drugset / Trial / NCT03294304
BLASST-1 (Bladder Cancer Signal Seeking Trial): Nivolumab, Gemcitabine, and Cisplatin in Treatment of Muscle Invasive Bladder Cancer (MIBC) Undergoing Cystectomy
Phase 2
Completed
43 enrolled
Masonic Cancer Center, University of Minnesota
Bristol-Myers Squibb · collab
NaSingle-groupOpen-labelTreatment
Summary
This is a multi-center Phase II study to determine the safety and efficacy of nivolumab when given in combination with cisplatin and gemcitabine as neoadjuvant treatment in patients with muscle-invasive bladder cancer (MIBC) prior to standard of care radical cystectomy. Patients will receive neoadjuvant treatment with nivolumab in combination with gemcitabine-cisplatin (GC) every 3 weeks for 4 treatment cycles over 12 weeks followed by standard of care radical cystectomy.
Timeline
- Start
- 2018-01-29
- Primary completion
- 2020-06-05
- Completion
- 2021-07-01
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Cisplatin | Other / unclassified | 35 mg/m2 | Intravenous |
| Subject | Cisplatin | Other / unclassified | 70 mg/m2 | Intravenous |
| Subject | Gemcitabine | Small molecule | 1000 mg/m2 | Intravenous |
| Subject | Nivolumab | Monoclonal antibody | 360 mg | Intravenous |