This expanded access protocol is designed to provide Recombinant Mycobacterium BCG(rMBCG) to patients with Non-muscle invasive bladder cancer (NMIBC) who are eligible toreceive TICE® BCG, may benefit from its use, and who are ineligible to participate in aclinical trial using rMBCG, or for other reasons cannot participate (eg, geographicallyunable to access a study site).
Not Provided
Biological: rMBCG
1-19.2e8 colony-forming units (CFU) of rMBCG
Inclusion Criteria:
Participants must meet all of the following criteria for inclusion in the study:
1. Age ≥18 years old.
2. Histologic confirmation of non-muscle invasive bladder cancer of the transitional
cell carcinoma high-grade subtype (mixed histology tumors allowed if transitional
cell histology is predominant histology).
3. Ineligible to participate in a clinical trial using rMBCG or geographically unable
to access a rMBCG clinical trial site.
4. Voluntary written informed consent and agreement to comply with all protocol
specified procedures and follow-up evaluations.
Exclusion Criteria:
Participants with any of the following criteria are excluded from participation in the
study:
1. Other illness or condition, including laboratory abnormalities, which in the opinion
of the Investigator would exclude the participant from participating in this study.
This includes, but is not limited to, serious medical conditions or psychiatric
illness likely to interfere with participation in the study.
2. Women who are pregnant or nursing. Female participants of childbearing potential
must have a negative pregnancy test and must adhere to using a medically acceptable
method of birth control prior to screening and agree to continue its use during the
study and for 30 days after the last dose of study drug, or be surgically sterilized
(eg, hysterectomy or tubal ligation). Women of childbearing potential are defined as
any female who has experienced menarche and who is NOT permanently sterile or
postmenopausal. Postmenopausal is defined as 12 consecutive months with no menses
without an alternative medical cause. Males must agree to use barrier methods of
birth control while on study and for 90 days post last dose of study drug.
Urology Centers of Alabama
Homewood, Alabama, United States
University Urology
Mobile, Alabama, United States
Urology Associates
Mobile, Alabama, United States
Mayo Clinic
Phoenix, Arizona, United States
Center for Neurosciences
Tucson, Arizona, United States
UC San Diego Moores Cancer Center
La Jolla, California, United States
USC/ Norris Comprehensive Cancer Center
Los Angeles, California, United States
Urology Center of Southern California
Murrieta, California, United States
Saint John's Cancer Institute (Providence)
Santa Monica, California, United States
MedStar Washington Hospital Center
Washington D.C., District of Columbia, United States
Broward Urology Center
Fort Lauderdale, Florida, United States
Genesis Care
Fort Myers, Florida, United States
Mayo Clinic
Jacksonville, Florida, United States
Cohen Urology
Lake Worth, Florida, United States
Sebring Urology Center
Sebring, Florida, United States
Florida Urology Partners
Tampa, Florida, United States
Albany Urology Clinic and Surgery Center
Albany, Georgia, United States
Emory University
Atlanta, Georgia, United States
Georgia Urology
Atlanta, Georgia, United States
Augusta Urology Associates, LLC
Evans, Georgia, United States
Hawaii Cancer Care
Honolulu, Hawaii, United States
Island Urology Oahu
Honolulu, Hawaii, United States
North Idaho Urology, PLLC
Coeur d'Alene, Idaho, United States
The Urology Clinic
Meridian, Idaho, United States
Advanced Urology Skokie
Skokie, Illinois, United States
Urology of Indiana
Carmel, Indiana, United States
US Urology Partners - Carmel
Greenwood, Indiana, United States
First Urology, P.S.C
Jeffersonville, Indiana, United States
Kansas City Urology Care, PA
Lenexa, Kansas, United States
Wichita Urology
Wichita, Kansas, United States
Louisiana Healthcare Associates
Covington, Louisiana, United States
NRMC Urology Associates
Natchitoches, Louisiana, United States
Willis Knighton Urologic Oncology at Pierremont
Shreveport, Louisiana, United States
Pioneer Valley Urology, P.C.
Springfield, Massachusetts, United States
Karmanos Cancer Institute
Detroit, Michigan, United States
Comprehensive Urology
Waterford, Michigan, United States
Essentia Health - Duluth Clinic
Duluth, Minnesota, United States
Allina Health Cancer Institute- Abbott Northwestern Hospital
Minneapolis, Minnesota, United States
Minnesota Urology
Woodbury, Minnesota, United States
Cancer Partners of Nebraska
Lincoln, Nebraska, United States
The Urology Center, P. C. D/B/A/ UroHealth Partners
Omaha, Nebraska, United States
University Urology of NJ
Hamilton, New Jersey, United States
Advance Urology Associates Enterprises/ HLP Urology Associates
Manasquan, New Jersey, United States
Garden State Urology
Morristown, New Jersey, United States
Capital Health Urology
Pennington, New Jersey, United States
NYU Langone Health
New York, New York, United States
SUNY Upstate Medical University
Syracuse, New York, United States
Advanced Urology, Center for Robotic Surgery
Leland, North Carolina, United States
Cleveland Clinic
Garfield Heights, Ohio, United States
Department of Urology, Jefferson Einstein Hospital
Philadelphia, Pennsylvania, United States
Center for Urologic Care of Berks County
Wyomissing, Pennsylvania, United States
Urology Associates of Charleston
Mt. Pleasant, South Carolina, United States
AUC Urologists, LLC
Myrtle Beach, South Carolina, United States
Erlanger Health, Inc.
Chattanooga, Tennessee, United States
The West Clinic, PLLC dba West Cancer Center
Germantown, Tennessee, United States
The University of Tennessee Medical Center
Knoxville, Tennessee, United States
Rio Grande Urology
El Paso, Texas, United States
The Urology Place
San Antonio, Texas, United States
Danville Urologic Clinic
Danville, Virginia, United States
Potomac Urology
Fairfax, Virginia, United States
Virginia Urology
Richmond, Virginia, United States
Valley Health Urology
Winchester, Virginia, United States
Jayson Garmizo
310-912-2230
jayson.garmizo@immunitybio.com
Not Provided