OncoMatch/Clinical Trials/NCT05037279
Evaluating Safety and Efficacy of Verity-BCG in BCG-naïve Patients With Intermediate and High-risk Non-muscle Invasive Bladder (NMIBC)
Is NCT05037279 recruiting? Yes, currently enrolling (May 2026). This Phase 3 trial studies multiple treatments including Bacillus Calmette-Guerin: Strain Russian BCG-I and Bacillus Calmette-Guerin: Strain TICE for bladder cancer.
Treatment: Bacillus Calmette-Guerin: Strain Russian BCG-I · Bacillus Calmette-Guerin: Strain TICE — The aim of this study is to evaluate the effect of Verity-BCG in patients with intermediate and high-risk non-muscle-invasive bladder cancer (NMIBC) and to compare our findings to the standard of care BCG formulation, OncoTICE (BCG) in order to examine our hypothesis that Verity-BCG is at least non-inferior to OncoTICE in achieving 24-month Recurrence Free Survival in NMIBC patients who are at high risk of recurrence and have never been treated with intradermal or intravesical BCG before, with the exception of tuberculosis vaccination in childhood.
Check if I qualifyExtracted eligibility criteria
Cancer type
Urothelial Carcinoma
Disease stage
Grade: LowHighGrade 2Grade 3 (2004 WHO/ISUP and 1973 classification)
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
Performance status
ECOG 0–2(Ambulatory, capable of self-care)
Prior therapy
Must have received: transurethral resection of bladder tumor (TURBT)
completely resected stage Ta or T1 urothelial cell carcinoma
Cannot have received: intravesical BCG
Exception: tuberculosis vaccination in childhood
Prior intravesical BCG or intradermal BCG, within 5 years of screening, with the exception of tuberculosis vaccination in childhood
Cannot have received: chemoradiation treatment (trimodal therapy or 'TMT') for bladder cancer
Prior chemoradiation treatment (trimodal therapy or 'TMT') for bladder cancer
Lab requirements
Blood counts
leukocytes ≥3,000/mcL; absolute neutrophil count ≥1,500/mcL; platelets ≥100,000/mcL
Kidney function
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
Liver function
total bilirubin ≤ 1.5 × institutional upper limit of normal (ULN); AST(SGOT)/ALT(SGPT) ≤3 × institutional ULN
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
Structured fields extracted by AI. May contain errors — verify against the official protocol.
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