Clinical Trial

A Study of SHR-1501 Combination With BCG Versus Placebo Combined With BCG in Subjects With Papillary-Only NMIBC

Study acronym: NiBladder 2
Not Yet Recruiting Phase 3
View on ClinicalTrials.gov →
Summary
This is a multicenter, randomized, Double-blind phase III study to determine the efficacy and safety of intravesical SHR-1501 combined with Bacillus Calmette Guerin (BCG) versus Placebo Combined with BCG in patients with high-risk BCG-naive Papillary-Only non-muscle-invasive bladder cancer (NMIBC)
Trial Details
NCT Number NCT07726992
Lead Sponsor Suzhou Suncadia Biopharmaceuticals Co., Ltd.
Conditions Papillary-Only Non-muscle-invasive Bladder Cancer
Enrollment 750 participants
Start Date 2026-07
Primary Completion 2029-12 (estimated)
Study Completion 2030-08 (estimated)
Updated on ClinicalTrials.gov 2026-07-27