Back to resultsA Study Evaluating Toripalimab Injection Combined With Standard Chemotherapy as a First-line Treatment for Locally Advanced or Metastatic Urothelial Carcinoma
Primary Purpose
Locally Advanced or Metastatic Urothelial Carcinoma
Status
Not yet recruiting
Phase
Phase 3
Locations
China
Study Type
Interventional
Intervention
Toripalimab Injection
Gemcitabine Hydrochloride for Injection
Cisplatin for Injection / Carboplatin Injection
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Locally Advanced or Metastatic Urothelial Carcinoma
Eligibility Criteria
Inclusion criteria
- Have full knowledge on this study and are willing to sign informed consent form (ICF);
- Age 18-75 years at time of signing ICF, male or female;
- The investigator judged that the subject is eligible for platinum-based chemotherapy;
- Presence of histopathologically confirmed unresectable locally advanced (T4, any N; or any T, N2-3) or metastatic urothelial carcinoma;
- No prior systemic anti-tumor therapy;
- 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;
- With at least one measurable lesion as per RECIST 1.1 criteria;
- ECOG performance status score of 0-1;
- Adequate function of vital organs.
Exclusion criteria
- Have received anti-tumor treatments, including chemotherapy, radiotherapy or investigational product within 28 days before randomization;
- Have received traditional Chinese medicines with anti-tumor activity or immunomodulators (eg. Interferon and Interleukin) within 14 days before randomization;
- Previous use of anti-PD-1/PD-L1 agent or a drug acting on another co-inhibitory T cell receptor;
- Subjects who are currently participating in or have participated in a study with investigational product within 4 weeks before administration;
- Having received systemic corticosteroid therapy (dose equivalent to prednisone > 10 mg/day) within 14 days before randomization;
- Subjects with active central nervous system (CNS) metastasis;
- Grade 2 or higher peripheral neuropathy or hearing loss.
Sites / Locations
- Peking University Cancer Hospital
- Peking University First Hospital
- Renji Hospital Affiliated to Shanghai Jiaotong University School of Medicine
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Toripalimab Injection + chemotherapy group
Placebo + chemotherapy group
Arm Description
Outcomes
Primary Outcome Measures
Investigator-assessed progression-free survival (INV-PFS) as per RECIST 1.1 criteria
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
IRC-PFS
Independent central radiological review committee-assessed progression-free survival as per RECIST1.1 criteria
INV-ORR, IRC-ORR
Investigator- and IRC-assessed overall response rate
INV-DCR, IRC-DCR
Investigator- and IRC-assessed disease control rate
INV-DoR, IRC- DoR
Investigator- and IRC-assessed duration of response
OS
Overall survival
OS rate at 1 year
Overall survival rate at 1 year
OS rate at 2 years
Overall survival rate at 2 years
INV-PFS rate and IRC-PFS rate at 6 months
Investigator- and IRC-assessed progression-free survival rate at 6 months
INV-PFS rate and IRC-PFS rate at 1 year
Investigator- and IRC-assessed progression-free survival rate at 1 year
Incidence of AEs/SAEs
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
Full Information
NCT ID
NCT04568304
First Posted
September 17, 2020
Last Updated
September 23, 2020
Sponsor
Shanghai Junshi Bioscience Co., Ltd.
1. Study Identification
Unique Protocol Identification Number
NCT04568304
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
Study Type
Interventional
2. Study Status
Record Verification Date
September 2020
Overall Recruitment Status
Not yet recruiting
Study Start Date
November 30, 2020 (Anticipated)
Primary Completion Date
November 30, 2023 (Anticipated)
Study Completion Date
November 30, 2025 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Shanghai Junshi Bioscience Co., Ltd.
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Locally Advanced or Metastatic Urothelial Carcinoma
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
364 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Toripalimab Injection + chemotherapy group
Arm Type
Experimental
Arm Title
Placebo + chemotherapy group
Arm Type
Placebo Comparator
Intervention Type
Biological
Intervention Name(s)
Toripalimab Injection
Intervention Description
Toripalimab Injection 240 mg iv infusion on Day 1 of each 3-week cycle. The cumulative duration of Toripalimab Injection is up to 2 years.
Intervention Type
Drug
Intervention Name(s)
Gemcitabine Hydrochloride for Injection
Intervention Description
Gemcitabine 1000mg/㎡ iv infusion, on Day 1 and Day 8 of each cycle, each treatment cycle is 3 weeks.
The chemotherapy regimen will be administered for 6 cycles.
Intervention Type
Drug
Intervention Name(s)
Cisplatin for Injection / Carboplatin Injection
Intervention Description
Cisplatin 70mg/㎡ iv infusion, on Day 1 or Day 2 of each cycle, each treatment cycle is 3 weeks.
Carboplatin AUC 4.5 iv infusion, on Day 1 or Day 2 of each cycle, each treatment cycle is 3 weeks.
The chemotherapy regimen will be administered for 6 cycles.
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Placebo iv infusion on Day 1 of each 3-week cycle. The cumulative duration of placebo is up to 2 years.
Primary Outcome Measure Information:
Title
Investigator-assessed progression-free survival (INV-PFS) as per RECIST 1.1 criteria
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
Time Frame
Approximately 3 years
Secondary Outcome Measure Information:
Title
IRC-PFS
Description
Independent central radiological review committee-assessed progression-free survival as per RECIST1.1 criteria
Time Frame
Approximately 3 years
Title
INV-ORR, IRC-ORR
Description
Investigator- and IRC-assessed overall response rate
Time Frame
Approximately 3 years
Title
INV-DCR, IRC-DCR
Description
Investigator- and IRC-assessed disease control rate
Time Frame
Approximately 3 years
Title
INV-DoR, IRC- DoR
Description
Investigator- and IRC-assessed duration of response
Time Frame
Approximately 3 years
Title
OS
Description
Overall survival
Time Frame
Approximately 5 years
Title
OS rate at 1 year
Description
Overall survival rate at 1 year
Time Frame
Approximately 3 years
Title
OS rate at 2 years
Description
Overall survival rate at 2 years
Time Frame
Approximately 4 years
Title
INV-PFS rate and IRC-PFS rate at 6 months
Description
Investigator- and IRC-assessed progression-free survival rate at 6 months
Time Frame
Approximately 2.5 years
Title
INV-PFS rate and IRC-PFS rate at 1 year
Description
Investigator- and IRC-assessed progression-free survival rate at 1 year
Time Frame
Approximately 3 years
Title
Incidence of AEs/SAEs
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
Time Frame
Approximately 4 years
Other Pre-specified Outcome Measures:
Title
Investigator-assessed PFS
Description
Investigator-assessed progression-free survival to explore the efficacy of crossover to Toripalimab Injection in control group
Time Frame
Approximately 4 years
Title
Investigator-assessed ORR
Description
Investigator-assessed overall response rate to explore the efficacy of crossover to Toripalimab Injection in control group
Time Frame
Approximately 4 years
Title
Investigator-assessed DCR
Description
Investigator-assessed disease control rate to explore the efficacy of crossover to Toripalimab Injection in control group
Time Frame
Approximately 4 years
Title
Investigator-assessed DoR
Description
Investigator-assessed duration of response to explore the efficacy of crossover to Toripalimab Injection in control group
Time Frame
Approximately 4 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion criteria
Have full knowledge on this study and are willing to sign informed consent form (ICF);
Age 18-75 years at time of signing ICF, male or female;
The investigator judged that the subject is eligible for platinum-based chemotherapy;
Presence of histopathologically confirmed unresectable locally advanced (T4, any N; or any T, N2-3) or metastatic urothelial carcinoma;
No prior systemic anti-tumor therapy;
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;
With at least one measurable lesion as per RECIST 1.1 criteria;
ECOG performance status score of 0-1;
Adequate function of vital organs.
Exclusion criteria
Have received anti-tumor treatments, including chemotherapy, radiotherapy or investigational product within 28 days before randomization;
Have received traditional Chinese medicines with anti-tumor activity or immunomodulators (eg. Interferon and Interleukin) within 14 days before randomization;
Previous use of anti-PD-1/PD-L1 agent or a drug acting on another co-inhibitory T cell receptor;
Subjects who are currently participating in or have participated in a study with investigational product within 4 weeks before administration;
Having received systemic corticosteroid therapy (dose equivalent to prednisone > 10 mg/day) within 14 days before randomization;
Subjects with active central nervous system (CNS) metastasis;
Grade 2 or higher peripheral neuropathy or hearing loss.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jun Guo, Prof
Phone
86-010-88196348
Email
guoj307@126.com
Facility Information:
Facility Name
Peking University Cancer Hospital
City
Beijing
Country
China
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jun Guo, Prof
Facility Name
Peking University First Hospital
City
Beijing
Country
China
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Zhisong He, Prof
Facility Name
Renji Hospital Affiliated to Shanghai Jiaotong University School of Medicine
City
Shanghai
Country
China
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yiran Huang, Prof
12. IPD Sharing Statement
Learn more about this trial
A Study Evaluating Toripalimab Injection Combined With Standard Chemotherapy as a First-line Treatment for Locally Advanced or Metastatic Urothelial Carcinoma
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