OncoMatch/Clinical Trials/NCT06663137
Open Label Study to Evaluate the Safety and Efficacy of NDV01 KIT in High Grade NMIBC
Is NCT06663137 recruiting? Yes, currently enrolling (May 2026). This Phase 2 trial studies non-drug interventions for non muscle invasive bladder cancer.
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.
Check if I qualifyExtracted eligibility criteria
Cancer type
Urothelial Carcinoma
Disease stage
Required: Stage HIGH GRADE NON-MUSCLE INVASIVE
Excluded: Stage MUSCLE INVASIVE, IV
Grade: high grade
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.
Performance status
ECOG 0–2(Ambulatory, capable of self-care)
Prior therapy
Must have received: BCG therapy — induction
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
Cannot have received: systemic therapy for bladder cancer
Current systemic therapy for bladder cancer
Lab requirements
Kidney function
no clinically significant and unexplained elevated renal function tests
Liver function
no clinically significant and unexplained elevated liver function tests
Structured fields extracted by AI. May contain errors — verify against the official protocol.
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