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.
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
Drug | Synonyms | Arms |
---|
Toripalimab Injection | | Toripalimab Injection + chemotherapy group |
Gemcitabine Hydrochloride for Injection | | Placebo + chemotherapy group |
Cisplatin for Injection / Carboplatin Injection | | Placebo + chemotherapy group |
Placebo | | Placebo + 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
Name | Type | Description | Interventions |
---|
Toripalimab Injection + chemotherapy group | Experimental | | - Toripalimab Injection
- Gemcitabine Hydrochloride for Injection
- Cisplatin for Injection / Carboplatin Injection
|
Placebo + chemotherapy group | Placebo 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 29, 2020