Perioperative Tislelizumab Combined With Nab-Paclitaxel for Muscle-invasive Urothelial Bladder Cancer: A Multicenter Study

NCT05328336 | Unknown Phase 2

• 1 other identifier: TRUCE-11
• Study Type: interventional
• Target: 74
• Locations: 1 country
• Sites: 1

Brief Summary

This is a single-arm, open-label, multicenter clinical trial to investigate 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 perioperative treatment with tislelizumab in combination with nab-paclitaxel every 3 weeks for 3 treatment cycles over 9 weeks followed by radical cystectomy or complete TURBT.

Conditions

Muscle Invasive Bladder Cancer Urothelial Carcinoma

Keywords

neoadjuvant treatment

Outcome Measures

Primary Outcomes (1)

• complete response (CR) rate

  defined as the percentage of participants having CR. CR is defined as absence of viable tumor in examined tissue

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

Secondary Outcomes (5)

• Number of subjects that reach pathological downstaging to <pT2

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

• 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

• Number of adverse events and severity by grade (CTCAE)

  up to 1 years

Study Arms (1)

Experimental: Tislelizumab and Nab Paclitaxel

EXPERIMENTAL

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 cycles followed by surgery.

Drug: Tislelizumab Nab paclitaxel

Interventions

Tislelizumab Nab paclitaxel DRUG

Drug: Tislelizumab Tislelizumab 200mg will be administered on Day 1 every 3 weeks for 3 cycles Other Names: • BGB-A317 Drug: Nab paclitaxel Nab paclitaxel 200mg will

Experimental: Tislelizumab and Nab Paclitaxel

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• At least one measurable lesion meeting RECISTv1.1 criteria prior to transurethral bladder tumor electrosurgery (MR/CT long diameter of ≥10 mm or short diameter of ≥15 mm of enlarged lymph node required for this measurable lesion according to RECISTv1.1)
• 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 NxM0 disease by CT (or MRI).
• Expected survival time is greater than 12 weeks.
• Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 1 or 2.
• 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:
• Hematological indicators: absolute neutrophil count ≥1.5×10\^9/ L, platelet count ≥80×10\^9/L, hemoglobin ≥6.0 g/dL (can be maintained by symptomatic treatment);
• Liver function: total bilirubin ≤ 1.5 times the upper limit of normal value, alanine aminotransferase and aspartate aminotransferase
• ≤ 2.5 times the upper limit of normal value, if there is intrahepatic transaminase ≤ 5 times the upper limit of normal value;
• Renal function: creatinine ≤ 2 times the upper limit of normal, and creatinine clearance ≥ 30 ml/min;

You may not qualify if:

• 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.
• Those who are participating in other clinical research.
• Reproductive men or women who are likely to become pregnant have not taken reliable contraceptive measures.
• Uncontrolled concurrent diseases include but are not limited to:
• HIV-infected persons (HIV antibody positive).
• Serious infections that are active or poorly clinically controlled.

Sponsors & Collaborators

• Tianjin Medical University Second Hospital: lead

Study Sites (1)

ianjin Medical University Second Hospital

Tianjin, Tianjin Municipality, 300211, China

RECRUITING

Central Study Contacts

Hailong Hu, MD,PhD

CONTACT

+86-13662096232; hhllove2004@163.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 6, 2022
• First Posted: April 14, 2022
• Study Start: November 11, 2021
• Primary Completion: July 1, 2025
• Study Completion: November 1, 2025
• Last Updated: June 13, 2022

Record last verified: 2022-04

Locations

CN (1)