Ignite Creation Date:
2024-10-26 @ 3:35 PM
Last Modification Date:
2024-10-26 @ 3:35 PM
Study NCT ID:
NCT06503614
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-07-10
Brief Title:
A Trial of Durvalumab MEDI4736 Plus Monalizumab in Non-Muscle-Invasive Bladder Cancer
Sponsor:
None
Organization:
None
Study Overview
Official Title:
ENHANCE Elevated NKG2A and HLA-E Amplify NKCD8 Checkpoint Engagers A Phase 2 Trial of Durvalumab MEDI4736 Plus Monalizumab in Non-Muscle-Invasive Bladder Cancer
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-09
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:
ENHANCE
Brief Summary:
This is a phase 2 open-label two cohort study of durvalumab plus monalizumab in patients with BCG-unresponsive or exposed CIS NMIBC Arm A will enroll 43 participants who have cancer in situ CIS with or without high grade papillary urothelial cancer Arm B will enroll 17 participants who do not have cancer in situ CIS but do have high grade papillary urothelial cancer Eligible patients will be enrolled to receive up to 13 cycles of monthly combination of monalizumab and durvalumab Both monalizumab and durvalumab will be administered intravenously IV every 28 days
Detailed Description:
None
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