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HCRN GU14-188

Phase Ib/II Study of Neoadjuvant Pembrolizumab With Gemcitabine-Cisplatin (Cisplatin-Eligible) or Gemcitabine (Cisplatin-Ineligible) in Subjects With T2-4aN0M0 Urothelial Cancer: HCRN GU14-188

Status: Closed to Accrual

This 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.

  • Condition: Urothelial Carcinoma
  • Intervention:
    • Drug: Pembrolizumab
    • Drug: Gemcitabine
    • Drug: Cisplatin
    • Procedure: Consolidative Surgery
  • Phase: Phase 1b/2

For full description, see www.clinicaltrials.gov.


  • Christopher J. Hoimes, Nabil Adra, Mark T. Fleming, Hristos Z. Kaimakliotis, Joel Picus, Zachary L Smith, Radhika Walling, Edouard John Trabulsi, Jean H. Hoffman-Censits, Michael O. Koch, Clint Cary, Robert Abouassaly, Cheryl Eitman, Pingfu Fu, Gordon Goolamier, Adam C Calaway, Lee Evan Ponsky, William Kevin Kelly. Phase Ib/II neoadjuvant (N-) pembrolizumab (P) and chemotherapy for locally advanced urothelial cancer (laUC): Final results from the cisplatin (C)- eligible cohort of HCRN GU14-188. Presented as a poster at the ASCO 2020 Annual Meeting. See abstract.
  • Hristos Z. Kaimakliotis, Nabil Adra, William Kevin Kelly, Edouard John Trabulsi, Richard C. Lauer, Joel Picus, Zachary L Smith, Radhika Walling, Timothy A. Masterson, Adam C Calaway, Michael O. Koch, Elizabeth Sonderman, Pingfu Fu, Gordon Goolamier, Cheryl Eitman, Lee Evan Ponsky, Christopher J. Hoimes. Phase II neoadjuvant (N-) gemcitabine (G) and pembrolizumab (P) for locally advanced urothelial cancer (laUC): Interim results from the cisplatin (C)-ineligible cohort of GU14-188. Presented as a poster discussion at the ASCO 2020 Annual Meeting. See abstract.
  • Hristos Kaimakliotis, Costantine Albany, Jean Hoffman-Censits, Edouard Trabulsi, W. Kevin Kelly, Joel Picus, Nabil Adra, Clint Cary, Michael Koch, Mark Fleming, Radhika Walling, J. Luke Godwin, Robert Abouassaly, Matthew Cooney, Pingfu Fu, Ariel Nelson, Ginu Xavier, Lee Ponsky, Christopher Hoimes. PD52-03: A multicenter Phase Ib/II study of neoadjuvant pembrolizumab and cisplatin chemotherapy for muscle-invasive urothelial cancer. Presented as a podium session abstract at the American Urological Association Annual Meeting, May 5, 2019, Chicago, IL. See abstract.
  • C.J. Hoimes, C. Albany, J. Hoffman-Censits, M. Fleming, E. Trabulsi, J. Picus, C. Cary, M.O. Koch, R. Walling, W.K. Kelly, J.L. Godwin, M. Cooney, P. Fu, A. Nelson, K. Patel, C. Eitman, T. Breen, A. Neal, H. Kaimakliotis. A Phase 1b/2 Multicenter Study of Neoadjuvant Pembrolizumab and Chemotherapy for Locally Advanced Urothelial Cancer (NCT02365766). Accepted as a late-breaking abstract poster discussion at the 2018 ESMO Congress, Oct. 20, 2018, Munich, Germany. See abstract.
  • C.J. Hoimes, R. Abouassaly, J.N. Saltzman, M.T. Fleming, J.H. Hoffman-Censits, T. Byrd, C. Eitman, M. Snyder-Willis, J. O’Neill, L. Wood, R. Elliott, M.M. Cooney. HCRN GU14-188: Neoadjuvant pembrolizumab (P) and gemcitabine (G) with or without cisplatin (C) in muscle invasive urothelial cancer (MIUC). Accepted as a trials in progress poster session at the ASCO Annual Meeting, June 3-7, 2016, Chicago IL. J Clin Oncol 34, 2016 (suppl; abstr TPS4578). See abstract.

Study Contact: studies@hoosiercancer.org; (317) 921-2050.