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High Dose IL 2 and Entinostat in RCC
NCT03501381 · View on ClinicalTrials.gov ↗
Study Summary
This is a multicenter, randomized, open label study of high dose interleukin 2 vs high dose interleukin 2 plus entinostat in clear cell RCC patients who are candidate for high dose interleukin 2. Patients will be randomized to ARM 1 (high dose interleukin 2 plus entinostat) or ARM 2 (high dose interleukin 2). Subjects will receive up to 3 courses of high dose interleukin 600,000 units/kg administered IV every 8 hrs on Days 1-5 and Days 15-19 (maximum 28 doses) +/- entinostat 5 mg orally given every 2 weeks starting on Day-14, continuously. Tumor response assessment will be performed between HD IL-2 courses.
Conditions Studied
Interventions
- DRUG Interleukin-2
- DRUG Entinostat
Study Locations (5)
California
- Univeristy of Southern California — Los Angeles
Illinois
- Rush University Medical Center — Chicago
Indiana
- Indiana Univeristy Melvin and Bren Simon Cancer Center — Indianapolis
Louisiana
- Hematology Oncology Clinic, LLC — Baton Rouge
Nebraska
- Nebraska Methodist Hospital — Omaha
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 46 participants |
| Start Date | 2018-05-24 |
| Est. Completion | 2024-04 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03501381
The ClinicalTrials.gov registry entry for NCT03501381 describes a study currently listed as active not recruiting. It is categorized as Phase 2, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 46 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Roberto Pili, which has 1 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 1 condition, with Renal Cell Carcinoma appearing as the primary indexed condition, and to 2 interventions — of which Interleukin-2 is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT03501381 reports 5 study locations spanning 5 distinct geographic areas — top geographies include California, Illinois, Indiana. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
Frequently Asked Questions
What is clinical trial NCT03501381 about?
NCT03501381 is a clinical study titled "High Dose IL 2 and Entinostat in RCC". This is a multicenter, randomized, open label study of high dose interleukin 2 vs high dose interleukin 2 plus entinostat in clear cell RCC patients who are candidate for high dose interleukin 2. Patients will be randomized to ARM 1 (high dose interleukin 2 plus entinostat) or ARM 2 (high dose inter...
What is the current status of trial NCT03501381?
This trial is currently active not recruiting. It is a Phase 2 study. The enrollment target is 46 participants. The study started on 2018-05-24. Estimated completion is 2024-04.
What conditions does trial NCT03501381 study?
This clinical trial studies the following conditions: Renal Cell Carcinoma. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT03501381?
The interventions under investigation include: Interleukin-2 (DRUG), Entinostat (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT03501381?
This trial is sponsored by Roberto Pili, which has 1 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT03501381 being conducted?
This trial has 5 study locations across California, Illinois, Indiana, Louisiana, Nebraska. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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