drugset / Trial / NCT04674683
Study Comparing Investigational Drug HBI-8000 + Nivolumab vs. Placebo + Nivolumab in Patients With Advanced Melanoma
Phase 3
Active not recruiting
450 enrolled
HUYABIO International, LLC.
Bristol-Myers Squibb · collab
RandomizedParallel-groupQuadruple-blindTreatment
Summary
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.
Timeline
- Start
- 2021-08-12
- Primary completion
- 2026-07
- Completion
- 2026-12
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Tucidinostat | Small molecule | 30 mg | Oral |
| Background | Nivolumab | Monoclonal antibody | — | Intravenous |