drugset / Trial / NCT03558087
Gemcitabine, Cisplatin, Plus Nivolumab in Patients With Muscle-invasive Bladder Cancer With Selective Bladder Sparing
Phase 2
Completed
76 enrolled
Matthew Galsky
Bristol-Myers Squibb · collabIcahn School of Medicine at Mount Sinai · collab
NaSingle-groupOpen-labelTreatment
Summary
This is a phase 2 trial seeking to define the safety and activity of gemcitabine, cisplatin, plus nivolumab as neoadjuvant therapy in patients with muscle-invasive bladder cancer and to define the role of clinical complete response in predicting benefit in patients opting to avoid cystectomy.
Timeline
- Start
- 2018-07-13
- Primary completion
- 2024-02-16
- Completion
- 2024-03-07
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Cisplatin | Other / unclassified | 70 mg/m2 | Intravenous |
| Subject | Gemcitabine | Small molecule | 1000 mg/m2 | Intravenous |
| Subject | Nivolumab | Monoclonal antibody | 240 mg | Intravenous |