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.
University Urology
Mobile 4076598, Alabama 4829764, United States
Urology Associates
Mobile 4076598, Alabama 4829764, United States
Genesis Care
Fort Myers 4155995, Florida 4155751, United States
Cohen Urology
Lake Worth 4161422, Florida 4155751, United States
Sebring Urology Center
Sebring 4172383, Florida 4155751, United States
Florida Urology Partners
Tampa 4174757, Florida 4155751, United States
Albany Urology Clinic and Surgery Center
Albany 4179320, Georgia 4197000, United States
Emory University
Atlanta 4180439, Georgia 4197000, United States
Advanced Urology Skokie
Skokie 4911600, Illinois 4896861, United States
Urology of Indiana
Carmel 4255466, Indiana 4921868, United States
US Urology Partners - Carmel
Greenwood 4258313, Indiana 4921868, United States
First Urology, P.S.C
Jeffersonville 4259671, Indiana 4921868, United States
Kansas City Urology Care, PA
Lenexa 4274356, Kansas 4273857, United States
NRMC Urology Associates
Natchitoches 4334720, Louisiana 4331987, United States
Willis Knighton Urologic Oncology at Pierremont
Shreveport 4341513, Louisiana 4331987, United States
Pioneer Valley Urology, P.C.
Springfield 4951788, Massachusetts 6254926, United States
Comprehensive Urology
Waterford 5014130, Michigan 5001836, United States
Essentia Health - Duluth Clinic
Duluth 5024719, Minnesota 5037779, United States
Cancer Partners of Nebraska
Lincoln 5072006, Nebraska 5073708, United States
University Urology of NJ
Hamilton 5098765, New Jersey 5101760, United States
Advance Urology Associates Enterprises/ HLP Urology Associates
Manasquan 5100809, New Jersey 5101760, United States
Cleveland Clinic
Garfield Heights 5155499, Ohio 5165418, United States
Center for Urologic Care of Berks County
Wyomissing 5220248, Pennsylvania 6254927, United States
Rio Grande Urology
El Paso 5520993, Texas 4736286, United States
Potomac Urology
Fairfax 4758023, Virginia 6254928, United States
Jayson Garmizo
310-912-2230
jayson.garmizo@immunitybio.com
Not Provided