drugset / Trial / NCT03702179
Durvalumab Plus Tremelimumab With Concurrent Radiotherapy for Localized Muscle Invasive Bladder Cancer Treated With a Selective Bladder Preservation Approach
Phase 2
Completed
32 enrolled
Spanish Oncology Genito-Urinary Group
AstraZeneca · collabMFAR · collab
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
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| 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 |