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

WITHDRAWNPHASE3

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)

NCT07313891•Relmada Therapeutics, Inc.

View on ClinicalTrials.gov

Summary

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.

Detailed Description

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.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

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.

Key Dates

Start Date

May 1, 2026

Primary Completion Date

September 1, 2029

Completion Date

November 1, 2029

Last Updated

March 17, 2026

Conditions

Bladder (Urothelial, Transitional Cell) Cancer Superficial (Non-Invasive)Bladder (Urothelial, Transitional Cell) CancerUrothelial Carcinoma BladderUrologic Cancer

Interventions

NDV-01 (sustained-release gemcitabine-docetaxel)

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: March 17, 2026Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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

Inclusion Criteria

Exclusion Criteria

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