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NCT04322643 · ClinicalTrials.gov registry record · Phase 2
Intermittent Checkpoint Inhibitor Therapy In Patients With Advanced Urothelial Carcinoma
A Phase 2 study, sponsored by Case Comprehensive Cancer Center.
- Terminated
- Registry status
- Phase 2
- Development phase
- 4
- Enrollment target
NCT04322643 is a Phase 2 study that was terminated before completion, run by Case Comprehensive Cancer Center. The registered enrollment target is 4 participants.
The verdict
NCT04322643, a Phase 2 study, was terminated before completion, sponsored by Case Comprehensive Cancer Center.
- TERMINATED
- Registry status
- Phase 2
- Development phase
- 4 participants
- Enrollment target
Study 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.
Interventions
- DRUG Pembrolizumab
- DRUG Atezolizumab
- DRUG Nivolumab
- DRUG Durvalumab
- DRUG Avelumab
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 4 participants |
| Start Date | 2020-03-23 |
| Est. Completion | 2023-04-17 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04322643
The ClinicalTrials.gov registry entry for NCT04322643 describes a study currently listed as terminated, categorized as Phase 2. The registered enrollment target is 4 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Case Comprehensive Cancer Center, which has 407 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 5 interventions - of which Pembrolizumab is the first listed.
NCT04322643 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT04322643 about?
NCT04322643 is a clinical study titled "Intermittent Checkpoint Inhibitor Therapy In Patients With Advanced Urothelial Carcinoma". 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. ...
What is the current status of trial NCT04322643?
This trial is currently terminated. It is a Phase 2 study. The enrollment target is 4 participants. The study started on 2020-03-23. Estimated completion is 2023-04-17.
What interventions are being tested in trial NCT04322643?
The interventions under investigation include: Pembrolizumab (DRUG), Atezolizumab (DRUG), Nivolumab (DRUG), Durvalumab (DRUG), Avelumab (DRUG).
Who is sponsoring clinical trial NCT04322643?
This trial is sponsored by Case Comprehensive Cancer Center, which has 407 total clinical trials registered on ClinicalTrials.gov.
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