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Trial Summary

Protocol No.GU14-188
StatusOPEN TO ACCRUAL
Principal InvestigatorAlbany, Costantine
ScopeNational
PhasePhase I/II
Age GroupAdult
TitlePhase Ib/II Study of Neoadjuvant Pembrolizumab (MK-3475) with Gemcitabine-Cisplatin (cisplatin eligible) or Gemcitabine (cisplatin-ineligible) in Subjects with T2-4aN0M0 Urothelial Cancer
DescriptionThis is a two-part trial with a one-arm phase Ib portion followed by a two-arm phase II portion. The study treatment is stratified into two cohorts based on cisplatin eligibility.
Key EligibilityIn order to be eligible to take part in this trial, patients must meet the following criteria:

  • Have histologically confirmed muscle invasive disease of the urinary bladder, renal pelvis, or ureters.
  • Histology must be urothelial carcinoma (transitional cell carcinoma) or urothelial carcinoma with mixed histology/features.
For a full list of participation criteria, please visit clinicaltrials.gov.
Applicable Disease SitesBladder Cancer
Kidney (Renal Cell) Cancer
Urethral Cancer
Participating InstitutionsIU Health Central Indiana Cancer Centers
  • CICC Carmel
  • CICC East
  • CICC Fishers
  • CICC Methodist
Indiana University (IU)
  • Eskenazi Hospital
  • Indiana University Hospital / IU Simon Cancer Center
Treatment TypeTreatment
ContactMarietta L Moore, RNPhone: 317-274-7477
Pager: 317-312-1102
Email: marlmoor@iupui.edu