Open Label Study to Evaluate the Safety and Efficacy of NDV01 KIT in High Grade NMIBC
Trial Parameters
Brief Summary
This is a prospective, single-arm study evaluating the safety and efficacy of NDV01 KIT, a fixed-dose combination of gemcitabine HCl and docetaxel, administered via intravesical instillation in patients with high-grade Non-Muscle Invasive Bladder Cancer (NMIBC). NDV01 KIT includes 60 mL Carbopol Gel followed by 15 g NDV01 solution (gemcitabine HCl 1000 mg and docetaxel 40 mg), administered biweekly for six treatments, followed by monthly maintenance therapy for up to 12 months. The study includes a pharmacokinetic (PK) sub-study assessing systemic exposure to NDV01's active ingredients.
Eligibility Criteria
Subjects may participate in the study if they meet all the following criteria: Inclusion criteria: * Aged 18 - 80 years old * Able to give informed consent * Histologically confirmed diagnosis of high grade non-muscle invasive bladder cancer (NMIBC) - patients having high-grade disease at first evaluation after induction BCG alone (at least 5 of 6 doses) may qualify in the absence of disease progression. * Participants must be ineligible for or have elected not to undergo radical cystectomy. * Available for the whole duration of the study. * Life expectancy \>2 years, in the opinion of the investigator. * Eastern Cooperative Oncology Group (ECOG) status 2 or less. * Absence of concomitant upper tract urothelial carcinoma or urothelial carcinoma within the prostatic urethra. Freedom from upper tract disease (if clinically indicated) as indicated by no evidence of upper tract tumor by either intravenous pyelogram, retrograde pyelogram, computed tomography (CT) scan with or without urogra