Ignite Creation Date:
2024-05-06 @ 10:33 AM
Last Modification Date:
2024-10-26 @ 12:32 PM
Study NCT ID:
NCT03294304
Status:
COMPLETED
Last Update Posted:
2021-12-16
First Post:
2017-09-22
Brief Title:
BLASST-1 Bladder Cancer Signal Seeking Trial Nivolumab Gemcitabine and Cisplatin in Treatment of Muscle Invasive Bladder Cancer MIBC Undergoing Cystectomy
Sponsor:
Masonic Cancer Center University of Minnesota
Organization:
Masonic Cancer Center University of Minnesota
Study Overview
Official Title:
BLASST-1 Bladder Cancer Signal Seeking Trial Phase II Trial of Neoadjuvant Nivolumab With Cisplatin and Gemcitabine in Muscle-Invasive Bladder Cancer MIBC Patients Undergoing Radical Cystectomy
Status:
COMPLETED
Status Verified Date:
2021-11
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:
None
Brief Summary:
This is a multi-center Phase II study to determine the safety and efficacy of nivolumab when given in combination with cisplatin and gemcitabine as neoadjuvant treatment in patients with muscle-invasive bladder cancer MIBC prior to standard of care radical cystectomy Patients will receive neoadjuvant treatment with nivolumab in combination with gemcitabine-cisplatin GC every 3 weeks for 4 treatment cycles over 12 weeks followed by standard of care radical cystectomy
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