Ignite Creation Date:
2024-10-26 @ 3:39 PM
Last Modification Date:
2024-10-26 @ 3:39 PM
Study NCT ID:
NCT06589609
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-09-06
Brief Title:
Phase 1 Clinical Trial of FluBHPVE6E7 Immunotherapy for HPV16-Associated Oropharyngeal Cancer
Sponsor:
None
Organization:
None
Study Overview
Official Title:
A Phase 1 Study of FluBHPVE6E7 Immunotherapy in Patients With HPV16- Associated Oropharyngeal Squamous Cell Carcinoma
Status:
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:
None
Brief Summary:
A clinical study of an immunotherapy in patients with head or neck cancers associated with the HPV16 virus
Detailed Description:
Squamous cell carcinomas of the head and neck HNSCC rank as the sixth most common cancer globally with approximately 575000 new cases diagnosed each year In recent years there has been a rising incidence in younger patients who have limited exposure to traditional risk factors such as smoking and alcohol This increase is closely associated with HPV infection particularly HPV-16 which is strongly linked to oropharyngeal cancer Treatment for HPV-positive oropharyngeal squamous cell carcinoma OPSCC is highly individualized depending on the disease stage patient comorbidities and personal preferences In this phase 1 study patients with HPV-16-associated OPSCC are being treated with the immunotherapeutic delNS-vector expressing the HPV-16 oncogenes E6 and E7 administered both intratumorally and intramuscularly
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