Ignite Creation Date:
2024-05-06 @ 1:41 PM
Last Modification Date:
2024-10-26 @ 1:18 PM
Study NCT ID:
NCT04090528
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2024-05-31
First Post:
2019-09-12
Brief Title:
pTVG-HP DNA Vaccine With or Without pTVG-AR DNA Vaccine and Pembrolizumab in Patients With Castration-Resistant Metastatic Prostate Cancer
Sponsor:
University of Wisconsin Madison
Organization:
University of Wisconsin Madison
Study Overview
Official Title:
Phase II Trial of pTVG-HP DNA Vaccine With or Without pTVG-AR DNA Vaccine and Pembrolizumab in Patients With Castration-Resistant Metastatic Prostate Cancer
Status:
ACTIVE_NOT_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:
This trial will evaluate the use of one versus two DNA vaccines delivered concurrently with PD-1 blockade using pembrolizumab followed by treatment with pembrolizumab alone and delivered over a prolonged period of time for a maximum of 2 years 32 cycles or until radiographic progression on the treatment of castrate-resistant metastatic prostate cancer The hypothesis to be tested is that delivering two vaccines with PD-1 blockade will elicit a greater frequency and magnitude of tumor-directed CD8 T cells and thereby increase the percentage of patients experiencing objective anti-tumor effect as measured by PSA declines andor objective radiographic responses Participants must be 18 years of age or older and can expect to be on treatment for 2 years 32 cycles and on study for up to 7 years including 5 years of follow up via phone
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
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| Protocol Version 1192022 | OTHER | UW Madison | None |
| 2018-0938 | OTHER | None | None |
| SMPHMEDICINEHEM-ONC | OTHER | None | None |
| A534260 | OTHER | None | None |
| NCI-2019-07273 | REGISTRY | None | None |