An Open Label, Single-arm, Phase 2 Study of Perioperative Tislelizumab Combined With Nab-Paclitaxel Before Cystectomy or Complete TURBT for Patients With Muscle-invasive Urothelial Bladder Cancer.

Tianjin Medical University Second Hospital1 site in 1 country48 target enrollmentJuly 11, 2020

ConditionsMuscle Invasive Bladder Cancer Urothelial Carcinoma

InterventionsTislelizumab Nab paclitaxel

DrugsTislelizumab Nab paclitaxel

Overview

Phase: Phase 2
Intervention: Tislelizumab
Conditions: Muscle Invasive Bladder Cancer
Sponsor: Tianjin Medical University Second Hospital
Enrollment: 48
Locations: 1
Primary Endpoint: Clinical Complete Response (cCR) rate
Status: Active, not recruiting
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 perioperative treatment in patients with muscle-invasive bladder cancer (MIBC) prior to cystectomy or complete TURBT. Patients will receive treatment with tislelizumab in combination with nab-paclitaxel every 3 weeks for 3 treatment cycles over 9 weeks followed by standard radical cystectomy or complete TURBT.

Registry

clinicaltrials.gov

Start Date

July 11, 2020

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.
•Suitable and planned for complete transurethral resection of bladder tumor or radical cystectomy
•Histopathologically confirmed urothelial carcinoma. Patients with mixed histologies are required to have a dominant (i.e. 50% at least) urothelial cell pattern.
•Clinical stage T2-T4a N0 M0 disease by CT (or MRI). If the clinical stage is T2-4aN1-3M0, it must be judged by the investigator. If it is judged that radical surgery can still be performed, it can be included in the study.
•Expected survival time is greater than 12 weeks.
•Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 1 or
•Agree to provide tissue examination specimens (used to detect PD-L1 expression, tumor mutation burden, etc.)
•The organ function level must meet the following requirements:

Exclusion Criteria

•Receive live attenuated vaccines within 4 weeks before treatment or plan to receive live attenuated vaccines during the study period.
•Active, known or suspected autoimmune diseases.
•Known history of primary immunodeficiency.
•Known history of allogeneic organ transplantation and allogeneic hematopoietic stem cell transplantation.
•Female patients who are pregnant or breastfeeding.
•Untreated acute or chronic active hepatitis B or C infection. In the case of patients receiving antiviral therapy, the doctor will judge whether they are eligible for enrollment according to the individual conditions of the patient while monitoring the virus copy number.
•Have used immunosuppressive drugs in the past 4 weeks before starting treatment, excluding nasal spray and inhaled corticosteroids or physiological doses of systemic steroids (that is, prednisolone or equivalent physiological doses of no more than 10 mg/day) Other corticosteroids).
•Those who are known or suspected to be allergic to tislelizumab and nab paclitaxel.
•Have a clear history of active tuberculosis.
•Have 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 cycles followed by surgery.

Intervention: Tislelizumab

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 cycles followed by surgery.

Intervention: Nab paclitaxel

Outcomes

Primary Outcomes

Clinical Complete Response (cCR) rate

Time Frame: At the time of complete transurethral resection of bladder tumor or radical cystectomy (within 12 weeks of the first dose of tislelizumab)

defined as the absence of tumor residual confirmed by surgery (RC-PLND or complete TURBT), negative urine cytology and no evidence of lymph nodes or distant metastasis on imaging.

Secondary Outcomes

Objective response rate (ORR)(At the time of complete transurethral resection of bladder tumor or radical cystectomy (within 12 weeks of the first dose of tislelizumab))
Event-free survival (EFS)(up to 3 years)
Overall Survival (OS)(up to 3 years)
Disease-specific survival (DSS)(up to 3 years)
Number of adverse events and severity by grade (CTCAE)(up to 1 years)