is mainly designed for people who are not able to or do not want to have their bladder removed through surgery.

Doctors will carefully review your medical history and recent scans to make sure this study is the right fit for you. They will ensure your cancer diagnosis matches the specific types needed for the study and check that your previous BCG treatment history qualifies.

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 an adult (18-100 years old)?
Do you have non-muscle-invasive bladder cancer (NMIBC)?
Has your bladder cancer been diagnosed as high-grade (Ta, T1, or CIS)?
Did you receive BCG treatment for your bladder cancer, but it didn't work (it's 'BCG-unresponsive')?
Have any visible bladder tumours been completely removed recently?
Are you unwilling or unable to have surgery to remove your bladder?

Answer every question to see your result.

What does participation involve?

If you join this study, your treatment will involve receiving the drug mitomycin medac directly into your bladder. This drug will be gently warmed to 43°C and delivered using a special device called HIVEC®. A thin tube (catheter) will be used to put the drug into your bladder, where it will stay for 60 minutes.

You will receive a total of 15 treatments over one year. Initially, you'll have one treatment each week for the first six weeks. After a short break, you'll then have one treatment per month for nine months. Most of these treatment visits will also include a cystoscopy (where a small camera looks into your bladder) and a urine test. To make things easier, these appointments will usually happen on the same day.

All participants will be followed for another year after treatment ends, making the total study period about two years. During this follow-up, you'll have regular checks to see how you're doing, ensure the cancer hasn't returned, and monitor for any side effects from the treatment. If you are in 'Sub-Study 1' (which means you have CIS), you will have some extra bladder biopsies taken at 24 weeks to help researchers look at your cells in more detail.

Potential risks and benefits

The main benefit of taking part in this study is the chance to receive a new treatment for your bladder cancer, which might help you avoid bladder removal surgery. However, like all medical treatments, there's a possibility you might experience side effects from the drug mitomycin medac. Your health will be carefully monitored throughout the treatment and follow-up, and if necessary, your treatment can be stopped. Taking part in this study means you'll have many scheduled visits over two years, though many of these are similar to the normal checks you'd have for your condition. There will be a few extra blood tests and, for some, an additional bladder biopsy under anaesthetic. You are always free to leave the study at any time.

Locations (11)

Leicester General Hospital
Approximate
Leicester, England
The Royal Wolverhampton NHS Trust
City only
Wolverhampton, England
Worcestershire Acute Hospitals NHS Trust
Approximate
Worcester, England
The Newcastle upon Tyne Hospitals NHS Foundation Trust
City only
Newcastle upon Tyne, England
Gstt @ Eastbourne District General Hospital
City only
Eastbourne, England
Imperial College Healthcare NHS Trust
Unverified
London, England
North Bristol NHS Trust
Unverified
Bristol, England
University Hospital Southampton NHS Foundation Trust
Unverified
Southampton, England
Gloucestershire Hospitals NHS Foundation Trust
Unverified
Cheltenham, England
Kingston Hospital
Unverified
Kingston upon Thames, England
Bedfordshire Hospitals NHS Foundation Trust
Unverified
Luton, England

Common questions

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

NMIBC is a type of bladder cancer where the cancer cells are only in the inner lining of your bladder and haven't grown into the bladder muscle.

What is BCG treatment?

BCG (Bacillus Calmette-Guerin) is a common immunotherapy treatment for bladder cancer, often given after surgery to help prevent the cancer from coming back.

What does 'BCG-unresponsive' mean?

It means your bladder cancer didn't improve or came back too soon after you had BCG treatment.

What is mitomycin medac?

Mitomycin medac is a medicine used to treat bladder cancer, and in this study, it will be warmed and put directly into the bladder.

Will I have more hospital visits than usual?

You will have a good number of scheduled visits over two years. Some visits, blood tests, and certain biopsies will be in addition to what you'd usually have, but the study tries to combine appointments where possible.

How to find out more

Carla Richardson

hivec@leicester.ac.uk +44 116 229 7936 Official trial record

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