NCT03013101

Safety and Efficacy of Recombinant Humanized Anti-PD-1 mAb for Patients With Locally Advanced or Metastatic Melanoma

A Phase II, Open, Multi-center and Single Arm Study Investigating Safety and Efficacy of Recombinant Humanized Anti-PD-1 mAb for Injection in Patients With Locally Advanced or Metastatic Melanoma and Standard Treatment Failure

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 128 (actual)
• Sponsor: Shanghai Junshi Bioscience Co., Ltd. · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is a multi-center, open-label, phase 2 study evaluating the humanized anti-PD-1 antibody JS001, as a monotherapy in patients with locally advanced or metastatic melanoma who have failed in routine systemic treatment.

Detailed description

This is a multiple-center, open-label, phase 2 study evaluating the humanized anti-PD-1 antibody JS001, as a monotherapy in patients with locally advanced or metastatic melanoma who have failed in previous routine systemic treatment. Patients are injected with JS001 with 3mg/kg every 2 weeks until disease progresses or unacceptable toxicity occurs. Response assessment is conducted by every 8 weeks.

Conditions

• Advanced Melanoma
• Metastatic 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.

Timeline

• Start date: 2016-12-28
• Primary completion: 2018-09-16
• Completion: 2021-12-01
• First posted: 2017-01-06
• Last updated: 2020-09-30

Locations

6 sites across 1 country: China