Study Comparing Investigational Drug HBI-8000 Combined With Nivolumab vs. Nivolumab in Patients With Advanced Melanoma
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
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Clinical Trial Information
Trial Contact: Frankos, Marie; Donaldson, Karin M; Grofsik, Kiera; Caldwell, Chloe M
Trial Phone: 321.841.7303 ; 321.841.9821 ; 321.841.6626 ; (321)841.1107
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IRB No: S21.157.09
Protocol Abbrev: HBI-8000-303
Principal Investigator: Sajeve Samuel Thomas, MD
Phase: Drug: Phase III
Age Group: Adult
Secondary Protocol No: HBI-8000-303
Treatment: Drug: HBI-8000 in combination with nivolumab Drug: Placebo in combination with nivolumab
Therapies Involved: Chemotherapy
ClinicalTrials.gov ID: NCT04674683
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Objective
To compare, between Test (HBI-8000 + nivolumab) and Control (placebo +nivolumab) arms:
• Objective Response Rate (ORR), defined as the percentage of patients enrolled in each study arm with a best response of CR or PR according to Response Evaluation Criteria in Solid Tumors (RECIST 1.1), as determined by the blinded independent review committee (BIRC)
• Progression-free Survival (PFS), defined as the time from the date of randomization to the first date of documented progression as determined by BIRC, or the date of death due to any cause, whichever occurs first.
Secondary Objectives
To compare, between Test and Control arms:
• Overall Survival (OS) defined as the time from the date of
randomization to the date of death due to any cause.
• Safety defined as incidence rate of adverse events, severity (CTCAE), causal relationship assessment, and outcomes at the time of randomization until the end of study.
Exploratory Objectives
• Duration of Response (DoR), defined as the time from the first date of objective response (PR or CR) as determined by BIRC to the first date of PD or death from any cause, compared between Test and Control arms
• Disease Control Rate (DCR), defined as the percentage of patients enrolled in each study arm with a best overall response of CR, PR or SD as determined by BIRC, compared between Test and Control arms
