NCT03178123

The Study of JS001 Compared to High-Dose Interferon In Patients With Mucosal Melanoma That Has Been Removed by Surgery

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

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 220 (estimated)
• Sponsor: Shanghai Junshi Bioscience Co., Ltd. · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Mucosal Melanoma

Interventions

Type	Name	Description
BIOLOGICAL	humanized anti-PD-1 monoclonal antibody Toripalimab	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.
BIOLOGICAL	high-dose recombinant interferon a-2B	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.

Timeline

• Start date: 2017-05-31
• Primary completion: 2022-04-30
• Completion: 2025-04-30
• First posted: 2017-06-06
• Last updated: 2020-09-30

Locations

1 site across 1 country: China