A Phase 3 interventional study of NDV-01 (sustained-release gemcitabine-docetaxel) in Bladder (Urothelial, Transitional Cell) Cancer Superficial (Non-Invasive), Bladder (Urothelial, Transitional Cell) Cancer and Urothelial Carcinoma Bladder, sponsored by Relmada Therapeutics, Inc.. Withdrawn. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-03-17.
Sponsored by Relmada Therapeutics, Inc. · Phase 3, Interventional, and Treatment
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.
294 studies on the registry are indexed under Non-Muscle Invasive Bladder Neoplasms; 126 are open to participants now.
Browse Non-Muscle Invasive Bladder Neoplasms studies →Relmada Therapeutics, Inc. is the lead sponsor of 11 studies on the registry; 2 are open to participants now.
Compared within Non-Muscle Invasive Bladder Neoplasms, this study's primary condition as ClinicalTrials.gg classifies it; the registry's first condition term is Neoplasms. The counts are of registry records indexed under each term, refreshed daily. How we classify →
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The diagnosis was confirmed by looking at a sample under a microscope: tissue from a biopsy or surgery (histology), or cells from a fluid or needle sample (cytology).
Your pathology report is the document that shows this.
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
Histologically or cytologically confirmed
The diagnosis was confirmed by looking at a sample under a microscope: tissue from a biopsy or surgery (histology), or cells from a fluid or needle sample (cytology).
Your pathology report is the document that shows this.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Metastases
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Intervention with NDV-01 (sustained-release gemcitabine-docetaxel)
Drug: NDV-01 (sustained-release gemcitabine-docetaxel)
Surveillance with Cystoscopy, Urine Cytology, Biopsy (if indicated)
Intravesical instillation of NDV-01 (sustained-release gemcitabine-docetaxel)
To compare DFS between study arms
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. This study will randomize 302 participants in a 1:1 randomization ratio. The primary efficacy analysis for DFS will be performed when approximately 133 DFS events have been observed. Assuming a 25% recurrence rate (hazard rate 0.14384) in the 2-year DFS in the treated arm, vs. a 40% recurrence rate (hazard rate 0.2554) in the control arm (i.e., a hazard ratio of 0.563 under the exponential distribution assumption for DFS, 53 vs. 80 events.
Time frame: From date of randomization to at least 2 years of follow-up assessing for DFS events.
No study locations are listed for this record.
Plan to share: No — Individual participant data will not be shared due to participant privacy concerns, limitations of informed consent, and regulatory and data governance constraints. De-identified aggregate results will be made publicly available through ClinicalTrials.gov and scientific publications.
Start is estimated for May 2026; primary completion for Sep 2029, 40 months later.
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This study is withdrawn, as verified in Mar 2026. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Sustained-Release Gemcitabine-Docetaxel NDV-01
Non-Muscle Invasive Bladder Neoplasms →
Relmada Therapeutics, Inc.