Androgen Deprivation, With or Without pTVG-AR, and With or Without T-Cell Checkpoint Blockade, in Patients With Newly Diagnosed, High-Risk Prostate Cancer

Part of paid clinical trials in Madison, Wisconsin.

Sponsor
University of Wisconsin, Madison
Study ID
NCT04989946
Phase
PHASE1/PHASE2
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
MALE
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Degarelix — DRUG
    standard Gonadotropin-releasing hormone (GnRH) antagonist
  • pTVG-AR — BIOLOGICAL
    DNA vaccine encoding androgen receptor ligand-binding domain
  • Nivolumab — DRUG
    Nivolumab is a human programmed death receptor-1 (PD-1)-blocking antibody indicated for the treatment of patients with multiple different types of cancer.
  • Cemiplimab — DRUG
    Cemiplimab is a human PD-1 blocking antibody approved for the treatment of patients with non-small cell lung cancer, cutaneous squamous cell carcinoma, and locally advanced basal cell carcinoma.
  • Fianlimab — DRUG
    Lymphocyte activation gene-3 (LAG-3) is a protein that is upregulated on activated CD4+ and CD8+ T cells following T-cell receptor engagement. Binding of LAG-3 to MHC II on professional antigen-presenting cells suppresses the proliferation, activation, and cytokine secretion of T cells. Fianlimab is a human IgG4 antibody to lymphocyte activation gene-3 (LAG-3) that blocks LAG-3/MHC II-mediated T-cell inhibition.
  • FLT PET/CT — DRUG
    Arms 1-3 only, FLT PET/CT scan at baseline (within 1-6 days of Day 1) and Day 43

Study Details

The current protocol will examine the use of a plasmid DNA vaccine encoding AR, alone or with T-cell checkpoint blockade, 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.

Key Dates

Start date
Dec 16, 2021
Status verified
Sep 2025
Primary completion
Dec 31, 2026
Completion
Dec 31, 2028

Study Design

Enrollment
60 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Active Comparator: Arm 1: Degarelix
    \- Degarelix 240 mg s.c. day 29, 80 mg s.c. day 57
  • Experimental: Arm 2: 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: Arm 3: 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
  • Experimental: Arm 4: Degarelix and pTVG-AR and Cemiplimab
    * 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 * Cemiplimab 350 mg IV administered at days 1, 22, 43 and 64
  • Experimental: Arm 5: Degarelix and pTVG-AR and Cemiplimab and Fianlimab
    * 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 * Cemiplimab 350 mg IV administered at days 1, 22, 43 and 64 * Fianlimab 1600 mg IV administered at days 1, 22, 43 and 64

Primary Outcome Measure

Pathological Complete Response Rate (pCR) [ Time Frame: at prostatectomy (up to 3 months) ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
University of Wisconsin Carbone Cancer CenterMadisonWisconsin53792
Cancer Connect
[email protected]
800-622-8922
Christos Kyriakopoulos, MD (PRINCIPAL_INVESTIGATOR)

Find similar trials in Madison, WI

By condition
Prostate cancer
By specialty
OncologyProstate oncologyMen's healthUrology
By research site
University of Wisconsin Carbone Cancer Center· Madison, WI

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