24
Participants
Start Date
April 18, 2017
Primary Completion Date
June 20, 2023
Study Completion Date
December 1, 2023
PROSTVAC-V/F
PROSTVAC-V (vaccinia) will be administered subcutaneously in an extremity (e.g., thigh) at a dose of 2x10\^8 infectious units. PROSTVAC-F (fowlpox) will be administered subcutaneously in an extremity (e.g., thigh) at a dose of 1x10\^9 infectious units.
Nivolumab
Nivolumab is to be administered as a flat dose over approximately 30-minutes via intravenous (IV) infusion.
Prostatectomy
Participants in the neoadjuvant cohort will undergo a radical prostatectomy in week 9. (If surgery is scheduled earlier than 9 weeks after initial dosing, the 6 and 8 week dosing may be skipped, and surgery may be done as early as week 5.)
Biopsy
A baseline biopsy is performed for participants in the neoadjuvant cohort that do not have a previous collection of biopsy material.
Tylenol
Participants who experience aches or fever after vaccination may take Tylenol as directed.
National Institutes of Health Clinical Center, Bethesda
National Cancer Institute (NCI)
NIH