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
← catalyst calendarNCT07342517 · readout in 315 d
Sponsored by Relmada Therapeutics, Inc. (industry) · RLMD — their whole pipeline →.
Phase
Phase 3
Status
Withdrawn
Study type
Interventional
Design
Na · None · Treatment
Enrollment
0actual
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
Why the sponsor stopped it
This study has been incorporated into the Relmada REL-NDV01-303 study.
As filed on the registry record, in the sponsor's own words.
Dates
each axis at the precision it was filed, with the registry's own basis| Date | Filed | Basis | What it is |
|---|---|---|---|
| Start | 2026-06-30 | estimated | When the study began enrolling |
| Primary completion | 2027-06-30 | estimated | The date the last participant is measured for the primary outcome — the readout window |
| Study completion | 2028-06-30 | estimated | The whole study's end, after follow-up |
| First posted | 2026-01-15 | actual | When this record first appeared on the registry |
| Results posted | — | When the sponsor posted results to the registry | |
| Record updated | 2026-03-17 | 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 outcome
what the primary-completion date above is the date OFTo 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 12 months
Publications
- 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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