Ignite Creation Date:
2025-12-24 @ 4:55 PM
Ignite Modification Date:
2025-12-30 @ 3:48 AM
Study NCT ID:
NCT04878250
Status:
UNKNOWN
Last Update Posted:
2021-05-07
First Post:
2021-04-30
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Preoperative Bintrafusp Alfa in Operable Urothelial Carcinoma of the Bladder
Sponsor:
Queen Mary University of London
Organization:
Study Overview
Official Title:
A Phase II Study Investigating Preoperative Bintrafusp Alfa in Operable Urothelial Carcinoma of the Bladder
Status:
UNKNOWN
Status Verified Date:
2021-05
Last Known Status:
NOT_YET_RECRUITING
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:
PEBBLE
Brief Summary:
PEBBLE is an open-label, international, multicentre, window of opportunity phase II trial that aims to evaluate the effects of short-term preoperative therapy with bintrafusp alfa in patients with histologically confirmed urothelial carcinoma requiring radical surgery with bilateral pelvic lymph node dissection. Eligible patients will receive 4 doses of bintrafusp alfa (1200mg flat dose) at 14 day intervals before undergoing radical surgery. Patients will attend study visits at 6, 12 and 24 weeks following their surgery. After the 24-week post-surgical visit, patients will enter a follow up phase during which they will be contacted annually for 2 years after their surgery to collect survival and disease status data. The efficacy of bintrafusp alfa will be assessed on CT/MRI scan images and tumour tissue samples collected at baseline and after treatment with bintrafusp alfa.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: