drugset / Trial / NCT04506554
A Study of Risk Enabled Therapy After Neoadjuvant Immunochemotherapy for Bladder Cancer
NaSingle-groupOpen-labelTreatment
Summary
Neoadjuvant accelerated methotrexate/vinblastine/adriamycin/cisplatin (AMVAC) in combination with nivolumab is under evaluation for the treatment of muscle invasive bladder cancer (MIBC). Patients with pre-specified tumor mutations and complete clinical response with neoadjuvant therapy will preserve their bladders and go on active surveillance.
Timeline
- Start
- 2020-12-01
- Primary completion
- 2026-05
- Completion
- 2028-11
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Cisplatin | Other / unclassified | 70 mg/m2 | Intravenous |
| Subject | Doxorubicin | Other / unclassified | 30 mg/m2 | Intravenous |
| Subject | Methotrexate | Small molecule | 30 mg/m2 | Intravenous |
| Subject | Nivolumab | Monoclonal antibody | 240 mg | Intravenous |
| Subject | Vinblastine | Small molecule | 3 mg/m2 | Intravenous |
| Background | Pegfilgrastim | Protein / enzyme biologic | — | — |