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NCT03552380 · ClinicalTrials.gov registry record · Phase 2
Study of Entinostat With Nivolumab Plus Ipilimumab in Previously Treated Renal Cell Carcinoma
A Phase 2 study, sponsored by Roberto Pili.
- Terminated
- Registry status
- Phase 2
- Development phase
- 12
- Enrollment target
NCT03552380: Clinical Trial Phase 2 study, sponsored by Roberto Pili.
NCT03552380 is a Phase 2 study that was terminated before completion, run by Roberto Pili. The registered enrollment target is 12 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (91% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03552380, a Phase 2 study, was terminated before completion, sponsored by Roberto Pili.
- TERMINATED
- Registry status
- Phase 2
- Development phase
- 12 participants
- Enrollment target
Study Summary
This is a Phase II, open-label, safety, pharmacodynamic and efficacy study of entinostat in combination with nivolumab and ipilimumab in subjects with metastatic renal cell carcinoma (RCC) who have progressed on ipilimumab + nivolumab regimen. Prior to Phase II, a safety lead-in will be conducted to establish the RP2D of entinostat when used in combination with ipilimumab + nivolumab. Subjects will initially be treated with the combination of oral entinostat and intravenous (IV) nivolumab plus ipilimumab. Entinostat will be dosed weekly, and nivolumab and ipilimumab will be dosed every 3 weeks, for a total of four, 3-week cycles. Following these first four cycles, entinostat will continue to be administered weekly in combination with nivolumab every 4 weeks or every 2 weeks based on subject tolerance (ipilimumab will be discontinued), with treatment continued until disease progression or prohibitive toxicity. Anti-tumor activity will be assessed by radiological tumor assessments conducted at baseline and every 6 weeks thereafter using RECIST version 1.1.
Primary Outcome
Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.
Interventions
- DRUG Nivolumab
- DRUG Ipilimumab
- DRUG Entinostat
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 12 participants |
| Start Date | 2018-07-31 |
| Est. Completion | 2024-02-15 |
| Phase | Phase 2 |
Why NCT03552380 stopped before completion
NCT03552380 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 12 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (91% lower).
The record links to 0 conditions, and to 3 interventions - of which Nivolumab is the first listed.
NCT03552380 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03552380 about?
NCT03552380 is a clinical study titled "Study of Entinostat With Nivolumab Plus Ipilimumab in Previously Treated Renal Cell Carcinoma". This is a Phase II, open-label, safety, pharmacodynamic and efficacy study of entinostat in combination with nivolumab and ipilimumab in subjects with metastatic renal cell carcinoma (RCC) who have progressed on ipilimumab + nivolumab regimen. Prior to Phase II, a safety lead-in will be conducted to...
What is the current status of trial NCT03552380?
This trial is currently terminated. It is a Phase 2 study. The enrollment target is 12 participants. The study started on 2018-07-31. Estimated completion is 2024-02-15.
What interventions are being tested in trial NCT03552380?
The interventions under investigation include: Nivolumab (DRUG), Ipilimumab (DRUG), Entinostat (DRUG).
Who is sponsoring clinical trial NCT03552380?
This trial is sponsored by Roberto Pili, which has 3 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03552380's enrollment target sits among peer trials
12 1948th of 2000 higher than 34 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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