CI

At a glance

ClinicalIndex Comparison Record
Phase 1Completed· 52 enrolled
Drug / intervention
Pembrolizumab +1 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02619253
NCT02619253Phase 1Completed

A Phase I/Ib, Open Label, Dose Finding Study to Evaluate Safety, Pharmacodynamics and Efficacy of Pembrolizumab (MK-3475) in Combination With Vorinostat in Patients With Advanced Renal or Urothelial Cell Carcinoma

Nabil Adra·interventional·Posted Dec 2, 2015·Updated Nov 18, 2024

In Brief

A Phase 1 clinical trial evaluating Pembrolizumab and Vorinostat for Renal Cell Carcinoma and Urinary Bladder Neoplasms. Completed, enrolled 52 participants across 4 sites.

Detailed 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)

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States
Collaborators--

Timeline

Phase 1CompletedFinished
20162017201820192020202120222023202420252026
First PostedDec 2, 2015
Enrollment StartFeb 23, 2016
Primary CompletionMar 28, 2023
TodayJul 2, 2026
Enrollment to primary: 7.1 yearsPosted 10.6 years ago

Interventions

Pembrolizumabdrug

Vorinostatdrug