NCT04289779

Study of CAbozantinib in Combination with AtezolizumaB for Muscle-Invasive BladdEr Cancer

A Phase 2 Study of CAbozantinib in Combination with AtezolizumaB As NeoAdjuvant Treatment for Muscle-Invasive BladdEr Cancer

• Status: Active Not Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 46 (actual)
• Sponsor: Deepak Kilari · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is an open-label phase II study assessing the activity of cabozantinib combined with atezolizumab in patients with resectable muscle-invasive urothelial carcinoma who are ineligible for cisplatin-based therapy or decline cisplatin-based therapy. Each cycle equals 21 days. The dose of atezolizumab is 1200 mg IV flat dose every 3 weeks (Day 1) plus cabozantinib 40 mg orally daily (Day 1 through Day 21). Patients will receive three cycles of treatment prior to cystectomy unless they discontinue treatment for unacceptable toxicity or progressive disease by RECIST v1.1 or withdraw consent.

Conditions

• Bladder Cancer

Interventions

Type	Name	Description
DRUG	Cabozantinib	Cabozantinib 40 mg orally daily for 3 cycles
DRUG	Atezolizumab	Atezolizumab 1200 mg IV every 3 weeks for 3 cycles
PROCEDURE	Cystectomy	Patients will receive three cycles of treatment prior to cystectomy unless they discontinue treatment for unacceptable toxicity or progressive disease by RECIST v1.1 or withdraw consent.

Timeline

• Start date: 2020-05-21
• Primary completion: 2025-06-01
• Completion: 2025-12-01
• First posted: 2020-02-28
• Last updated: 2024-12-04

Locations

6 sites across 1 country: United States

Regulatory

• FDA-regulated drug study