drugset / Trial / NCT03702179

Durvalumab Plus Tremelimumab With Concurrent Radiotherapy for Localized Muscle Invasive Bladder Cancer Treated With a Selective Bladder Preservation Approach

NCT03702179 ↗

NaSequentialOpen-labelTreatment

Summary

Combined-modality treatment of localized muscle invasive bladder cancer including transurethral resection (TUR), radiotherapy and dual checkpoint inhibition immunotherapy could achieve pathological complete response in some patients. These patients could avoid to undergone radical surgery with radical cystectomy and preserve their bladder, without the side-effects associated with chemotherapy and surgery. This study has been design to determine the efficacy of durvalumab plus tremelimumab with concurrent radiotherapy in terms of pathological response rate in patients with localized muscle invasive bladder cancer treated with bladder preservation intent.

Timeline

Start
2018-11-19
Primary completion
2020-09-29
Completion
2022-08-16

Drugs

EvaluationDrugModalityDoseRoute
Subject Durvalumab Monoclonal antibody 20 mg/kg Intravenous
Subject Durvalumab Monoclonal antibody 1500 mg Intravenous
Subject Tremelimumab Monoclonal antibody 1 mg/kg Intravenous
Subject Tremelimumab Monoclonal antibody 75 mg Intravenous