NMIBC
Conditions
Brief summary
This expanded access protocol is designed to provide Recombinant Mycobacterium BCG (rMBCG) to patients with Non-muscle invasive bladder cancer (NMIBC) who are eligible to receive TICE® BCG, may benefit from its use, and who are ineligible to participate in a clinical trial using rMBCG, or for other reasons cannot participate (eg, geographically unable to access a study site).
Interventions
1-19.2e8 colony-forming units (CFU) of rMBCG
Sponsors
Eligibility
Inclusion criteria
Participant Eligibility: Women and men of all races and ethnic groups are eligible for this trial. Inclusion Criteria and Contraindications: Participants must meet the inclusion criteria and contraindications determined by the standards of their institution per the TICE BCG label. In BCG naïve subjects with NMIBC, enrollment should occur only if TICE BCG is unavailable.
Countries
United States