Unresectable or Metastatic Melanoma
Conditions
Interventions
Development code, Generic name of investigational material etc.: HBI-8000, Tucidinostat (Hiyasta(R) Tablets)
Generic name of control material etc.: Placebo
Generic name of concomitant material etc.: n
Sponsors
Onogi Hiroshi
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: -Histopathologically confirmed diagnosis of non-uveal, Stage III (unresectable), or Stage IV (metastatic) melanoma according to AJCC staging system (8th edition). -Males or females 18 years of age or older. -Eastern Cooperative Oncology Group (ECOG) performance status 4 weeks before administration of Study Treatment. - Adjuvant or neoadjuvant therapy with PD-1 or PD-L1 inhibitors, or anti-CTLA-4 is allowed if disease progression/or recurrence had occurred at least 6 months after the last dose of neoadjuvant/adjuvant therapy and prior to receiving the first dose on this study and no clinically significant immune related toxicities leading to treatment discontinuation were observed - Adjuvant interferon therapy must have been completed > 6 weeks before administration of Study Treatment
Exclusion criteria
Exclusion criteria: -Previous treatment with a PD-1, PD-L1, PD-L2, CTLA-4 inhibitor, or any other agents targeting T-cell co-stimulation or immune checkpoint pathways for unresectable or metastatic melanoma. -History of a cardiovascular illness including: congestive heart failure (New York Heart Association Grade III or IV); unstable angina or myocardial infarction within the previous 6 months; or symptomatic cardiac arrhythmia despite medical management. QT interval corrected by heart rate using QTcF >450 ms in males or >470 ms in females, or congenital long QT syndrome. -Patients with new, active, or progressive brain metastases or leptomeningeal disease. -History of hemorrhagic diarrhea, inflammatory bowel disease, active uncontrolled peptic ulcer, or bowel resection that affects absorption of orally administered drugs. -Active, known, or suspected autoimmune disease, except for Type I diabetes mellitus, hypothyroidism requiring only hormone replacement, or skin disorders (such as vitiligo, psoriasis, or alopecia) not requiring systemic therapy. -Active uncontrolled bacterial, viral, or fungal infection requiring systemic therapy. -Pregnant or breast-feeding women. -Underlying medical conditions that, in the Investigator's opinion, will make the administration of Study Treatment hazardous or obscure the interpretation of toxicity determination or AEs. -Patients with a history of or active interstitial lung disease (ILD) or non-infectious pneumonitis.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| - Progression-free Survival (PFS) defined as the time (in days) from the date of randomization to the first date of documented disease progression as determined by BIRC, or the date of death due to any cause, whichever occurs first. | — |
Secondary
| Measure | Time frame |
|---|---|
| - Objective Response Rate (ORR) defined as the percentage of patients enrolled in each study arm with a best response of confirmed CR or PR as determined by BIRC. - Overall Survival (OS) defined as the time from date of randomization to the date of death due to any cause. - Safety defined as incidence rate of adverse events (AEs), severity (CTCAE v.5.0), causal relationship assessment, and outcomes of reported AEs. | — |
Countries
Australia, Austria, Belgium, Brazil, Czech Republic, France, Germany, Italy, Japan, New Zealand, Puerto Rico, Singapore, South Africa, South Korea, Spain, UK, USA
Contacts
Public ContactChikako Rosario
Parexel International Inc.
Outcome results
None listed