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: a Multi-center Study

Tianjin Medical University Second Hospital1 site in 1 country63 target enrollmentDecember 27, 2021

ConditionsHigh-Risk Non-Muscle Invasive Bladder Urothelial Carcinoma

InterventionsTislelizumab Nab paclitaxel

DrugsTislelizumab Nab paclitaxel

Overview

Phase: Phase 2
Intervention: Tislelizumab Nab paclitaxel
Conditions: High-Risk Non-Muscle Invasive Bladder Urothelial Carcinoma
Sponsor: Tianjin Medical University Second Hospital
Enrollment: 63
Locations: 1
Primary Endpoint: Complete Response (CR) Rate for tilelizumab combined with nab-paclitaxel
Last Updated: 3 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

December 27, 2021

End Date

July 2024

Last Updated

3 years ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

Tianjin Medical University Second Hospital

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Willing and able to provide written informed consent;
•Ability to comply with the protocol;
•Age ≥ 18 years;
•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);
•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;
•Eastern Cooperative Oncology Group (ECOG) Performance Status of 0-2;
•Agreed to provide tissue examination samples (for detection of PD-L1 expression, tumor mutation load, IHC, detection of DNA and RNA, etc;)
•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);

Exclusion Criteria

•Receive live attenuated vaccine within 4 weeks before treatment or during the study period;
•Active, known or suspected autoimmune diseases;
•History of primary immunodeficiency;
•Known history of allogeneic organ transplantation and allogeneic hematopoietic stem cell transplantation;
•Pregnant or lactating female patients;
•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;
•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);
•Known or suspected allergy to tislelizumab and albumin paclitaxel;
•Have a clear history of active tuberculosis;
•Received PD-1 / PD-L1 / CTLA-4 antibody or other immunotherapy in the past;

Arms & Interventions

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.

Intervention: Tislelizumab Nab paclitaxel

Outcomes

Primary Outcomes

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 Outcomes

Cystectomy-Free Survival (CFS)(up to 3 years)
Duration of Response (DOR)(up to 3 years)
Number of adverse events and severity by grade (CTCAE) Number of adverse events and severity by grade (CTCAE)(12 weeks of treatment plus 30 days for toxicity followup)