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NCT03565406 · ClinicalTrials.gov registry record · Phase 1
A Phase 1b Study of the Selective HDAC Inhibitor Mocetinostat in Combination With Ipilimumab and Nivolumab in Patients With Unresectable Stage III or Stage IV Melanoma
A Phase 1 study, sponsored by NYU Langone Health.
- Terminated
- Registry status
- Phase 1
- Development phase
- 11
- Enrollment target
NCT03565406: Clinical Trial Phase 1 study, sponsored by NYU Langone Health.
NCT03565406 is a Phase 1 study that was terminated before completion, run by NYU Langone Health. The registered enrollment target is 11 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (82% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03565406, a Phase 1 study, was terminated before completion, sponsored by NYU Langone Health.
- TERMINATED
- Registry status
- Phase 1
- Development phase
- 11 participants
- Enrollment target
Study Summary
This is a Phase 1b, open-label, dose-escalation cohort study. The study will consist of a dose escalation assessment of the safety and tolerability of Mocetinostat administered concurrently in combination with ipilimumab and nivolumab to patients with advanced melanoma. Treatment will be divided into induction and maintenance phases. It is anticipated that this clinical study will enable selection of the RP2D and dose schedule of this 3-drug combination for further clinical testing. The trial will include an assessment of the pharmacodynamic activity of Mocetinostat administered in combination with ipilimumab and nivolumab.
Interventions
- DRUG Mocetinostat Induction Phase + Ipilimumab + Nivolumab
- DRUG Mocetinostat Maintenance Phase + Ipilimumab + Nivolumab
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 11 participants |
| Start Date | 2018-04-25 |
| Est. Completion | 2020-01-13 |
| Phase | Phase 1 |
Why NCT03565406 stopped before completion
NCT03565406 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 11 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (82% lower).
The record links to 0 conditions, and to 2 interventions - of which Mocetinostat Induction Phase + Ipilimumab + Nivolumab is the first listed.
NCT03565406 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03565406 about?
NCT03565406 is a clinical study titled "A Phase 1b Study of the Selective HDAC Inhibitor Mocetinostat in Combination With Ipilimumab and Nivolumab in Patients With Unresectable Stage III or Stage IV Melanoma". This is a Phase 1b, open-label, dose-escalation cohort study. The study will consist of a dose escalation assessment of the safety and tolerability of Mocetinostat administered concurrently in combination with ipilimumab and nivolumab to patients with advanced melanoma. Treatment will be divided int...
What is the current status of trial NCT03565406?
This trial is currently terminated. It is a Phase 1 study. The enrollment target is 11 participants. The study started on 2018-04-25. Estimated completion is 2020-01-13.
What interventions are being tested in trial NCT03565406?
The interventions under investigation include: Mocetinostat Induction Phase + Ipilimumab + Nivolumab (DRUG), Mocetinostat Maintenance Phase + Ipilimumab + Nivolumab (DRUG).
Who is sponsoring clinical trial NCT03565406?
This trial is sponsored by NYU Langone Health, which has 1,164 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03565406's enrollment target sits among peer trials
11 1911th of 2000 higher than 88 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 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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