Bladder (Urothelial, Transitional Cell) CancerPhase 3RESCUENCT07342517
A Study of NDV-01 as an Intravesical Administration to Patients With BCG-Unresponsive Non-Muscle Invasive Bladder Cancer (NMIBC), Refractory to First-line Therapy
A Phase 3 study testing NDV-01 (sustained-release gemcitabine-docetaxel) in people with Bladder (Urothelial, Transitional Cell) Cancer and Bladder (Urothelial, Transitional Cell) Cancer Superficial (Non-Invasive), run by Relmada Therapeutics, Inc..
Trial summary
This is a Phase 3, open-label single-arm trial designed to evaluate the safety and efficacy of NDV-01 (sustained-release gemcitabine-docetaxel) in adult participants with NMIBC with CIS who have failed BCG therapy and who have failed first-line therapy for BCG-unresponsive NMIBC (approved or in development) and are… Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Bladder (Urothelial, Transitional Cell) Cancer, Bladder (Urothelial, Transitional Cell) Cancer Superficial (Non-Invasive), Urothelial Carcinoma Bladder
- What is being tested?
- NDV-01 (sustained-release gemcitabine-docetaxel)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- 30 Jun 2026to 30 Jun 2028
- Phase
- Phase 3
- Are there results?
- None posted in the registry
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 Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- 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 experienced 1) CIS disease within 12 months of treatment.
- Participants with BCG-unresponsive disease must have received up to two first-line therapies or BCG-unresponsive disease and who are recommended for radical cystectomy. Such therapies may include agents approved or in development (e.g., pembrolizumab, nadofaragene firodenovec, nogapendekin alfa inbakicept-pmln, cretostimogene grenadenorepvec, detalimogene voraplasmid, TARA-002, gemcitabine intravesical system (INLEXZO®), gemcitabine, MMC, or valrubicin monotherapy. Participants will have demonstrated recurrence or intolerance after one or two first-line therapy(ies).
- All specimens must be predominantly urothelial (transitional cell) carcinoma with or without squamous or glandular differentiation. Pure squamous or glandular tumors will not be included. Participants with less than 10% micropapillary histology will be included. All other variant histology (e.g. plasmacytoid, small cell, nested, trophoblastic variants) will not be included.
Who cannot join
- 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: Participant has tumor(s) involving the prostatic urethra (ductal or stromal); N+ and/or M+ per computerized tomography (CT)/Magnetic Resonance Imagery (MR) urography. History of prior T2/T3 urothelial carcinoma of the bladder.
About this study
Official title: A Phase 3 Study of NDV-01 as an Intravesical Administration to Patients With BCG-Unresponsive Non-Muscle Invasive Bladder Cancer (NMIBC), Refractory to First-line Therapy
This is a Phase 3, open-label single-arm trial designed to evaluate the safety and efficacy of NDV-01 (sustained-release gemcitabine-docetaxel) in adult participants with NMIBC with CIS who have failed BCG therapy and who have failed first-line therapy for BCG-unresponsive NMIBC (approved or in development) and are recommended for radical cystectomy.
Read the detailed description
This is a Phase 3, open-label single-arm trial designed to evaluate the safety and efficacy of NDV-01 (sustained-release gemcitabine-docetaxel) in adult participants with NMIBC with CIS who have failed BCG therapy and who have failed first-line therapy for BCG-unresponsive NMIBC (approved or in development) and are recommended for radical cystectomy.
Participants will receive an induction course and then monthly maintenance courses of NDV-1 (sustained-release gemcitabine-docetaxel) through 3 years, if there is no disease recurrence.
Participants will received an induction course of NDV-01 (6-bi-weekly intravesical instillations). Those who achieve a complete response (CR) at 3 months will be eligible for monthly maintenance instillations through year 3.
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 or until disease recurrence.
- Conditions
- Bladder (Urothelial, Transitional Cell) Cancer, Bladder (Urothelial, Transitional Cell) Cancer Superficial (Non-Invasive), Urothelial Carcinoma Bladder, Urothelial Carcinoma Recurrent, Urologic Cancer
- Being tested
- NDV-01 (sustained-release gemcitabine-docetaxel)
- Medical subject headings
- Neoplasms, Urologic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NDV-01 (sustained-release gemcitabine-docetaxel)Drug
Intravesical instillation of NDV-01 (sustained-release gemcitabine-docetaxel)
| Study group | Role | What they receive |
|---|---|---|
| NDV-01 (sustained-release gemcitabine-docetaxel) | Experimental | Drug: NDV-01 (sustained-release gemcitabine-docetaxel) Description: Intravesical instillation of NDV-01 (sustained-release gemcitabine-docetaxel) Receives: Drug: NDV-01 (sustained-release gemcitabine-docetaxel) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jan 2026
- Study start30 Jun 2026 (estimated)
- Primary completion30 Jun 2027 (estimated)
- Study completion30 Jun 2028 (estimated)
Why it stopped: This study has been incorporated into the Relmada REL-NDV01-303 study.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Bladder (Urothelial, Transitional Cell) 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 3
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- A Phase 3, Open-label Single-arm Study of NDV-01
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Relmada Therapeutics, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07342517
- Sponsor's protocol ID
- REL-NDV01-302
- Acronym
- RESCUE
- Status last verified
- Jan 2026
- First submitted
- 13 Jan 2026
- Last updated
- 17 Mar 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Steinberg RL, Thomas LJ, O'Donnell MA, Nepple KG. Sequential Intravesical Gemcitabine and Docetaxel for the Salvage Treatment of Non-Muscle Invasive Bladder Cancer. Bladder Cancer. 2015 Apr 30;1(1):65-72. doi: 10.3233/BLC-150008.
PubMed 30561441
Study at a glance
From the registry record, last updated by the sponsor on 17 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 3 Study of NDV-01 as an Intravesical Administration to Patients With BCG-Unresponsive Non-Muscle Invasive Bladder Cancer (NMIBC), Refractory to First-line Therapy
- ClinicalTrials.gov ID
- NCT07342517
- Acronym / sponsor ID
- RESCUE / REL-NDV01-302
- Conditions
- Bladder (Urothelial, Transitional Cell) Cancer, Bladder (Urothelial, Transitional Cell) Cancer Superficial (Non-Invasive), Urothelial Carcinoma Bladder, Urothelial Carcinoma Recurrent, Urologic Cancer
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: This study has been incorporated into the Relmada REL-NDV01-303 study.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Relmada Therapeutics, Inc.Industry (pharma, biotech, devices)
- Study start
- 30 Jun 2026 (estimated)
- Primary completion
- 30 Jun 2027 (estimated)
- Study completion
- 30 Jun 2028 (estimated)
- First posted
- 15 Jan 2026 (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 Phase 3, open-label single-arm trial designed to evaluate the safety and efficacy of NDV-01 (sustained-release gemcitabine-docetaxel) in adult participants with NMIBC with CIS who have failed BCG therapy and who have failed first-line therapy for BCG-unresponsive NMIBC (approved or in development) and are recommended for radical cystectomy.
Detailed description
This is a Phase 3, open-label single-arm trial designed to evaluate the safety and efficacy of NDV-01 (sustained-release gemcitabine-docetaxel) in adult participants with NMIBC with CIS who have failed BCG therapy and who have failed first-line therapy for BCG-unresponsive NMIBC (approved or in development) and are recommended for radical cystectomy.
Participants will receive an induction course and then monthly maintenance courses of NDV-1 (sustained-release gemcitabine-docetaxel) through 3 years, if there is no disease recurrence.
Participants will received an induction course of NDV-01 (6-bi-weekly intravesical instillations). Those who achieve a complete response (CR) at 3 months will be eligible for monthly maintenance instillations through year 3.
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 or until disease recurrence.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- A Phase 3, Open-label Single-arm Study of NDV-01
| Arm | Type | Receives |
|---|---|---|
| NDV-01 (sustained-release gemcitabine-docetaxel) | Experimental | Drug: NDV-01 (sustained-release gemcitabine-docetaxel)Drug: NDV-01 (sustained-release gemcitabine-docetaxel) Description: Intravesical instillation of NDV-01 (sustained-release gemcitabine-docetaxel) |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- 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 experienced 1) CIS disease within 12 months of treatment.
- Participants with BCG-unresponsive disease must have received up to two first-line therapies or BCG-unresponsive disease and who are recommended for radical cystectomy. Such therapies may include agents approved or in development (e.g., pembrolizumab, nadofaragene firodenovec, nogapendekin alfa inbakicept-pmln, cretostimogene grenadenorepvec, detalimogene voraplasmid, TARA-002, gemcitabine intravesical system (INLEXZO®), gemcitabine, MMC, or valrubicin monotherapy. Participants will have demonstrated recurrence or intolerance after one or two first-line therapy(ies).
- All specimens must be predominantly urothelial (transitional cell) carcinoma with or without squamous or glandular differentiation. Pure squamous or glandular tumors will not be included. Participants with less than 10% micropapillary histology will be included. All other variant histology (e.g. plasmacytoid, small cell, nested, trophoblastic variants) will not be included.
Key exclusion criteria (1 listed)
- 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: Participant has tumor(s) involving the prostatic urethra (ductal or stromal); N+ and/or M+ per computerized tomography (CT)/Magnetic Resonance Imagery (MR) urography. History of prior T2/T3 urothelial carcinoma of the bladder.
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 |
|---|---|---|
| NDV-01 (sustained-release gemcitabine-docetaxel)Intravesical instillation of NDV-01 (sustained-release gemcitabine-docetaxel) | Drug | NDV-01 (sustained-release gemcitabine-docetaxel) |
Primary outcome
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).
Time frame: 12 months
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
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Mar 2026.
- Background: PubMed 30561441Steinberg RL, Thomas LJ, O'Donnell MA, Nepple KG. Sequential Intravesical Gemcitabine and Docetaxel for the Salvage Treatment of Non-Muscle Invasive Bladder Cancer. Bladder Cancer. 2015 Apr 30;1(1):65-72. doi: 10.3233/BLC-150008.
- AUA/SUO Guidelines for NMIBCLink provided by the sponsor.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing NDV-01 (sustained-release gemcitabine-docetaxel) in people with Bladder (Urothelial, Transitional Cell) Cancer and Bladder (Urothelial, Transitional Cell) Cancer Superficial (Non-Invasive), run by Relmada Therapeutics, Inc..
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 3 inclusion and 1 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: withdrawn, as of the sponsor's last update on 17 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome 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). (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07342517, which also lists 1 linked publication.
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 17 Mar 2026.