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Safety and Efficacy of Toripalimab for Patients With Locally Advanced or Metastatic Bladder Urothelial Carcinoma

Bladder Urothelial Carcinoma Clinical Trial

Official title:
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 Bladder Urothelial Carcinoma

Clinical Trial 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 bladder urothelial carcinoma who have failed in routine systemic treatment.

Clinical Trial Description

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 bladder urothelial carcinoma who have failed in routine systemic treatment.The implementation of study meet the GCP.370 patients will be enrolled in the study to evaluate the safety and efficacy of JS001.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 in first year, every 12 weeks in second year and every 16 weeks in third year and beyond. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT03113266
Study type Interventional
Source Shanghai Junshi Bioscience Co., Ltd.
Contact Ling Xiao
Phone 051286876925
Email ling_xiao@topalliancebio.com
Status Recruiting
Phase Phase 2
Start date April 6, 2017
Completion date February 2022
View Details
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