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NCT02619253 · ClinicalTrials.gov registry record · Phase 1
Phase I/Ib Study of Pembrolizumab With Vorinostat for Patients With Advanced Renal or Urothelial Cell Carcinoma
A Phase 1 study, sponsored by Nabil Adra.
- Completed
- Registry status
- Phase 1
- Development phase
- 52
- Enrollment target
NCT02619253: Completed Phase 1 study, sponsored by Nabil Adra.
NCT02619253 is a Phase 1 study that has completed, run by Nabil Adra. The registered enrollment target is 52 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (13% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02619253, a Phase 1 study, has completed, sponsored by Nabil Adra.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 52 participants
- Enrollment target
Study Summary
Primary objective: To assess the early signals for anti-tumor activity (i.e. objective response rate, progression-free survival) of pembrolizumab in combination with vorinostat in patients with advanced prostate, renal or urothelial cell carcinoma. Secondary objectives: (1) To evaluate the overall safety profile of pembrolizumab in combination with vorinostat; (2) To assess the safety and tolerability of pembrolizumab in combination with vorinostat in patients with advanced prostate, renal or urothelial cell carcinoma in order to select the recommended Phase 2 Dose (RP2D)
Primary Outcome
Measured by RECIST v1.1 Complete response: Disappearance of all target lesions Partial response: At least a 30% decrease in the sum of the longest diameter of target lesions, taking as reference the baseline sum longest diameter The percentage of patients with objective response and its 95% confidence interval will be provided.
Interventions
- DRUG Pembrolizumab
- DRUG Vorinostat
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 52 participants |
| Start Date | 2016-02-23 |
| Est. Completion | 2023-03-28 |
| Phase | Phase 1 |
What the finished NCT02619253 record still lists
NCT02619253 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 52 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (13% lower).
The record links to 0 conditions, and to 2 interventions - of which Pembrolizumab is the first listed.
NCT02619253 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02619253 about?
NCT02619253 is a clinical study titled "Phase I/Ib Study of Pembrolizumab With Vorinostat for Patients With Advanced Renal or Urothelial Cell Carcinoma". Primary objective: To assess the early signals for anti-tumor activity (i.e. objective response rate, progression-free survival) of pembrolizumab in combination with vorinostat in patients with advanced prostate, renal or urothelial cell carcinoma. Secondary objectives: (1) To evaluate the overall ...
What is the current status of trial NCT02619253?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 52 participants. The study started on 2016-02-23. Estimated completion is 2023-03-28.
What interventions are being tested in trial NCT02619253?
The interventions under investigation include: Pembrolizumab (DRUG), Vorinostat (DRUG).
Who is sponsoring clinical trial NCT02619253?
This trial is sponsored by Nabil Adra, which has 4 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02619253's enrollment target sits among peer trials
52 956th of 2000 higher than 1,032 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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