Safety and Efficacy of BCG Combined With Tislelizumab for BCG-untreated Patients With High-risk Non-muscle Invasive Bladder Cancer

NCT05580354 | Unknown Phase 4

• 1 other identifier: SPARE-007
• Study Type: interventional
• Target: 42
• Locations: 1 country
• Sites: 1

Brief Summary

For patients with high-risk non-muscle-invasive bladder cancer (NMIBC), intravesical therapy of BCG is the standard treatment proved to reduce the risk of recurrence and progression. However, there are patients failed to complete the whole treatment due to the long period and some patients showed no response to BCG or suffered tumor progression after BCG treatment. The aim of this study is to examine the efficacy and safety of intravesical therapy of BCG combined with PD-1 monoclonal antibody as the treatment of high-risk NMIBC patients without BCG treatment. At the same time, transcriptome sequencing is used to analyze the correlation between the efficacy of the treatment and the level of immune cell infiltration and tumor molecular subtypes.

Conditions

Non-muscle-invasive Bladder Cancer

Keywords

Non-muscle-invasive Bladder Cancer; Tislelizumab; BCG

Outcome Measures

Primary Outcomes (1)

• Relapse-Free Survival （RFS）

  Relapse-Free Survival （RFS） is defined as the time from enrollment to any event of recurrence or death.

  12 month

Secondary Outcomes (5)

• Overall survival (OS)

  12 month

• Cystectomy-free survival

  12 month

• Duration of Response (DOR)

  12 month

• Progression free survival to muscle-invasive or metastatic disease or death.

  12 month

• Correlation between biological markers and tumor molecular subtypes and efficacy.

  12 month

Study Arms (1)

Arm 1

EXPERIMENTAL

Patients will receive 17 cycles of Tislelizumab (200mg per cycle) in combination with BCG (6-week induction course of 120mg followed by maintenance with 3 weekly infusions of 120mg at months 3,6,12).

Drug: BCG combined with Tislelizumab

Interventions

BCG combined with Tislelizumab DRUG

Patients will receive 17 cycles of Tislelizumab (200mg per cycle) in combination with BCG (6-week induction course of 120mg followed by maintenance with 3 weekly infusions of 120mg at months 3,6,12).

Arm 1

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• ≥ 18 and ≤75 years old on day of signing informed consent
• Signing informed consent
• Patients with histologically confirmed high-risk NMIBC after TURBT (Patients with mixed histology, predominantly transitional cells, could be enrolled.) High grade pathology (any of the following conditions)
• CIS
• \>3cm
• Multifocal
• Patients must be willing to provide a blood sample and a TURBT specimen must be taken at baseline.
• For patients with T1 or suspected incomplete tumor resection after first TURBT, incomplete initial resection or no muscle in original specimen, they should undergo TURBT again within 2-6 weeks.
• No distant metastasis confirmed by CT or MRI in the chest, abdomen, or pelvic cavity within 42 days before treatment.
• ECOG performance status of ≤2
• Life expectancy ≥12 weeks
• Well-controlled blood pressure and within 7 days before treatment \<160/95mmHg
• Normal organ function within 7 days before treatment
• HB≥90 g/L
• ANC≥1.5×109 /L

You may not qualify if:

• Received prior therapies targeting PD-1 or PD-L1.
• Received prior intravesical therapy of BCG.
• Receive any approved anticancer therapy, including systemic and intravesical chemotherapy within 21 days before enrollment.
• Receive any other trial drug or participate in another therapeutic clinical study within 28 days before enrollment.
• History of severe hypersensitivity reactions to other monoclonal antibodies.
• History of other malignancy.
• Active tuberculosis.
• Severe infections occur within 4 weeks prior to enrollment, including but not limited to infectious complications leading to hospitalization, bacteremia, or severe pneumonia.
• A known history of HIV infection.
• Untreated chronic hepatitis B patients or hepatitis B virus carriers whose HBV DNA≥500 IU/mL
• Patients with active hepatitis C
• Participants with active autoimmune diseases or history of autoimmune diseases that may relapse
• Clinically significant cardiovascular disease, including heart disease (NYHA ≥Ⅲ), myocardial infarction, unstable arrhythmia or unstable angina within 3 months before enrollment.
• A known history of LVEF\<40%
• Prior allogeneic stem cell transplantation or organ transplantation

Sponsors & Collaborators

• Ruijin Hospital: lead

Study Sites (1)

Ruijin Hospital, Shanghai Jiaotong University School of Medicine

Shanghai, Shanghai Municipality, China

Location

MeSH Terms

Conditions

Non-Muscle Invasive Bladder Neoplasms

Interventions

tislelizumab

Condition Hierarchy (Ancestors)

Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Urinary Bladder Neoplasms; Urologic Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Urinary Bladder Diseases; Urologic Diseases; Male Urogenital Diseases

Central Study Contacts

Danfeng Xu

CONTACT

(021)64370045; xdf12036@rjh.com.cn

Zhiyang Ma

CONTACT

+8618917359966; zy_ma2017@163.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: BCG combined with Tislelizumab

Study Record Dates

• First Submitted: October 12, 2022
• First Posted: October 14, 2022
• Study Start: October 9, 2022
• Primary Completion: October 9, 2024
• Study Completion: May 31, 2025
• Last Updated: October 14, 2022

Record last verified: 2022-10

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)