Ignite Creation Date:
2025-12-25 @ 1:23 AM
Ignite Modification Date:
2025-12-27 @ 4:51 AM
Study NCT ID:
NCT05289193
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2025-10-23
First Post:
2022-03-11
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
CD8+ T Cell Imaging During Pre-surgery Immunotherapy in People With Melanoma
Sponsor:
Memorial Sloan Kettering Cancer Center
Organization:
Study Overview
Official Title:
CD8+ Cell Imaging During Neoadjuvant ImmunoTherapy (The C-IT Neo Trial)
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2025-10
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:
Combination treatment with nivolumab and ipilimumab before surgery may help people with melanoma because the drugs are designed to help the immune system target and destroy cancer cells (immunotherapy), which may shrink the cancer and prevent recurrence after surgery. Treatment given before surgery is called neoadjuvant therapy. The purpose of this study is to find out whether neoadjuvant therapy with nivolumab and ipilimumab can kill melanoma tumors before surgery and prevent disease from coming back after surgery. This study also explores a new, experimental PET scan that images the immune system to see if it is related to treatment outcomes.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
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?: