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

NCT05418309 | Unknown Phase 2

• 1 other identifier: TRUCE-22
• Study Type: interventional
• Target: 63
• Locations: 1 country
• Sites: 1

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.

Conditions

High-Risk Non-Muscle Invasive Bladder Urothelial Carcinoma

Keywords

Tislelizumab Nab-Paclitaxe

Outcome Measures

Primary Outcomes (1)

• Complete Response (CR) Rate for tilelizumab combined with nab-paclitaxel

  At the time of transurethral resection biopsy (within 9 or 12 weeks of the first dose of tislelizumab)

Secondary Outcomes (3)

• 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

Study Arms (1)

Tislelizumab and Nab-Paclitaxel

EXPERIMENTAL

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 Nab paclitaxel

Interventions

Tislelizumab Nab paclitaxel DRUG

Tislelizumab 200mg will be administered on Day 1 of each cycle for 4 treatment cycles;Nab-paclitaxel 200mg will be administered on Day 2 of each cycle for 4 treatment cycles.

Also known as: BGB-A317

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;
• 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);
• Liver function: total bilirubin \<=1.5 ULN, alanine aminotransferase and aspartate aminotransferase \<=2.5 ULN;
• The subjects volunteered to join the study, signed informed consent, and had good compliance with follow-up;

You may not qualify if:

• 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;
• Participating in other clinical researchers;
• Men with reproductive capacity or women who are likely to become pregnant do not take reliable contraceptive measures;
• Uncontrolled concurrent diseases, including but not limited to:
• HIV infected (HIV antibody positive);
• Severe infection in active stage or poorly controlled;

Sponsors & Collaborators

• Tianjin Medical University Second Hospital: lead

Study Sites (1)

Tianjin Medical University Second Hospital

Tianjin, Tianjin Municipality, 300211, China

RECRUITING

MeSH Terms

Interventions

tislelizumab

Study Officials

• Hailong Hu, MD,PhD

  Tianjin Medical University Second Hospital

  PRINCIPAL INVESTIGATOR

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

Model Details: Single Group Assignment

Study Record Dates

• First Submitted: June 9, 2022
• First Posted: June 14, 2022
• Study Start: December 27, 2021
• Primary Completion: February 1, 2024
• Study Completion: July 1, 2024
• Last Updated: June 14, 2022

Record last verified: 2021-10

Locations

CN (1)