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

NCT07090148 · Status: RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 14

Last updated 2026-03-11

No results posted yet for this study

Summary

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

Conditions

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

Interventions

BIOLOGICAL

pTVG-HP DNA vaccine

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.

DRUG

Anti-PD-1 monoclonal antibody

Nivolumab is a potent human immunoglobulin G4 (IgG4) monoclonal antibody (mAb). Participants will receive two 10mg doses.

Sponsors & Collaborators

  • United States Department of Defense

    collaborator FED

  • University of Wisconsin, Madison

    lead OTHER

Principal Investigators

  • Douglas McNeel, MD, PhD · University of Wisconsin, Madison

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-03-03
Primary Completion
2030-10-31
Completion
2030-10-31
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07090148 on ClinicalTrials.gov