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Trial Summary

Protocol No.IUSCC-0551
StatusOPEN TO ACCRUAL
Principal InvestigatorPili, Roberto
ScopeNational
PhasePhase I/II
Age GroupAdult
TitleA 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
DescriptionPrimary objective: To assess the safety and tolerability of pembrolizumab in combination with vorinostat in patients with advanced renal or urothelial cell carcinoma in order to estimate the maximum tolerated dose (MTD) and select the recommended Phase 2 dose (RP2D). Secondary objectives: (1) To evaluate the overall safety profile of pembrolizumab in combination with vorinostat; (2) To assess the anti-tumor activity (i.e. objective response rate, progression-free survival) of pembrolizumab in combination with vorinostat in patients with advanced renal or urothelial cell carcinoma; (3) To characterize PD-L1/2, immune cell subsets, and miRs in tumor and/or blood.
Key EligibilityIn order to be eligible to take part in this trial, patients must meet the following criteria:

  • All subjects must have previously treated either locally advanced or metastatic renal or urothelial cell carcinoma to be eligible for participation.
  • Subjects with urothelial carcinoma must be platinum-resistant (i.e., treatment-free interval 6< months)
For a full list of participation criteria, please visit clinicaltrials.gov.
Applicable Disease SitesKidney (Renal Cell) Cancer
Urethral Cancer
Participating InstitutionsIU Health Central Indiana Cancer Centers
Indiana University (IU)
  • Indiana University Hospital / IU Simon Cancer Center
Johns Hopkins University
  • Johns Hopkins University (site)
University of Southern California
  • University of Southern California (site)
Treatment TypeTreatment
ContactPhone: (317) 278-5632
Email: iutrials@iu.edu