drugset / Trial / NCT05203913
Cisplatin, Nab-paclitaxel, Nivolumab With Radiotherapy After Resection of Non-Metastatic Muscle Invasive Bladder Cancer
NaSingle-groupOpen-labelTreatment
Summary
In this phase II study, eligible patients will be treated with maximal tumor resection and then started treatment within 8 weeks. Chemotherapy, Nivolumab and radiotherapy (RT) will be started on day one. Chemotherapy will be administered weekly during radiotherapy. Radiotherapy will be performed from Monday to Friday for five weeks. Nivolumab will be administered for one year (13 infusions). Patients will have the complete tumour assessment by computed tomography scan (CT-scan) and cystoscopy up to 5 years after radiotherapy.
Timeline
- Start
- 2023-05-01
- Primary completion
- 2025-12-15
- Completion
- 2026-06-15
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Cisplatin | Other / unclassified | 20 mg/m2 | Intravenous |
| Subject | Nab-paclitaxel | Small molecule | 60 mg/m2 | Intravenous |
| Subject | Nivolumab | Monoclonal antibody | 480 mg | Intravenous |