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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: Clinical Trial Phase 1 study, sponsored by Roberto Pili.
NCT03024437 is a Phase 1 study that was terminated before completion, run by Roberto Pili. The registered enrollment target is 31 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (48% lower). According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
Three dose levels of entinostat (1 mg, 3 mg and 5 mg) were tested according to the 3 + 3 standard design. The starting dose level of entinostat was 1 mg orally every 7 days. DLTs attributable to entinostat and/or bevacizumab and/or atezolizumab were evaluated during the first 21 days of the combination treatment. If a DLT occurs in 1 patient treated at the starting dose level, a minimum of 3 additional patients will be treated at this dose level. If DLTs occur in 2 or more of the first 6 patien
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 |
Why NCT03024437 stopped before completion
NCT03024437 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 31 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (48% lower).
The record links to 0 conditions, and to 3 interventions - of which Bevacizumab is the first listed.
NCT03024437 does not publish any study locations in the registry export this page uses.
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
How this trial's enrollment target compares
Where NCT03024437's enrollment target sits among peer trials
31 1322nd of 2000 higher than 669 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 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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