Ignite Creation Date:
2024-05-06 @ 4:15 PM
Last Modification Date:
2024-10-26 @ 2:06 PM
Study NCT ID:
NCT04922047
Status:
UNKNOWN
Last Update Posted:
2021-06-11
First Post:
2021-06-06
Brief Title:
Safety and Efficacy Study of Tislelizumab in Combination With BCG in HR-NMIBC Patients TACBIN-01
Sponsor:
RenJi Hospital
Organization:
RenJi Hospital
Study Overview
Official Title:
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 TrialTACBIN-01
Status:
UNKNOWN
Status Verified Date:
2021-06
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
TACBIN-01
Brief 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 130000 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 eg CD4 and CD8T 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 studyTACBIN-02
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 eg CD4 and CD8T 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 studyTACBIN-02
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| BGB-A317-2002-IIT | OTHER | Beigene | None |