Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT03024437 · ClinicalTrials.gov registry record · Phase 1
Atezolizumab in Combination With Entinostat and Bevacizumab in Patients With Advanced Renal Cell Carcinoma
A Phase 1 study, sponsored by Roberto Pili.
- Terminated
- Registry status
- Phase 1
- Development phase
- 31
- Enrollment target
NCT03024437 is a Phase 1 study that was terminated before completion, run by Roberto Pili. The registered enrollment target is 31 participants.
The verdict
NCT03024437, a Phase 1 study, was terminated before completion, sponsored by Roberto Pili.
- TERMINATED
- Registry status
- Phase 1
- Development phase
- 31 participants
- Enrollment target
Study Summary
This study will assess the immunomodulatory activity of entinostat in patients with advanced renal cell carcinoma receiving the PD-L1 inhibitor atezolizumab. The overall hypothesis is that entinostat will increase the immune response and anti-tumor effect induced by the PD-L1 inhibition by suppressing Treg function. We have chosen renal cell carcinoma that has been reported to respond to PD1/PD-L 1 inhibition. The schedule of entinostat is based on our previous experience with this agent. Based on our working hypothesis that low dose HDAC inhibitors will have a suppressive function on Tregs but not on T effector cells, the starting dose of entinostat will be 1 mg and will be escalated up to 5 mg rather than the 10 mg dose. The combination also with bevacizumab will provide an effective VEGF inhibition that may potentiate the immune response and anti-tumor effect induced by atezolizumab. The proposed dose and schedule for atezolizumab and bevacizumab has been shown to be well tolerated in prior Phase/I/II studies and is currently tested in a Phase III randomized study in patients with renal cell carcinoma with sunitinib as a control arm. The highest proposed dose level for entinostat (5 mg) represents 50% of the recommended Phase II dose for this compound as a single agent.
Interventions
- DRUG Bevacizumab
- DRUG Atezolizumab
- DRUG Entinostat
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 31 participants |
| Start Date | 2017-06-29 |
| Est. Completion | 2024-06-24 |
| Phase | Phase 1 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03024437
The ClinicalTrials.gov registry entry for NCT03024437 describes a study currently listed as terminated, categorized as Phase 1. The registered enrollment target is 31 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 Bevacizumab is the first listed.
NCT03024437 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT03024437 about?
NCT03024437 is a clinical study titled "Atezolizumab in Combination With Entinostat and Bevacizumab in Patients With Advanced Renal Cell Carcinoma". This study will assess the immunomodulatory activity of entinostat in patients with advanced renal cell carcinoma receiving the PD-L1 inhibitor atezolizumab. The overall hypothesis is that entinostat will increase the immune response and anti-tumor effect induced by the PD-L1 inhibition by suppressi...
What is the current status of trial NCT03024437?
This trial is currently terminated. It is a Phase 1 study. The enrollment target is 31 participants. The study started on 2017-06-29. Estimated completion is 2024-06-24.
What interventions are being tested in trial NCT03024437?
The interventions under investigation include: Bevacizumab (DRUG), Atezolizumab (DRUG), Entinostat (DRUG).
Who is sponsoring clinical trial NCT03024437?
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.