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A Multicenter, Randomized, Double-Blind Phase 3 Study of HBI-8000 Combined With Nivolumab Versus Placebo With Nivolumab in Patients With Unresectable or Metastatic Melanoma Not Previously Treated With PD-1 or PD-L1 Inhibitors

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Trial Profile

A Multicenter, Randomized, Double-Blind Phase 3 Study of HBI-8000 Combined With Nivolumab Versus Placebo With Nivolumab in Patients With Unresectable or Metastatic Melanoma Not Previously Treated With PD-1 or PD-L1 Inhibitors

Status: Active, no longer recruiting
Phase of Trial: Phase III

Latest Information Update: 13 Oct 2024

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At a glance

  • Drugs Tucidinostat (Primary) ; Nivolumab
  • Indications Brain metastases; Malignant melanoma
  • Focus Therapeutic Use
  • Sponsors HUYA Bioscience International

Most Recent Events

  • 24 Jun 2024 Status changed from recruiting to active, no longer recruiting.
  • 06 Jan 2024 This trial has been discontinued in Austria.
  • 26 Apr 2023 According to Meiji Seika Pharma media release, the company announces initiation of this trial in Japanese patient, This clinical trial (jRCT2061220112) is conducted by HUYABIO in Japan as a part of an International multicenter, randomized, double blinded, placebo-controlled Phase III registration study (NCT04674683)

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