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A Randomized, Double-blinded, Phase II Study of Maintenance Pembrolizumab Versus Placebo After First-Line Chemotherapy in Patients With Metastatic Urothelial Cancer: Hoosier Cancer Research Network GU14-182

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Trial Profile

A Randomized, Double-blinded, Phase II Study of Maintenance Pembrolizumab Versus Placebo After First-Line Chemotherapy in Patients With Metastatic Urothelial Cancer: Hoosier Cancer Research Network GU14-182

Status: Completed
Phase of Trial: Phase II

Latest Information Update: 04 Oct 2022

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At a glance

  • Drugs Pembrolizumab (Primary)
  • Indications Bladder cancer; Carcinoma; Renal cancer; Ureteral neoplasms; Urethral cancer; Urogenital cancer
  • Focus Therapeutic Use

Most Recent Events

  • 05 Jan 2021 Planned End Date changed from 1 Jan 2020 to 1 Jan 2021.
  • 09 Apr 2020 Status changed from active, no longer recruiting to completed.
  • 09 Apr 2020 The study was amended in 2017, after enrollment of 70 patients, on the basis of two considerations, first is the stuy was accruing at slower than the projected rate and secondly concerns regarding whether the HR is an optimal approach to measure the potential benefits conferred by immune checkpoint blockade. And then amended the study on the basis of assumptions related to three theoretical phases of treatment effect

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