Comparing Bacillus Calmette-Guerin: Strain with Bacillus Calmette-Guerin: Strain TICE for bladder cancer

Inclusion

• +Patients with T1 disease must have imaging demonstrating no evidence of metastatic disease (based on MRI or CT scan) within (before or after) 90 days of registration, to confirm stage T1N0M0 disease.
• +Male or Female
• +18 years and older
• +Low or high-grade NMIBC as defined by 2004 World Health Organization (WHO)/International Society of Urological Pathology (ISUP) classification and Grade 2 or 3 in the 1973 classification, diagnosed within 45 days of registration.
• +Pathologically confirmed and completely resected stage Ta or T1 urothelial cell carcinoma, with or without associated carcinoma in situ (CIS), diagnosed within 45 days of registration.
• +For patients with stage T1 disease, a repeat TURBT must be performed as per standard of careStandard of careThe treatment normally given for a condition outside a study.Read more →/CUA guidelines. A repeat TURBT may also be required for patients with Ta disease. Repeat TURBT must be performed within 60 days of the initial TURBT and within 45 days of registration. Pathological confirmation is required after the repeat TURBT.
• +Patients may have intermediate or high recurrence risk disease, as indicated by the probability of 2-year recurrence of ≥ 50% based on the EORTC Bladder Cancer risk calculator.
• +Adequate organ and marrow function as defined below:
• +leukocytes ≥3,000/mcL
• +absolute neutrophil count ≥1,500/mcL
• +platelets ≥100,000/mcL
• +total bilirubin ≤ 1.5 × institutional upper limit of normal (ULN)
• +AST(SGOT)/ALT(SGPT) ≤3 × institutional ULN
• +creatinine ≤ institutional ULN OR glomerular filtration rate (GFR) ≥50 mL/min/1.73 m2 unless data exists supporting safe use of BCG at lower kidney function values, no lower than 30 mL/min/1.73 m2
• +Has had surgical sterilization (hysterectomy, bilateral oophorectomy, or bilateral salpingectomy);
• +Has had a cessation of menses for at least 12 months without an alternative medical cause, and a follicle-stimulating hormone (FSH) test confirming nonchildbearing potential (refer to laboratory reference ranges for confirmatory levels).
• +Male patients must agree to refrain from donating sperm during the treatment period and for at least 120 days after the last dose of study treatment.
• +ECOG performance status of 0-2
• +For women of childbearing potential involved in any sexual intercourse that could lead to pregnancy: Negative pregnancy test and willingness to use contraceptive (consistent with local regulations) during 120 days after the last dose of the study treatment. Note: The use of contraceptive methods does not apply to subjects who are abstinent for at least 4 weeks before Day 1 and will continue to be abstinent from penile-vaginal intercourse 120 days after last dose of study drug treatment. The reliability of sexual abstinence needs to be evaluated in relation to the duration of the clinical trialInterventional studyA study where participants are given something to see what happens.Read more → and the preferred and usual lifestyle of the participant.
• +Note: A woman of non-childbearing potential is defined as follows:
• +Male patients with female partner of childbearing potential must agree to be abstinent or practice an effective method of contraception.