Urinary Bladder Neoplasms Clinical Trial
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 Trial(TACBIN-01)
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.
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) ;
Status | Clinical Trial | Phase | |
---|---|---|---|
Terminated |
NCT02612194 -
LCI-GU-URO-CRI-001: Crizotinib in Patients With c-MET or RON-Positive Metastatic Urothelial Cancer
|
Phase 2 | |
Active, not recruiting |
NCT02805608 -
uPAR PET/CT and FDG PET/MRI for Preoperative Staging of Bladder Cancer
|
Phase 2 | |
Not yet recruiting |
NCT02534623 -
Postoperative Quality of Recovery After Transurethral Resection of the Bladder
|
N/A | |
Recruiting |
NCT02228473 -
Effect of Glycopyrrolate and Atropine on Catheter-Related Bladder Discomfort
|
N/A | |
Completed |
NCT02778243 -
Sexual Steroids: Relationship Between Serum and Prostatic Tissue Level
|
N/A | |
Recruiting |
NCT05007106 -
MK-7684A With or Without Other Anticancer Therapies in Participants With Selected Solid Tumors (MK-7684A-005) (KEYVIBE-005)
|
Phase 2 | |
Completed |
NCT01688999 -
Cabozantinib for Advanced Urothelial Cancer
|
Phase 2 | |
Completed |
NCT03219333 -
A Study of Enfortumab Vedotin for Patients With Locally Advanced or Metastatic Urothelial Bladder Cancer
|
Phase 2 | |
Recruiting |
NCT05068180 -
Low-dose Neuroleptanalgesia for Postoperative Delirium in Elderly Patients
|
Phase 4 | |
Terminated |
NCT02560038 -
Trial of Paclitaxel Plus Gemcitabine and Cisplatin in Bladder Cancer
|
Phase 2 | |
Not yet recruiting |
NCT02252445 -
Propofol and Sevoflurane for Catheter-Related Bladder Discomfort
|
N/A | |
Not yet recruiting |
NCT02760953 -
TURBt With Adjuvant Cryoablation to Treat Bladder Cancer
|
N/A | |
Terminated |
NCT04430036 -
AGEN1884 Plus AGEN2034 Combined With Cisplatin-Gemcitabine for Muscle-Invasive Bladder Cancer
|
Phase 2 | |
Active, not recruiting |
NCT06289283 -
Microbiota in Urine and Urothelium Can be a Factor for Induction of Urinary Bladder Cancer. The Study Will Examine Urine and Bladder Cancer Tissues From Male Patients and Urine of Controls Using Whole Genomic Sequencing Techniques and 16S rRNA. The Aim is to Elucidate Role of Microbiota in Bladder
|
||
Active, not recruiting |
NCT03288545 -
A Study of Enfortumab Vedotin Alone or With Other Therapies for Treatment of Urothelial Cancer
|
Phase 1/Phase 2 | |
Active, not recruiting |
NCT03661320 -
A Study to Compare Chemotherapy Alone Versus Chemotherapy Plus Nivolumab or Nivolumab and BMS-986205, Followed by Continued Therapy After Surgery With Nivolumab or Nivolumab and BMS-986205 in Participants With Muscle Invasive Bladder Cancer
|
Phase 3 | |
Completed |
NCT01478685 -
A Phase 1 Study of CC-486 as a Single Agent and in Combination With Carboplatin or ABI-007 in Subjects With Relapsed or Refractory Solid Tumors
|
Phase 1 | |
Completed |
NCT03404791 -
A Study of TAR-200 in Participants With Muscle-Invasive Urothelial Carcinoma of the Bladder Who Are Ineligible for or Refuse Cisplatin-based Chemotherapy and Who Are Unfit for Radical Cystectomy
|
Phase 1 | |
Terminated |
NCT01479348 -
Imaging Study for FdCyd and THU Cancer Treatment
|
Early Phase 1 | |
Recruiting |
NCT05742867 -
A Study to Evaluate Treatment Preferences for Japanese Participants With Muscle-invasive Urothelial Carcinoma of the Bladder
|