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

NCT03113266 · Status: UNKNOWN · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 370

Last updated 2020-09-30

No results posted yet for this study

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.

Conditions

  • Bladder Urothelial Carcinoma

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.

Sponsors & Collaborators

  • Shanghai Junshi Bioscience Co., Ltd.

    lead OTHER

Principal Investigators

  • Jun Guo · Peking University Cancer Hospital & Institute

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-04-06
Primary Completion
2020-03-15
Completion
2022-02-28

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03113266 on ClinicalTrials.gov