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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 is a Phase 1 study that was terminated before completion, run by NYU Langone Health. The registered enrollment target is 11 participants.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03565406
The ClinicalTrials.gov registry entry for NCT03565406 describes a study currently listed as terminated, categorized as Phase 1. The registered enrollment target is 11 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is NYU Langone Health, which has 1,164 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Mocetinostat Induction Phase + Ipilimumab + Nivolumab is the first listed.
NCT03565406 reports 0 study locations.
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.
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