Spots Global Cancer Trial Database for QUILT-3.032: A Multicenter Clinical Trial of Intravesical Bacillus Calmette-Guerin (BCG) in Combination With ALT-803 (N-803) in Patients With BCG Unresponsive High Grade Non-Muscle Invasive Bladder Cancer
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Trial Identification
Brief Title: QUILT-3.032: A Multicenter Clinical Trial of Intravesical Bacillus Calmette-Guerin (BCG) in Combination With ALT-803 (N-803) in Patients With BCG Unresponsive High Grade Non-Muscle Invasive Bladder Cancer
Official Title: QUILT-3.032: A Multicenter Clinical Trial of Intravesical Bacillus Calmette-Guerin (BCG) in Combination With ALT-803 (N-803) in Patients With BCG Unresponsive High Grade Non-Muscle Invasive Bladder Cancer
Study ID: NCT03022825
Conditions
Study Description
Brief Summary: This is a Phase II/III, open-label, single-arm, multicenter study of intravesical BCG plus N-803 or N-803 only in patients with BCG unresponsive high grade non-muscle invasive bladder cancer (NMIBC). All patients treated in the study will receive via a urinary catheter in the bladder, BCG plus N-803 or N-803 only weekly for 6 consecutive weeks (initial induction treatment period). 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. The study duration is 60 months.
Detailed Description:
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
Alaska Clinical Research Center, Anchorage, Alaska, United States
Arkansas Urology, Little Rock, Arkansas, United States
UCLA Department of Urology, Los Angeles, California, United States
Hoag Memorial Hospital, Newport Beach, California, United States
Skyline Urology, Sherman Oaks, California, United States
Skyline Urology, Torrance, California, United States
Urology Associates, PC, Englewood, Colorado, United States
University of Miami Miller School of Medicine-Sylvester Comprehensive Cancer Center, Miami, Florida, United States
Clinical Research Center of Florida, Pompano Beach, Florida, United States
Moffitt Cancer Center, Tampa, Florida, United States
Dwight D. Eisenhower Army Medical Center, Augusta, Georgia, United States
University of Hawaii Cancer Center, Honolulu, Hawaii, United States
University of Chicago Medical Center, Chicago, Illinois, United States
University of Michigan, Ann Arbor, Michigan, United States
Karmanos Cancer Institute, Detroit, Michigan, United States
Adult & Pediatric Urology, Omaha, Nebraska, United States
Accument Rx, Albuquerque, New Mexico, United States
Roswell Park Cancer Insitute, Buffalo, New York, United States
Winthrop University Hospital Department of Urology, Garden City, New York, United States
Manhattan Medical Research, New York, New York, United States
Premier Medical Group of the Hudson Valley, Poughkeepsie, New York, United States
University of Rochester, Rochester, New York, United States
UNC Chapel Hill, Chapel Hill, North Carolina, United States
Associated Urologists of North Carolina, Raleigh, North Carolina, United States
Thomas Jefferson University, Philadelphia, Pennsylvania, United States
Vanderbilt University Medical Center, Nashville, Tennessee, United States
Virginia Urology, Richmond, Virginia, United States
Madigan Army Medical Center, Tacoma, Washington, United States
Contact Details
Name: Karim Chamie, MD
Affiliation: University of California, Los Angeles
Role: PRINCIPAL_INVESTIGATOR
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