# Study Comparing Investigational Drug HBI-8000 + Nivolumab vs. Placebo + Nivolumab in Patients With Advanced Melanoma

Source: https://onco.cc/trials/nct04674683/  
OnCo record `nct04674683` (Trial). Data CC BY-NC 4.0, attribute "Data from OnCo (onco.cc)"; commercial use needs a licence.

## TL;DR

A phase 3 trial of Nivolumab in melanoma, run by HUYABIO International, LLC., active and no longer recruiting.

## Summary

Study Comparing Investigational Drug HBI-8000 + Nivolumab vs. Placebo + Nivolumab in Patients With Advanced Melanoma is a phase 3 interventional study registered as NCT04674683 by HUYABIO International, LLC., with 450 participants enrolled, started 2021-08-12 and due to reach its primary completion in 2026-07. Interventions recorded: HBI-8000 in combination with nivolumab, Placebo in combination with nivolumab. Conditions listed: Unresectable or Metastatic Melanoma, Progressive Brain Metastasis. No results are recorded here; the registry entry is the source.

## Fields

- Kind: Trial
- Status: active
- Last checked: 2026-09-16
- Tags: ctgov-ingest
- Registry id: NCT04674683
- Phase: 3
- Setting: 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
- Sponsor: HUYABIO International, LLC.
- Enrolled: 450

## Sources

- ClinicalTrials.gov NCT04674683: https://clinicaltrials.gov/study/NCT04674683

## Connected records

- cancers: [Melanoma](https://onco.cc/cancers/melanoma/)
- drugs: [Nivolumab](https://onco.cc/drugs/nivolumab/)
- companies: [HUYABIO International](https://onco.cc/companies/huyabio/)

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JSON: https://onco.cc/api/v1/entities/nct04674683.json