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Prostate Cancer PatientsPhase 1NCT07090148

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

A Phase 1 study testing pTVG-HP DNA vaccine and Anti-PD-1 monoclonal antibody in people with Prostate Cancer Patients and Non-castrate Prostate Cancer, run by University of Wisconsin, Madison at 1 site in United States.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record

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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older, men only
What is being tested?
pTVG-HP DNA vaccine and Anti-PD-1 monoclonal antibody
Type of treatment
Vaccines
Could I receive a placebo?
No, everyone receives an active treatment
How many people
14 participants
Where
1 siteUnited States
Study dates
3 Mar 2026to Oct 2030
Phase
Phase 1

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • Men only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Participants must be at least 18 years of age with a histologic diagnosis of adenocarcinoma of the prostate
  • Participants must have undergone radical prostatectomy
  • Participants must have completed local therapy by surgery, and any adjuvant/salvage radiation therapy (if required), at least 3 months prior to entry, with removal or ablation of all visible disease, including seminal vesical and/or local lymph node involvement.
  • Participants must have biochemically recurrent disease defined by the following:
  • PSA doubling time, calculated from most recent 4 serum PSA values (collected up to one year prior to enrollment, at least 2 weeks apart, and all from the same clinical laboratory), must be a positive number (i.e. evidence of PSA rise over time).
  • Participants must have oligometastatic disease, defined as:
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  • < 3 lesions consistent with metastases as detected by CT of the abdomen/pelvis and bone scintigraphy (bone scan)
  • Lesions consistent with metastatic prostate cancer as detected by PSMA PET/CT
  • Participants with a prior history of a second malignancy are eligible provided they have been treated with curative intent and have been free of disease greater than three years. There will be no exclusion for patients with a history of basal cell carcinoma, squamous cell skin cancer, superficial bladder cancer, or other in situ carcinoma that has been adequately treated.
  • Participants who are sexually active must use a reliable form of contraception while on study and for 4 weeks after the last immunization.
  • ECOG performance score < 2 and life expectancy of at least 12 months.
  • Participants must have normal hematologic, renal and liver function
  • Participants must be informed of the experimental nature of the study and its potential risks and must sign an IRB-approved written informed consent form indicating such an understanding.
  • Willingness to provide blood samples for immune studies, per study calendar, up to one year after study, even if off treatment.

Who cannot join

  • Small cell or other variant prostate cancer histology
  • Participants cannot have evidence of immunosuppression or have been treated with immunosuppressive therapy, such as chemotherapy or chronic treatment dose corticosteroids (greater than the equivalent of 10 mg prednisone per day), within 3 months of the first vaccination.
  • Seropositive for HIV, hepatitis B (HBV) or hepatitis C (HCV) per patient history due to the immunosuppressive features of these diseases.
  • Prior treatment with an LHRH agonist or nonsteroidal antiandrogen, except in the following circumstances: Neoadjuvant/adjuvant androgen deprivation therapy administered with radiation therapy or at the time of prostatectomy is acceptable, provided that there was no evidence of PSA progression while on treatment. In this situation, patients must not have received more than 24 months of androgen deprivation treatment. Other treatment with androgen deprivation therapy is prohibited.
  • Serum testosterone at screening < 50 ng/dL.
  • Participants must not be concurrently taking other medications or supplements with known hormonal effects, including PC-SPES, megestrol acetate, finasteride, ketoconazole, estradiol, or Saw Palmetto. All other medications with possible anti-cancer effects must be discussed with the PI prior to study entry.
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  • Participants previously treated with other potential or experimental therapies for prostate cancer must have discontinued these treatments and completed at least a 4 week washout prior to beginning treatment.
  • Participants must not have known psychological or sociological conditions, addictive disorders or family problems, which would preclude compliance with the protocol.
  • Participants with unstable or severe intercurrent medical conditions or laboratory abnormalities that would impart, in the judgment of the PI, excess risk associated with study participation or study agent administration.
  • Participants who have concurrent enrollment on other phase I, II, or III investigational therapeutic treatment studies for prostate cancer cannot be actively receiving treatment and the last dose cannot be within 4 weeks of day 1. They must be in the follow up phase of the study.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Cancer Connect contact

800-622-8922

clinicaltrials@cancer.wisc.edu

United States1 site, 1 recruiting

  • University of Wisconsin - Madison

    Madison, Wisconsin, 53705

    Cancer Connect, 800-622-8922, clinicaltrials@cancer.wisc.edu

    John Floberg, MD, PhD

    Recruiting

Other trials in United States

About this study

Official title: Pilot Trial of a DNA Vaccine Encoding Prostatic Acid Phosphatase (pTVG-HP) and PD-1 Blockade, With Targeted Ablation of Resistant Lesions, in Patients With Non-Castrate Recurrent Oligometastatic Prostate Cancer

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
Read the detailed description

To explore the use of an investigational DNA vaccine, pTVG-HP, a plasmid DNA encoding human prostatic acid phosphatase (PAP), in combination with nivolumab delivered with vaccination, and in combination with targeted ablation of treatment-resistant lesions, to eradicate metastatic tumor lesions in patients with non-castrate, recurrent, oligometastatic prostate cancer.

Being tested
pTVG-HP DNA vaccine, Anti-PD-1 monoclonal antibody
Medical subject headings
Prostatic Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • pTVG-HP DNA vaccineBiological

    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 antibodyDrug

    Also called Opdivo, nivolumab

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

Study groups in NCT07090148
Study groupRoleWhat they receive
Participants with non-castrate, recurrent, oligometastatic prostate cancerExperimentalParticipants will receive a combination of vaccine and immunotherapy.
Receives: Biological: pTVG-HP DNA vaccine; Drug: Anti-PD-1 monoclonal antibody

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. PSA (prostate-specific antigen) complete response rate

    Defined as a serum PSA <0.2 ng/mL at 1 year after prostatectomy

    Measured: 12 months

  2. Incidence of Adverse Events

    Adverse events will be evaluated using the most recent version of the Common Terminology Criteria for Adverse Events (CTCAE).

    Measured: 5 years

  3. Toxicity Rates

    Toxicity rates (grade 2, grade 3, grade 4, grade ≥ 2, grade ≥ 3, etc.) will be calculated for each study arm and reported along the corresponding 95% confidence intervals. The 95% confidence intervals will be constructed using the Wilson score method.

    Measured: 5 years

Secondary outcomes (6)

  1. Metastasis-free survival rate at 1 year

    Measured: 12 months

  2. Metastasis-free survival rate at 2 years

    Measured: 2 years

  3. Progression-free survival (PSA) at 5 years

    Defined as a serum PSA <0.2 ng/mL at 5 years after prostatectomy, in patients with non-castrate (>25 ng/dL) testosterone levels.

    Measured: 5 years

  4. Change in PSA doubling time

    Measured: Baseline to 5 years

  5. Change in PSA slope

    Measured: Baseline to 5 years

  6. Overall PSA response rate

    Measured: Up to 5 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted29 Jul 2025
  2. Study start3 Mar 2026
  3. Primary completionOct 2030 (estimated)
  4. Study completionOct 2030 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
14 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07090148
Sponsor's protocol ID
2025-0825
Other IDs
HT94252411043, A533300, SMPH/HUMAN ONCOLOGY/HUMAN ONCO, UW25025, Protocol Version 12/27/2025
Status last verified
Mar 2026
First submitted
22 Jul 2025
Last updated
11 Mar 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes

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