Ignite Creation Date:
2024-05-06 @ 8:16 PM
Last Modification Date:
2024-10-26 @ 3:24 PM
Study NCT ID:
NCT06315257
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-03-18
First Post:
2024-03-11
Brief Title:
A Clinical Trial to Assess PVX7 Immunotherapy Regimens in Advanced Cervical Cancer Patients
Sponsor:
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Organization:
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Study Overview
Official Title:
A Randomized Open-label Clinical Trial to Assess the Safety Feasibility and Immunogenicity of Adjuvant PVX7 Immunotherapy Regimens in Advanced Cervical Cancer Patients
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
A Feasibility Trial of PVX7 vaccine in advanced cervical cancer patients who have completed primary definitive therapy
Detailed Description:
A Feasibility Trial of PVX7 in advanced cervical cancer patients who have completed primary definitive therapy
Safety and immunogenicity study
Patients are randomized in a 11 ratio to two cohorts up to 16 patients in each of intramuscular or skin scarification vaccine injection up to 32 patients total
Human Immunodeficiency Virus HIV-negative patients only
Treatment dose Arm A pBI-11 DNA 3 mg twice via intramuscular IM injection followed by one dose of TA-HPV 25x105 pfu via skin scarification Arm B pBI-11 DNA 3 mg twice followed by one dose of TA-HPV 107 pfu via IM injection
Schedule for administration PVX7 vaccination at weeks 1 5 and 9
Follow-up for 2 years per standard of care SoC
Safety and immunogenicity study
Patients are randomized in a 11 ratio to two cohorts up to 16 patients in each of intramuscular or skin scarification vaccine injection up to 32 patients total
Human Immunodeficiency Virus HIV-negative patients only
Treatment dose Arm A pBI-11 DNA 3 mg twice via intramuscular IM injection followed by one dose of TA-HPV 25x105 pfu via skin scarification Arm B pBI-11 DNA 3 mg twice followed by one dose of TA-HPV 107 pfu via IM injection
Schedule for administration PVX7 vaccination at weeks 1 5 and 9
Follow-up for 2 years per standard of care SoC
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
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| IRB00388854 | OTHER | Johns Hopkins | None |