Trial Identifiers
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Scientific Title
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
Commercial Sponsor
HUYA Bioscience International
Summary
This is a multicentre, randomised, double-blind, placebo-controlled trial with Experimental and Placebo Comparator arms. All Eligible patients will be randomized to either the Experimental or Placebo Comparator arm at a 1:1 ratio. Study treatment will be initiated within 3 days of randomization. In both arms of the trial, treatment cycles consist of 28 days.