Ignite Creation Date:
2024-10-26 @ 3:38 PM
Last Modification Date:
2024-10-26 @ 3:38 PM
Study NCT ID:
NCT06567743
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-08-14
Brief Title:
Brief Title Phase 2 Study to Evaluate Safety and Efficacy of Cretostimogene Grenadenorepvec in High-Risk NMIBC
Sponsor:
None
Organization:
None
Study Overview
Official Title:
A Phase 2 Multi-Arm Multi-Cohort Open-Label Study to Evaluate the Safety and Efficacy of Cretostimogene Grenadenorepvec in Participants With High-Risk Non-Muscle-Invasive Bladder Cancer NMIBC
Status:
RECRUITING
Status Verified Date:
2024-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This is a Phase 2 Multi-Arm Multi-Cohort Open-Label Study to Evaluate the Safety and Efficacy of Cretostimogene Grenadenorepvec in Participants with High-Risk Non-Muscle-Invasive Bladder Cancer
Detailed Description:
In Cohort A up to 50 participants will be enrolled with pathologically confirmed CIS-containing high-risk NMIBC ie CIS with or without concomitant TaT1 who are naïve to BCG treatment Participants will be randomized 11 to receive DDM and cretostimogene via the current Arm 1 or an alternative instillation procedure Arm 2
Cretostimogene and DDM will be administered as a weekly induction course for the first 6 weeks with a reinduction course administered to patients who have CIS andor high-grade Ta disease at the 3-month evaluation Following induction if no high-grade disease is detected maintenance treatment will begin This consists of a cycle of three weekly treatments every three months during the first year and every six months during the second year with an optional extension to the third year following the same six-month schedule
Disease status will be assessed using urine cytology complete bladder visualization eg cystoscopy upper tract assessment and and directed TURBTbiopsy if indicated every 3 months for the first 2 years after randomization and then every 6 months for a further 2 years or until disease recurrence
Cretostimogene and DDM will be administered as a weekly induction course for the first 6 weeks with a reinduction course administered to patients who have CIS andor high-grade Ta disease at the 3-month evaluation Following induction if no high-grade disease is detected maintenance treatment will begin This consists of a cycle of three weekly treatments every three months during the first year and every six months during the second year with an optional extension to the third year following the same six-month schedule
Disease status will be assessed using urine cytology complete bladder visualization eg cystoscopy upper tract assessment and and directed TURBTbiopsy if indicated every 3 months for the first 2 years after randomization and then every 6 months for a further 2 years or until disease recurrence
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