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
Overview
- Phase
- Phase 3
- Intervention
- Toripalimab Injection
- Conditions
- Locally Advanced or Metastatic Urothelial Carcinoma
- Sponsor
- Shanghai Junshi Bioscience Co., Ltd.
- Enrollment
- 364
- Locations
- 3
- Primary Endpoint
- Investigator-assessed progression-free survival (INV-PFS) as per RECIST 1.1 criteria
- Status
- Not yet recruiting
- Last Updated
- 5 years ago
Overview
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.
Investigators
Eligibility Criteria
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Arms & Interventions
Toripalimab Injection + chemotherapy group
Intervention: Toripalimab Injection
Toripalimab Injection + chemotherapy group
Intervention: Gemcitabine Hydrochloride for Injection
Toripalimab Injection + chemotherapy group
Intervention: Cisplatin for Injection / Carboplatin Injection
Placebo + chemotherapy group
Intervention: Gemcitabine Hydrochloride for Injection
Placebo + chemotherapy group
Intervention: Cisplatin for Injection / Carboplatin Injection
Placebo + chemotherapy group
Intervention: Placebo
Outcomes
Primary Outcomes
Investigator-assessed progression-free survival (INV-PFS) as per RECIST 1.1 criteria
Time Frame: 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 Outcomes
- OS rate at 1 year(Approximately 3 years)
- INV-ORR, IRC-ORR(Approximately 3 years)
- OS rate at 2 years(Approximately 4 years)
- INV-DoR, IRC- DoR(Approximately 3 years)
- IRC-PFS(Approximately 3 years)
- OS(Approximately 5 years)
- INV-PFS rate and IRC-PFS rate at 6 months(Approximately 2.5 years)
- INV-PFS rate and IRC-PFS rate at 1 year(Approximately 3 years)
- INV-DCR, IRC-DCR(Approximately 3 years)
- Incidence of AEs/SAEs(Approximately 4 years)