Ignite Creation Date:
2024-05-06 @ 8:25 PM
Last Modification Date:
2024-10-26 @ 3:27 PM
Study NCT ID:
NCT06373380
Status:
RECRUITING
Last Update Posted:
2024-05-07
First Post:
2024-04-15
Brief Title:
A Study of HB-202HB-201 in People With Human Papilloma Virus 16-Positive Head and Neck Squamous Cell Cancer HPV 16 HNSCC
Sponsor:
Memorial Sloan Kettering Cancer Center
Organization:
Memorial Sloan Kettering Cancer Center
Study Overview
Official Title:
Phase II Multicenter Randomized Double-Blind Placebo-Controlled Study Evaluating the Efficacy of HB-200 in Patients With Positive TTMV-HPV DNA After Definitive Treatment for HPV16 Positive HNSCC
Status:
RECRUITING
Status Verified Date:
2024-07
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:
The researchers are doing this study to find out if HB-202HB-201 is an effective treatment for people with HPV 16-positive head and neck squamous cell cancer HPV 16 HNSCC who have received standard treatment for their disease but then tested positive for HPV 16-related tumor DNA in the blood through a test called NavDx Participants will have no evidence of cancer on imaging scans radiographically or by medical examination clinically Past studies have shown that a positive NavDx test strongly suggests the possible presence of microscopic cancer though we do not know if testing positive will definitely lead to the cancer coming back recurrence The NavDx blood test has not been approved by the FDA and is considered investigational
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?:
None