Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
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 is a Phase 2 study that was terminated before completion, run by Roberto Pili. The registered enrollment target is 12 participants.
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.
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 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03552380
The ClinicalTrials.gov registry entry for NCT03552380 describes a study currently listed as terminated, categorized as Phase 2. The registered enrollment target is 12 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Roberto Pili, which has 3 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 3 interventions - of which Nivolumab is the first listed.
NCT03552380 reports 0 study locations.
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
Explore more on PlainTrial
Read our methodology - how this data is sourced, computed, and verified.
Related
Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.