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HCRN GU14-182

A Randomized, Double-Blinded, Phase II Study of Maintenance Pembrolizumab versus Placebo after First-line Chemotherapy in Patients with Metastatic Urothelial Cancer: HCRN GU14-182

Status: Closed to Accrual

This is a multi-institutional, randomized, placebo controlled, double-blinded phase II trial of maintenance pembrolizumab versus placebo after first-line chemotherapy in patients with metastatic urothelial cancer who have achieved at least stable disease on first-line chemotherapy.

  • Condition: Urothelial Cancer, Bladder Cancer
  • Intervention:
    • Drug: Pembrolizumab
    • Other: Placebo
  • Phase: Phase 2

For full description, see www.clinicaltrials.gov.

Read news release about this trial.

Manuscripts/Articles:

  • Matthew D. Galsky, MD; Amir Mortazavi, MD; Matthew I. Milowsky, MD; Saby George, MD; Sumati Gupta, MD; Mark T. Fleming, MD; Long H. Dang, MD, PhD; Daniel M. Geynisman, MD; Radhika Walling, MD; Robert S. Alter, MD; Mohamad Kassar, MD; Jue Wang, MD; Shilpa Gupta, MD; Nancy Davis, MD; Joel Picus, MD; George Philips, MD, MPH, MBBS; David I. Quinn, PhD; G. Kenneth Haines III, MD; Noah M. Hahn, MD; Qianqian Zhao, MS; Menggang Yu, PhD; Sumanta K. Pal, MD. Randomized Double-Blind Phase II Study of Maintenance Pembrolizumab Versus Placebo After First-Line Chemotherapy in Patients With Metastatic Urothelial Cancer. DOI: 10.1200/JCO.19.03091 Journal of Clinical Oncology. See abstract.

Abstracts/Posters/Presentations:

  • Matt D. Galsky, Sumanta K. Pal, Amir Mortazavi, Matthew I. Milowsky, Saby George, Sumati Gupta, Mark T. Fleming, Long H. Dang, Daniel M. Geynisman, Radhika Walling, Robert S. Alter, Erwin L. Robin, Jue Wang, Shilpa Gupta, David D. Chism, Joel Picus, George Philips, David I. Quinn, Noah M. Hahn, Menggang Yu. Randomized double-blind phase II study of maintenance pembrolizumab versus placebo after first-line chemotherapy in patients (pts) with metastatic urothelial cancer (mUC): HCRN GU14-182. Accepted as an oral abstract at the ASCO Annual Meeting, May 31 – June 4, 2019, Chicago IL. DOI: 10.1200/JCO.2019.37.15_suppl.4504 Journal of Clinical Oncology 37, no. 15_suppl (May 20 2019) 4504-4504. See abstract.

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