Non Muscle Invasive Bladder CancerPhase 2NMIBCNCT06663137
A Study to Evaluate the Safety and Efficacy of NDV-01 in Participants With NMIBC
A Phase 2 study of Non Muscle Invasive Bladder Cancer, run by Relmada Therapeutics, Inc. at 1 site in Israel.
Trial summary
This is a prospective, single-arm study evaluating the safety and efficacy of NDV01 KIT, a fixed-dose combination of gemcitabine HCl and docetaxel, administered via intravesical instillation in patients with high-grade Non-Muscle Invasive Bladder Cancer (NMIBC). Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Non Muscle Invasive Bladder Cancer
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 1 siteIsrael
- Study dates
- 1 Aug 2024to Dec 2027
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Aged 18 - 80 years old
- Able to give informed consent
- Histologically confirmed diagnosis of high grade non-muscle invasive bladder cancer (NMIBC) - patients having high-grade disease at first evaluation after induction BCG alone (at least 5 of 6 doses) may qualify in the absence of disease progression.
- Participants must be ineligible for or have elected not to undergo radical cystectomy.
- Available for the whole duration of the study.
- Life expectancy >2 years, in the opinion of the investigator.
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- Eastern Cooperative Oncology Group (ECOG) status 2 or less.
- Absence of concomitant upper tract urothelial carcinoma or urothelial carcinoma within the prostatic urethra. Freedom from upper tract disease (if clinically indicated) as indicated by no evidence of upper tract tumor by either intravenous pyelogram, retrograde pyelogram, computed tomography (CT) scan with or without urogram, or MRI with or without urogram performed within 6 months of enrolment.
- Patients with prostate cancer on active surveillance at low risk for progression, defined as Prostate-Specific Antigen (PSA) < 10 ng/dL, Gleason score 6 and clinical stage tumor-1 (cT1) are permitted to be in the study at the discretion of the investigator (see exclusion criterion 10).
- Female patients of childbearing potential must use maximally effective birth control during the period of therapy, must be willing to use contraception for 1 month following the last study drug infusion and must have a negative urine or serum pregnancy test upon entry into this study. Otherwise, female patients must be postmenopausal (no menstrual period for a minimum of 12 months) or surgically sterile. 'Maximally effective birth control' means that the patient, if sexually active, should be using a combination of two methods of birth control that are approved and recognized to be effective by Regulatory Agencies.
Who cannot join
- Current or previous evidence of muscle invasive (muscularis propria) or metastatic disease presented. Examples that increase the risk of metastatic disease are (but not limited to):
- Presence of lymphovascular invasion and/micropapillary disease as shown in the histology of the biopsy sample.
- Patients with T1 disease accompanied by the presence of hydronephrosis secondary to the primary tumor - Unless scheduled for treatment like nephrostomy or JJ stent insertion..
- Current systemic therapy for bladder cancer.
- Symptomatic urinary tract infection or bacterial cystitis (once satisfactorily treated, patients can enter the study).
- Clinically significant and unexplained elevated liver or renal function tests.
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- Women who are pregnant or lactating or refuse to commit to using contraception anytime during the study.
- Any other significant disease or other clinical findings which in the investigator's opinion would prevent study entry.
- History of malignancy of other organ system within past 5 years, except treated basal cell carcinoma or squamous cell carcinoma of the skin and ≤ pathological tumor-2 (pT2) upper tract urothelial carcinoma at least 24 months after nephroureterectomy.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Israel1 site, 1 recruiting
- Recruiting
Relmada Site
Raanana, 4363007
Boris Chertin
About this study
Official title: A Single-Center, Open Label, Single Arm Study, to Evaluate the Safety and Efficacy of NDV-01 KIT in Participants With Non Muscle Invasive Bladder Cancer (NMIBC)
This is a prospective, single-arm study evaluating the safety and efficacy of NDV01 KIT, a fixed-dose combination of gemcitabine HCl and docetaxel, administered via intravesical instillation in patients with high-grade Non-Muscle Invasive Bladder Cancer (NMIBC). NDV01 KIT includes 60 mL Carbopol Gel followed by 15 g NDV01 solution (gemcitabine HCl 1000 mg and docetaxel 40 mg), administered biweekly for six treatments, followed by monthly maintenance therapy for up to 12 months. The study includes a pharmacokinetic (PK) sub-study assessing systemic exposure to NDV01's active ingredients.
Read the detailed description
Eligible patients who sign informed consent will receive intravesical treatment with NDV01 KIT, consisting of a sequential instillation of Carbopol Gel followed by NDV01 solution using a 14F urethral catheter. The treatment phase includes six instillations on Days 1, 14, 28, 42, 56, and 70. Primary Disease Evaluation (PDE) will be conducted on Day 100 (±3). Patients achieving a complete response may continue into a maintenance phase with monthly instillations through Month 12.
Maintenance period of monthly treatments on Day 107, Day 140, Day 187, Day 220, Day 250, Day 287, Day 310, and Day 340.
The Primary Disease Evaluation (PDE) will be performed on Study Day 100±3.
A subset of patients will participate in a PK sub-study involving up to 15 blood draws to assess systemic levels of gemcitabine and docetaxel during the first treatment cycle.
Primary Objectives:
Assess safety of NDV01 KIT through the study period. Evaluate the complete response (CR) rate in patients with high-grade NMIBC.
Secondary Objectives:
Assess the durability of CR. Evaluate event-free survival (defined as high-grade recurrence-free survival). Assess the durability of event-free survival. Determine incidence and time to cystectomy. Determine overall survival. Monitor response durability through long-term follow-up.
Exploratory Objective:
Evaluate pharmacokinetic parameters of NDV01 KIT in a subset of patients during the initial treatment phase.
A subject that fails to meet CR at PDE visit will undergo reinduction of 6 biweekly installations of NDV01, which will be followed by maintenance treatments per the protocol schedule.
- Conditions
- Non Muscle Invasive Bladder Cancer
- Being tested
- NDV01 intravesical controlled release formulation of gemcitabine and docetaxel
- Medical subject headings
- Non-Muscle Invasive Bladder Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NDV01 intravesical controlled release formulation of gemcitabine and docetaxelDrug
Also called Gemcitabine and docetaxel
NDV01 is administered intravesically using a catheter.
| Study group | Role | What they receive |
|---|---|---|
| NDV01 | Experimental | 1. Treatment phase: 6 biweekly instillations - six instillations on Days 1, 14, 28, 42, 56, and 70
2. Maintenance phase: monthly administration - maintenance period of monthly treatments on Day 107, Day 140, Day 187, Day 220, Day 250, Day 287, Day 310, and Day 340
A subject that fails to meet CR at PDE visit will undergo reinduction of 6 biweekly installations of NDV01, which will be followed by maintenance treatments per the protocol schedule. Receives: Drug: NDV01 intravesical controlled release formulation of gemcitabine and docetaxel |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Patients with Complete Response (CR) in High-Grade NMIBC
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.
Measured: 48 weeks
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)
Any new Change from Baseline to End of Study (EOS) in investigators assessment
Measured: 48 weeks
Secondary outcomes (4)
Durability of Complete Response (CR) in High-Grade NMIBC
Evaluate how long patients maintain CR over time.
Measured: 48 weeks
Number of Patients with CR Among Those with Carcinoma In Situ (CIS)
Includes those with or without co-existing high-grade Ta or T1 papillary disease.
Measured: 48 weeks
Incidence of Event-Free Survival (EFS) at 12 Months
Event-free survival is defined as survival without recurrence of high-grade disease.
Measured: 48 weeks
Durability of event-free survival in patients with high-grade Ta or T1 papillary disease (without concomitant CIS), who have no recurrence of high-grade Ta or T1 papillary disease
Tumor recurrence
Measured: 48 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Oct 2024
- Study start1 Aug 2024
- Primary completionNov 2027 (estimated)
- Study completionDec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Non Muscle Invasive Bladder CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Open label, single arm
- Masking
- None (open label)
- Enrolment
- 70 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Relmada Therapeutics, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Boris Chertin, Principal investigator, Head of Urology Dep Share Tzedek Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06663137
- Sponsor's protocol ID
- TRGC-011
- Acronym
- NMIBC
- Status last verified
- Aug 2026
- First submitted
- 8 Aug 2024
- Last updated
- 2 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Not yet
Study at a glance
From the registry record, last updated by the sponsor on 2 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single-Center, Open Label, Single Arm Study, to Evaluate the Safety and Efficacy of NDV-01 KIT in Participants With Non Muscle Invasive Bladder Cancer (NMIBC)
- ClinicalTrials.gov ID
- NCT06663137
- Acronym / sponsor ID
- NMIBC / TRGC-011
- Conditions
- Non Muscle Invasive Bladder Cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- Relmada Therapeutics, Inc.Industry (pharma, biotech, devices)
- Study start
- 1 Aug 2024 (actual)
- Primary completion
- Nov 2027 (estimated)
- Study completion
- Dec 2027 (estimated)
- First posted
- 29 Oct 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a prospective, single-arm study evaluating the safety and efficacy of NDV01 KIT, a fixed-dose combination of gemcitabine HCl and docetaxel, administered via intravesical instillation in patients with high-grade Non-Muscle Invasive Bladder Cancer (NMIBC). NDV01 KIT includes 60 mL Carbopol Gel followed by 15 g NDV01 solution (gemcitabine HCl 1000 mg and docetaxel 40 mg), administered biweekly for six treatments, followed by monthly maintenance therapy for up to 12 months. The study includes a pharmacokinetic (PK) sub-study assessing systemic exposure to NDV01's active ingredients.
Detailed description
Eligible patients who sign informed consent will receive intravesical treatment with NDV01 KIT, consisting of a sequential instillation of Carbopol Gel followed by NDV01 solution using a 14F urethral catheter. The treatment phase includes six instillations on Days 1, 14, 28, 42, 56, and 70. Primary Disease Evaluation (PDE) will be conducted on Day 100 (±3). Patients achieving a complete response may continue into a maintenance phase with monthly instillations through Month 12.
Maintenance period of monthly treatments on Day 107, Day 140, Day 187, Day 220, Day 250, Day 287, Day 310, and Day 340.
The Primary Disease Evaluation (PDE) will be performed on Study Day 100±3.
A subset of patients will participate in a PK sub-study involving up to 15 blood draws to assess systemic levels of gemcitabine and docetaxel during the first treatment cycle.
Primary Objectives:
Assess safety of NDV01 KIT through the study period. Evaluate the complete response (CR) rate in patients with high-grade NMIBC.
Secondary Objectives:
Assess the durability of CR. Evaluate event-free survival (defined as high-grade recurrence-free survival). Assess the durability of event-free survival. Determine incidence and time to cystectomy. Determine overall survival. Monitor response durability through long-term follow-up.
Exploratory Objective:
Evaluate pharmacokinetic parameters of NDV01 KIT in a subset of patients during the initial treatment phase.
A subject that fails to meet CR at PDE visit will undergo reinduction of 6 biweekly installations of NDV01, which will be followed by maintenance treatments per the protocol schedule.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Open label, single arm
| Arm | Type | Receives |
|---|---|---|
| NDV01 | Experimental | Drug: NDV01 intravesical controlled release formulation of gemcitabine and docetaxel1. Treatment phase: 6 biweekly instillations - six instillations on Days 1, 14, 28, 42, 56, and 70 2. Maintenance phase: monthly administration - maintenance period of monthly treatments on Day 107, Day 140, Day 187, Day 220, Day 250, Day 287, Day 310, and Day 340 A subject that fails to meet CR at PDE visit will undergo reinduction of 6 biweekly installations of NDV01, which will be followed by maintenance treatments per the protocol schedule. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Aged 18 - 80 years old
- Able to give informed consent
- Histologically confirmed diagnosis of high grade non-muscle invasive bladder cancer (NMIBC) - patients having high-grade disease at first evaluation after induction BCG alone (at least 5 of 6 doses) may qualify in the absence of disease progression.
- Participants must be ineligible for or have elected not to undergo radical cystectomy.
- Available for the whole duration of the study.
Key exclusion criteria (9 listed)
- Current or previous evidence of muscle invasive (muscularis propria) or metastatic disease presented. Examples that increase the risk of metastatic disease are (but not limited to):
- Presence of lymphovascular invasion and/micropapillary disease as shown in the histology of the biopsy sample.
- Patients with T1 disease accompanied by the presence of hydronephrosis secondary to the primary tumor - Unless scheduled for treatment like nephrostomy or JJ stent insertion..
- Current systemic therapy for bladder cancer.
- Symptomatic urinary tract infection or bacterial cystitis (once satisfactorily treated, patients can enter the study).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| NDV01 intravesical controlled release formulation of gemcitabine and docetaxelAlso: Gemcitabine and docetaxelNDV01 is administered intravesically using a catheter. | Drug | NDV01 |
Primary outcome
Number of Patients with Complete Response (CR) in High-Grade NMIBC
Time frame: 48 weeks
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.
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)
Time frame: 48 weeks
Any new Change from Baseline to End of Study (EOS) in investigators assessment
4 secondary outcomes
Durability of Complete Response (CR) in High-Grade NMIBC
Time frame: 48 weeks
Number of Patients with CR Among Those with Carcinoma In Situ (CIS)
Time frame: 48 weeks
Incidence of Event-Free Survival (EFS) at 12 Months
Time frame: 48 weeks
Durability of event-free survival in patients with high-grade Ta or T1 papillary disease (without concomitant CIS), who have no recurrence of high-grade Ta or T1 papillary disease
Time frame: 48 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Sep 2026.
- Individual participant dataSharing planned: No. Not yet
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Boris Chertin principal investigator
Head of Urology Dep Share Tzedek Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study of Non Muscle Invasive Bladder Cancer, run by Relmada Therapeutics, Inc. at 1 site in Israel.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 2 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Scott White (+1 646-428-5264, swhite@relmada.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Patients with Complete Response (CR) in High-Grade NMIBC (time frame: 48 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Sep 2026.