Ignite Creation Date:
2024-06-16 @ 11:50 AM
Last Modification Date:
2024-10-26 @ 3:31 PM
Study NCT ID:
NCT06443944
Status:
AVAILABLE
Last Update Posted:
2024-06-05
First Post:
2024-05-30
Brief Title:
An Expanded Access Program of Cretostimogene Grenadenorepvec for Treatment of NMIBC for Patients Unresponsive to BCG
Sponsor:
CG Oncology Inc
Organization:
CG Oncology Inc
Study Overview
Official Title:
An Expanded Access Program of Cretostimogene Grenadenorepvec in Patients With Non-Muscle Invasive Bladder Cancer NMIBC Unresponsive to Bacillus Calmette-Guerin BCG
Status:
AVAILABLE
Status Verified Date:
2024-05
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 an open-label expanded access trial designed to provide access to cretostimogene in patients with NMIBC unresponsive to BCG
Detailed Description:
All participants will be assigned the same treatment schedule Participants will receive an induction course and if there is no disease recurrence at Week 13 participants will receive a cycle of 3 weekly treatments up to Week 15
If there is persistent HG Ta andor CIS at Week 13 participants may receive a second induction course
If there is no disease present thereafter participants will receive 3 weekly treatment cycles every 12 weeks through Month 12
After Month 12 participants will receive 3 weekly treatment cycles every 6 months through the last treatment cycle at Month 24 or until discontinuation from the study treatment
Disease status will be assessed using urine cytology cystoscopy and directed TURBTbiopsy if indicated every 12 weeks and CTUMRU every 24 weeks for up to 2 years
If there is persistent HG Ta andor CIS at Week 13 participants may receive a second induction course
If there is no disease present thereafter participants will receive 3 weekly treatment cycles every 12 weeks through Month 12
After Month 12 participants will receive 3 weekly treatment cycles every 6 months through the last treatment cycle at Month 24 or until discontinuation from the study treatment
Disease status will be assessed using urine cytology cystoscopy and directed TURBTbiopsy if indicated every 12 weeks and CTUMRU every 24 weeks for up to 2 years
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None