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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: Clinical Trial Phase 2 study, sponsored by Case Comprehensive Cancer Center.
NCT04322643 is a Phase 2 study that was terminated before completion, run by Case Comprehensive Cancer Center. The registered enrollment target is 4 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (97% lower). According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
Efficiency, as measured by number of participants that sustain a response post CPI suspension. Response is defined as tumor burden reduction of 10% or greater. Response is measured based on RECIST criteria version 1.1. RECIST 1.1 responses include Complete Response (CR) which is defined as disappearance of all lesions and pathologic lymph nodes; Partial Response (PR) defined as ≥ 30% decrease SLD, no new lesions, no progression of non-target lesions; Stable disease (SD) which is defined as no pa
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 |
Why NCT04322643 stopped before completion
NCT04322643 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 4 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (97% lower).
The record links to 0 conditions, and to 5 interventions - of which Pembrolizumab is the first listed.
NCT04322643 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04322643's enrollment target sits among peer trials
4 2001st of 2000 the lowest of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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