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.
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.
Presence of lymphovascular invasion and/micropapillary disease as shown in the histology of the biopsy sample.
Patients with T1 disease accompanied by the presence of hydronephrosis secondary to the primary tumor - Unless scheduled for treatment like nephrostomy or JJ stent insertion..
Current systemic therapy for bladder cancer.
Symptomatic urinary tract infection or bacterial cystitis (once satisfactorily treated, patients can enter the study).
Single group
NDV01 intravesical controlled release formulation of gemcitabine and docetaxel
DrugNDV01 is administered intravesically using a catheter.
Number of Patients with Complete Response (CR) in High-Grade NMIBC
Complete response is defined by at least one of the following criteria: Negative cystoscopy and negative or atypical urine cytology; and/or Positive cystoscopy with biopsy-confirmed benign or low-grade NMIBC, along with negative urine cytology.
Frequency and severity of Adverse Events (AEs), including Serious Adverse Events (SAEs) and Treatment-emergent AEs (TEAEs) occurring at any time during the study Serious Adverse Events (SAEs) Treatment-Emergent Adverse Events (TEAEs)
Any new Change from Baseline to End of Study (EOS) in investigators assessment
Durability of Complete Response (CR) in High-Grade NMIBC
Evaluate how long patients maintain CR over time.
Number of Patients with CR Among Those with Carcinoma In Situ (CIS)
Includes those with or without co-existing high-grade Ta or T1 papillary disease.
Incidence of Event-Free Survival (EFS) at 12 Months
Event-free survival is defined as survival without recurrence of high-grade disease.
Durability of event-free survival in patients with high-grade Ta or T1 papillary disease (without concomitant CIS), who have no recurrence of high-grade Ta or T1 papillary disease
Tumor recurrence
Pharmacokinetic parameters of NDV01 KIT will be evaluated
PK measurement expressed as maximum plasma concentration for NDV01 and PK measurement expressed as half-life and area under curve for NDV01 Pharmacokinetic (PK).
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