A Study of Intravesical SHR-1501 Combination With BCG Versus Investigator-selected Chemotherapy in Subjects With BCG-unresponsive NMIBC
A Multicenter, Randomized, Open-label Phase III Clinical Study of Intravesical SHR-1501 Combined With Bacillus Calmette Guerin (BCG) Versus Investigator-selected Chemotherapy In Patients With BCG-unresponsive High-risk Non-muscle-invasive Bladder Cancer (NMIBC) (NiBladder 1)
1 other identifier
interventional
236
1 country
2
Brief Summary
This is a multicenter, randomized, open-label phase III study to determine the efficacy and safety of intravesical SHR-1501 combined with Bacillus Calmette Guerin (BCG) versus investigator-selected chemotherapy in patients with BCG-unresponsive high-risk non-muscle-invasive bladder cancer (NMIBC).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3
Started Mar 2026
Typical duration for phase_3
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 13, 2026
CompletedFirst Posted
Study publicly available on registry
February 20, 2026
CompletedStudy Start
First participant enrolled
March 1, 2026
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2030
ExpectedStudy Completion
Last participant's last visit for all outcomes
June 1, 2030
February 20, 2026
February 1, 2026
4.3 years
February 13, 2026
February 13, 2026
Conditions
Outcome Measures
Primary Outcomes (1)
Event-Free Survival (EFS)
Event free survival is defined as the time from randomization to date of EFS event.
Up to approximately 5 years.
Secondary Outcomes (6)
Complete response (CR) rate
Up to approximately 5 years.
Duration of Response (DoR)
Up to approximately 5 years.
Disease-Free Survival (DFS)
Up to approximately 5 years.
Overall Survival (OS)
Up to approximately 5 years.
Number of adverse events (AEs) as assessed by CTCAE v6.0.
Up to approximately 5 years.
- +1 more secondary outcomes
Study Arms (2)
SHR-1501 + BCG Group
EXPERIMENTALSHR-1501, Bacillus Calmette Guerin (BCG).
Investigator-selected Chemotherapy Group
ACTIVE COMPARATOREpirubicin or Pirarubicin or Gemcitabine or Hydroxycamptothecin or Mitomycin.
Interventions
Epirubicin hydrochloride for injection.
Pirarubicin hydrochloride for injection.
Gemcitabine hydrochloride for injection.
Hydroxycamptothecin for injection.
Eligibility Criteria
You may qualify if:
- Aged at least 18 years, gender is not limited;
- Eastern Cooperative Oncology Group (ECOG) performance status of ≤ 2;
- Histologic confirmation of high-risk non-muscle invasive bladder cancer; BCG-unresponsive;
- Cystoscopy within 6 weeks before the randomization shows that the lesion has been completely removed; for T1 stage lesions, pathological results must show the presence of bladder muscle tissue;
- Not suitable for or unwilling to undergo radical cystectomy;
- Sufficient hematology and organ function.
You may not qualify if:
- 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 the following treatments and have not experienced disease recurrence or progression before enrolment: a) Intravesical infusion of cytotoxic chemotherapy or other drugs (such as oncolytic viruses), etc; b) Immune checkpoint inhibitors; c) Other investigatory drugs for the treatment of NMIBC;
- Those who have previously received immunostimulant therapy;
- Upper urinary tract tumor detected by CTU or MRU during screening period, urethral prostate tumor detected by cystoscopy, or other concomitant malignant tumors within 5 years before the first administration;
- Previous medical history or examination suggests active tuberculosis within 1 year prior to the randomization.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
Peking University First Hospital
Beijing, Beijing Municipality, 100034, China
Renji Hospital Affiliated to Shanghai Jiao Tong University School
Shanghai, Shanghai Municipality, 200120, China
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 13, 2026
First Posted
February 20, 2026
Study Start
March 1, 2026
Primary Completion (Estimated)
June 1, 2030
Study Completion (Estimated)
June 1, 2030
Last Updated
February 20, 2026
Record last verified: 2026-02