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NCT04674683 · ClinicalTrials.gov registry record · Phase 3
Study Comparing Investigational Drug HBI-8000 + Nivolumab vs. Placebo + Nivolumab in Patients With Advanced Melanoma
A Phase 3 study of Unresectable or Metastatic Melanoma and Progressive Brain Metastasis, sponsored by HUYABIO International.
- Active
- Registry status
- Phase 3
- Development phase
- 450
- Enrollment target
- 20
- Study locations
NCT04674683: Active Phase 3 study of Unresectable or Metastatic Melanoma and Progressive Brain Metastasis, sponsored by HUYABIO International.
NCT04674683 is a Phase 3 study of Unresectable or Metastatic Melanoma and Progressive Brain Metastasis that is active but no longer recruiting, run by HUYABIO International. The registered enrollment target is 450 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (42% lower). The trial reports 20 study locations across 7 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04674683, a Phase 3 study of Unresectable or Metastatic Melanoma and Progressive Brain Metastasis, is active but no longer recruiting, sponsored by HUYABIO International.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 3
- Development phase
- 450 participants
- Enrollment target
- 20
- Study locations
Study 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.
Primary Outcome
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.
Conditions Studied
Interventions
- DRUG HBI-8000 in combination with nivolumab
- DRUG Placebo in combination with nivolumab
Study Locations (20)
California
- Comprehensive Blood and Cancer Center - Bakersfield
- UC San Diego Moores Cancer Center - La Jolla
- Innovative Clinical Research Institute (ICRI) - Pasadena
- Emad Ibrahim, MD, INC - Redlands
- Kaiser Permanente Oncology Research - Riverside
- California Cancer Associates for Research and Excellence, Inc. (cCARE) - San Marcos
Florida
- Boca Raton Regional Hospital, Lynn Cancer Institute - Boca Raton
- Memorial Regional Hospital - Hollywood
- Baptist MD Anderson Cancer Center - Jacksonville
- Orlando Health - Orlando
- Ascension Sacred Heart Medical Oncology - Pensacola
- Moffitt Cancer Center - Tampa
Missouri
- St Louis Cancer Care - Bridgeton
- AMR Kansas City - Kansas City
- Medisearch Clinical Trials - Saint Joseph
Kentucky
- St. Elizabeth Healthcare - Edgewood
- Baptist Health Lexington - Lexington
Indiana
- Goshen Center for Cancer Care - Goshen
Maryland
- Frederick Memorial Healthcare System - Frederick
Montana
- St. Vincent - Frontier Cancer Center - Billings
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 450 participants |
| Start Date | 2021-08-12 |
| Est. Completion | 2026-12 |
| Phase | Phase 3 |
What the registry record for NCT04674683 still lists
NCT04674683 is an interventional study that assigns participants to a tested intervention. The registered 450 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (42% lower).
The record links to 2 conditions, with Unresectable or Metastatic Melanoma appearing as the primary indexed condition, and to 2 interventions - of which HBI-8000 in combination with nivolumab is the first listed.
NCT04674683 names 20 study sites across 7 states, led by California, Florida, Missouri.
Frequently Asked Questions
What is clinical trial NCT04674683 about?
NCT04674683 is a clinical study titled "Study Comparing Investigational Drug HBI-8000 + Nivolumab vs. Placebo + Nivolumab in Patients With Advanced Melanoma". 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 pr...
What is the current status of trial NCT04674683?
This trial is currently active not recruiting. It is a Phase 3 study. The enrollment target is 450 participants. The study started on 2021-08-12. Estimated completion is 2026-12.
What conditions does trial NCT04674683 study?
This clinical trial studies the following conditions: Unresectable or Metastatic Melanoma, Progressive Brain Metastasis.
What interventions are being tested in trial NCT04674683?
The interventions under investigation include: HBI-8000 in combination with nivolumab (DRUG), Placebo in combination with nivolumab (DRUG).
Who is sponsoring clinical trial NCT04674683?
This trial is sponsored by HUYABIO International, which has 7 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04674683 being conducted?
This trial has 20 study locations across California, Florida, Indiana, Kentucky, Maryland. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04674683's enrollment target sits among peer trials
450 838th of 2000 higher than 1,137 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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