Study Comparing Investigational Drug HBI-8000 + Nivolumab vs. Placebo + Nivolumab in Patients With Advanced Melanoma
Public ClinicalTrials.gov record NCT04674683. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
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
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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.
Study identification
- NCT ID
- NCT04674683
- Recruitment status
- Active, not recruiting
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 450 participants
Conditions and interventions
Interventions
Drug
Eligibility (public fields only)
- Age range
- 12 Years and older
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Aug 12, 2021 (Actual)
- Primary completion
- Jul 2026 (Estimated)
- Completion
- Dec 2026 (Estimated)
- Last update posted
- Sep 24, 2025
2021 – 2026
United States locations
- U.S. sites
- 31
- U.S. states
- 15
- U.S. cities
- 31
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Comprehensive Blood and Cancer Center | Bakersfield | California | 93309 | — |
| UC San Diego Moores Cancer Center | La Jolla | California | 92037 | — |
| Innovative Clinical Research Institute (ICRI) | Pasadena | California | 91105 | — |
| Emad Ibrahim, MD, INC | Redlands | California | 92373 | — |
| Kaiser Permanente Oncology Research | Riverside | California | 92505 | — |
| California Cancer Associates for Research and Excellence, Inc. (cCARE) | San Marcos | California | 92069 | — |
| Boca Raton Regional Hospital, Lynn Cancer Institute | Boca Raton | Florida | 33486 | — |
| Memorial Regional Hospital | Hollywood | Florida | 33021 | — |
| Baptist MD Anderson Cancer Center | Jacksonville | Florida | 32207 | — |
| Orlando Health | Orlando | Florida | 32806 | — |
| Ascension Sacred Heart Medical Oncology | Pensacola | Florida | 32504 | — |
| Moffitt Cancer Center | Tampa | Florida | 33612 | — |
| Goshen Center for Cancer Care | Goshen | Indiana | 46526 | — |
| St. Elizabeth Healthcare | Edgewood | Kentucky | 41017 | — |
| Baptist Health Lexington | Lexington | Kentucky | 40503 | — |
| Frederick Memorial Healthcare System | Frederick | Maryland | 21701 | — |
| St Louis Cancer Care | Bridgeton | Missouri | 63044 | — |
| AMR Kansas City | Kansas City | Missouri | 64114 | — |
| Medisearch Clinical Trials | Saint Joseph | Missouri | 64506 | — |
| St. Vincent - Frontier Cancer Center | Billings | Montana | 59102 | — |
| Levine Cancer Institute | Charlotte | North Carolina | 28204 | — |
| Southeastern Medical Oncology Center | Goldsboro | North Carolina | 27534 | — |
| Gabrail Cancer Center Research | Canton | Ohio | 44718 | — |
| Toledo Clinic Cancer Center | Toledo | Ohio | 43623 | — |
| Thomas Jefferson University Medical Oncology Clinic | Philadelphia | Pennsylvania | 19107 | — |
| AnMed Health | Anderson | South Carolina | 29621 | — |
| Carolina Blood and Cancer Care Associates | Lancaster | South Carolina | 29720 | — |
| Renovatio Clinical | The Woodlands | Texas | 77380 | — |
| Utah Cancer Specialists | Salt Lake City | Utah | 84106 | — |
| Inova Schar Cancer Institute | Fairfax | Virginia | 22031 | — |
| Froedtert Hospital, Medical College of Wisconsin | Milwaukee | Wisconsin | 53226 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
Non-U.S. locations
This page focuses on the U.S. directory. The official record also lists 108 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT04674683, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Sep 24, 2025 · Synced Oct 27, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT04674683 live on ClinicalTrials.gov.