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 Associates
Mobile, Alabama, United States
Genesis Care
Fort Myers, Florida, United States
Cohen Urology
Lake Worth, Florida, United States
Emory University
Atlanta, Georgia, United States
Advanced Urology Skokie
Skokie, Illinois, United States
Urology of Indiana
Carmel, Indiana, United States
First Urology, P.S.C
Jeffersonville, Indiana, United States
Kansas City Urology Care, PA
Lenexa, Kansas, United States
NRMC Urology Associates
Natchitoches, Louisiana, United States
Pioneer Valley Urology, P.C.
Springfield, Massachusetts, United States
University Urology of NJ
Hamilton, New Jersey, United States
Paula Bradshaw
844-413-8500
paula.bradshaw@immunitybio.com
Not Provided