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NCT04586244 · ClinicalTrials.gov registry record · Phase 2
An Umbrella Study to Determine the Safety and Efficacy of Various Monotherapy or Combination Therapies in Neoadjuvant Urothelial Carcinoma
A Phase 2 study, sponsored by Incyte Corporation.
- Terminated
- Registry status
- Phase 2
- Development phase
- 30
- Enrollment target
NCT04586244: Clinical Trial Phase 2 study, sponsored by Incyte Corporation.
NCT04586244 is a Phase 2 study that was terminated before completion, run by Incyte Corporation. The registered enrollment target is 30 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (77% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04586244, a Phase 2 study, was terminated before completion, sponsored by Incyte Corporation.
- TERMINATED
- Registry status
- Phase 2
- Development phase
- 30 participants
- Enrollment target
Study Summary
This is a multicenter, open-label, randomized, Phase 2 umbrella study of various neoadjuvant treatment combinations in participants who have muscle-invasive urothelial carcinoma of the bladder and are cisplatin-ineligible or refusing cisplatin therapy and awaiting radical cystectomy.
Primary Outcome
Fold Change from Baseline in CD8+ lymphocytes = CD8+ Lymphocytes at cystectomy divided by CD8+ lymphocytes at Screening. Translational data in all but the retifanlimab 500 mg Q4W treatment group were limited and insufficient to assess this outcome measure.
Interventions
- DRUG INCAGN02385
- DRUG INCAGN02390
- DRUG retifanlimab
- DRUG epacadostat
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 30 participants |
| Start Date | 2022-01-14 |
| Est. Completion | 2024-01-29 |
| Phase | Phase 2 |
Why NCT04586244 stopped before completion
NCT04586244 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 30 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (77% lower).
The record links to 0 conditions, and to 4 interventions - of which INCAGN02385 is the first listed.
NCT04586244 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04586244 about?
NCT04586244 is a clinical study titled "An Umbrella Study to Determine the Safety and Efficacy of Various Monotherapy or Combination Therapies in Neoadjuvant Urothelial Carcinoma". This is a multicenter, open-label, randomized, Phase 2 umbrella study of various neoadjuvant treatment combinations in participants who have muscle-invasive urothelial carcinoma of the bladder and are cisplatin-ineligible or refusing cisplatin therapy and awaiting radical cystectomy.
What is the current status of trial NCT04586244?
This trial is currently terminated. It is a Phase 2 study. The enrollment target is 30 participants. The study started on 2022-01-14. Estimated completion is 2024-01-29.
What interventions are being tested in trial NCT04586244?
The interventions under investigation include: INCAGN02385 (DRUG), INCAGN02390 (DRUG), retifanlimab (DRUG), epacadostat (DRUG).
Who is sponsoring clinical trial NCT04586244?
This trial is sponsored by Incyte Corporation, which has 239 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04586244's enrollment target sits among peer trials
30 1582nd of 2000 higher than 332 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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