190
Participants
Start Date
June 2, 2017
Primary Completion Date
October 1, 2024
Study Completion Date
March 1, 2029
N-803 and BCG
BCG and N-803 will be mixed together (with saline) and administered via intravesical instillation weekly for 6 consecutive weeks (induction). After the first disease assessment, eligible patients will receive either a 3-week maintenance course or a 6-week re-induction course (second treatment period) at Month 3. Eligible patients will continue to receive maintenance treatment in the third treatment period at Months 6, 9, 12, and 18. Eligible patients have the option to receive maintenance treatment in the fourth treatment period at Months 24, 30, and 36.
N-803
N-803 will be administered via intravesical instillation weekly for 6 consecutive weeks (induction). After the first disease assessment, eligible patients will receive either a 3-week maintenance course or a 6-week re-induction course (second treatment period) at Month 3. Eligible patients will continue to receive maintenance treatment in the third treatment period at Months 6, 9, 12, and 18. Eligible patients have the option to receive maintenance treatment in the fourth treatment period at Months 24, 30, and 36.
Integrated Medical Professionals, New York
Winthrop University Hospital Department of Urology, Garden City
Premier Medical Group of the Hudson Valley, Poughkeepsie
Roswell Park Cancer Insitute, Buffalo
University of Rochester, Rochester
Thomas Jefferson University, Philadelphia
Virginia Urology, Richmond
UNC Chapel Hill, Chapel Hill
Associated Urologists of North Carolina, Raleigh
Dwight D. Eisenhower Army Medical Center, Augusta
Clinical Research Center of Florida, Pompano Beach
University of Miami Miller School of Medicine-Sylvester Comprehensive Cancer Center, Miami
Moffitt Cancer Center, Tampa
Vanderbilt University Medical Center, Nashville
University of Michigan, Ann Arbor
Karmanos Cancer Institute, Detroit
University of Chicago Medical Center, Chicago
Adult & Pediatric Urology, Omaha
Arkansas Urology, Little Rock
Urology Associates, PC, Englewood
Accument Rx, Albuquerque
UCLA Department of Urology, Los Angeles
Skyline Urology, Torrance
Skyline Urology, Sherman Oaks
Hoag Memorial Hospital, Newport Beach
University of Hawaii Cancer Center, Honolulu
Madigan Army Medical Center, Tacoma
Alaska Clinical Research Center, Anchorage
Lead Sponsor
ImmunityBio, Inc.
INDUSTRY