drugset / Trial / NCT04876313
An Open Label, Single-arm, Phase 2 Study of Neoadjuvant Nivolumab and Nab-paclitaxel Before Radical Cystectomy for Patients With Muscle-invasive Bladder Cancer (NURE-Combo)
NaSingle-groupOpen-labelTreatment
Summary
To assess whether nivolumab+nab-paclitaxel combination results in patients with muscle-invasive bladder cancer
Timeline
- Start
- 2022-01-27
- Primary completion
- 2024-12
- Completion
- 2025-06
Outcome
Met primary endpoint
paper The trial met its primary end point: 10 patients (32.3%; 95% CI, 16.7 to 51.4) achieved an ypT0N0 response. PMID 39241203 ↗
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Nab-paclitaxel | Small molecule | 125 mg/m2 | Intravenous |
| Subject | Nivolumab | Monoclonal antibody | 360 mg | Intravenous |