This is a phase II randomized, control, multi-center study of recombinant humanized anti-PD-1 mAb for injection compared to high-Dose interferon in patients with mucosal melanoma that has been removed by surgery.
This is a multi-centre,open, randomized, parallel-group study of mucosal melanoma adjuvant therapy to evaluate the efficacy of recombinant humanized anti-PD-1 mAb for injection compared to high-Dose interferon in patients with mucosal melanoma that has been removed by surgery.There will be 220 subjects enrolling the study, and randomized 1:1 grouped into recombinant humanized anti-PD-1 mAb for injection group (experimental group) or interferon group (control group).Each group will have 110 subjects.Random stratification factor is the disease stage (I vs II vs III).The whole research lasts about 60 months.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
220
humanized anti-PD-1 monoclonal antibody (JS001) is a programmed death-1 (PD-1) immune checkpoint inhibitor antibody, which selectively interferes with the combination of PD-1 with its ligands, PD-L1 and PD-L2, resulting in the activation of lymphocytes and elimination of malignancy theoretically.
15\*10\^9 U/m2/d recombinant interferon a-2B intravenously on days 1-5 weekly for 4 weeks.Then 15\*10\^9 U/m2/d recombinant interferon a-2B intravenously three times weekly for 48 weeks.
Beijing Cancer Hospital
Beijing, Beijing Municipality, China
Recurrence-free survival rate
to evaluate the Recurrence free survival (RFS) of the patients with mucosal melanoma treated by JS001 and high-Dose interferon
Time frame: 5 years
Distant metastases-free survival
to evaluate the distant metastases-free survival of the patients with mucosal melanoma treated by JS001 and high-Dose interferon
Time frame: 5 years
recurrence - free survival rate at 3 years
to evaluate the recurrence - free survival rate at 3 years of the patients with mucosal melanoma treated by JS001 and high-Dose interferon
Time frame: 3 years
Overall survival (OS)
to evaluate the Overall survival (OS) of the patients with mucosal melanoma treated by JS001 and high-Dose interferon
Time frame: 5 years
Number of participants with treatment-related adverse events
Number of participants with treatment-related adverse events as assessed by CTCAE v4.0
Time frame: 5 years
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.