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Tilelizumab Combined With Nab-Paclitaxel for High-Risk Non-Muscle-Invasive Urothelial Bladder Carcinoma Which is Not Completely Resectable

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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04730232
Recruitment Status : Recruiting
First Posted : January 29, 2021
Last Update Posted : October 29, 2021
Sponsor:
Information provided by (Responsible Party):
Tianjin Medical University Second Hospital

Study Description
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Brief Summary:
This is a phase II study to determine the safety and efficacy of tislelizumab when given in combination with nab-paclitaxel as treatment for patients with high-risk non-muscle-invasive bladder cancer (HR NMIBC) which is not completely resectable. Patients will receive treatment with tislelizumab in combination with nab-paclitaxel every 3 weeks for 4 treatment cycles over 12 weeks followed by transurethral resection biopsy.

Condition or disease Intervention/treatment Phase
High-Risk Non-Muscle Invasive Bladder Urothelial Carcinoma Drug: Tislelizumab Drug: Nab-paclitaxel Phase 2

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 63 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: An Open Label, Single-arm, Phase 2 Study of Tislelizumab Combined With Nab-Paclitaxel for Patients With High-Risk Non-Muscle-Invasive Urothelial Bladder Carcinoma Which is Not Completely Resectable
Actual Study Start Date : December 27, 2020
Estimated Primary Completion Date : February 2024
Estimated Study Completion Date : July 2024

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Bladder Cancer
Drug Information available for: Paclitaxel

Arms and Interventions
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Arm Intervention/treatment
Experimental: Tislelizumab and Nab-Paclitaxel
Tislelizumab 200mg IV on day 1 in combination with nab-paclitaxel 200mg IV on day 2 every 3 weeks for 3 or 4 cycles followed by transurethral resection biopsy.
 Drug: Tislelizumab
Tislelizumab 200mg will be administered on Day 1 of each cycle for 4 treatment cycles.
Other Name: BGB-A317

Drug: Nab-paclitaxel
Nab-paclitaxel 200mg will be administered on Day 2 of each cycle for 4 treatment cycles.


Outcome Measures
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Primary Outcome Measures :
  1. Complete Response (CR) Rate for tilelizumab combined with nab-paclitaxel [ Time Frame: At the time of transurethral resection biopsy (within 9 or 12 weeks of the first dose of tislelizumab) ]

Secondary Outcome Measures :
  1. Cystectomy-Free Survival (CFS) [ Time Frame: up to 3 years ]
    defined from D1 of treatment until cystectomy.

  2. Duration of Response (DOR) [ Time Frame: up to 3 years ]
  3. Number of adverse events and severity by grade (CTCAE) [ Time Frame: 12 weeks of treatment plus 30 days for toxicity followup ]
    Safety and toxicity will be characterized according to the reported adverse event (AE) profile using NCI Common Terminology Criteria for Adverse Events (CTCAE) v5.0, as well as a patient questionnaire derived from the Patient Reported Outcomes (PRO)-CTCAE and Patient Reported Outcomes Measurement Information System (PROMIS).


Eligibility Criteria
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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:

  1. Willing and able to provide written informed consent;
  2. Ability to comply with the protocol;
  3. Age ≥ 18 years;

  4. High-risk non-muscle-invasive urothelial carcinoma or high-risk non-muscle-invasive urothelial carcinoma as the main pathological component > 50%, difined as following:

    a. T1 b. High-grade Ta c.Carcinoma in situ(CIS);

  5. Multi-point biopsy of bladder shows there are more than 2 section and over 3 points of pathological specimens are diagnosed as above, meanwhile, the tumor has to be diagnosed as not completely resectable by at least 2 senior urologist;
  6. Eastern Cooperative Oncology Group (ECOG) Performance Status of 0-2;
  7. Agreed to provide tissue examination samples (for detection of PD-L1 expression, tumor mutation load, IHC, detection of DNA and RNA, etc;)

  8. Organ function level must meet the following requirements:

    • Hematological indexes: neutrophil count >= 1.5x10^9/L, platelet count >= 80x10^9/L, hemoglobin >= 6.0 g/dl (can be maintained by blood transfusion);
    • Liver function: total bilirubin <=1.5 ULN, alanine aminotransferase and aspartate aminotransferase <=2.5 ULN;
  9. The subjects volunteered to join the study, signed informed consent, and had good compliance with follow-up;

Exclusion Criteria:

  1. Receive live attenuated vaccine within 4 weeks before treatment or during the study period;
  2. Active, known or suspected autoimmune diseases;
  3. History of primary immunodeficiency;
  4. Known history of allogeneic organ transplantation and allogeneic hematopoietic stem cell transplantation;
  5. Pregnant or lactating female patients;
  6. Untreated acute or chronic active hepatitis B or hepatitis C infection. Under the condition of monitoring the virus copy number of patients receiving antiviral treatment, doctors can judge whether they are in line with the patients' individual conditions;
  7. Prior use of immunosuppressive drugs within 4 weeks prior to the start of treatment, excluding nasal and inhaled corticosteroids or physiological doses of systemic steroids (i.e. not more than 10 mg / day prednisolone or other corticosteroids with the same physiological dose);
  8. Known or suspected allergy to tislelizumab and albumin paclitaxel;
  9. Have a clear history of active tuberculosis;
  10. Received PD-1 / PD-L1 / CTLA-4 antibody or other immunotherapy in the past;
  11. Participating in other clinical researchers;
  12. Men with reproductive capacity or women who are likely to become pregnant do not take reliable contraceptive measures;

  13. Uncontrolled concurrent diseases, including but not limited to:

    • HIV infected (HIV antibody positive);
    • Severe infection in active stage or poorly controlled;
    • Evidence of serious or uncontrollable systemic diseases (such as severe mental, neurological, epilepsy or dementia, unstable or uncompensated respiratory, cardiovascular, liver or kidney diseases, uncontrolled hypertension [i.e. hypertension greater than or equal to CTCAE grade 2 after drug treatment]);
    • Patients with active bleeding or new thrombotic disease.
Contacts and Locations
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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): NCT04730232


Contacts
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Contact: Hailong Hu, MD,PhD +86-13662096232 hhllove2004@163.com

Locations
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China, Tianjin
Tianjin Medical University Second Hospital Recruiting
Tianjin, Tianjin, China, 300211
Contact: Hailong Hu    +86-13662096232    hhllove2004@163.com   
Sponsors and Collaborators
Tianjin Medical University Second Hospital
Investigators
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Principal Investigator: Hailong Hu, MD,PhD Tianjin Medical University Second Hospital
More Information
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Responsible Party: Tianjin Medical University Second Hospital
ClinicalTrials.gov Identifier: NCT04730232    
Other Study ID Numbers: Truce-02
First Posted: January 29, 2021    Key Record Dates
Last Update Posted: October 29, 2021
Last Verified: October 2021

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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 Tianjin Medical University Second Hospital:
Tislelizumab
Nab-Paclitaxel
Additional relevant MeSH terms:
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Carcinoma
Urinary Bladder Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Urologic Neoplasms
Urogenital Neoplasms
Neoplasms by Site
Urinary Bladder Diseases
 Urologic Diseases
Paclitaxel
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action