NCT04730232

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

An Open Label, Single-arm, Phase 2 Study of Tislelizumab Combined With Nab-Paclitaxel for Patients With High-Risk Non-Muscle-Invasive Urothelial Bladder Carcinoma Which is Not Completely Resectable

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 63 (estimated)
• Sponsor: Tianjin Medical University Second Hospital · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Interventions

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

Timeline

• Start date: 2020-12-27
• Primary completion: 2024-02-01
• Completion: 2024-07-01
• First posted: 2021-01-29
• Last updated: 2021-10-29

Locations

1 site across 1 country: China