Overview

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.

Eligibility

Inclusion Criteria:

1. Male and Female aged between 18 and 75 years are eligible;
2. It was confirmed by histopathology that it was a acral melanoma;
3. Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1;
4. Complete excision of primary focal area, surgical incision; All patients must have disease-free status documented by a complete physical examination and imaging studies prior to registration;
5. No adjuvant therapy was received;
6. No treatment contraindication, peripheral blood, normal liver, kidney function and electrocardiogram are normal; ANC1.510^9/L,PLT9010^9/L,Hgb90.g/dL; serum urea nitrogen, cr1.5ULN; ALT,ASTI2.5ULN,
7. Female subjects of childbearing age or male subjects of women of childbearing age need effective contraception during the entire treatment period and 6 months after the treatment period

Exclusion Criteria

1. Mucosal-derived melanoma, uveal melanoma.
2. Previous exposure to any anti-CTLA-4, anti-PD-1, anti-PD-L1 / 2 antibody or interferon.
3. Hyperthyroidism or hypothyroidism. Note: Subjects who are stable after hormone replacement therapy can be enrolled.
4. Participate in another clinical study at the same time.
5. Have received any research drug within 4 weeks before the first dose of study treatment.