Trial of pTVG-HP+Nivo+Targeted Ablation of Resistant Lesions in Non-Castrate RecurrentOMPC

Part of paid clinical trials in Madison, Wisconsin.

Sponsor
University of Wisconsin, Madison
Study ID
NCT07090148
Phase
PHASE1
Status
Recruiting
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Conditions

  • Non-castrate Prostate Cancer
  • Oligometastatic Prostate Cancer (OMPC)
  • Prostate Cancer Patients
  • Recurrent Prostate Cancer

Eligibility Criteria

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

Interventions

  • pTVG-HP DNA vaccine — BIOLOGICAL
    The vaccine will be injected into the outer side of the upper area of the arm in two adjacent sites, with 0.25 mL administered at each site.
  • Anti-PD-1 monoclonal antibody — DRUG
    Nivolumab is a potent human immunoglobulin G4 (IgG4) monoclonal antibody (mAb). Participants will receive two 10mg doses.

Study Details

The goal of this clinical trial is to learn whether an experimental vaccine called pTVG-HP ("vaccine" or "DNA vaccine"), combined with a drug called nivolumab can increase the cancer-fighting ability of a person's immune cells. The main question it aims to answer is whether the combination of medicines can get rid of metastatic tumors in participants with non-castrate, recurrent, oligometastatic prostate cancer. Participants will undergo: * Treatment with pTVG-HP * Treatment with Nivolumab * Radiation Therapy

Key Dates

Start date
Mar 3, 2026
Status verified
Mar 2026
Primary completion
Oct 31, 2030
Completion
Oct 31, 2030

Study Design

Enrollment
14 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Participants with non-castrate, recurrent, oligometastatic prostate cancer
    Participants will receive a combination of vaccine and immunotherapy.

Primary Outcome Measure

PSA (prostate-specific antigen) complete response rate [ Time Frame: 12 months ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
University of Wisconsin - MadisonMadisonWisconsin53705
Cancer Connect
[email protected]
800-622-8922
John Floberg, MD, PhD (PRINCIPAL_INVESTIGATOR)

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By research site
University of Wisconsin - Madison· Madison, WI

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