NCT07464145Phase 3Not yet recruiting

A Study of NDV-01 (Sustained-release Gemcitabine-docetaxel) in Participants With Non-muscle Invasive Bladder Cancer

Study sponsor: Relmada Therapeutics, Inc. · RLMD

Compare the available registry edits below. Primary completion is the date data collection ends for the main study measures; it does not tell you when results will be published.

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Primary completion2029-12Estimated

Enrollment · participants393Estimated

Source updated2026-09-02Last update listed in the registry record

Version history

Changes to this trial

Last 12 months

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Posted 2026-09-02 · 1 field changed

Primary completion date changed

− Before

~~Sep 2029~~

+ After

Dec 2029

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Study details

Conditions studied

Bladder (Urothelial, Transitional Cell) Cancer; Bladder (Urothelial, Transitional Cell) Cancer Superficial (Non-Invasive); Urothelial Carcinoma Bladder; Urothelial Carcinoma Recurrent; Urologic Cancer

Treatments or interventions studied

NDV-01 (sustained-release gemcitabine-docetaxel)Drug

Primary outcomes · main study measures

Read the study measures

measure: Disease Free Survival in participants with Intermediate Risk NMIBC; description: Time from randomization to either time of the first recurrence or progression, or death due to any cause, whichever occurs first. It is hypothesized that sustained local delivery of GEM and DOCE (via NDV-01) in participants with IR-NMIBC will result in longer DFS than achieved with observation after TURBT. Under the exponential distribution assumption for DFS, this translates into testing the statistical hypothesis that the hazard ratio is significantly less than 1.0. Primary endpoint will be tested using a one-sided 2.5% level of significance.; timeFrame: From date of randomization to at least 2 years of follow-up assessing for DFS events.; measure: To evaluate the efficacy of NDV-01 (determined by complete response [CR] anytime) administered by intravesical instillation in patients with BCG-unresponsive NMIBC who have recurred after first-line intravesical therapy (approved or in development).; description: Percentage of participants with CR at anytime based on cystoscopy, urine cytology, and biopsies. Protocol-driven mapping biopsies (as assessed by central pathology) will be performed at 12 months; timeFrame: From date of randomization through 3 years of follow-up assessing for CR.

History coverage

Research sample: selected versions from May 2023 onward plus a preceding baseline where available. Only selected fields were retained; endpoint measures were truncated to 300 characters. This is not complete trial or sponsor history. Daily snapshots begin when collection starts.

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