A Study of Adjuvant NDV-01 (Sustained-release Gemcitabine-docetaxel) for the Treatment of Intermediate Risk NMIBC Following TURBT

A Phase 3, Randomized Study Evaluating the Efficacy and Safety of NDV-01 Versus Observation in Participants With Intermediate-risk Non-muscle Invasive Bladder Cancer (BOOST)

This is a Phase 3, open-label, randomized trial designed to evaluate the DFS of TURBT followed by NDV-1 (sustained-release gemcitabine-docetaxel) versus TURBT followed by surveillance for the treatment of participants with IR-NMIBC.

Participants will be randomized 1:1 to NDV-1 (sustained-release gemcitabine-docetaxel) after TURBT (Arm A) vs surveillance after TURBT (Arm B).

Participants in Arm A will receive an induction course and then monthly maintenance courses of NDV-1 (sustained-release gemcitabine-docetaxel) through Month 12, if there is no disease recurrence.

Disease status will be assessed using urine cytology, cystoscopy, and directed TURBT/biopsy (if indicated) every 3 months for the first 2 years after randomization and then every 6 months for an additional year or until disease recurrence.

Participants in Arm B who recur with IR-NMIBC after TURBT and surveillance will be offered treatment with NDV-1 (sustained-release gemcitabine-docetaxel) as per the treatment schedule in Arm A.

Inclusion Criteria:

1. Have a histologically confirmed diagnosis (within 90 days of randomization) of IR NMIBC based on the AUA/SUO criteria of IR NMIBC.
2. Participants must have ≥ 1 IBCG risk factors: multiple tumors, early recurrence (Within 1 year), frequent recurrences (> 1 per year), tumor size (> 3 cm), failure of prior intravesical therapy.
3. Visible papillary disease must be fully resected prior to randomization, and absence of disease must be documented at Screening cystoscopy. The same method for visualizing disease at Screening cystoscopy should be used throughout for the participant (white light versus enhanced assessment method).
4. Patients with LG T1 may be eligible after repeat-TURBT (within 4 weeks of first TURBT) if the repeat pathology shows non-invasive (Ta or less) or no disease. Original and repeat-TURBT must confirm that muscularis propria is present and uninvolved in the specimen. TURBT to occur within 4 months of screening. All pathology specimens must be predominantly urothelial (transitional cell) and have less than 20% variant (e.g., sarcomatoid, squamous component) histology.

Exclusion Criteria:

1. Histologically confirmed diagnosis of HR NMIBC (including CIS) or MIBC, locally advanced, nonresectable, or metastatic urothelial carcinoma at any time prior to enrollment.
2. Has had urothelial carcinoma outside of the urinary bladder, (including prostatic urethra, ureter, or renal pelvis) or has a predominant histological variant of UC. Ta/any T1, CIS of the upper urinary tract is allowable if treated with complete nephroureterectomy more than 24 months prior to initiating study.
3. Participant has tumor(s) involving the prostatic urethra (ductal or stromal).
4. N+ and/or M+ per CT/MR urography.