NCT06462001

BCG + MMC: Adding Mitomycin C to BCG in High-risk, Non-muscle-invasive Bladder Cancer

BCG + MMC: Adding Mitomycin C to BCG as Adjuvant Intravesical Therapy for High-risk, Non-muscle-invasive Bladder Cancer: a Randomised Phase 3 Trial

• Status: Active Not Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 500 (actual)
• Sponsor: Nottingham University Hospitals NHS Trust · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Instillation of Bacillus of Calmette-Guerin (BCG) into the urinary bladder (intravesical administration) improves rates of disease recurrence and progression after transurethral resection (TUR) of high risk, non-muscle-invasive bladder cancer (NMIBC), but over 30% of people still develop recurrent transitional cell carcinoma (TCC) despite optimal therapy with adjuvant intravesical BCG. Our meta-analysis, including a recent randomised phase 2 trial, suggests that outcomes might be improved further by using an adjuvant intravesical regimen that includes both Mitomycin (MM) and BCG. These promising findings require corroboration in a definitive, large scale, randomised phase 3 trial using standard techniques for intravesical administration.

Conditions

• Transitional Cell Carcinoma
• Transurethral Resection

Interventions

Type	Name	Description
BIOLOGICAL	Bacillus Calmette-Guerin Vaccine Intravesical	BCG (Oncotice) is administered intravesically as per usual standard of care
DRUG	Mitomycin	MMC is administered intravesically as per usual standard of care

Timeline

• Start date: 2020-12-10
• Primary completion: 2026-12-01
• Completion: 2026-12-01
• First posted: 2024-06-17
• Last updated: 2024-06-17

Locations

1 site across 1 country: United Kingdom