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Bladder Urothelial CarcinomaPhase 2NCT03113266

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

A Phase 2 study testing humanized anti-PD-1 monoclonal antibody toripalimab in people with Bladder Urothelial Carcinoma, run by Shanghai Junshi Bioscience Co., Ltd. at 1 site in China.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Bladder Urothelial Carcinoma
What is being tested?
humanized anti-PD-1 monoclonal antibody toripalimab
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
370 participants
Where
1 siteChina
Study dates
6 Apr 2017to Feb 2022
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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;
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  • 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.

Who cannot join

  • 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)
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  • 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.

Trial locations and contacts

1 site in 1 country.

Ling Xiao contact

051286876925

ling_xiao@topalliancebio.com

China1 site, 1 recruiting

  • Beijing Cancer Hospital

    Beijing, Beijing Municipality, 100142

    Jun Guo, Phd; Md, guoj307@126.com

    Jun Guo, PhD; MD

    Recruiting

Other trials in China

About this study

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

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.

Read the 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.

Being tested
humanized anti-PD-1 monoclonal antibody toripalimab
Keywords
anti-PD-1 monoclonal antibody, Metastatic, Advanced, Bladder Urothelial Carcinoma
Medical subject headings
Neoplasm Metastasis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • humanized anti-PD-1 monoclonal antibody toripalimabBiological

    Also called JS001, TAB001

    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.

Study groups in NCT03113266
Study groupRoleWhat they receive
humanized anti-PD-1monoclonal antibodyExperimentalhumanized anti-PD-1 monoclonal antibody is to be injected intravenously 3mg/kg Q2w until disease progresses or unacceptable tolerability occurs
Receives: Biological: humanized anti-PD-1 monoclonal antibody toripalimab

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Objective response rate (ORR) by RECIST 1.1 and irRECIST

    The treatment effect of JS001 will be assessed using irRC and RECIST 1.1 to determine tumor response.

    Measured: 3 years

Secondary outcomes (5)

  1. Duration of response (DOR) by RECIST1.1 and irRECIST

    The treatment effect of JS001 will be assessed using irRC and RECIST 1.1 to determine duration of response.

    Measured: 3 years

  2. Progression free survival (PFS) by RECIST1.1 and irRECIST

    The treatment effect of JS001 will be assessed using irRC and RECIST 1.1 to determine progression-free survival time.

    Measured: 3 years

  3. Overall survival (OS)

    The treatment effect of JS001 will be assessed using irRC and RECIST 1.1 to determine overall survival.

    Measured: 3 years

  4. Immunogenicity of anti-PD-1 monoclonal antibody

    To test immunogenicity of anti-PD-1 monoclonal antibody

    Measured: 3 years

  5. Number of participants with treatment-related adverse events as assessed by CTCAE v4.0

    Number of participants with treatment-related adverse events as assessed by CTCAE v4.0

    Measured: 3 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted13 Apr 2017
  2. Study start6 Apr 2017
  3. Primary completion15 Mar 2020
  4. Study completionFeb 2022 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
370 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03113266
Sponsor's protocol ID
Junshi-JS001-009
Status last verified
Sep 2020
First submitted
6 Apr 2017
Last updated
30 Sep 2020
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing humanized anti-PD-1 monoclonal antibody toripalimab in people with Bladder Urothelial Carcinoma, run by Shanghai Junshi Bioscience Co., Ltd. at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 12 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 30 Sep 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Ling Xiao (051286876925, ling_xiao@topalliancebio.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Objective response rate (ORR) by RECIST 1.1 and irRECIST (time frame: 3 years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03113266.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Sep 2020.

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