This is a phase III randomized, control, multi-center study of recombinant humanized anti-PD-1 mAb in combination with CTLA4 mAb for injection compared to high-Dose interferon in patients with acral melanoma that has been removed by surgery.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
136
In this group, subjects will be given IBI310 3mg/kg IV Q3W in combination with IBI308 200mg IV Q3W for 4 cycles, then follow up a maintenance therapy performed with IBI310 3mg/kg IV Q12W in combination with IBI308 200mg IV Q3W until disease progression or loss of clinical benefit.
In this group, subjects will be given IBI308 200mg IV Q3W until disease progression or loss of clinical benefit
In this group, subjects will be given 15\*10\^9 U/m2/d recombinant interferon a-2B intravenously on days 1-5 weekly for 4 weeks.Then 9\*10\^9 U/m2/d recombinant interferon a-2B intravenously three times weekly for 48 weeks
Beijing cancer hospital
Beijing, China
Recurrence-free survival rate
to evaluate the Recurrence free survival (RFS) of the patients with acral melanoma treated by IBI310 in Combination With IBI308 and high-Dose interferon
Time frame: up to 5 years after enrollment
Overall survival (OS)
to evaluate the Overall survival (OS) of the patients with acral melanoma treated by IBI310 in Combination With IBI308 and high-Dose interferon
Time frame: up to 5 years after enrollment
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