Bladder (Urothelial, Transitional Cell) Cancer Superficial (Non-Invasive)Phase 3BOOSTNCT07313891
A Study of Adjuvant NDV-01 (Sustained-release Gemcitabine-docetaxel) for the Treatment of Intermediate Risk NMIBC Following TURBT
A Phase 3 study testing NDV-01 (sustained-release gemcitabine-docetaxel) in people with Bladder (Urothelial, Transitional Cell) Cancer Superficial (Non-Invasive) and Bladder (Urothelial, Transitional Cell) Cancer, run by Relmada Therapeutics, Inc..
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Bladder (Urothelial, Transitional Cell) Cancer Superficial (Non-Invasive), Bladder (Urothelial, Transitional Cell) Cancer, 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
- 1 May 2026to 1 Nov 2029
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Have a histologically confirmed diagnosis (within 90 days of randomization) of IR NMIBC based on the AUA/SUO criteria of IR NMIBC.
- Participants must have ≥ 1 IBCG risk factors: multiple tumors, early recurrence (Within 1 year), frequent recurrences (> 1 per year), tumor size (> 3 cm), failure of prior intravesical therapy.
- 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 assessment method).
- Patients with LG T1 may be eligible after repeat-TURBT (within 4 weeks of first TURBT) if the repeat pathology shows non-invasive (Ta or less) or no disease. Original and repeat-TURBT must confirm that muscularis propria is present and uninvolved in the specimen. TURBT to occur within 4 months of screening. All pathology specimens must be predominantly urothelial (transitional cell) and have less than 20% variant (e.g., sarcomatoid, squamous component) histology.
Who cannot join
- Histologically confirmed diagnosis of HR NMIBC (including CIS) or MIBC, locally advanced, nonresectable, or metastatic urothelial carcinoma at any time prior to enrollment.
- Has had urothelial carcinoma outside of the urinary bladder, (including prostatic 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 CT/MR urography.
About this study
Official title: A Phase 3, Randomized Study Evaluating the Efficacy and Safety of NDV-01 Versus Observation in Participants With Intermediate-risk Non-muscle Invasive Bladder Cancer (BOOST)
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.
Read the detailed description
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.
- Conditions
- Bladder (Urothelial, Transitional Cell) Cancer Superficial (Non-Invasive), Bladder (Urothelial, Transitional Cell) Cancer, Urothelial Carcinoma Bladder, Urologic Cancer
- Being tested
- NDV-01 (sustained-release gemcitabine-docetaxel)
- Keywords
- NMIBC; non-muscle-invasive bladder cancer; bladder cancer
- Medical subject headings
- Neoplasms, Urologic Neoplasms, Non-Muscle Invasive Bladder Neoplasms, Urinary Bladder 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 |
|---|---|---|
| Arm A: NDV-01 (sustained-release gemcitabine-docetaxel) | Experimental | Intervention with NDV-01 (sustained-release gemcitabine-docetaxel) Receives: Drug: NDV-01 (sustained-release gemcitabine-docetaxel) |
| Arm B: surveillance | No intervention | Surveillance with Cystoscopy, Urine Cytology, Biopsy (if indicated) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: From date of randomization to at least 2 years of follow-up assessing for DFS events.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jan 2026
- Study start1 May 2026 (estimated)
- Primary completion1 Sep 2029 (estimated)
- Study completion1 Nov 2029 (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 (2)Papers the sponsor has linked to this study.
- Other trials for Bladder (Urothelial, Transitional Cell) Cancer Superficial (Non-Invasive)Studies 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
- Randomised
- Intervention model
- Parallel groups
- Model description
- A Phase 3, Open-label Randomized Study
- 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
- Investigators
- Raj S Pruthi, MD MHA, Study director, Relmada Therapeutics
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07313891
- Sponsor's protocol ID
- REL-NDV01-301
- Acronym
- BOOST
- Status last verified
- Mar 2026
- First submitted
- 29 Dec 2025
- Last updated
- 17 Mar 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- 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.
Publications
Tan WS, McElree IM, Davaro F, Steinberg RL, Bree K, Navai N, Dinney CP, O'Donnell MA, Li R, Kamat AM, Packiam VT. Sequential Intravesical Gemcitabine and Docetaxel is an Alternative to Bacillus Calmette-Guerin for the Treatment of Intermediate-risk Non-muscle-invasive Bladder Cancer. Eur Urol Oncol. 2023 Oct;6(5):531-534. doi: 10.1016/j.euo.2023.06.011. Epub 2023 Jul 18.
PubMed 37468392Holzbeierlein JM, Bixler BR, Buckley DI, Chang SS, Holmes R, James AC, Kirkby E, McKiernan JM, Schuckman AK. Diagnosis and Treatment of Non-Muscle Invasive Bladder Cancer: AUA/SUO Guideline: 2024 Amendment. J Urol. 2024 Apr;211(4):533-538. doi: 10.1097/JU.0000000000003846. Epub 2024 Jan 24.
PubMed 38265030
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, Randomized Study Evaluating the Efficacy and Safety of NDV-01 Versus Observation in Participants With Intermediate-risk Non-muscle Invasive Bladder Cancer (BOOST)
- ClinicalTrials.gov ID
- NCT07313891
- Acronym / sponsor ID
- BOOST / REL-NDV01-301
- Conditions
- Bladder (Urothelial, Transitional Cell) Cancer Superficial (Non-Invasive), Bladder (Urothelial, Transitional Cell) Cancer, Urothelial Carcinoma Bladder, Urologic Cancer
- Keywords
- NMIBC; non-muscle-invasive bladder cancer; bladder 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
- 1 May 2026 (estimated)
- Primary completion
- 1 Sep 2029 (estimated)
- Study completion
- 1 Nov 2029 (estimated)
- First posted
- 2 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, 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.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- A Phase 3, Open-label Randomized Study
| Arm | Type | Receives |
|---|---|---|
| Arm A: NDV-01 (sustained-release gemcitabine-docetaxel) | Experimental | Drug: NDV-01 (sustained-release gemcitabine-docetaxel)Intervention with NDV-01 (sustained-release gemcitabine-docetaxel) |
| Arm B: surveillance | No intervention | –Surveillance with Cystoscopy, Urine Cytology, Biopsy (if indicated) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Have a histologically confirmed diagnosis (within 90 days of randomization) of IR NMIBC based on the AUA/SUO criteria of IR NMIBC.
- Participants must have ≥ 1 IBCG risk factors: multiple tumors, early recurrence (Within 1 year), frequent recurrences (> 1 per year), tumor size (> 3 cm), failure of prior intravesical therapy.
- 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 assessment method).
- Patients with LG T1 may be eligible after repeat-TURBT (within 4 weeks of first TURBT) if the repeat pathology shows non-invasive (Ta or less) or no disease. Original and repeat-TURBT must confirm that muscularis propria is present and uninvolved in the specimen. TURBT to occur within 4 months of screening. All pathology specimens must be predominantly urothelial (transitional cell) and have less than 20% variant (e.g., sarcomatoid, squamous component) histology.
Key exclusion criteria (4 listed)
- Histologically confirmed diagnosis of HR NMIBC (including CIS) or MIBC, locally advanced, nonresectable, or metastatic urothelial carcinoma at any time prior to enrollment.
- Has had urothelial carcinoma outside of the urinary bladder, (including prostatic 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 CT/MR urography.
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 | Arm A: NDV-01 (sustained-release gemcitabine-docetaxel) |
Primary outcome
To compare DFS between study arms
Time frame: From date of randomization to at least 2 years of follow-up assessing for DFS events.
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.
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.
- Results publication: PubMed 37468392Tan WS, McElree IM, Davaro F, Steinberg RL, Bree K, Navai N, Dinney CP, O'Donnell MA, Li R, Kamat AM, Packiam VT. Sequential Intravesical Gemcitabine and Docetaxel is an Alternative to Bacillus Calmette-Guerin for the Treatment of Intermediate-risk Non-muscle-invasive Bladder Cancer. Eur Urol Oncol. 2023 Oct;6(5):531-534. doi: 10.1016/j.euo.2023.06.011. Epub 2023 Jul 18.
- Results publication: PubMed 38265030Holzbeierlein JM, Bixler BR, Buckley DI, Chang SS, Holmes R, James AC, Kirkby E, McKiernan JM, Schuckman AK. Diagnosis and Treatment of Non-Muscle Invasive Bladder Cancer: AUA/SUO Guideline: 2024 Amendment. J Urol. 2024 Apr;211(4):533-538. doi: 10.1097/JU.0000000000003846. Epub 2024 Jan 24.
- AUA/SUO Guidelines for NMIBCLink provided by the sponsor.
- Individual participant dataSharing planned: 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.
Related trials for Bladder (Urothelial, Transitional Cell) Cancer Superficial (Non-Invasive)
Not yet recruitingPhase 3
A Study of NDV-01 (Sustained-release Gemcitabine-docetaxel) in Participants With Non-muscle Invasive Bladder Cancer
Bladder (Urothelial, Transitional Cell) Cancer, Bladder (Urothelial, Transitional Cell) Cancer Superficial (Non-Invasive)
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.
Raj S Pruthi, MD MHA study director
Relmada Therapeutics
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 Superficial (Non-Invasive) and Bladder (Urothelial, Transitional Cell) Cancer, 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 4 inclusion and 4 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 compare DFS between study arms (time frame: From date of randomization to at least 2 years of follow-up assessing for DFS events.). 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 NCT07313891, which also lists 2 linked publications.
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.