Ask to take part

Contact the study team using the details below to take part. If there are no contact details below please ask your doctor in the first instance.

Contact Information:

Dr Leyshon Griffiths
+44 116 229 7309
trlg1@leicester.ac.uk


Miss Carla Richardson
+44 116 229 7936
hivec@leicester.ac.uk


Study Location:

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Be Part of Research - Trial Details - 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
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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

Recruiting

Open to: All Genders

Age: Adult

Leicester

Medical Conditions

Non-Muscle-Invasive Bladder Cancer (NMIBC)

This information is provided directly by researchers, and we recognise that it isn't always easy to understand. We are working with researchers to improve the accessibility of this information. In some summaries, you may come across links to external websites. These websites will have more information to help you better understand the study.


Not provided at time of registration

Start dates may differ between countries and research sites. The research team are responsible for keeping the information up-to-date.  

The recruitment start and end dates are as follows:

01 Apr 2025 01 Apr 2027

There is no randomisation into the trial but those participants entering the study will be split into one of two sub studies. The study group a participant will end up in will be largely dependent on if they have carcinoma in situ (CIS) which is a type of NMIBC. A full breakdown of the study groups can be seen below;
• Sub-Study 1: 123 participants will be required for CIS +/- completely resected papillary Ta/T1 disease that have not responded to having BCG treatment
• Sub-Study 2: 115 participants for completely resected high-grade papillary Ta/T1 disease without CIS that have not responded to having BCG treatment.

Both study groups will be allocated the same trial treatment over a 1 year period with 15 treatments of mitomycin medac drug given via a catheter into the bladder. This will be gently warmed to 43°C using the HIVEC device, for 60 minutes The treatment schedule will be once a week for the 1st 6 weeks and after the 12 week timepoint, treatment will be given monthly for 9 months (maintenance) treatment. In Sub study 1 there will be mandatory biopsies for patients so that a retrospective analysis can be completed in an external lab. All participants will be followed up for another year after treatment to have disease assessments to ensure they remain free of cancer and to check for any treatment related adverse events.


We aim to consent and recruit 238 participants in UK hospital urology departments. These will have non-muscle-invasive Bladder Cancer (NMIBC) and have previously had BCG treatment (Bacillus Calmette-Guerin, a vaccine which is a type of immunotherapy medicine) but have not responded. The next treatment option is a cystectomy (removal of the bladder) and this trial is for those patients that are unsuitable or unwilling to undergo this procedure. There are two depths of this high-grade cancer (papillary stage Ta or T1). High-grade cancer cells can also be flat patches in the bladder called Carcinoma in Situ (CIS).

You can take part if:



You may not be able to take part if:


1. BCG-unresponsive urothelial carcinoma that has been detected with enhanced cystoscopic techniques. 2. A history of muscle-invasive (T2, T3, T4), lymph node-positive (N1, N2, N3), or metastatic (M1) bladder cancer.3. High-grade T1 NMIBC where lymphovascular invasion is reported. 4. Histology subtypes of bladder cancer other than pure urothelial carcinoma, excluding urothelial carcinoma with squamous or glandular differentiation which are permissible.5. Unlikely to complete or adhere to the clinical trial due to:5.1. Life expectancy <2 years.5.2. Unable or unwilling to receive the required follow-up care or diagnostic interventions.6. Any condition that, in the opinion of the investigator, could lead to protocol non-compliance.7. Any pelvic radiotherapy.8. Prior salvage immunotherapy or chemotherapy for BCG-U NMIBC.9. Participants must not have received any live or live attenuated vaccine within 4 weeks of the first treatment.10. Unresolved bladder perforation11. History of urothelial carcinoma of the upper urinary tract (ureter, renal pelvis) or prostatic urethra within 24 months of treatment initiation.12. Mitomycin-C allergy.13. Inability to undergo HIVEC® treatment:13.1. Urinary frequency or urgency that precludes a 1-hour HIVEC® dwell time.13.2. Urethral stricture preventing urethral catheterisation with the Combat BRS system 16 F catheter.14. Uncontrolled visible haematuria. 15. Active or untreated urinary tract infection.16. Pregnancy, breastfeeding, or planning to conceive during the treatment and/or the post-treatment period.17. Participant must not be simultaneously enrolled in any interventional clinical trial.


Below are the locations for where you can take part in the trial. Please note that not all sites may be open.

  • Leicester General Hospital
    Gwendolen Road
    Leicester
    LE5 4PW

Benefits:
Not provided at time of registration
Risks:
There is a possibility some participants may experience side effects to the drug and that it’s possible to have toxicities but participants will be monitored throughout treatment and regularly followed up to check any adverse events. Treatment will be stopped if needed.
There are a lot of scheduled visits over a 2 year period, although only a few are additional to that of standard of care
Blood tests: The only blood tests in excess of standard of care are at baseline, visit 6 and visit 16.
CT Urograms: We have ensured that these are not in excess of standard of care. In the event that 12 weeks have elapsed from CT Urogram to joining the trial, the CT Urogram will be repeated. This is in the best interests of the potential participant to ensure that they are still eligible for the trial treatment and that other treatments are not now needed.
Cystoscopies: The number of cystoscopies are not in excess of standard of care
Minimising the risk from cystoscopic random bladder biopsies in Sub-Study 1: Cystoscopic random bladder biopsies will only be performed by experienced Urologists. The cystoscopic random bladder biopsies at week 24 under general/spinal anaesthetic even if no bladder recurrence has been detected is in excess of standard of care. There is a small risk of bladder perforation from bladder biopsies.
Minimising number of visits: Urine cytology, cystoscopy and HIVEC treatment will usually take place sequentially on the same day, thereby minimising the number of visits
Minimising difficulties providing a urine specimen for cytology: It is recognised that some patients have difficulty providing a timely voided urine cytology specimen. If so, a bladder washings urine cytology specimen will be collected at the time of cystoscopy
All reasonable participant travel for up to a maximum of 25 visits per patient will be paid.

Dr Leyshon Griffiths
+44 116 229 7309
trlg1@leicester.ac.uk


Miss Carla Richardson
+44 116 229 7936
hivec@leicester.ac.uk



The study is sponsored by University of Leicester and funded by Combat Medical Ltd.



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Read full details for Trial ID: ISRCTN49174478

Or CPMS 55197

Last updated 20 May 2025

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