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)
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;
Previous histopathological diagnosis was muscle-invasive, locally advanced or metastatic urothelial carcinoma (T2 or T3 or T4 or N+ or M+).
Received surgery such as TURBT or radiotherapy for bladder lesions within 2 weeks before the randomization; Major surgery was performed within 28 days before randomization;
Those who have previously received immunostimulant therapy or immune checkpoint inhibitors;
Those who have previously received intravesical instillation of cytotoxic chemotherapy and have not experienced disease recurrence or progression before enrolment as assessed by investigator;
Parallel
SHR-1501+BCG
DrugSHR-1501+BCG
Placebo +BCG
DrugPlacebo +BCG
Disease-Free Survival (DFS) assessed by BICR: Disease-free survival is defined as the time from randomization to date of DFS event assessed by BICR.
Disease-Free Survival (DFS) assessed by investigator: Disease-free survival is defined as the time from randomization to date of DFS event assessed by investigator.
Overall Survival (OS): Overall Survival defined as the time from randomization to the date of death from any cause.
Number of adverse events (AEs) as assessed by CTCAE v6.0.
Number of serious adverse events (SAEs) as assessed by CTCAE v6.0.
Click on the lead sponsor to view all of their trials.
