BCG+MM Trial
Research type
Research Study
Full title
BCG+MM Trial Adding mitomycin to BCG as adjuvant intravesical therapy for high-risk, non–muscle-invasive bladder cancer: a randomised phase 3 trial
IRAS ID
266640
Contact name
Will Green
Contact email
Sponsor organisation
Nottingham University Hospitals NHS Trust
Eudract number
2020-000235-51
Duration of Study in the UK
3 years, 4 months, 0 days
Research summary
Instillation of an immunotherapy drug called Bacillus of Calmette-Guerin (BCG) into the bladder has been shown to reduce rates of disease recurrence and progression to more serious disease after initial operation for high risk, non–muscle-invasive bladder cancer (NMIBC). However, over 30% of people still recur despite optimal therapy with this drug. A recent high quality study, including a randomised phase 2 trial, suggests that outcomes might be improved further by adding a second drug called Mitomycin (MM) alongside BCG. These promising findings require corroboration in a definitive, large scale, randomised phase 3 trial using standard techniques for bladder drug administration.
REC name
East Midlands - Leicester South Research Ethics Committee
REC reference
20/EM/0176
Date of REC Opinion
26 Aug 2020
REC opinion
Further Information Favourable Opinion