drugset / Trial / NCT02812420
Durvalumab and Tremelimumab in Treating Patients With Muscle-Invasive, High-Risk Urothelial Cancer That Cannot Be Treated With Cisplatin-Based Therapy Before Surgery
Phase 0
Active not recruiting
54 enrolled
M.D. Anderson Cancer Center
National Cancer Institute (NCI) · collab
NaSingle-groupOpen-labelTreatment
Summary
This pilot phase I trial studies the side effects of durvalumab and tremelimumab in treating patients with muscle-invasive, high-risk urothelial cancer that cannot be treated with cisplatin-based therapy before surgery. Immunotherapy with monoclonal antibodies, such as durvalumab and tremelimumab, may induce changes in the body's immune system and may interfere with the ability of tumor cells to grow and spread.
Timeline
- Start
- 2017-03-07
- Primary completion
- 2027-12-31
- Completion
- 2027-12-31
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Durvalumab | Monoclonal antibody | — | Intravenous |
| Subject | Tremelimumab | Monoclonal antibody | — | Intravenous |
Indications
hydronephrosis
infiltrating bladder urothelial carcinoma sarcomatoid variant
kidney pelvis sarcomatoid transitional cell carcinoma
micropapillary variant infiltrating bladder urothelial carcinoma
plasmacytoid variant infiltrating bladder urothelial carcinoma
ureter transitional cell carcinoma
urethra transitional cell carcinoma