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.
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.
China1 site, 1 recruiting
- Recruiting
Beijing Cancer Hospital
Beijing, Beijing Municipality, 100142
Jun Guo, Phd; Md, guoj307@126.com
Jun Guo, PhD; MD
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.
- Conditions
- Bladder Urothelial Carcinoma
- 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 group | Role | What they receive |
|---|---|---|
| humanized anti-PD-1monoclonal antibody | Experimental | humanized 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.
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)
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
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
Overall survival (OS)
The treatment effect of JS001 will be assessed using irRC and RECIST 1.1 to determine overall survival.
Measured: 3 years
Immunogenicity of anti-PD-1 monoclonal antibody
To test immunogenicity of anti-PD-1 monoclonal antibody
Measured: 3 years
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.
- First posted13 Apr 2017
- Study start6 Apr 2017
- Primary completion15 Mar 2020
- Study completionFeb 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bladder Urothelial CarcinomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- Shanghai Junshi Bioscience Co., Ltd.
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jun Guo, Principal investigator, Peking University Cancer Hospital & Institute
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
Study at a glance
From the registry record, last updated by the sponsor on 30 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03113266
- Acronym / sponsor ID
- Junshi-JS001-009
- Conditions
- Bladder Urothelial Carcinoma
- Keywords
- anti-PD-1 monoclonal antibody, Metastatic, Advanced, Bladder Urothelial Carcinoma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 370 participants (estimated)
- Lead sponsor
- Shanghai Junshi Bioscience Co., Ltd.University, hospital or other
- Study start
- 6 Apr 2017 (actual)
- Primary completion
- 15 Mar 2020 (actual)
- Study completion
- Feb 2022 (estimated)
- First posted
- 13 Apr 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| humanized anti-PD-1monoclonal antibody | Experimental | Biological: humanized anti-PD-1 monoclonal antibody toripalimabhumanized anti-PD-1 monoclonal antibody is to be injected intravenously 3mg/kg Q2w until disease progresses or unacceptable tolerability occurs |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- 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);
Key exclusion criteria (17 listed)
- 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);
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| humanized anti-PD-1 monoclonal antibody toripalimabAlso: JS001, TAB001humanized 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. | Biological | humanized anti-PD-1monoclonal antibody |
Primary outcome
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.
5 secondary outcomes
Duration of response (DOR) by RECIST1.1 and irRECIST
Time frame: 3 years
Progression free survival (PFS) by RECIST1.1 and irRECIST
Time frame: 3 years
Overall survival (OS)
Time frame: 3 years
Immunogenicity of anti-PD-1 monoclonal antibody
Time frame: 3 years
Number of participants with treatment-related adverse events as assessed by CTCAE v4.0
Time frame: 3 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Sep 2020.
- Individual participant dataSharing planned: Yes
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jun Guo principal investigator
Peking University Cancer Hospital & Institute
1 site in 1 country: see every site and its status.
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?
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.