Prime-boost Immunotherapeutic Trial in Men With Biochemical Recurrence After Definitive Local The… (NCT05617040) | Clinical Trial Compass
TerminatedPhase 1/2
Prime-boost Immunotherapeutic Trial in Men With Biochemical Recurrence After Definitive Local Therapy for Prostate Cancer
Stopped: The trial was discontinued following completion of the Phase 1 portion. This discontinuation was not based on safety concerns.
United States22 participantsStarted 2023-01-30
Plain-language summary
This is a multi-centre, Phase 1/2, open-label clinical trial of the VTP-850 prime-boost immunotherapeutic in men with biochemical recurrence after definitive local therapy for prostate cancer.
Who can participate
Age range18 Years
SexMALE
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Inclusion criteria
✓. Males aged 18 years and above at the time of signing the informed consent.
✓. Histologically or cytologically confirmed adenocarcinoma of the prostate.
✓. Has undergone primary therapy for prostate cancer (radical prostatectomy and/or definitive external beam radiation and/or brachytherapy). Salvage external radiation therapy (XRT) following radical prostatectomy \>6 months prior to Day 1 is allowed.
✓. No further local therapy to prostate or systemic therapy for prostate cancer and no metastasis-directed therapy for PSA positron emission tomography (PET) positive lesions planned within 4 months after the first dose of VTP-850.
✓. Serum testosterone \>175 ng/dL.
✓. Nonmetastatic (M0) disease and no evidence of prostatic bed recurrence verified by whole body bone scintigraphy and either CT or MRI. Note that a positive PSMA PET does not exclude the participant if the conventional scans are negative.
✓. Serum PSA of \>0.3 ng/mL for participants with prior radical prostatectomy (with or without salvage radiotherapy), or serum PSA of 2 ng/mL above nadir for participants with prior external beam radiation or brachytherapy.
✓. PSA doubling time ≤12 months.
Exclusion criteria
✕. Any other prior malignancy within the past 5 years except for basal cell or squamous epithelial carcinomas of the skin that have been resected with no evidence of metastatic disease for 3 years.
✕
What they're measuring
1
The Safety of VTP-850 Prime-boost Regimens, With the Booster Dose Administered Either IM or IV, and the Recommended Phase 2 Regimen (RP2R)
Timeframe: From the start of the first VTP-850 administration continuing until Month 6
. Unstable medical condition, drug or alcohol abuse, or medical or psychiatric condition that in the opinion of the investigator would affect the safety of the participant or the evaluation of the data or interfere with adherence to the trial requirements.
✕. Significant history of or current cardiovascular, respiratory, renal, gastrointestinal, endocrinological, haematological or neurological disorders constituting a risk when taking the trial intervention or interfering with the interpretation of data; cardiac event or heart failure in the previous 6 months.
✕. Current or chronic history of liver disease. This includes but is not limited to: hepatitis virus infections, cirrhosis, drug- or alcohol-related liver disease, non alcoholic steatohepatitis, autoimmune hepatitis, hemochromatosis, Wilson's disease, α-1 antitrypsin deficiency, primary biliary cholangitis, primary sclerosing cholangitis or any other liver disease considered clinically significant by the investigator. (Note that history of hepatitis C infection, Gilbert's syndrome or non alcoholic fatty liver not associated with steatohepatitis are not exclusions. In line with Exclusion Criterion 10, active hepatitis C infection is exclusionary.)
✕. Active autoimmune disease that has required systemic treatment in past 2 years with use of disease modifying agents, chronic corticosteroids (\>14 days) or immunosuppressive drugs. Hormone replacement therapy (e.g., thyroxine, insulin or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency) is allowed.
✕. History of severe allergy to eggs or history of severe reaction to any previous vaccination that required medical attention.