At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 172 enrolled
Drug / intervention
Atezolizumabdrug
Likely dose
Atezolizumab IV (specific dose not stated in interventions or arms)AI-extracted
Key inclusion· 9
- ✓Histologically proven recurrent non-muscle invasive urothelial carcinoma of bladder, stage T1 high-grade, CIS, or Ta high-grade, within 60 days prior to registration
- ✓Complete resection of all visible tumor within 60 days prior to registration with tumor tissue available for central pathology review
- ✓Cystoscopy confirming no visible papillary tumor within 21 days prior to registration
- ✓Urine cytology within 21 days prior to registration
Key exclusion· 9
- ✕Prior systemic chemotherapy for bladder cancer or systemic immunotherapy (interferon alfa-2b, IL-2, PEG-IFN, PD-1, anti-PD-L1); vaccine therapies within 6 weeks prior to registration; prior intravesical administration allowed if ≥30 days before registration
- ✕Cannot be planning concomitant other biologic therapy, radiation therapy, intravesical chemotherapy, surgery, or other anti-cancer therapy during protocol treatment
- ✕No prior radiation to bladder for bladder cancer
- ✕No systemic immunosuppressive medications within 4 weeks prior to registration (e.g., prednisone, cyclophosphamide, azathioprine, methotrexate, thalidomide, anti-TNF); exceptions: acute low-dose medications, inhaled corticosteroids, and mineralocorticoids allowed
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Phase II Trial of Atezolizumab in BCG-Unresponsive Non-Muscle Invasive Bladder Cancer
In Brief
A Phase 2 clinical trial evaluating Atezolizumab for Recurrent Bladder Urothelial Carcinoma and 3 related conditions. Completed, enrolled 172 participants across 272 sites in 2 countries.
Detailed Summary
This phase II trial studies how well atezolizumab works in treating patients with non-muscle invasive bladder cancer that has come back (recurrent) and has not responded to treatment (refractory) with Bacillus Calmette-Guerin (BCG). Immunotherapy with monoclonal antibodies, such as atezolizumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsRecurrent Bladder Urothelial Carcinoma, Stage 0a Bladder Urothelial Carcinoma AJCC v6 and v7, Stage 0is Bladder Urothelial Carcinoma AJCC v6 and v7, Stage I Bladder Urothelial Carcinoma AJCC v6 and v7
CountriesCanada, United States
CollaboratorsCanadian Cancer Trials Group
Timeline
Phase 2CompletedFinished
2017201820192020202120222023202420252026
First PostedJul 2016
Enrollment StartMar 2017
Primary CompletionJun 2023
Study CompletionJun 2024
TodayJul 2026
First PostedJul 26, 2016
Enrollment StartMar 13, 2017
Primary CompletionJun 1, 2023
Study CompletionJun 26, 2024
TodayJul 2, 2026
Enrollment to primary: 6.2 yearsPosted 9.9 years ago
Interventions
Atezolizumabdrug
Given IV