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

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 ID

NCT07726992

Phase

PHASE3

Sponsor

Suzhou Suncadia Biopharmaceuticals Co., Ltd.

Status

RECRUITING

Cancer Type

Bladder Cancer

Interventions

SHR-1501+BCG
Placebo +BCG

Locations (sample)

Beijing, Beijing Municipality, China|39.9075,116.39723
Guangzhou, Guangdong, China|23.11667,113.25

Key Eligibility Criteria

Aged at least 18 years, gender is not limited;
Eastern Cooperative Oncology Group (ECOG) performance status of ≤ 2;
Histologic confirmation of high-riskpapillary-only non-muscle invasive bladder cancer (high-grade Ta and/or any T1, no carcinoma in situ);
No previous BCG therapy;

For full eligibility, visit ClinicalTrials.gov.

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