PROSTVAC in Combination With Nivolumab in Men With Prostate Cancer

PHASE1/PHASE2CompletedINTERVENTIONAL
Enrollment

24

Participants

Timeline

Start Date

April 18, 2017

Primary Completion Date

June 20, 2023

Study Completion Date

December 1, 2023

Conditions
Prostate Cancer
Interventions
BIOLOGICAL

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.

DRUG

Nivolumab

Nivolumab is to be administered as a flat dose over approximately 30-minutes via intravenous (IV) infusion.

PROCEDURE

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.)

PROCEDURE

Biopsy

A baseline biopsy is performed for participants in the neoadjuvant cohort that do not have a previous collection of biopsy material.

DRUG

Tylenol

Participants who experience aches or fever after vaccination may take Tylenol as directed.

Trial Locations (1)

20892

National Institutes of Health Clinical Center, Bethesda

All Listed Sponsors
lead

National Cancer Institute (NCI)

NIH

NCT02933255 - PROSTVAC in Combination With Nivolumab in Men With Prostate Cancer | Biotech Hunter | Biotech Hunter