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

Phase 3

Not yet recruiting

• Conditions: Locally Advanced or Metastatic Urothelial Carcinoma
• Interventions: Biological: Toripalimab Injection; Drug: Gemcitabine Hydrochloride for Injection; Drug: Placebo; Drug: Cisplatin for Injection / Carboplatin Injection

• Registration Number: NCT04568304
• Lead Sponsor: Shanghai Junshi Bioscience Co., Ltd.

Brief 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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2020-09
• Study First Submitted: 2020-09-17
• Study First Submitted QC: 2020-09-23
• Last Update Submitted: 2020-09-23
• Study First Posted: 2020-09-29
• Last Update Posted: 2020-09-29
• Study Start: 2020-11-30
• Primary Completion: 2023-11-30
• Study Completion: 2025-11-30

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 364

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Toripalimab Injection + chemotherapy group	Toripalimab Injection	-
Placebo + chemotherapy group	Placebo	-
Toripalimab Injection + chemotherapy group	Gemcitabine Hydrochloride for Injection	-
Toripalimab Injection + chemotherapy group	Cisplatin for Injection / Carboplatin Injection	-
Placebo + chemotherapy group	Gemcitabine Hydrochloride for Injection	-
Placebo + chemotherapy group	Cisplatin for Injection / Carboplatin Injection	-

Primary Outcome Measures

Name	Time	Method
Investigator-assessed progression-free survival (INV-PFS) as per RECIST 1.1 criteria	Approximately 3 years	To evaluate the investigator-assessed progression-free survival following 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

Secondary Outcome Measures

Name	Time	Method
OS rate at 1 year	Approximately 3 years	Overall survival rate at 1 year
INV-ORR, IRC-ORR	Approximately 3 years	Investigator- and IRC-assessed overall response rate
OS rate at 2 years	Approximately 4 years	Overall survival rate at 2 years
INV-DoR, IRC- DoR	Approximately 3 years	Investigator- and IRC-assessed duration of response
IRC-PFS	Approximately 3 years	Independent central radiological review committee-assessed progression-free survival as per RECIST1.1 criteria
OS	Approximately 5 years	Overall survival
INV-PFS rate and IRC-PFS rate at 6 months	Approximately 2.5 years	Investigator- and IRC-assessed progression-free survival rate at 6 months
INV-PFS rate and IRC-PFS rate at 1 year	Approximately 3 years	Investigator- and IRC-assessed progression-free survival rate at 1 year
INV-DCR, IRC-DCR	Approximately 3 years	Investigator- and IRC-assessed disease control rate
Incidence of AEs/SAEs	Approximately 4 years	Study drug related adverse events, serious adverse events graded in accordance with the National Cancer Institute Common Terminology Criteria for Adverse Events version 5.0

Trial Locations

Locations (3)

Peking University Cancer Hospital; 🇨🇳 Beijing, China

Renji Hospital Affiliated to Shanghai Jiaotong University School of Medicine; 🇨🇳 Shanghai, China

Peking University First Hospital; 🇨🇳 Beijing, China