A Phase 3 interventional study of NDV-01 (sustained-release gemcitabine-docetaxel) in Bladder (Urothelial, Transitional Cell) Cancer, Bladder (Urothelial, Transitional Cell) Cancer Superficial (Non-Invasive) and Urothelial Carcinoma Bladder, sponsored by Relmada Therapeutics, Inc.. Not yet recruiting. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-09-02.
Sponsored by Relmada Therapeutics, Inc. · Phase 3, Interventional, and Treatment
Study REL-NDV01-303 is a Phase 3, open-label, multi-center study to determine the safety and efficacy of NDV-01 in adult participants with NMIBC. The study will include two cohorts:
Cohort 2: an open-label, multi-center, single-arm Phase 3 study evaluating the efficacy and safety of the NDV-01 in two populations of high-risk NMIBC:
This study will evaluate the safety and efficacy of intravesical administration of NDV-01, and its effect on disease recurrence and progression in patients with NMIBC who have IR disease and have recently undergone a TURBT (Cohort 1) and in patients who have HR BCG-unresponsive disease and who have recurred after first-line therapy for BCG-unresponsive patients - both approved and in development - and are unwilling or unable to undergo radical cystectomy (Cohort 2). Both GEM and DOCE have established safety and efficacy across a range of tumor types, including IR and BCG-unresponsive NMIBC. By combining both GEM and DOCE in an intravesical extended-release formulation, Relmada believes that NDV-01 has the potential to be an agent for second-line therapy in patients who have recurred after first-line therapy in BCG-unresponsive disease, thereby avoiding radical cystectomy. This study will serve as a master protocol for all cohorts included in the study.
The study is comprised of two cohorts, described in the sections that follow.
Cohort 1 (Intermediate Risk)
Cohort 1 is a randomized, open-label, parallel group, multi-center, Phase 3 study evaluating the efficacy and safety of the NDV-01 versus observation in participants with histologically confirmed IR-NMIBC. Eligible participants must have IR-NMIBC according to the AUA/Society of Urologic Oncology (SUO) guidelines definition and at least one of the following risk factors: multiple LG tumors (Ta), solitary LG tumor >3 cm, solitary HG tumor \< 3 cm, early recurrence of LG tumor (\<1 year), frequent recurrence (>1 per year), or recurrence after prior intravesical chemotherapy. LGT1 tumors are the exception. The IR-NMIBC diagnosis qualifying the participant for the study must be within 90 days of randomization. All participants in Cohort 1 will have undergone TURBT with complete resection of all papillary diseases and will be confirmed to be disease-free within 90 days prior to randomization. All enrolled participants will have histologically confirmed IR-NMIBC.
A target of 276 participants will be randomized 1:1 (N=138 per arm) to treatment with either NDV-01 (Treatment Group) or observation (Control Group). Participants will be stratified based on 1) low-grade vs. high-grade disease and 2) the use of perioperative chemotherapy (Yes/No). Eligible participants should have had a TURBT or tumor excision within 90 days of randomization. The TURBT procedure may include a single dose of perioperative chemotherapy per the Investigators' decision and local standard of care.
Participants in the Treatment Group will have NDV-01 instilled into the bladder via a urethral catheter on Day 1 of the Treatment Phase (i.e., start of Week 0) and NDV-01 will be delivered biweekly for 12 weeks, followed by maintenance therapy once every month for up to 12 months after Day 1.
Participants in the Control Group will be observed with cystoscopy, urinary cytology, and biopsy (if indicated). Participants in the Control Group who demonstrate recurrence will be provided the option for crossover and receive treatment with NDV-01 within 12 weeks of disease recurrence. Crossover participants will begin NDV-01 instillations (within 12 weeks of recurrence) at Treatment Day 1 (see Table 2) and will complete Years 2-3 of the Follow-up Period, or will be discontinued at study closure, whichever occurs first.
Additionally, in the event of a positive study result (compelling results for disease-free survival [DFS]) at any of the planned analyses, and upon further notification by the Sponsor at the discretion of the IDMC, participants in the Control Group may have the opportunity to crossover and receive NDV-01 for up to one year.
For all participants, an End of Treatment (EOT) visit will take place at the time of the last dose of the participant's randomized treatment, observation, or discontinuation of study treatment (±1 week). After the EOT visit, participants will continue into the Follow-up Phase of the study, comprised of a 30-day Safety Follow-Up Period (30 days [+1 week] from EOT), and a follow-up period of 2 to 5 years, culminating at the time of death, withdrawal of consent, or end of study, whichever occurs first.
The end of study is considered as 5 years after the last participant is randomized in the study. This will ensure approximately 4 years of follow-up after the final dose of study drug.
Cohort 2 (HR BCG-Unresponsive Disease Refractory to First-Line Therapies)
Cohort 2 is an open-label, multicenter, single-arm, Phase 3 study evaluating the efficacy and safety of NDV-01 in two high-risk NIMBC populations:
All participants in Cohort 2 will undergo a screening Period of up to 28 days and will receive study drug on Days 1, 14, 28, 42, 56, and 70. Participants will then have a Day 90 disease assessment visit, which should occur within 20 days (±5 days) of the Day 70 instillation of NDV-01.
At Day 90:
Participants without CR (non-responders) at Day 180 will discontinue treatment. Additionally, participants who do not maintain CR any time after Day 180 will discontinue treatment.
Participants demonstrating CR at the Day 180 (±4 days) Disease Assessment visit will receive NDV-01 monthly maintenance instillations from Day 180 to Day 1080 or until disease recurrence. Disease Assessment visits will be performed every 3 months.
Participants who are non-responders and come off treatment will be followed for safety for 8 weeks, and after the 8-week assessment visit, they will be followed by telephone call every 3 months until 1 year after the EOT Visit to determine treatment and cystectomy-related information. Tissue from participants who elect to undergo cystectomy may be analyzed for exploratory purposes, if available.
Participants who have continued CR at Day 360 may continue with monthly Maintenance instillations through Day 1080 (with maintained CR) or enter the Follow-Up Period for quarterly visits (every 3 months) through Day 1080 or until non-response (persistent disease, recurrent disease, or progression). Participants will undergo an End of Treatment visit following the last Maintenance Treatment instillation.
294 studies on the registry are indexed under Non-Muscle Invasive Bladder Neoplasms; 126 are open to participants now.
This study's planned enrollment of 393 is above the median of 62 across 231 interventional studies indexed under Non-Muscle Invasive Bladder Neoplasms.
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 →
Cohort 1 Inclusion Criteria:
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 cystoscopic method [e.g., blue light cystoscopy, narrow-band imaging]).
All pathology specimens must be predominantly urothelial (transitional cell) and have less than 20% variant (e.g., sarcomatoid, squamous component) histology.
Cohort 1 Exclusion Criteria:
Cohort 2 Inclusion Criteria:
Cohort 2a: BCG-unresponsive NMIBC with CIS of the bladder, with or without coexisting papillary Ta/T1 tumor(s) who are ineligible for or have elected not to undergo cystectomy at the time of enrollment and have received 1 or 2 after meeting criteria for BCG unresponsiveness and experienced confirmed CIS disease within 12 months of last treatment, where:
Cohort 2b: BCG-unresponsive NMIBC of the bladder, with papillary Ta/T1 tumor(s) and without co-existing CIS, who are ineligible for or have elected not to undergo cystectomy at the time of enrollment and have experienced recurrent Ta/T1 disease within 12 months of treatment with 1 or 2 lines of therapy after BCG-unresponsive status.
All Cohort 2
Cohort 2 Exclusion Criteria:
Has had urothelial carcinoma outside of the urinary bladder (i.e., 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 and is considered to be without evidence of recurrent disease.
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.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
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.
A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.
Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Neoadjuvant treatment is given before the main treatment (usually surgery), often to shrink a tumour. Adjuvant treatment is given after it, to lower the chance of the cancer coming back.
A line of therapy is one course of treatment, which may combine several drugs. First-line is the first course given; second-line follows when that stops working or is not tolerated.
“Two prior lines” means two courses that count separately under the study’s rules — not simply two drugs. Ask the study team if you are unsure how yours are counted.
A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.
Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
ECOG performance status
A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.
Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.
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.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Adjuvant and neoadjuvant
Neoadjuvant treatment is given before the main treatment (usually surgery), often to shrink a tumour. Adjuvant treatment is given after it, to lower the chance of the cancer coming back.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Line of therapy
A line of therapy is one course of treatment, which may combine several drugs. First-line is the first course given; second-line follows when that stops working or is not tolerated.
“Two prior lines” means two courses that count separately under the study’s rules — not simply two drugs. Ask the study team if you are unsure how yours are counted.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Biopsy and archival tissue
A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.
Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
NDV-01 (sustained-release gemcitabine-docetaxel)
Drug: NDV-01 (sustained-release gemcitabine-docetaxel)
Surveillance with Cystoscopy, Urine Cytology, and Biopsy (if indicated)
NDV-01 (sustained-release gemcitabine-docetaxel)
Drug: NDV-01 (sustained-release gemcitabine-docetaxel)
NDV-01 (sustained-release gemcitabine-docetaxel)
Disease Free Survival in participants with Intermediate Risk NMIBC
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.
Time frame: From date of randomization to at least 2 years of follow-up assessing for DFS events.
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).
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
Time frame: From date of randomization through 3 years of follow-up assessing for CR.
No study locations are listed for this record.
Plan to share: No
This study is not yet recruiting, as verified in Aug 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.