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

Conditions

• Progressive Brain Metastasis
• Unresectable or Metastatic Melanoma

Eligibility Criteria

Sex

ALL

Age

12 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• HBI-8000 in combination with nivolumab — DRUG
  Patients will take 30 mg of HBI-8000 orally approximately 30 minutes after a full meal, beginning on Day 1 and continue every 3 to 4 days on the BIW schedule. On Day 1 of each cycle nivolumab IV will be administered by intravenous infusion at specific doses on specific days in accordance with OPDIVO® manufacturer regional product information insert and the institution's prescribing practice. In adolescent patients with body weight \< 40 kg, nivolumab will be dosed at specific doses on specific days.
• Placebo in combination with nivolumab — DRUG
  Patients will take 30 mg of Placebo orally approximately 30 minutes after a full meal, beginning on Day 1 and continue every 3 to 4 days on the BIW schedule. On Day 1 of each cycle nivolumab IV at specific doses will be administered by intravenous infusion in accordance with OPDIVO® manufacturer regional product information insert and the institution's prescribing practice.

Study Details

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.

Key Dates

Start date

Aug 12, 2021

Status verified

Sep 2025

Primary completion

Jul 31, 2026

Completion

Dec 31, 2026

Study Design

Enrollment

450 participants (actual)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: Test Arm
  HBI-8000 30 mg oral BIW + nivolumab IV at specific doses on specific days
• Placebo Comparator: Control Arm
  Placebo oral BIW + nivolumab IV at specific doses on specific days

Primary Outcome Measure

Primary Outcome [ Time Frame: From date of randomization to the earliest date of documented progressive disease (PD), assessed up to 48 months ]

Locations (31)

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