Clinical Trials /

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

NCT04568304

Description:

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.

Related Conditions:
  • Urothelial Carcinoma
Recruiting Status:

Not yet recruiting

Phase:

Phase 3

Trial Eligibility

Document

Title

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

Clinical Trial IDs

  • ORG STUDY ID: JS001-038-III-UBC
  • NCT ID: NCT04568304

Conditions

  • Locally Advanced or Metastatic Urothelial Carcinoma

Interventions

DrugSynonymsArms
Toripalimab InjectionToripalimab Injection + chemotherapy group
Gemcitabine Hydrochloride for InjectionPlacebo + chemotherapy group
Cisplatin for Injection / Carboplatin InjectionPlacebo + chemotherapy group
PlaceboPlacebo + chemotherapy group

Purpose

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.

Trial Arms

NameTypeDescriptionInterventions
Toripalimab Injection + chemotherapy groupExperimental
  • Toripalimab Injection
  • Gemcitabine Hydrochloride for Injection
  • Cisplatin for Injection / Carboplatin Injection
Placebo + chemotherapy groupPlacebo Comparator
  • Gemcitabine Hydrochloride for Injection
  • Cisplatin for Injection / Carboplatin Injection
  • Placebo

Eligibility Criteria

        Inclusion criteria

          1. Have full knowledge on this study and are willing to sign informed consent form (ICF);

          2. Age 18-75 years at time of signing ICF, male or female;

          3. The investigator judged that the subject is eligible for platinum-based chemotherapy;

          4. Presence of histopathologically confirmed unresectable locally advanced (T4, any N; or
             any T, N2-3) or metastatic urothelial carcinoma;

          5. No prior systemic anti-tumor therapy;

          6. Subjects who are able to provide tumor tissue slides (≥ 5 slides) for PD-L1 test and
             the corresponding pathology report and whose PD-L1 test must be positive before
             randomization;

          7. With at least one measurable lesion as per RECIST 1.1 criteria;

          8. ECOG performance status score of 0-1;

          9. Adequate function of vital organs.

        Exclusion criteria

          1. Have received anti-tumor treatments, including chemotherapy, radiotherapy or
             investigational product within 28 days before randomization;

          2. Have received traditional Chinese medicines with anti-tumor activity or
             immunomodulators (eg. Interferon and Interleukin) within 14 days before randomization;

          3. Previous use of anti-PD-1/PD-L1 agent or a drug acting on another co-inhibitory T cell
             receptor;

          4. Subjects who are currently participating in or have participated in a study with
             investigational product within 4 weeks before administration;

          5. Having received systemic corticosteroid therapy (dose equivalent to prednisone > 10
             mg/day) within 14 days before randomization;

          6. Subjects with active central nervous system (CNS) metastasis;

          7. Grade 2 or higher peripheral neuropathy or hearing loss.
      
Maximum Eligible Age:75 Years
Minimum Eligible Age:18 Years
Eligible Gender:All
Healthy Volunteers:No

Primary Outcome Measures

Measure:Investigator-assessed progression-free survival (INV-PFS) as per RECIST 1.1 criteria
Time Frame:Approximately 3 years
Safety Issue:
Description: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

Measure:IRC-PFS
Time Frame:Approximately 3 years
Safety Issue:
Description:Independent central radiological review committee-assessed progression-free survival as per RECIST1.1 criteria
Measure:INV-ORR, IRC-ORR
Time Frame:Approximately 3 years
Safety Issue:
Description:Investigator- and IRC-assessed overall response rate
Measure:INV-DCR, IRC-DCR
Time Frame:Approximately 3 years
Safety Issue:
Description:Investigator- and IRC-assessed disease control rate
Measure:INV-DoR, IRC- DoR
Time Frame:Approximately 3 years
Safety Issue:
Description:Investigator- and IRC-assessed duration of response
Measure:OS
Time Frame:Approximately 5 years
Safety Issue:
Description:Overall survival
Measure:OS rate at 1 year
Time Frame:Approximately 3 years
Safety Issue:
Description:Overall survival rate at 1 year
Measure:OS rate at 2 years
Time Frame:Approximately 4 years
Safety Issue:
Description:Overall survival rate at 2 years
Measure:INV-PFS rate and IRC-PFS rate at 6 months
Time Frame:Approximately 2.5 years
Safety Issue:
Description:Investigator- and IRC-assessed progression-free survival rate at 6 months
Measure:INV-PFS rate and IRC-PFS rate at 1 year
Time Frame:Approximately 3 years
Safety Issue:
Description:Investigator- and IRC-assessed progression-free survival rate at 1 year
Measure:Incidence of AEs/SAEs
Time Frame:Approximately 4 years
Safety Issue:
Description: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

Details

Phase:Phase 3
Primary Purpose:Interventional
Overall Status:Not yet recruiting
Lead Sponsor:Shanghai Junshi Bioscience Co., Ltd.

Last Updated

September 23, 2020