Multi-centre, single-arm, interventional trial of HIVEC® (hyperthermic intravesical mitomycin medac) for patients with BCG-unresponsive nonmuscle-invasive bladder cancer. (HIVEC-HEAT)

Research summary

HIVEC is a Phase III,multi-centre,interventional,single-arm trial assessing the safety and effectiveness of Hyperthermic Intravesical Chemotherapy (HIVEC®) in BCG-unresponsive high-grade non-muscle-invasive bladder cancer (NMIBC) patients. Radical cystectomy has long been considered the standard of care for patients with BCG-unresponsive high-grade NMIBC which if untreated carries a high risk of progression. Many of these patients are elderly where morbidity and mortality associated with cystectomy are significant and cure is not their primary consideration. More recently,pembrolizumab has received FDA approval as an alternative systemic treatment for BCG-unresponsive CIS. There is a clinical need for an effective intravesical treatment in this arena which typically has less toxicity than systemic treatments. There are 2 separate sub-studies (i) Patients with BCG-unresponsive CIS +/- papillary Ta/T1 disease,the primary endpoint will be Complete Response (CR) rate at 3 months (ii) Patients with completely resected BCG-unresponsive high-grade papillary Ta/T1 disease without CIS,the primary endpoint will be the median duration of high-grade recurrence-free survivial. Patients will be treated with HIVEC® in combination with 80 mg mitomycin medac diluted in 80 mL of saline or sterile water (1 mg/mL) for 12 months; 6 weekly induction recirculations are followed by 9 maintenance recirculations (monthly except at week-23).

Principal Investigator

Catherine Hobbs

Contact us

Email: crndirectdelivery team@ouh.nhs.uk

IRAS number

1007375