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NCT03501381 · ClinicalTrials.gov registry record · Phase 2
High Dose IL 2 and Entinostat in RCC
A Phase 2 study of Renal Cell Carcinoma, sponsored by Roberto Pili.
- Active
- Registry status
- Phase 2
- Development phase
- 46
- Enrollment target
- 5
- Study locations
NCT03501381: Active Phase 2 study of Renal Cell Carcinoma, sponsored by Roberto Pili.
NCT03501381 is a Phase 2 study of Renal Cell Carcinoma that is active but no longer recruiting, run by Roberto Pili. The registered enrollment target is 46 participants, below the 243-participant average among 121 other Renal Cell Carcinoma trials with a reported enrollment target (81% lower). The trial reports 5 study locations across 5 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03501381, a Phase 2 study of Renal Cell Carcinoma, is active but no longer recruiting, sponsored by Roberto Pili.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 2
- Development phase
- 46 participants
- Enrollment target
- 5
- Study locations
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.
Primary Outcome
Compare PFS between arms. PFS is defined as the time from date of randomization until the criteria for disease progression is met as defined by RECIST 1.1 or death as a result of any cause.
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 |
What the registry record for NCT03501381 still lists
NCT03501381 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 46 participants, a relatively small participant target, below the 243-participant average among 121 other Renal Cell Carcinoma trials with a reported enrollment target (81% lower).
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.
NCT03501381 lists 5 locations in 5 states (California, Illinois, Indiana).
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.
What interventions are being tested in trial NCT03501381?
The interventions under investigation include: Interleukin-2 (DRUG), Entinostat (DRUG).
Who is sponsoring clinical trial NCT03501381?
This trial is sponsored by Roberto Pili, which has 3 total clinical trials registered on ClinicalTrials.gov.
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.
Learn More About Clinical Trials
Similar trials for Renal Cell Carcinoma
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT03501381's enrollment target sits among peer trials
46 82nd of 121 higher than 39 of 121 other Renal Cell Carcinoma trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Renal Cell Carcinoma 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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