Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
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 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. The trial reports 20 study locations across 7 states.
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.
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 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04674683
The ClinicalTrials.gov registry entry for NCT04674683 describes a study currently listed as active not recruiting, categorized as Phase 3. The registered enrollment target is 450 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is HUYABIO International, which has 7 total studies on file at ClinicalTrials.gov.
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 reports 20 study locations spanning 7 distinct geographic areas - top geographies include 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
Explore more on PlainTrial
Unresectable or Metastatic Melanoma
All registered trials for this condition
Progressive Brain Metastasis
All registered trials for this condition
California
All trials with a study site in California
Recruiting now
Find trials open to new participants near you
Rankings
Top sponsors, conditions, and phases
Read our methodology - how this data is sourced, computed, and verified.
Related
Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.