NCT04922047

Safety and Efficacy Study of Tislelizumab in Combination With BCG in HR-NMIBC Patients (TACBIN-01)

Safety and Efficacy Study of Tislelizumab Alone and in Combination With Bacille Calmette-Guérin (BCG) in High-Risk Non-Muscle-Invasive Bladder Cancer (NMIBC) Patients, a Prospective Open Single-site Trial（TACBIN-01）

• Status: Unknown
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 6 (estimated)
• Sponsor: RenJi Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

This study is a single-arm, open-label, single-center study to assess the safety of tislelizumab with BCG, and to obtain the preliminary efficacy results in subjects who have been diagnosed with high-risk NMIBC without prior BCG treatment.

Detailed description

An estimated 130,000 new cases were diagnosed with bladder cancer in China each year. About 75-85% of them are NMIBC. The standard care for high risk (HR) NMIBC is intravesicular BCG instillation. Despite BCG treatment, 40% of patients will eventually experience a recurrence, which is associated with a poorer prognosis. This is a single center Phase I safety and efficacy study of tislelizumab with BCG treatment. The study will determine the safety of administering tislelizumab at 200mg iv q3w in conjunction with intravesicular BCG treatment in HR NMIBC patients who was treatment-naïve or BCG naïve, but underwent TURBT to remove all resectable disease (residual CIS acceptable) within 6 weeks and confirm absence of muscle invasion. BCG installation was the stander treatment for HR NMIBC. Despite BCG treatment, 40% of patients will eventually experience a recurrence, which is associated with a poorer prognosis. It was reported that BCG increased antigen expression and cytokine release from tumor cells, leading to immune cell (e.g. CD4+ and CD8+T cells, NK, macrophages) recruitment and immune-mediated cytotoxicity (indirect effect). PD-L1 expression intravesicular is found to be extremely abundant in the tumor tissue in patients failing BCG treatment. Which may inhibit the T cell to eliminate cancer cells. Based on these data, a combination of tislelizumab with BCG may be effective in preventing recurrence of NMIBC. The 6 subjects will be treated at a dose of 200 mg tislelizumab with 120 mg BCG to explode safety for the combination though observing DLT within 28days. If no safety issues are present, we will carry out multi-cohort Phase II study（TACBIN-02）

Conditions

• Urinary Bladder Neoplasms
• Urologic Neoplasms
• Urogenital Neoplasms
• Antineoplastic Agents
• Urinary Bladder Diseases
• Tislelizumab Antineoplastic Agents, Immunological

Interventions

Type	Name	Description
DRUG	tislelizumab and BCG	Tislelizumab 200 mg administered by intravenous infusion every 3 weeks in first year and continue to second year based on physician choose. BCG 120 mg induction therapy administered via intravesical instillation (once weekly for 6 weeks). BCG induction therapy is followed by maintenance therapy (once weekly for 3 weeks at months 3, 6, 12, 18, 24m).

Timeline

• Start date: 2021-06-01
• Primary completion: 2021-12-01
• Completion: 2023-08-01
• First posted: 2021-06-10
• Last updated: 2021-06-11

Locations

1 site across 1 country: China