Ignite Creation Date:
2024-10-26 @ 3:36 PM
Last Modification Date:
2024-10-26 @ 3:36 PM
Study NCT ID:
NCT06524570
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-07-08
Brief Title:
Treatment of Cancer With Immune Checkpoint Inhibition Therapy Boosted by High Intensity Focused Ultrasound Histotripsy
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Treatment of Cancer With Immune Checkpoint Inhibition Therapy Boosted by High Intensity Focused Ultrasound Histotripsy the iFOCUS Study
Status:
RECRUITING
Status Verified Date:
2024-08
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:
iFOCUS
Brief Summary:
This phase 1 clinical trial aims to evaluate the safety tolerability and feasibility of combination treatment of High Intensity Focused Ultrasound Histotripsy HIFU-HT and immune checkpoint inhibitors ICI in adult patients with metastatic or unresectable cancer that have progressive disease after regular treatment Patients will undergo one single session of HIFU-HT during treatment with ipilimumab and nivolumab Safety tolerability and feasibility endpoints will be studied as well as radiologic immunologic and clinical response
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