drugset / Trial / NCT06462001
BCG + MMC: Adding Mitomycin C to BCG in High-risk, Non-muscle-invasive Bladder Cancer
Phase 3
Active not recruiting
500 enrolled
Nottingham University Hospitals NHS Trust
Australian and New Zealand Urogenital and Prostate Cancer Trials Group · collabUniversity of Sydney · collab
RandomizedParallel-groupOpen-labelTreatment
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.
Timeline
- Start
- 2020-12-10
- Primary completion
- 2026-12-01
- Completion
- 2026-12-01
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Mitomycin C | Other / unclassified | — | Other |
| Background | Bacillus Calmette-Guérin | Vaccine | — | Other |