Ignite Creation Date:
2024-05-06 @ 2:20 PM
Last Modification Date:
2024-10-26 @ 1:29 PM
Study NCT ID:
NCT04289779
Status:
RECRUITING
Last Update Posted:
2024-07-03
First Post:
2020-02-27
Brief Title:
Study of CAbozantinib in Combination With AtezolizumaB for Muscle-Invasive BladdEr Cancer
Sponsor:
Deepak Kilari
Organization:
Hoosier Cancer Research Network
Study Overview
Official Title:
A Phase 2 Study of CAbozantinib in Combination With AtezolizumaB as NeoAdjuvant Treatment for Muscle-Invasive BladdEr Cancer
Status:
RECRUITING
Status Verified Date:
2024-08
Last Known Status:
None
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:
ABATE
Brief 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 v11 or withdraw consent
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
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