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Safety and Efficacy of Toripalimab for Patients With Locally Advanced or Metastatic Bladder Urothelial Carcinoma

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03113266
Recruitment Status : Unknown
Verified September 2020 by Shanghai Junshi Bioscience Co., Ltd..
Recruitment status was:  Recruiting
First Posted : April 13, 2017
Last Update Posted : September 30, 2020
Sponsor:
Information provided by (Responsible Party):
Shanghai Junshi Bioscience Co., Ltd.

Brief Summary:
This is a multi-center, open-label, phase 2 study evaluating the humanized anti-PD-1 antibody JS001, as a monotherapy in patients with locally advanced or metastatic bladder urothelial carcinoma who have failed in routine systemic treatment.

Condition or disease Intervention/treatment Phase
Bladder Urothelial Carcinoma Biological: humanized anti-PD-1 monoclonal antibody toripalimab Phase 2

Detailed Description:
This is a multi-center, open-label, phase 2 study evaluating the humanized anti-PD-1 antibody JS001, as a monotherapy in patients with locally advanced or metastatic bladder urothelial carcinoma who have failed in routine systemic treatment.The implementation of study meet the GCP.370 patients will be enrolled in the study to evaluate the safety and efficacy of JS001.Patients are injected with JS001 with 3mg/kg every 2 weeks until disease progresses or unacceptable toxicity occurs.Response assessment is conducted by every 8 weeks in first year, every 12 weeks in second year and every 16 weeks in third year and beyond.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 370 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase II, Open, Multi-center and Single Arm Study Investigating Safety and Efficacy of Recombinant Humanized Anti-PD-1 mAb for Injection in Patients With Locally Advanced or Metastatic Bladder Urothelial Carcinoma
Actual Study Start Date : April 6, 2017
Actual Primary Completion Date : March 15, 2020
Estimated Study Completion Date : February 2022

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: humanized anti-PD-1monoclonal antibody
humanized anti-PD-1 monoclonal antibody is to be injected intravenously 3mg/kg Q2w until disease progresses or unacceptable tolerability occurs
Biological: humanized anti-PD-1 monoclonal antibody toripalimab
humanized anti-PD-1 monoclonal antibody (JS001) is a programmed death-1 (PD-1) immune checkpoint inhibitor antibody, which selectively interferes with the combination of PD-1 with its ligands, PD-L1 and PD-L2, resulting in the activation of lymphocytes and elimination of malignancy theoretically.
Other Name: JS001, TAB001




Primary Outcome Measures :
  1. Objective response rate (ORR) by RECIST 1.1 and irRECIST [ Time Frame: 3 years ]
    The treatment effect of JS001 will be assessed using irRC and RECIST 1.1 to determine tumor response.


Secondary Outcome Measures :
  1. Duration of response (DOR) by RECIST1.1 and irRECIST [ Time Frame: 3 years ]
    The treatment effect of JS001 will be assessed using irRC and RECIST 1.1 to determine duration of response.

  2. Progression free survival (PFS) by RECIST1.1 and irRECIST [ Time Frame: 3 years ]
    The treatment effect of JS001 will be assessed using irRC and RECIST 1.1 to determine progression-free survival time.

  3. Overall survival (OS) [ Time Frame: 3 years ]
    The treatment effect of JS001 will be assessed using irRC and RECIST 1.1 to determine overall survival.

  4. Immunogenicity of anti-PD-1 monoclonal antibody [ Time Frame: 3 years ]
    To test immunogenicity of anti-PD-1 monoclonal antibody

  5. Number of participants with treatment-related adverse events as assessed by CTCAE v4.0 [ Time Frame: 3 years ]
    Number of participants with treatment-related adverse events as assessed by CTCAE v4.0


Other Outcome Measures:
  1. Correlation analysis of PD-L1 expression of tumor by ORR [ Time Frame: 3 years ]
    correlation analysis of PD-L1 expression of tumor and objective response rate

  2. Correlation analysis of PD-L1 expression of tumor by Immunohistochemistry [ Time Frame: 3 years ]
    to analyse PD-L1 expression of tumor by Immunohistochemistry



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Male and Female aged 18 and older are eligible;
  • Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1;
  • Histologic diagnosis of locally advanced or metastatic bladder urothelial carcinoma, including the origin of renal pelvis, ureter, urinary tract;
  • At least 1 measurable lesion (only 1 measurable lymph node lesion is excluded) (routine CT scan >=20mm, spiral CT scan >=10mm, no prior radiation to measurable lesions);
  • Providing with tumor specimen (for testing the expression of PD -L1 and the infiltrating lymphocytes);
  • Predicted survival >=3 months;
  • Brain or meningeal metastases must be disposed with surgery or radiation, and be stable clinically for at least 3 months (prior systemic steroids was allowed, but concurrent administration of systemic steroids with the study drug is excluded).
  • Screening laboratory values must meet the following criteria(within past 14 days):

hemoglobin ≥ 9.0 g/dL; neutrophils ≥ 1500 cells/ µL; platelets ≥ 100 x 10^3/ µL; total bilirubin ≤ 1.5 x upper limit of normal (ULN); aspartic transaminase (AST) and alanine transaminase (ALT) ≤ 2.5 x ULN without, and ≤ 5 x ULN with hepatic metastasis; serum creatinine ≤1╳ULN,creatinine clearance >50ml/min (Cockcroft-Gault equation) INR, aPTT≤1.5 x ULN; Urine protein + 1 or less, if the urine protein > 1 +, need to collect 24 hours urinary protein determination, the total amount should be 1 gram or less

  • Without systemic steroids within past 4 weeks
  • Males or female of childbearing potential must: agree to use using a reliable form of contraception (eg, oral contraceptives, intrauterine device, control sex desire, double barrier method of condom and spermicidal) during the treatment period and for at least 12 months after the last dose of study drug.
  • Must have read, understood, and provided written informed consent voluntarily. Willing to adhere to the study visit schedule and the prohibitions and restrictions specified in this protocol.

Exclusion Criteria:

  • Prior treatment with anti-PD-1/PD-L1/PD-L2 antibody, including auxiliary treatment phase
  • Hypersensitivity to recombinant humanized anti-PD-1 monoclonal Abm or its components
  • Prior antitumor therapy (including corticosteroids and immunotherapy) or participation in other clinical trials within past 4 weeks, or have not recovered from toxicities since the last treatment;
  • Pregnant or nursing;
  • Positive tests for HIV, HCV, HBsAg or HBcAb with positive test for HBV DNA (>500IU/ml);
  • HBsAg or HBcAb with positive test for HBV DNA (>500IU/ml)
  • History with active tuberculosis;
  • Patients with any active autoimmune disease or a documented history of autoimmune disease, or history of syndrome that required systemic steroids or immunosuppressive medications, such as hypophysitis, pneumonia, colitis, hepatitis, nephritis, hyperthyroidism or hypothyroidism;
  • Severe, uncontrolled medical condition that would affect patients' compliance or obscure the interpretation of toxicity determination or adverse events, including active severe infection, uncontrolled diabetes, angiocardiopathy (heart failure > class II NYHA, heart block >II grade, myocardial infarction, unstable arrhythmia or unstable angina within past 6 months, cerebral infarction within past 3 months) or pulmonary disease ( interstitial pneumonia, obstructive pulmonary disease or symptomatic bronchospasm);
  • Evidence with active CNS disease;
  • Prior live vaccine therapy within past 4 weeks;
  • Received allogeneic hematopoietic stem cell transplantation or solid organ transplantation;
  • Prior major surgery within past 4 weeks (diagnostic surgery excluded);
  • Psychiatric medicines abuse without withdrawal, or history of psychiatric illness;
  • Associated with clinical symptoms or symptomatic treatment of pleural effusion or ascites;
  • Prior malignancy active within the previous 5 years except for locally curable cancers that have been apparently cured, such as basal cell skin cancer or carcinoma in situ of the cervix.
  • Underlying medical condition that, in the Investigator's opinion, would increase the risks of study drug administration or obscure the interpretation of toxicity determination or adverse events.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03113266


Contacts
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Contact: Ling Xiao 051286876925 ling_xiao@topalliancebio.com

Locations
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China, Beijing
Beijing Cancer Hospital Recruiting
Beijing, Beijing, China, 100142
Contact: Jun Guo, Phd; Md       guoj307@126.com   
Principal Investigator: Jun Guo, PhD; MD         
Sponsors and Collaborators
Shanghai Junshi Bioscience Co., Ltd.
Investigators
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Principal Investigator: Jun Guo Peking University Cancer Hospital & Institute
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Responsible Party: Shanghai Junshi Bioscience Co., Ltd.
ClinicalTrials.gov Identifier: NCT03113266    
Other Study ID Numbers: Junshi-JS001-009
First Posted: April 13, 2017    Key Record Dates
Last Update Posted: September 30, 2020
Last Verified: September 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Shanghai Junshi Bioscience Co., Ltd.:
anti-PD-1 monoclonal antibody
Metastatic
Advanced
Bladder Urothelial Carcinoma
Additional relevant MeSH terms:
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Carcinoma
Carcinoma, Transitional Cell
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Antibodies
Antibodies, Monoclonal
Immunologic Factors
Physiological Effects of Drugs