55
Participants
Start Date
November 21, 2017
Primary Completion Date
December 31, 2025
Study Completion Date
December 31, 2026
Durvalumab (Cohort 1-3)
Durvalumab 1120 mg intravenously Day 1 every 21 days x 8 cycles.
External Beam Radiotherapy (EBRT)
EBRT 6 Gy x 3; Cycle 1 Day 1, 3, and 5
Bacillus Calmette-Guérin (BCG)
"Dose level 0 (starting dose) = Full-dose~Dose level-1 = 1/3rd-dose BCG. Dose level -1 is expected to be utilized during the phase II portion of the study due to the ongoing and persistent shortage of BCG in the US."
Gemcitabine
Gemcitabine 1000 mg intravesical weekly (+/- 2 days) x 6 doses
Docetaxel
Docetaxel 37.5 mg intravesical weekly (+/- 2 days) x 6 doses.
Tremelimumab
Tremelimumab 75 mg intravenously Day 1 (+/- 2 days) every 28 days x 4 cycles.
Durvalumab (Cohort 4/5)
Durvalumab 1500 mg intravenously Day 1 (+/- 2 days) every 28 days x 6 cycles.
To be determined
Other regimens to be determined
RECRUITING
Columbia University Irving Medical Center, New York
RECRUITING
Fox Chase Cancer Center, Philadelphia
RECRUITING
Johns Hopkins University: Sidney Kimmel Comprehensive Cancer Center, Baltimore
ACTIVE_NOT_RECRUITING
University of North Carolina at Chapel Hill, Chapel Hill
RECRUITING
Indiana University Melvin and Bren Simon Cancer Center, Indianapolis
RECRUITING
University of Iowa Hospitals and Clinics, Iowa City
WITHDRAWN
Rush University Medical Cneter, Chicago
RECRUITING
Washington University School of Medicine, St Louis
RECRUITING
University of Nebraska Medical Center, Omaha
TERMINATED
BCG Oncology, Phoenix
WITHDRAWN
Stanford University, Stanford
WITHDRAWN
Dana-Farber Cancer Institute, Boston
Collaborators (2)
AstraZeneca
INDUSTRY
Hoosier Cancer Research Network
OTHER
Noah Hahn, M.D.
OTHER