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

> **NCT04674683** · PHASE3 · ACTIVE_NOT_RECRUITING · sponsor: **HUYABIO International, LLC.** · enrollment: 450 (actual)

## Conditions studied

- Unresectable or Metastatic Melanoma
- Progressive Brain Metastasis

## Interventions

- **DRUG:** HBI-8000 in combination with nivolumab
- **DRUG:** Placebo in combination with nivolumab

## Key facts

- **NCT ID:** NCT04674683
- **Lead sponsor:** HUYABIO International, LLC.
- **Sponsor class:** INDUSTRY
- **Phase:** PHASE3
- **Study type:** INTERVENTIONAL
- **Status:** ACTIVE_NOT_RECRUITING
- **Start date:** 2021-08-12
- **Primary completion:** 2026-07
- **Final completion:** 2026-12
- **Target enrollment:** 450 (ACTUAL)
- **Last updated:** 2025-09-24

## Collaborators

- [object Object]

## Primary source

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

## Citation

> US National Library of Medicine, ClinicalTrials.gov registration NCT04674683, "Study Comparing Investigational Drug HBI-8000 + Nivolumab vs. Placebo + Nivolumab in Patients With Advanced Melanoma". Retrieved via AI Analytics 2026-06-08 from https://api.ai-analytics.org/clinical/NCT04674683. Licensed CC0.

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