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SHR-1210 in Patients With Relapsed or Refractory Extranodal NK/T Cell Lymphoma

Extranodal NK/T-cell Lymphoma, Nasal Type Clinical Trial

Official title:
An Open-Label, Single Arm, Multi-Center, Phase 2 Study of PD-1 Antibody SHR-1210 in Subjects With Relapsed or Refractory Extranodal NK/T Cell Lymphoma

Clinical Trial Summary

This is an open-label, multi-center, nonrandomized, Phase 2 study to evaluate efficacy and safety of SHR-1210 in subjects with relapsed or refractory extranodal NK/T cell lymphoma.Efficacy will be assessed every 8 weeks according to 2014 Lugano criteria.Safety evaluations (both clinical and laboratory) are performed at baseline, before each study treatment, and throughout the study.

Clinical Trial Description

The primary objective of this phase 2 study is to assess objective response rate of SHR-1210 in patients with relapsed or refractory extranodal NK/T cell lymphoma. The secondary objective is to observe time to response,progression free survival rate at 2 years,overall survival rate at 2 years，safety and immunogenicity of SHR-1210 in relapsed or refractory extranodal NK/T cell lymphoma.The relationship of PD-L1 expression in tumor tissue and EBV-DNA copies in blood to SHR-1210 efficacy in these patients would also be explored. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT03363555
Study type Interventional
Source Jiangsu HengRui Medicine Co., Ltd.
Contact
Status Active, not recruiting
Phase Phase 2
Start date May 29, 2018
Completion date June 2021
View Details
See also
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