Trial of pTVG-HP+Nivo+Targeted Ablation of Resistant Lesions in Non-Castrate RecurrentOMPC (NCT07090148) | Clinical Trial Compass
RecruitingPhase 1
Trial of pTVG-HP+Nivo+Targeted Ablation of Resistant Lesions in Non-Castrate RecurrentOMPC
United States14 participantsStarted 2026-03-03
Plain-language 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
Who can participate
Age range18 Years
SexMALE
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Inclusion Criteria:
* 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 contra…