Trial Search Results

A Randomized, Double-blind, Phase 3 Efficacy Trial of PROSTVAC-V/F +/- GM-CSF in Men With Asymptomatic or Minimally Symptomatic Metastatic Castrate-Resistant Prostate Cancer

The purpose of this study is to determine whether PROSTVAC alone or in combination with GM-CSF is effective in prolonging overall survival in men with few or no symptoms from metastatic, castrate-resistant prostate cancer.

PROSTVAC is a PSA (prostate-specific antigen)-based immunization strategy. It is intended to generate immune responses to prostate specific antigens and prostate cancer cells. GM-CSF is a protein that is normally made by the body to increase the amount of certain white blood cells and make them more active. It is used to boost the body’s immune system.

Stanford is currently not accepting patients for this trial.

Lead Sponsor:

Bavarian Nordic, Inc.

Stanford Investigator(s):

Intervention(s):

  • Biological: PROSTVAC-V
  • Biological: PROSTVAC-F
  • Drug: GM-CSF
  • Other: GM-CSF Placebo
  • Biological: Placebo

Phase:

Phase 3

Eligibility


Inclusion Criteria:

Men, ≥18years of age with documented asymptomatic or minimally symptomatic metastatic
castration-resistant prostate cancer.

Documented progressive disease post surgical castration or during androgen suppression
therapy, or during complete androgen blockade therapy and withdrawal. Documented by either
criterion a (Radiological progression), OR criterion b (PSA progression).

   1. Radiological progression defined as any new/enlarging bone metastases or new/enlarging
   lymph node disease, consistent with prostate cancer.

   OR

   2. PSA progression defined by sequence of rising values separated by > 1 week (2 separate
   increasing values) over a threshold minimum of 2.0 ng/ml. (PCWG2 PSA eligibility
   criteria).

Chemotherapy naïve and Vaccinia-experienced (previous smallpox vaccination). Currently
using a GnRH agonist or antagonist (unless surgically castrated).

Exclusion Criteria:

Cancer-related pain requiring scheduled opioid narcotics for control (as needed, ≤ 2x per
week is allowed).

Metastasis to organ systems other than lymph nodes and/or bone. Estimated PSA doubling time
of <1 month as established within 6 months of the anticipated first dose of vaccine or
placebo.

Concurrent or prior Provenge (sipuleucel-T) immunotherapy for prostate cancer. Receipt of
an investigational agent within 30 days (or 60 days for an antibody-based therapy) of the
first planned dose of PROSTVAC-V/F.

History of prior malignancies other than prostate cancer within the past 3 years, excluding
successfully resected basal or squamous cell carcinoma of the skin.

Congestive heart failure (NYHA Class II, III, or IV), unstable angina, ventricular or
hemodynamically significant atrial arrhythmia, or cardiovascular disease such as stroke or
myocardial infarction (current or within the past 6 months) Confirmed positive for HIV,
hepatitis B, and /or hepatitis C. Immunodeficiency or splenectomy. History of or active
autoimmune disease, persons with vitiligo are not excluded. Diabetics are not excluded if
the condition is well controlled.

History of atopic dermatitis or active skin condition (acute, chronic, exfoliative) that
disrupts the epidermis.

Ages Eligible for Study

18 Years - N/A

Genders Eligible for Study

Male

Not currently accepting new patients for this trial

Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305
CCTO
650-498-7061
Not Recruiting