drugset / Trial / NCT05203913

Cisplatin, Nab-paclitaxel, Nivolumab With Radiotherapy After Resection of Non-Metastatic Muscle Invasive Bladder Cancer

NCT05203913 ↗

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

EvaluationDrugModalityDoseRoute
Subject Cisplatin Other / unclassified 20 mg/m2 Intravenous
Subject Nab-paclitaxel Small molecule 60 mg/m2 Intravenous
Subject Nivolumab Monoclonal antibody 480 mg Intravenous