drugset / Trial / NCT04322643
Intermittent Checkpoint Inhibitor Therapy In Patients With Advanced Urothelial Carcinoma
NaSingle-groupOpen-labelTreatment
Summary
The purpose of this study is to test the safety and effectiveness of immunotherapy (checkpoint inhibitor therapy) in advanced bladder cancer when given intermittently. An unanswered question with the use of CPI (checkpoint inhibitor) is the duration of therapy required for optimal clinical benefit. In the absence of progressive disease or unacceptable toxicities, there are currently no specified criteria for treatment discontinuation. Strategies to reduce toxicity and maximize benefit require investigation. Thus, novel dosing schedules, early discontinuation considerations, and biomarkers of response are needed to identify patients who can sustain disease regression while off of therapy.
Timeline
- Start
- 2020-03-23
- Primary completion
- 2022-08-08
- Completion
- 2023-04-17
Outcome
Outcome not reported
Stopped: “PI preference”
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Atezolizumab | Monoclonal antibody | 1200 mg | Intravenous |
| Subject | Avelumab | Monoclonal antibody | 800 mg | Intravenous |
| Subject | Durvalumab | Monoclonal antibody | 10 mg/kg | Intravenous |
| Subject | Nivolumab | Monoclonal antibody | 480 mg | Intravenous |
| Subject | Pembrolizumab | Monoclonal antibody | 200 mg | Intravenous |