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TERMINATED
NCT03178123
PHASE2

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

Sponsor: Shanghai Junshi Bioscience Co., Ltd.

View on ClinicalTrials.gov

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.

Official title: 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

Key Details

Gender

All

Age Range

18 Years - 75 Years

Study Type

INTERVENTIONAL

Enrollment

6

Start Date

2017-05-31

Completion Date

2019-06-30

Last Updated

2026-07-27

Healthy Volunteers

No

Interventions

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.

Locations (1)

Beijing Cancer Hospital

Beijing, Beijing Municipality, China