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

September 23, 2020 updated by: Shanghai Junshi Bioscience Co., Ltd.

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

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
364

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • China
      • Beijing, China
        • Peking University First Hospital
        • Contact:
          • Zhisong He, Prof
      • Beijing, China
        • Peking University Cancer Hospital
        • Contact:
          • Jun Guo, Prof
      • Shanghai, China
        • Renji Hospital Affiliated to Shanghai Jiaotong University School of Medicine
        • Contact:
          • Yiran Huang, Prof

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Toripalimab Injection + chemotherapy group
Biological: Toripalimab Injection
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.
Drug: Gemcitabine Hydrochloride for Injection

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.

Drug: Cisplatin for Injection / Carboplatin Injection

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.
Placebo Comparator: Placebo + chemotherapy group
Drug: Gemcitabine Hydrochloride for Injection

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.

Drug: Cisplatin for Injection / Carboplatin Injection

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.

Drug: Placebo
Placebo iv infusion on Day 1 of each 3-week cycle. The cumulative duration of placebo is up to 2 years.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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
Approximately 3 years

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
IRC-PFS
Time Frame: Approximately 3 years
Independent central radiological review committee-assessed progression-free survival as per RECIST1.1 criteria
Approximately 3 years
INV-ORR, IRC-ORR
Time Frame: Approximately 3 years
Investigator- and IRC-assessed overall response rate
Approximately 3 years
INV-DCR, IRC-DCR
Time Frame: Approximately 3 years
Investigator- and IRC-assessed disease control rate
Approximately 3 years
INV-DoR, IRC- DoR
Time Frame: Approximately 3 years
Investigator- and IRC-assessed duration of response
Approximately 3 years
OS
Time Frame: Approximately 5 years
Overall survival
Approximately 5 years
OS rate at 1 year
Time Frame: Approximately 3 years
Overall survival rate at 1 year
Approximately 3 years
OS rate at 2 years
Time Frame: Approximately 4 years
Overall survival rate at 2 years
Approximately 4 years
INV-PFS rate and IRC-PFS rate at 6 months
Time Frame: Approximately 2.5 years
Investigator- and IRC-assessed progression-free survival rate at 6 months
Approximately 2.5 years
INV-PFS rate and IRC-PFS rate at 1 year
Time Frame: Approximately 3 years
Investigator- and IRC-assessed progression-free survival rate at 1 year
Approximately 3 years
Incidence of AEs/SAEs
Time Frame: 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
Approximately 4 years

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Investigator-assessed PFS
Time Frame: Approximately 4 years
Investigator-assessed progression-free survival to explore the efficacy of crossover to Toripalimab Injection in control group
Approximately 4 years
Investigator-assessed ORR
Time Frame: Approximately 4 years
Investigator-assessed overall response rate to explore the efficacy of crossover to Toripalimab Injection in control group
Approximately 4 years
Investigator-assessed DCR
Time Frame: Approximately 4 years
Investigator-assessed disease control rate to explore the efficacy of crossover to Toripalimab Injection in control group
Approximately 4 years
Investigator-assessed DoR
Time Frame: Approximately 4 years
Investigator-assessed duration of response to explore the efficacy of crossover to Toripalimab Injection in control group
Approximately 4 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Shanghai Junshi Bioscience Co., Ltd.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
November 30, 2020

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
November 30, 2023

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
November 30, 2025

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
September 17, 2020

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 23, 2020

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
September 29, 2020

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
September 29, 2020

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 23, 2020

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
September 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • JS001-038-III-UBC

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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