A Study of NDV-01 (Sustained-release Gemcitabine-docetaxel) in Participants With Non-muscle Invasive Bladder Cancer
← catalyst calendarNCT07464145 · readout ≤ 1,138 d
Sponsored by Relmada Therapeutics, Inc. (industry) · RLMD — their whole pipeline →.
Phase
Phase 3
Status
Not yet recruiting
Study type
Interventional
Design
Randomized · None · Treatment
Enrollment
393estimated
Every value on this page is a field the sponsor filed with ClinicalTrials.gov, reproduced. Dates are their own estimates, revised as a study runs, unless the registry marks them actual. sources →
Source: ClinicalTrials.gov, retrieved 2026-08-19
Dates
each axis at the precision it was filed, with the registry's own basis| Date | Filed | Basis | What it is |
|---|---|---|---|
| Start | Jun 2026 | estimated | When the study began enrolling |
| Primary completion | Sep 2029 | estimated | The date the last participant is measured for the primary outcome — the readout window |
| Study completion | Sep 2032 | estimated | The whole study's end, after follow-up |
| First posted | 2026-03-11 | actual | When this record first appeared on the registry |
| Results posted | — | When the sponsor posted results to the registry | |
| Record updated | 2026-03-11 | actual | The sponsor's own last edit to this record — every projection above is as current as this date |
What it studies
Conditions
- Bladder (Urothelial, Transitional Cell) Cancer
- Bladder (Urothelial, Transitional Cell) Cancer Superficial (Non-Invasive)
- Urothelial Carcinoma Bladder
- Urothelial Carcinoma Recurrent
- Urologic Cancer
Intervention
- Drug: NDV-01 (sustained-release gemcitabine-docetaxel)
Primary outcomes
what the primary-completion date above is the date OFDisease Free Survival in participants with Intermediate Risk NMIBC
measured 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).
measured From date of randomization through 3 years of follow-up assessing for CR.
Publications
- PMID 38265030 — cited as background
- PMID 37468392 — cited as background
- PMID 30561441 — cited as background
Linked on the registry record. A “linked by the registry” entry is NLM's own automated PubMed match, not a claim by the sponsor that the paper reports this study.
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