A Study Evaluating Toripalimab Injection Combined With Standard Chemotherapy as a First-line Treatment for Locally Advanced or Metastatic Urothelial Carcinoma

Locally Advanced or Metastatic Urothelial Carcinoma Clinical Trial

Official title:
A Phase III, Randomized, Double-blind, Placebo-controlled, Multi-center Clinical Study to Evaluate the Efficacy and Safety of Toripalimab Injection (JS001) in Combination With Standard Chemotherapy Versus Placebo in Combination With Standard Chemotherapy as the 1st-line Therapy for Treatment-naive Subjects With PD-L1-positive Locally Advanced or Metastatic Urothelial Carcinoma

Status Not yet recruiting

Clinical Trial Summary

The study is being conducted to evaluate the efficacy and safety of Toripalimab Injection in combination with chemotherapy compared to placebo in combination with chemotherapy in subjects with PD-L1-positive unresectable locally advanced or metastatic urothelial carcinoma who have received no previous systemic therapy.

Clinical Trial Description

n/a

Study Design

Related Conditions & MeSH terms

Carcinoma
Carcinoma, Transitional Cell
Locally Advanced or Metastatic Urothelial Carcinoma

Clinical Trial Details

NCT number	NCT04568304
Study type	Interventional
Source	Shanghai Junshi Bioscience Co., Ltd.
Contact	Jun Guo, Prof
Phone	86-010-88196348
Email	guoj307@126.com
Status	Not yet recruiting
Phase	Phase 3
Start date	November 30, 2020
Completion date	November 30, 2025

View Details

See also
	Status	Clinical Trial	Phase
	Completed	`NCT04602078` - Study of Atezolizumab Combined With Split-dose Gemcitabine Plus Cisplatin in Urothelial Carcinoma	Phase 2
	Recruiting	`NCT05327530` - A Study of the Safety and Efficacy of Various Combinations of Avelumab as Therapy in Locally Advanced or Metastatic Urothelial Carcinoma (JAVELIN Bladder Medley)	Phase 2