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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 clinical study to compare the efficacy and safety of HBI-8000 combined with nivolumab to Placebo combined with nivolumab in patients with unresectable or metastatic melanoma. A separate open-label cohort of adults with new, progressive brain metastasis or adolescents with or without new progressive brain metastasis receive HBI-8000 combined with nivolumab.
Details
| Lead sponsor | HUYABIO International, LLC. |
|---|---|
| Phase | Phase 3 |
| Status | ACTIVE_NOT_RECRUITING |
| Enrolment | 450 |
| Start date | 2021-08-12 |
| Completion | 2026-12 |
Conditions
- Unresectable or Metastatic Melanoma
- Progressive Brain Metastasis
Interventions
- HBI-8000 in combination with nivolumab
- Placebo in combination with nivolumab
Primary outcomes
- Primary Outcome — From date of randomization to the earliest date of documented progressive disease (PD), assessed up to 48 months
Progression-free Survival (PFS) defined as the time (in days) from the date of randomization to the first date of documented disease progression as determined by BIRC, or the date of death due to any cause, whichever occurs first.
Countries
United States, Australia, Austria, Belgium, Brazil, Czechia, France, Germany, Italy, Japan, New Zealand, Puerto Rico, Singapore, South Africa, South Korea, Spain, United Kingdom