Phase II Study of Cisplatin, Nab-paclitaxel, and Nivolumab with Radiotherapy After Maximal Tumor Removal in Non-Metastatic Muscle Invasive Bladder Cancer

What this Trial Is About

This research aims to evaluate the combination of cisplatin, nab-paclitaxel, and nivolumab with radiotherapy following maximal tumor removal in patients with non-metastatic muscle invasive bladder cancer. This phase II study focuses on patients who have undergone surgery and seeks to assess disease-free survival over a period of up to five years. Participants will receive chemotherapy drugs cisplatin and nab-paclitaxel weekly during a five-week course of radiotherapy, which is delivered Monday through Friday. Nivolumab infusions begin on the first day of radiotherapy and continue every four weeks for a total of 13 infusions over one year. After completing the combined chemo-radiotherapy, patients continue nivolumab treatment alone until the end of the planned cycles. Throughout the study, patients will undergo regular tumor assessments using CT scans and cystoscopies for up to five years after radiotherapy. Follow-up imaging and evaluations occur every 16 weeks for the first two years and every six months thereafter. Safety, quality of life, and treatment-related side effects will be monitored, with ongoing assessments up to 30 days after treatment completion and long-term follow-up extending to five years.

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