{"entity":{"id":"nct04674683","kind":"trial","name":"Study Comparing Investigational Drug HBI-8000 + Nivolumab vs. Placebo + Nivolumab in Patients With Advanced Melanoma","aka":[],"tldr":"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.","status":"active","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT04674683","url":"https://clinicaltrials.gov/study/NCT04674683"}],"tags":["ctgov-ingest"],"related":[],"cancers":["melanoma","advanced-melanoma"],"sections":[],"technologies":["checkpoint-inhibitor"],"targets":[],"drugs":["nivolumab"],"companies":["huyabio"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"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.","participation":[{"nct":"NCT04674683","source":"https://clinicaltrials.gov/study/NCT04674683","fetchedAt":"2026-10-07T16:53:25.283Z","studySha256":"b3e473300f96029386f6b9e9fa66963a9462aac1fc67eb1db7192f92bdbc9575","overallStatus":"ACTIVE_NOT_RECRUITING","lastUpdatePosted":"2025-09-24","leadSponsor":"HUYABIO International, LLC.","collaboratorCount":1,"minimumAge":"12 Years","sex":"ALL","healthyVolunteers":false,"hasEligibility":true,"enrolment":450,"enrolmentType":"ACTUAL","siteCount":139,"recruitingSiteCount":0,"countries":["Australia","Austria","Belgium","Brazil","Czechia","France","Germany","Italy","Japan","New Zealand","Puerto Rico","Singapore","South Africa","South Korea","Spain","United Kingdom","United States"]}],"started":"2021-08-12","startedType":"actual","enrolled":450,"enrolledBasis":"registry","outcomes":[]},"route":"/trials/nct04674683/","neighbours":{"cancer":[{"id":"advanced-melanoma","kind":"cancer","name":"Advanced melanoma (unresectable stage III and stage IV)","route":"/cancers/advanced-melanoma/"},{"id":"melanoma","kind":"cancer","name":"Melanoma","route":"/cancers/melanoma/"}],"technology":[{"id":"checkpoint-inhibitor","kind":"technology","name":"Immune checkpoint inhibitors","route":"/technologies/checkpoint-inhibitor/"}],"drug":[{"id":"nivolumab","kind":"drug","name":"Nivolumab","route":"/drugs/nivolumab/"}],"company":[{"id":"huyabio","kind":"company","name":"HUYABIO International","route":"/companies/huyabio/"}]}}