drugset / Trial / NCT03871036
Improve Checkpoint-blockade Response in Advanced Urothelial Cancer
RandomizedParallel-groupOpen-labelTreatment
Summary
This trial will include metastatic urothelial carcinoma patients who progressed during or after treatment with anti-PD(L)1 therapy and have been treated by a platinum-containing regimen, or are cisplatin-ineligible. Patients will receive either paclitaxel in combination with durvalumab (anti-PDL-1) and a single dose (300 mg) of tremelimumab (anti-CTLA4), or paclitaxel with only a high dose of tremelimumab (750 mg). Tremelimumab (750 mg), without paclitaxel will be used as a comparison arm. A run-in safety phase will be followed by a non-comparative 3-arm randomized study with a Simon's 2-stage optimal design.
Timeline
- Start
- 2019-05-01
- Primary completion
- 2023-09-07
- Completion
- 2025-01-15
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Durvalumab | Monoclonal antibody | 1500 mg | — |
| Subject | Paclitaxel | Small molecule | 70 mg/m2 | — |
| Subject | Tremelimumab | Monoclonal antibody | 75 mg | — |
| Subject | Tremelimumab | Monoclonal antibody | 225 mg | — |
| Subject | Tremelimumab | Monoclonal antibody | 300 mg | — |
| Subject | Tremelimumab | Monoclonal antibody | 750 mg | — |