NCT06663137Phase 2Recruiting

A Study to Evaluate the Safety and Efficacy of NDV-01 in Participants With NMIBC

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 completion2027-11Estimated

Enrollment · participants70Estimated

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

~~Aug 2025~~

+ After

Nov 2027

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Study details

Conditions studied

Non Muscle Invasive Bladder Cancer

Treatments or interventions studied

NDV01 intravesical controlled release formulation of gemcitabine and docetaxelDrugAlso known as Gemcitabine and docetaxel

Primary outcomes · main study measures

Read the study measures

measure: Number of Patients with Complete Response (CR) in High-Grade NMIBC; description: Complete response is defined by at least one of the following criteria: Negative cystoscopy and negative or atypical urine cytology; and/or Positive cystoscopy with biopsy-confirmed benign or low-grade NMIBC, along with negative urine cytology.; timeFrame: 48 weeks; measure: Frequency and severity of Adverse Events (AEs), including Serious Adverse Events (SAEs) and Treatment-emergent AEs (TEAEs) occurring at any time during the study Serious Adverse Events (SAEs) Treatment-Emergent Adverse Events (TEAEs); description: Any new Change from Baseline to End of Study (EOS) in investigators assessment; timeFrame: 48 weeks

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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