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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| humanized anti-PD-1monoclonal antibody | Experimental | humanized anti-PD-1 monoclonal antibody is to be injected intravenously 3mg/kg Q2w until disease progresses or unacceptable tolerability occurs for 1 year (27 treatments) |
|
| high-dose recombinant interferon a-2B | Active Comparator | Patients receive 15*10^9 U/m2/d recombinant interferon a-2B intravenously on days 1-5. Treatment repeats weekly for 4 weeks in the absence of disease progression or unacceptable toxicity.Then patients receive 15*10^9 U/m2/d recombinant interferon a-2B intravenously three times weekly for 48 weeks. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| humanized anti-PD-1 monoclonal antibody Toripalimab | Biological | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Recurrence-free survival rate | to evaluate the Recurrence free survival (RFS) of the patients with mucosal melanoma treated by JS001 and high-Dose interferon | 5 years |
| Measure | Description | Time Frame |
|---|---|---|
| Distant metastases-free survival | to evaluate the distant metastases-free survival of the patients with mucosal melanoma treated by JS001 and high-Dose interferon | 5 years |
| recurrence - free survival rate at 3 years |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jun Guo, MD, PhD | Peking University Cancer Hospital & Institute | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Beijing Cancer Hospital | Beijing | Beijing Municipality | 100142 | China |
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|
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| high-dose recombinant interferon a-2B | Biological | 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. |
|
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to evaluate the recurrence - free survival rate at 3 years of the patients with mucosal melanoma treated by JS001 and high-Dose interferon
| 3 years |
| Overall survival (OS) | to evaluate the Overall survival (OS) of the patients with mucosal melanoma treated by JS001 and high-Dose interferon | 5 years |
| Number of participants with treatment-related adverse events | Number of participants with treatment-related adverse events as assessed by CTCAE v4.0 | 5 years |
| ID | Term |
|---|---|
| D007438 | Introns |
| ID | Term |
|---|---|
| D021901 | DNA, Intergenic |
| D040481 | Genome Components |
| D016678 | Genome |
| D040342 | Genetic Structures |
| D055614 | Genetic Phenomena |
| D040461 | Gene Components |
| D005796 | Genes |
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