Urothelial CarcinomaPhase 2NCT04211012
A Study on Toripalimab Plus Nab-Paclitaxel With or Without Cisplatin as First-line Treatment of Urothelial Carcinoma
A Phase 2 study testing Toripalimab plus Nab-Paclitaxel +/- cisplatin in people with Urothelial Carcinoma, run by Jun Guo at 1 site in China.
Trial summary
This is a single-center, open-label，phase II study designed to evaluate the efficacy and safety of Toripalimab plus nab-paclitaxel with or without cisplatin as first-line treatment of unresectable locally advanced or metastatic urothelial carcinoma.Each enrolled Patient will receive Toripalimab plus nab-paclitaxel… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Urothelial Carcinoma
- What is being tested?
- Toripalimab plus Nab-Paclitaxel +/- cisplatin
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteChina
- Study dates
- 30 Nov 2020to 30 Jan 2023
- 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
- Fully understand the study and are willing to sign informed consent form (ICF);
- Age of ≥ 18 years at screening, male or female;
- Histopathologically confirmed locally advanced (T4b, any N; or any T, N2-3) or metastatic (M1, stage IV) unresectable bladder urothelial carcinoma (including renal pelvis, ureter, bladder, urinary tract);
- Not previously treated with systemic chemotherapy; Patients with urothelial carcinoma who have received prior adjuvant or neoadjuvant treatment or radiochemotherapy are eligible, provided that progression has occurred >6 months from last therapy (for radiochemotherapy and adjuvant treatment) or >6 months from last surgery (for neoadjuvant treatment).
- At least 1 measurable lesion according to Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1;
- Providing tissue specimen for PD-L1 testing and related pathological report prior to enrollment for biomarker evaluation (tumor tissue specimen must be freshly obtained or archived within 3 months prior to enrollment; the fresh tissue must be a biopsy specimen of hollow needle punctured, excisedor resected);
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- ECOG performance status score of 0 or 1;
- Life expectancy ≥ 12 weeks in the Investigator's opinion;
- Adequate organ function:
- Hematology: absolute neutrophil count (ANC) ≥1.5×109/L; platelet count ≥100×109/L; hemoglobin ≥90g/L Renal: serum creatinine level ≤1.5 × ULN; urine protein ≤ 1+, if urine protein > 1 +, collect 24-hour urine protein determination, and the total amount should be ≤ 1 g,Liver: total bilirubin ≤ 1.5 × ULN; AST (SGOT) and ALT (SGPT) ≤ 2.5 × ULN; for patients with liver metastases, ALT and AST ≤ 5 × ULN Endocrine system: thyroid stimulating hormone (TSH) within normal range. Note: if the TSH is not within normal range at baseline, and T3 and free T4 are within normal range, the subject can still meet the inclusion criteria.
- Coagulation function: international normalized ratio (INR) or prothrombin time (PT), activated partial thromboplastin time (aPTT) ≤1.5 × ULN (unless the subject is receiving anticoagulation therapy, PT or aPTT just needs to be within the expected therapeutic range of the anticoagulant).
- Willingness and ability to comply with scheduled visits, treatment plan, laboratory tests and other study procedures.
- Men of reproduction ability or women of pregnant possibility [amputation of uterus, bilateral oophorectomy or bilateral tubal ligation not performed, or prior to menopause (total menopause ≥1 year)] must adopt highly-effective contraceptive methods (e.g. oral contraceptives, intrauterine contraceptive device, abstinence of sexual intercourse or barrier contraception in combination with spermatocide) during the whole study, and continue contraception for 12 months after the last dose of study drug.
Who cannot join
- Prior exposure to immune-mediated therapy (with the exclusion of Bacillus Calmette Guerin, BCG), including but not limited to, other anti-CTLA-4, anti-PD-1, anti-PD-L1, or anti-PD-L2 antibodies, including therapeutic anticancer vaccines;
- Currently participating in or having participated in another clinical study within 4 weeks prior to enrollment, unless it is an observational (non-interventional) clinical study;
- Radiotherapy affect more than 30% of the bone marrow or extensive radiotherapy within 4 weeks prior to enrollment;
- Major surgery within 4 weeks prior to enrollment;
- Use of any live vaccines within 4 weeks before enrollment. Including but not limited to the following:mumps, rubella, measles, varicella/ herpes zoster (chicken pox), yellow fever, Rabies, Bacille Calmette-Guérin (BCG) and typhoid vaccine (inactivated virus vaccine allowed);
- Treatment with immunosuppressive medications within 14 days prior to enrollment. The following are exceptions to this criterion:
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- Intranasal, intraocular local steroids, or local steroid injections (eg, intraarticular injection) Systemic corticosteroids at physiologic doses not to exceed 10 mg/day of prednisone or its equivalent Steroids as preventive medication for hypersensitivity reactions (eg, CT scan premedication)
- Use of antineoplastic chemotherapy, biotherapy, hormone therapy or traditional herbal medicine t within 4 weeks prior to enrollment, except for the following:
- Concomitant medication of hormonal therapy for non-cancer-related conditions (eg, hormone replacement therapy) is acceptable; Local treatment of isolated lesions, excluding target lesions, for palliative intent is acceptable (eg, local radiotherapy or surgery);
- History of (non-infectious) pneumonia/interstitial lung disease requiring steroid treatment, or ongoing pneumonia/interstitial lung disease requiring steroid treatment;
- Uncontrolled concomitant diseases including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, uncontrolled hypertension, unstable angina, arrhythmia, interstitial lung disease, or mental illness/social conditions consistent with the following characteristics: restricting study-specified compliance, significantly increasing the risk of developing AEs, or affecting patients' ability to provide informed consent form.
- Known human immunodeficiency virus (HIV) infection (positive HIV antibody);
- Active HBV or HCV infection; HBV DNA must be detected for patients with positive HbsAg or HBcAb at the screening; if HBV DNA test is positive at the same time (limit of quantitation 500 IU/ml, or reaching the positive value detected at the study center); Patients positive for hepatitis C (HCV) antibody are eligible only if polymerase chain reaction is negative for HCV RNA.
- Active tuberculosis;
- Allergies and adverse drug allergy reaction; Known hypersensitivity reactions to Toripalimab or any ingredient of Toripalimab Injection; History of serious hypersensitivity to nab-paclitaxel, cisplatin, or its preventive medication;
- Subjects with active central nervous system (CNS) metastasis will be excluded. Patients who have prior therapies for brain or meningeal metastasis and has been stabilized for ≥ 3 months and has discontinued systemic steroids therapy (>10 mg/day prednisone or equivalent) > 4 weeks prior to enrollment could be included. If the CNS metastasis can be adequately treated and meet the requirement specified in the enrollment criteria, and the neurological symptoms can be recovered to ≤CTCAE grade 1 prior to enrollment (except the residual sign or symptom related with CNS treatment) for at least two weeks, the subject can participate in the study;
- Active or previously recorded autoimmune or inflammatory diseases (including inflammatory bowel disease, systemic lupus erythematosus, rheumatoid arthritis, ankylosing spondylitis, etc.) within 2 years prior to enrollment. The following are exceptions to this criterion:
- Patients with vitiligo or alopecia; Patients with a history of autoimmune-related hypothyroidism on a stable dose of thyroid-replacement hormone (eg, treated Hashimoto's syndrome) or patients with psoriasis requiring no systemic treatment;
- Having other malignant tumors that have not been recovered within past 5 years prior to enrollment, with the exception of those have been markedly cured, or curable cancer, such as skin basal cell carcinoma or squamous cell carcinoma, thyroid papillary carcinoma, localized low-risk prostate cancer, carcinoma in situ of cervix or breast; note: patients with localized low-risk prostate cancer (defined as ≤T2a stage, Gleason score ≤6 and PSA<10ng/mL at the diagnosis of prostate cancer (if measured) who have received radical therapy and have no biochemical recurrence of prostate specific antigen (PSA) can participate in this study);
- Pregnant or lactating women;
- Previously received allogeneic hematopoietic stem cell transplantation or solid organ transplantation;
- History of any disease, therapy or abnormal laboratory examination that may confuse the study results, interfere with subject's participation in the whole study or not meet the best interest of subject's participation in the study, as judged by investigators.
Trial locations and contacts
1 site in 1 country.
China1 site
Beijing Cancer Hospital
Beijing, No.52 Fucheng Road, Haidian District, Beijing, China, 100142
xinan sheng
About this study
Official title: A Phase II Study to Evaluate the Efficacy and Safety of Toripalimab Plus Nab-Paclitaxel With or Without Cisplatin as First-line Treatment of Unresectable Locally Advanced or Metastatic Urothelial Carcinoma
This is a single-center, open-label，phase II study designed to evaluate the efficacy and safety of Toripalimab plus nab-paclitaxel with or without cisplatin as first-line treatment of unresectable locally advanced or metastatic urothelial carcinoma.Each enrolled Patient will receive Toripalimab plus nab-paclitaxel with or without cisplatin until progressive disease or intolerable toxicity occurs, then enter a survival follow-up period. Nab-paclitaxel with or without cisplatin will be administered for up to 6 cycles, and Toripalimab up to 2 years.
Read the detailed description
Unresectable locally advanced or metastatic urothelial carcinoma
- Conditions
- Urothelial Carcinoma
- Being tested
- Toripalimab plus Nab-Paclitaxel +/- cisplatin
- Medical subject headings
- Carcinoma, Transitional Cell
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Toripalimab plus Nab-Paclitaxel +/- cisplatinDrug
Toripalimab injection (JS001): 240mg, i.v.gtt, q3w; Nab-Paclitaxel: 260mg/m2, i.v.gtt, q3w Cisplatin: total dosage of 70 mg/m2 i.v.gtt, q3w，, complete all doses within the first 2 days of each cycle.
Study treatment will be continued until disease progression or intolerable toxicity, or withdrawal at the discretion of the investigator or the subject, loss to follow-up, or initiation of other anti-cancer therapy, or death, whichever occurs first. Toripalimab will be administered no more than 2 years,and nab-paclitaxel with or without cisplatin will be administered up to 6 cycles.. If the subject is intolerable to cisplatin treatment according to the investigator's judgment, JS001 + Nab-Paclitaxel may be dosed.
Dosing sequence: Toripalimab, Nab-Paclitaxel, cisplatin
| Study group | Role | What they receive |
|---|---|---|
| Treatment Arm | Experimental | Not described Receives: Drug: Toripalimab plus Nab-Paclitaxel +/- cisplatin |
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
ORR based on RECIST 1.1
Measured: Up to 2 years
Secondary outcomes (7)
To evaluate Progression-free Survival (PFS) assessed by the investigator based on RECIST 1.1 criteria.
Measured: Up to 2 years
To evaluate Duration of Response (DOR) assessed by the investigator based on RECIST 1.1 criteria.
Measured: Up to 2 years
To evaluate Time to Response (TTR) assessed by the investigator based on RECIST 1.1 criteria.
Measured: Up to 2 years
To evaluate Disease Control Rate (DCR) assessed by the investigator based on RECIST 1.1 criteria.
Measured: Up to 2 years
To evaluate Overall Survival (OS) assessed by the investigator based on RECIST 1.1 criteria.
Measured: Up to 2 years
Number of Participants With Abnormal Laboratory Values and/or Adverse Events That Are Related to Treatment.
Measured: Up to 2 years
To evaluate the correlation between biomarkers (i.e. PD-L1, etc) and clinical endpoint (ORR) and/or incidence of adverse event.
Measured: Up to 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Dec 2019
- Study start30 Nov 2020 (estimated)
- Primary completion30 Jan 2022 (estimated)
- Study completion30 Jan 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Jun Guo
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Jun Guo, Peking University Cancer Hospital & Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04211012
- Sponsor's protocol ID
- BJCH-UC-1015
- Status last verified
- Nov 2020
- First submitted
- 22 Nov 2019
- Last updated
- 13 Nov 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 13 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II Study to Evaluate the Efficacy and Safety of Toripalimab Plus Nab-Paclitaxel With or Without Cisplatin as First-line Treatment of Unresectable Locally Advanced or Metastatic Urothelial Carcinoma
- ClinicalTrials.gov ID
- NCT04211012
- Acronym / sponsor ID
- BJCH-UC-1015
- Conditions
- Urothelial Carcinoma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Jun GuoUniversity, hospital or other
- Study start
- 30 Nov 2020 (estimated)
- Primary completion
- 30 Jan 2022 (estimated)
- Study completion
- 30 Jan 2023 (estimated)
- First posted
- 26 Dec 2019 (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 single-center, open-label，phase II study designed to evaluate the efficacy and safety of Toripalimab plus nab-paclitaxel with or without cisplatin as first-line treatment of unresectable locally advanced or metastatic urothelial carcinoma.Each enrolled Patient will receive Toripalimab plus nab-paclitaxel with or without cisplatin until progressive disease or intolerable toxicity occurs, then enter a survival follow-up period. Nab-paclitaxel with or without cisplatin will be administered for up to 6 cycles, and Toripalimab up to 2 years.
Detailed description
Unresectable locally advanced or metastatic urothelial carcinoma
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Treatment Arm | Experimental | Drug: Toripalimab plus Nab-Paclitaxel +/- cisplatin |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- Fully understand the study and are willing to sign informed consent form (ICF);
- Age of ≥ 18 years at screening, male or female;
- Histopathologically confirmed locally advanced (T4b, any N; or any T, N2-3) or metastatic (M1, stage IV) unresectable bladder urothelial carcinoma (including renal pelvis, ureter, bladder, urinary tract);
- Not previously treated with systemic chemotherapy; Patients with urothelial carcinoma who have received prior adjuvant or neoadjuvant treatment or radiochemotherapy are eligible, provided that progression has occurred >6 months from last therapy (for radiochemotherapy and adjuvant treatment) or >6 months from last surgery (for neoadjuvant treatment).
- At least 1 measurable lesion according to Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1;
Key exclusion criteria (22 listed)
- Prior exposure to immune-mediated therapy (with the exclusion of Bacillus Calmette Guerin, BCG), including but not limited to, other anti-CTLA-4, anti-PD-1, anti-PD-L1, or anti-PD-L2 antibodies, including therapeutic anticancer vaccines;
- Currently participating in or having participated in another clinical study within 4 weeks prior to enrollment, unless it is an observational (non-interventional) clinical study;
- Radiotherapy affect more than 30% of the bone marrow or extensive radiotherapy within 4 weeks prior to enrollment;
- Major surgery within 4 weeks prior to enrollment;
- Use of any live vaccines within 4 weeks before enrollment. Including but not limited to the following:mumps, rubella, measles, varicella/ herpes zoster (chicken pox), yellow fever, Rabies, Bacille Calmette-Guérin (BCG) and typhoid vaccine (inactivated virus vaccine allowed);
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 |
|---|---|---|
| Toripalimab plus Nab-Paclitaxel +/- cisplatinToripalimab injection (JS001): 240mg, i.v.gtt, q3w; Nab-Paclitaxel: 260mg/m2, i.v.gtt, q3w Cisplatin: total dosage of 70 mg/m2 i.v.gtt, q3w，, complete all doses within the first 2 days of each cycle. Study treatment will be continued until disease progression or intolerable toxicity, or withdrawal at the discretion of the investigator or the subject, loss to follow-up, or initiation of other anti-cancer therapy, or death, whichever occurs first. Toripalimab will be administered no more than 2 years,and nab-paclitaxel with or without cisplatin will be administered up to 6 cycles.. If the subject is intolerable to cisplatin treatment according to the investigator's judgment, JS001 + Nab-Paclitaxel may be dosed. Dosing sequence: Toripalimab, Nab-Paclitaxel, cisplatin | Drug | Treatment Arm |
Primary outcome
Objective response rate (ORR) by RECIST 1.1
Time frame: Up to 2 years
ORR based on RECIST 1.1
7 secondary outcomes
To evaluate Progression-free Survival (PFS) assessed by the investigator based on RECIST 1.1 criteria.
Time frame: Up to 2 years
To evaluate Duration of Response (DOR) assessed by the investigator based on RECIST 1.1 criteria.
Time frame: Up to 2 years
To evaluate Time to Response (TTR) assessed by the investigator based on RECIST 1.1 criteria.
Time frame: Up to 2 years
To evaluate Disease Control Rate (DCR) assessed by the investigator based on RECIST 1.1 criteria.
Time frame: Up to 2 years
To evaluate Overall Survival (OS) assessed by the investigator based on RECIST 1.1 criteria.
Time frame: Up to 2 years
Number of Participants With Abnormal Laboratory Values and/or Adverse Events That Are Related to Treatment.
Time frame: Up to 2 years
To evaluate the correlation between biomarkers (i.e. PD-L1, etc) and clinical endpoint (ORR) and/or incidence of adverse event.
Time frame: Up to 2 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Nov 2020.
- Individual participant dataSharing planned: Undecided
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Toripalimab plus Nab-Paclitaxel +/- cisplatin in people with Urothelial Carcinoma, run by Jun Guo 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 13 inclusion and 22 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 13 Nov 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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Objective response rate (ORR) by RECIST 1.1 (time frame: Up to 2 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 13 Nov 2020.