Title
Phase I/II Trial of Androgen Deprivation, with or without pTVG-AR, and with or without T-Cell Checkpoint Blockade, in Patients with Newly Diagnosed, High-Risk Prostate Cancer

Description
The current protocol will examine the use of a plasmid DNA vaccine encoding AR, alone or with nivolumab, to induce and/or augment therapeutic T-cells following androgen deprivation in patients with newly diagnosed prostate cancer scheduled to undergo prostatectomy. Patients without evidence of metastatic disease, with tissue remaining from a pre-treatment biopsy, and who are being considered for standard treatment by prostatectomy, will be invited to participate and will be on study for up to 15 months.

Objective
Primary Objectives:

To evaluate the safety of androgen deprivation and pTVG-AR DNA vaccine, alone or in combination with nivolumab, in patients with newly diagnosed prostate cancer

To determine if pathological complete responses or minimal residual disease (MRD) can occur in patients with prostate cancer treated with androgen deprivation and pTVG-AR, alone or in combination with nivolumab, prior to definitive surgery

Treatment Active Comparator: Degarelix
Degarelix 240 mg s.c. day 29, 80 mg s.c. day 57

Experimental: Degarelix and pTVG-AR
Degarelix 240 mg s.c. day 29, 80 mg s.c. day 57 pTVG-AR (100 µg) administered intradermally (i.d.) at days 1, 8, 15, 22, 29, 43, 57 and 71

Experimental: Degarelix and pTVG-AR and Nivolumab
Degarelix 240 mg s.c. day 29, 80 mg s.c. day 57 pTVG-AR (100 µg) administered intradermally (i.d.) at days 1, 8, 15, 22, 29, 43, 57 and 71 Nivolumab 240 mg IV administered at days 29, 43, 57 and 71

Key Eligibility For full eligibility, please see this study's ClinicialTrials.gov record.

Applicable Disease Sites
Prostate

Participating Institutions
UW Health Eastpark Medical Center; UW Health University Hospital