drugset / Trial / NCT04322643

Intermittent Checkpoint Inhibitor Therapy In Patients With Advanced Urothelial Carcinoma

NCT04322643 ↗

Phase 2 Terminated 4 enrolled Case Comprehensive Cancer Center
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

EvaluationDrugModalityDoseRoute
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

Indications