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Poly-ICLC Prostate Cancer Vaccine

Project Description

  • Novel neoadjuvant 'autovaccination' strategy prior to radical prostatectomy in patients with intermediate and high-risk prostate cancer
  • Hypothesis: Injection of poly-ICLC, a double-stranded RNA "viral mimic" danger signal, directly into an intact primary prostate tumor, plus "booster" injections administered intra-muscularly (IM), will generate a local and systemic anti-tumor immune response.
  • Potential to favorably modulate the tumor microenvironment, impact micro-metastatic disease, improve local and systemic anti-tumor immune responses and improve oncological outcomes.

TRIAL Design

  • Pilot
  • Phase I
  • Clinical Trial
  • Single center
  • Neoadjuvant immunotherapy
  • IT + IM poly-ICLC
  • 2 phases
  • Indication: Patients with intermediate and high-risk prostate cancer undergoing radical prostatectomy as the definitive treatment.


  • Primary Objectives:
  • Phase Ia

Determine safe dosing frequency

  • Phase Ib

Determine feasibility

  • Secondary Objectives
  • Phase Ia& Ib

Determine local and systemic immune responses

Positive surgical margin rate

Biochemical Recurrence rate at 1, 2 and 5 year

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