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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
This is a phase 3 study to compare the efficacy and safety of HBI-8000 or Placebo combined with nivolumab on patients with unresectable or metastatic melanoma and eligible patients who are not adolescents or patients with new, progressive brain metastasis will be stratified by PD-L1 expression and LDH level.
To compare, between Test (HBI-8000 + nivolumab) and Control (placebo + nivolumab) arms: ORR according to RECIST v.1.1, defined as the percentage of patients in each study arm with best response of CR and PR as determined by the BIRC PFS, defined as the time from the date of randomization to the first date of documented progression as determined by BIRC, or death due to any cause, whichever occurs first
Immunotherapy; Therapy (NOS)
BMS-936558 (Nivolumab); HBI-8000 (chidamide); Nivolumab (Opdivo); Placebo ()
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