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NCT03886493 · ClinicalTrials.gov registry record · Phase 2
Neoadjuvant Dupilumab in Men With Localized High-Risk Prostate Cancer
A Phase 2 study, sponsored by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins.
- Terminated
- Registry status
- Phase 2
- Development phase
- 7
- Enrollment target
NCT03886493: Clinical Trial Phase 2 study, sponsored by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins.
NCT03886493 is a Phase 2 study that was terminated before completion, run by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins. The registered enrollment target is 7 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (95% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03886493, a Phase 2 study, was terminated before completion, sponsored by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins.
- TERMINATED
- Registry status
- Phase 2
- Development phase
- 7 participants
- Enrollment target
Study Summary
This is a single-center, single arm, open-label phase II study evaluating the safety, anti-tumor effect, and immunogenicity of neoadjuvant Dupixent given prior to radical prostatectomy.
Primary Outcome
Change in M2-TAM infiltration (number of macrophages / cell nuclei per high power field \[hpf\]) measured in pre- dupilumab biopsy to M2-TAM infiltration measured in post-dupilumab specimen collected at time of radical prostatectomy (up to 59 days post-intervention). Degree of TAM infiltration will be analyzed using immunohistochemical staining for CD206. It is hypothesized that a positive value will be associated with better outcome and a negative value will reflect a worse outcome.
Interventions
- DRUG Dupilumab
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 7 participants |
| Start Date | 2019-08-28 |
| Est. Completion | 2020-10-06 |
| Phase | Phase 2 |
Why NCT03886493 stopped before completion
NCT03886493 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 7 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (95% lower).
The record links to 0 conditions, and to 1 intervention - of which Dupilumab is the first listed.
NCT03886493 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03886493 about?
NCT03886493 is a clinical study titled "Neoadjuvant Dupilumab in Men With Localized High-Risk Prostate Cancer". This is a single-center, single arm, open-label phase II study evaluating the safety, anti-tumor effect, and immunogenicity of neoadjuvant Dupixent given prior to radical prostatectomy.
What is the current status of trial NCT03886493?
This trial is currently terminated. It is a Phase 2 study. The enrollment target is 7 participants. The study started on 2019-08-28. Estimated completion is 2020-10-06.
What interventions are being tested in trial NCT03886493?
The interventions under investigation include: Dupilumab (DRUG).
Who is sponsoring clinical trial NCT03886493?
This trial is sponsored by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins, which has 523 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03886493's enrollment target sits among peer trials
7 1996th of 2000 higher than 5 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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