A Phase 1 Study To Evaluate Escalating Doses Of A Vaccine-Based Immunotherapy Regimen For Prostate Cancer (PrCa VBIR)

The study will evaluate the safety, pharmacokinetics and pharmacodynamics of increasing doses of a vaccine-based immunotherapy regimen for patients with prostate cancer.

Inclusion Criteria

• Histological or cytological diagnosis of prostate cancer
• Adequate bone marrow, kidney and liver function
• Hormone sensitive relapsing prostate cancer after definitive local therapy (biochemical relapse) OR
• Progressive disease post-surgical castration or during androgen suppression therapy (pre-secondary hormone CRPC) OR
• Failed prior therapy with a secondary hormone (e.g. enzalutamide, abiraterone) with documented progressive disease (post-secondary hormone CRPC)

Exclusion Criteria

• ECOG performance status greater than or equal to 2
• Concurrent immunotherapy for prostate cancer
• History of or active autoimmune disorders (including but not limited to: myasthenia gravis, thyroiditis, pneumonitis, rheumatoid arthritis, multiple sclerosis, systemic lupus erythematosus, scleroderma) and other conditions that disorganize or alter the immune system.
• History of inflammatory bowel disease.
• Current use of any implanted electronic stimulation device
• For biochemically relapsed patients, no concurrent use of ADT or orchiectomy and no known prior or current evidence of any metastatic involvement of distant organs
• For pre-secondary hormone patients, no prior or concurrent treatment with a secondary hormone (e.g. enzalutamide, abiraterone)
• For post-secondary hormone patients, no concurrent treatment with a secondary hormone (e.g. enzalutamide, abiraterone), no metastasis to the liver or brain

Lead Organization
Pfizer

Primary ID B7791001
Secondary IDs NCI-2016-00393, PRCA VBIR FIP STUDY
Clinicaltrials.gov ID NCT02616185