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Protocol No. UW15014

Principal Investigator Liu, Glenn

Phase I/II Pilot (Cancer Control)

Age Group Adult

Scope Local

Sponsor Type Industry; Institutional

Title Pilot trial of pTVG-HP DNA Vaccine and Pembrolizumab in Patients with Castration-Resistant, Metastatic Prostate Cancer

Objective We are trying to find new methods to more safely and effectively treat prostate cancer. In this study, we want to see if we can increase how a person's own body responds against the cancer.

Treatment We will be testing the effectiveness of an experimental vaccine called pTVG-HP ("vaccine") with an experimental drug called pembrolizumab that is thought to increase the cancer fighting ability of a person's immune cells. The vaccine will also be given with an investigational drug called granulocyte-macrophage colony-stimulating factor (GM-CSF), which is thought to imnprove the effect of the vaccine. The vaccine and GM-CSF are both experimental anti-cancer agents that have not been approved by the Food and Drug Administration (FDA). "Experimental" means that the benefits and side effects are not fully known. Pembrolizumab is an FDA-approved drug for the treatment of melanoma, which at this point is not known to have an effect on prostate cancer.

Description You will receive the pTVG-HP vaccine with GM-CSF 6 times as an injection given under the skin. Pembrolizumab is administered by inserting a needle into one of your veins at 3-week intervals. You will also have two leukapheresis procedures for research purposes to study the immune responses before and following treatment. Leukapheresis is a process where your blood goes through a machine that separates and collects some of your white blood cells while putting the rest of the liquid and blood parts back in. Click here for more info

Key Eligibility
  • Histologically confirmed diagnosis of prostate cancer (adenocarcinoma of the prostate)
  • Metastatic disease as evidenced by the presence of soft tissue and/or bone metastases on imaging studies
  • All patients must have received (and be receiving) standard of care androgen deprivation treatment and subjects receiving GnRH analogue or antagonist must continue this treatment throughout the time on this study
  • Patients may or may not have been treated previously with a nonsteroidal antiandrogen. For patients previously treated with an antiandrogen, they must be off use of anti-androgen for at least 4 weeks (for flutamide) or 6 weeks (for bicalutamide or nilutamide) prior to registration
  • Patients must have a castrate serum level of testosterone (< 50 ng/dL) within 6 weeks of day 1
  • Progressive disease while receiving androgen deprivation therapy
  • Prior treatment with abiraterone or enzalutamide is permitted, but patients must have been off prior corticosteroid treatment for at least 3 months
  • No known history of HIV 1 and 2, HTLV-1, or active Hepatitis B or Hepatitis C
  • Patients may not be receiving other investigational agents or be receiving concurrent anticancer therapy other than standard androgen deprivation therapy
  • Concurrent bisphosphonate therapy is not excluded, however patients should not start bisphosphonate therapy while on this study; those patients already receiving bisphosphonate therapy should continue at the same dosing and schedule as prior to study entry
  • Patients may not have been treated with prior sipuleucel-T
  • Prior cytotoxic chemotherapy (for example, but not limited to, docetaxel, mitoxantrone, cabazitaxel) within 6 months of registration is prohibited
  • Patients with a history of life-threatening autoimmune disease are not eligible
  • Patients who have undergone splenectomy are not eligible
  • Patients with known brain metastases are not eligible

Applicable Disease Sites Prostate

Therapies Involved Immunotherapy

Drugs Involved Keytruda (pembrolizumab); MK-3475 (pembrolizumab); PTVG-HP/GM-CSF; pembrolizumab

Status Open

Participating Institutions UW Hospital and Clinics