Protocol Title: A Multicenter, Randomized, and Double-Blind Phase 3 Study of HBI-8000 combined with Nivolumab versus Placebowith Nuvolumab in Patients with Unresctable or Metastatic Melanoma Not previously treated with PD-1

Sponsor: Huya Bio

Protocol Number: HBI-8000-303

Key Criteria

Histopathologically confirmed diagnosis of non-uveal, Stage III (unresectable), or Stage IV (metastatic) melanoma according to AJCC staging system (8th edition).  

Known BRAF V600 mutation  

In order to be randomized, a patient must be classified (by central lab) as PD-L1 positive or PD-L1 negative  

1 measurable lesion per RECIST 1.1  

Have not received anti-PD-1, anti-PD-L1 or other systemic therapy for unresectable or metastatic melanoma, except for the following, provided that the patient recovered from all treatment related toxicities:

a. BRAF mutation targeted therapy >4 weeks before administration of Study Treatment.

b. Adjuvant or neoadjuvant therapy with PD-1 or PD-L1 inhibitors, anti- cytotoxic T lymphocyte-associated protein 4 (CTLA4) is allowed if disease progression/or recurrence occurred at least 6 months after the last dose and no clinically significant immune related toxicities leading to treatment discontinuation were observed.

c. Adjuvant interferon therapy must have been completed >6 weeks before administration of Study Treatment.

Talking Points

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