This is a phase 1/2, open-label, multicenter study of intravesical Recombinant Mycobacterium Bacillus Calmette-Guérin (BCG) in participants with Non-muscle invasive bladder cancer (NMIBC) who have not received Bacillus Calmette-Guérin and have histologically confirmed presence of Carcinoma in situ (CIS) or have primary or recurrent stage Ta and/or T1 papillary tumors following Transurethral resection.
Male or female participants 18 years of age or older.
Histologic confirmation of BCG naïve non-muscle invasive urothelial carcinoma of the bladder (mixed histology tumors allowed if urothelial histology is predominant histology) AND either i) histologically confirmed presence of NMIBC CIS (with or without Ta/T1 papillary disease) OR ii) primary or recurrent stage Ta and/or T1 papillary tumors following transurethral resection (TUR).
Absence of resectable disease after TURBT procedures (residual CIS acceptable; participants with T1 tumors must undergo repeat resection and biopsy [inclusive of muscularis propria] of the T1 tumor site if initial biopsy did not include muscularis propria).
Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2.
Life expectancy <2 years
Absolute neutrophil count (ANC) <800/μL
Platelets < 50,000/μL
Liver function abnormalities as indicated by ongoing hepatic enzyme elevation (aspartate aminotransferase [AST] or alanine aminotransferase [ALT]) > 2 X upper limit of normal (ULN)
Single group
Intravesical Recombinant Mycobacterium (rMBCG)
Biological/Vaccine19.2e8 Colony-forming unit(s) CFU (1 vial) rMBCG via a urinary catheter in the bladder (ie, intravesical administration)
The primary endpoint is to assess safety as measured by the incidence and severity of adverse events.
Safety assessments will include demographics/medical history, vital signs, hematology, chemistry, urinalysis, and pregnancy.
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