Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT07464145 | A Study of NDV-01 (Sustained-release Gemcitabine-docetaxel) in Participants With Non-muscle Invasive Bladder Cancer | PHASE3 | NOT YET_RECRUITING | 393 | — | — | Jun 1, 2026 | Sep 1, 2032 | Mar 11, 2026 | - | — |
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.
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
| Arm | Type | Description |
|---|---|---|
| Intermediate Risk NMIBC, NDV-01 Treatment Group | EXPERIMENTAL | NDV-01 (sustained-release gemcitabine-docetaxel) |
| Intermediate Risk NMIBC, Observation Group | NO_INTERVENTION | Surveillance with Cystoscopy, Urine Cytology, and Biopsy (if indicated) |
| BCG-Unresponsive High-Risk NMIBC, NDV-01 Treatment Group | EXPERIMENTAL | NDV-01 (sustained-release gemcitabine-docetaxel) |
| Name | Type | Description |
|---|---|---|
| NDV-01 (sustained-release gemcitabine-docetaxel) | DRUG | NDV-01 (sustained-release gemcitabine-docetaxel) |
Cohort 1 Inclusion Criteria: 1. Be ≥18 years of age (or the legal age of majority in the jurisdiction in which the study is taking place) at the time of informed consent. 2. Have a histologically confirmed diagnosis (within 90 days of randomization) of IR NMIBC based on the AUA/SUO criteria of IR N...