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).