Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.

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.

View on ClinicalTrials.gov ↗

View your shortlist →

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

FieldValue
Enrollment Target 52 participants
Start Date 2016-02-23
Est. Completion 2023-03-28
Phase Phase 1
Nabil Adra

4 total trials

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.

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

Nationwide trials with similar profiles

Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.

Similar enrollment target

  • NCT02630121 · 52 participants · Phase 4

    Effect of Oxymetazoline Hydrochloride in Combination With Fluticasone Propionate on the Apnea Hypopnea Index (AHI) in Subject With Persistent Nasal Congestion and Mild Obstructive Sleep Apnea

  • NCT03629171 · 52 participants · Phase 2

    Liposome-encapsulated Daunorubicin-Cytarabine and Venetoclax in Treating Participants With Relapsed, Refractory or Untreated Acute Myeloid Leukemia

  • NCT04128748 · 52 participants · Phase 1

    Liposomal Cytarabine and Daunorubicin (CPX-351) and Quizartinib for the Treatment of Acute Myeloid Leukemia and High Risk Myelodysplastic Syndrome

  • NCT04150497 · 52 participants · Phase 1

    Phase 1/2 Study of UCART22 in Patients With Relapsed or Refractory CD22+ B-cell Acute Lymphoblastic Leukemia (BALLI-01)

Similar registry start date

  • NCT05962346 · started 2026-12 · NA

    Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia

  • NCT07125183 · started 2026-12 · Phase 2

    Study on Efficacy and Tolerability of Weekly Doxorubicin in Elderly Patients With Advanced or Metastatic Leiomyosarcoma

  • NCT07292298 · started 2026-11 · Phase 2

    Phase 2 Single-Arm Rectal Cancer Brachytherapy for Patients With Low-Lying Residual Adenocarcinoma After Total Neoadjuvant Therapy to Improve Organ Preservation Rates

  • NCT04263285 · started 2026-10 · NA

    Treatment of Depression Post-SCI

Source: ClinicalTrials.gov NCT02619253, the US trial registry maintained by the National Library of Medicine. NCT02619253 (small enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.