Modern Immunotherapy in BCG-Unresponsive, BCG-Relapsing, and High-Risk BCG-Naïve, Non-muscle Invasive Urothelial Carcinoma of the Bladder
Categories (click each to see list of all clinical trials associated with that category): GU (ONC)
Current Status: Open
Phase: I (Cancer Control)
Principal Investigator: Teply, Benjamin
Contact Information:
Heather Mittelstedt
hmittelstedt@unmc.edu
Eligibility: https://clinicaltrials.gov/study/NCT03317158?term=NCT03317158&rank=1
Summary
Primary Outcome Measures :
Phase 1: Determine the recommended phase 2 dose (RP2D) from BCG-unresponsive non-muscle invasive bladder cancer (NMIBC) patients treated with immunotherapy doublet combinations [ Time Frame: 6 months ]
durvalumab plus BCG, durvalumab plus radiation
Phase 2: Determine the 6-month relapse-free survival (RFS) rates of BCG-relapsing or persistent non-muscle invasive bladder cancer (NMIBC) subjects treated with immunotherapy doublet combinations or BCG re-treatment [ Time Frame: 6 months ]
durvalumab plus BCG, durvalumab plus radiation, BCG monotherapy
Secondary Outcome Measures :
Phase 1: Characterize the 6-month relapse-free survival (RFS) rate of BCG-unresponsive non-muscle invasive bladder cancer (NMIBC) subjects treated with immunotherapy monotherapy or doublet combinations [ Time Frame: 6 months ]
durvalumab monotherapy, durvalumab plus BCG, durvalumab plus radiation
Assess the safety profile of BCG-unresponsive non-muscle invasive bladder cancer (NMIBC) subjects treated with immunotherapy monotherapy or doublet combinations by reporting the highest grade adverse event per patient, as assessed by CTCAE v4.0. [ Time Frame: up to 24 months ]
durvalumab monotherapy, durvalumab plus BCG, durvalumab plus radiation
Phase 2: Determine the 24-month relapse-free survival (RFS) rates of BCG-relapsing or persistent non-muscle invasive bladder cancer (NMIBC) subjects treated with immunotherapy doublet combinations or BCG re-treatment [ Time Frame: up to 24 months ]
durvalumab plus BCG, durvalumab plus radiation, BCG monotherapy
Phase 2: Identify significant associations between 6- and 24-month RFS rates and baseline tumor immunohistochemistry staining patterns of PD-L1 and other relevant mechanism of action targets for each drug studied within each study arm. [ Time Frame: up to 24 months ]
Determine the relapse-free survival (RFS) rate
Phase 2: Determine the 6-month relapse-free survival (RFS) rate of BCG-unresponsive non-muscle invasive bladder cancer (NMIBC) subjects treated with durvalumab [ Time Frame: 6 months ]
Determine the 6 month relapse-free survival (RFS) rate
Phase 2: Determine the 24-month relapse-free survival (RFS) rate of BCG-unresponsive non-muscle invasive bladder cancer (NMIBC) subjects treated with durvalumab. [ Time Frame: up to 24 months ]
Determine the 24 month relapse-free survival (RFS) rate
Assess the safety profile of subjects treated with immunotherapy monotherapy, doublet combinations or BCG re-treatment by reporting the highest grade adverse event per patient as assessed by CTCAE v4.0. [ Time Frame: up to 24 months ]
durvalumab plus BCG, durvalumab plus radiation, BCG monotherapy