Study Comparing Investigational Drug HBI-8000 + Nivolumab vs. Placebo + Nivolumab in Patients With Advanced Melanoma (NCT04674683)
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
🩺 Plain-English Summary (8th-Grade Level)
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.
Who can join: Review the eligibility criteria below.
Location: Comprehensive Blood and Cancer Center — Bakersfield, California
Age range: 12 Years
🧪 Interventions in This Study
📋 "Do I Qualify?" — 1-Minute Self Screener
Instant ChecklistFull eligibility criteria are available on the official NIH protocol. View the criteria ↗
📍 All Participating Trial Locations (139 Sites)
Showing the first 25 of 139 sites.
- Comprehensive Blood and Cancer Center — Bakersfield, California
- UC San Diego Moores Cancer Center — La Jolla, California
- Innovative Clinical Research Institute (ICRI) — Pasadena, California
- Emad Ibrahim, MD, INC — Redlands, California
- Kaiser Permanente Oncology Research — Riverside, California
- California Cancer Associates for Research and Excellence, Inc. (cCARE) — San Marcos, California
- Boca Raton Regional Hospital, Lynn Cancer Institute — Boca Raton, Florida
- Memorial Regional Hospital — Hollywood, Florida
- Baptist MD Anderson Cancer Center — Jacksonville, Florida
- Orlando Health — Orlando, Florida
- Ascension Sacred Heart Medical Oncology — Pensacola, Florida
- Moffitt Cancer Center — Tampa, Florida
- Goshen Center for Cancer Care — Goshen, Indiana
- St. Elizabeth Healthcare — Edgewood, Kentucky
- Baptist Health Lexington — Lexington, Kentucky
- Frederick Memorial Healthcare System — Frederick, Maryland
- St Louis Cancer Care — Bridgeton, Missouri
- AMR Kansas City — Kansas City, Missouri
- Medisearch Clinical Trials — Saint Joseph, Missouri
- St. Vincent - Frontier Cancer Center — Billings, Montana
- Levine Cancer Institute — Charlotte, North Carolina
- Southeastern Medical Oncology Center — Goldsboro, North Carolina
- Gabrail Cancer Center Research — Canton, Ohio
- Toledo Clinic Cancer Center — Toledo, Ohio
- Thomas Jefferson University Medical Oncology Clinic — Philadelphia, Pennsylvania
💰 Cost, Insurance & Patient Rights
- 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
- Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
- Voluntary Participation: You may withdraw at any time without affecting your standard medical care.
More studies in Unresectable or Metastatic Melanoma
- PICSTAT Pilot Study for CD8 PET/CT-Guided Lifileucel Treatment in Advanced Melanoma — Philadelphia, Pennsylvania
Explore by condition: All Unresectable or Metastatic Melanoma clinical trials
💡 How to Participate
- Check the checklist above to see if you may qualify.
- Review the official NIH record below to find the coordinating site.
- Ask about the visit schedule, what is covered at no cost, and any travel support.
- Confirm with your own doctor before making a decision.