This study was a phase IB, single-center, open-label, two part(part A involved dose reduction, and part B involved cohort expansion) clinical trial evaluating the safety and clinical activity of AK104 or AK112 in combination with axitinib in patients with advanced mucosal melanoma.
None
Prior treatment with anti-PD-1/PD-L1/PD-L2 antibody and Axitinib
Is currently participating in a study of an investigational agent or using an investigational device
Has a diagnosis of immunodeficiency or is receiving systemic steroid therapy within 2 years prior to the first dose of study treatment
Has undergone major surgery within 30 days of Study Day 1
Parallel
AK104+Axitinib
DrugSubjects receive AK104 10mg/kg intravenously (IV) every 3-week cycle plus Axitinib until progression.
AK112+Axitinib
DrugSubjects receive AK112 20mg/kg intravenously (IV) every 3-week cycle plus Axitinib until progression.
Number of participants with treatment-related adverse events as assessed by CTCAE v4.0
Safety assessments including vital signs, laboratory tests, and adverse event monitoring
Objective Response Rate (ORR) by irRC and RECIST 1.1
The treatment effect of AK104 or AK112 in combination with axitinib, will be assessed using irRC and RECIST 1.1 to determine tumor response.
Duration of Response (DOR) by irRC and RECIST 1.1
The treatment effect of AK104 or AK112 in combination with axitinib, will be assessed using irRC and RECIST 1.1 to determine duration of response.
Disease Control Rate (DCR) by irRC and RECIST 1.1
The treatment effect of AK104 or AK112 in combination with axitinib, will be assessed using irRC and RECIST 1.1 to determine disease control rate.
Time to response (TTR) by irRC and RECIST 1.1
The treatment effect of AK104 or AK112 in combination with axitinib, will be assessed using irRC and RECIST 1.1 to determine time to response.
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