Trial of pTVG-HP and Nivolumab for Recurrent Prostate Cancer
This study is looking at whether a special vaccine called pTVG-HP, combined with a drug called nivolumab, can help your body's immune system fight recurrent prostate cancer. You might be able to join if you are a man at least 18 years old with prostate cancer that has come back (recurrent) and has spread to a few spots (oligometastatic), and you've already had surgery. The main goal is to see if this combination can get rid of these metastatic tumors. Researchers will also be checking for side effects and how safe the treatment is. The study plans to enroll 14 participants.
- Study design
- This is an interventional study, meaning participants will receive specific treatments. It is not specified if it's randomized or blinded, and the phase is not mentioned.
- What's involved
- Participants will receive injections of the pTVG-HP vaccine, doses of nivolumab, and radiation therapy. The specific schedule and number of visits are not detailed.
- Compensation
- Not stated in the trial record.
- Follow-up
- Researchers will track your prostate-specific antigen (PSA) response for 12 months. They will also monitor for side effects and toxicity for up to 5 years.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
NCT07090148
Trial of pTVG-HP+Nivo+Targeted Ablation of Resistant Lesions in Non-Castrate RecurrentOMPC
Recruiting
PHASE1Ages 18+InterventionalTreatmentUniversity of Wisconsin, MadisonInvestigator-initiated
~14 participants
Updated 2026-03-11 on ClinicalTrials.gov
What's tested:pTVG-HP DNA vaccineAnti-PD-1 monoclonal antibody
At a glance
Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
PSA (prostate-specific antigen) complete response rate
Measured over 12 months
+2 more outcomes measured
Conditions
Where it's being run
1 sites across 1 statesWisconsin1
Study leadership
- Douglas McNeel, MD, PhD · PRINCIPAL_INVESTIGATOR · University of Wisconsin, Madison
Who to contact
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Do you actually qualify for this trial?
Add a private profile and we'll compare every criterion below against your situation — and tell you which ones are met, uncertain, or excluding.
Eligibility criteria
Inclusion
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:
\< 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.
Exclusion
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.
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.
What this trial measures
- PSA (prostate-specific antigen) complete response rate12 months
Defined as a serum PSA \<0.2 ng/mL at 1 year after prostatectomy
- Incidence of Adverse Events5 years
Adverse events will be evaluated using the most recent version of the Common Terminology Criteria for Adverse Events (CTCAE).
- Toxicity Rates5 years
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.