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

Name: A Study of SHR-1501 Combination With BCG Versus Placebo Combined With BCG in Subjects With Papillary-Only NMIBC — clinical trial record (NCT07726992)
Creator: DataLookout
License: https://creativecommons.org/licenses/by/4.0/

Study acronym: NiBladder 2

StatusRecruiting

PhasePhase 3

SponsorSuzhou Suncadia Biopharmaceuticals Co., Ltd.

Started2026-08-25

View on ClinicalTrials.gov ↗

Amendment history

2026-09-03

Study Status, Contacts/Locations v1

Recruitment opened

Start dateestimated 2026-07→confirmed 2026-08-25

Study sitesdetails revised at 2 of 2 sites

2026-07-21

Original filing

Suzhou Suncadia Biopharmaceuticals Co., Ltd.

75 trials monitored

See 7 trials at risk

Bladder Cancer

1,018 trials monitored

See 64 trials at risk

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	2026-08-25
Primary Completion	2029-12 (estimated)
Study Completion	2030-08 (estimated)
Updated on ClinicalTrials.gov	2026-09-08