Clinical Trial

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

Study acronym: ABATE
Active, Not Recruiting Phase 2
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Record status
This record was last updated December 4, 2024 (before its estimated June 2025 completion). Its status may not reflect the trial's current state.
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.
Protocol Amendment History 17 amendments
This ClinicalTrials.gov record has been amended 17 times since 2020-02-27; most recent amendment 2024-12-03.
Status change: Recruiting → Active, Not Recruiting 2024-12-03
Status change: Not Yet Recruiting → Recruiting 2020-06-15
Trial Details
NCT Number NCT04289779
Lead Sponsor Deepak Kilari
Collaborators: Exelixis, Genentech, Inc., Medical College of Wisconsin
Conditions Bladder Cancer
Enrollment 46 participants
Start Date 2020-05-21
Primary Completion 2025-06 (estimated)
Study Completion 2025-12 (estimated)
Updated on ClinicalTrials.gov 2024-12-04