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A Phase 1 Study To Evaluate Escalating Doses Of A Vaccine-Based Immunotherapy Regimen For Prostate Cancer (PrCa VBIR)
Trial Status: administratively complete
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
Failed prior therapy with a novel hormone (e.g. enzalutamide, abiraterone) with documented progressive disease (post-novel hormone therapy 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 post-novel hormone patients, no concurrent treatment with a secondary hormone (e.g. enzalutamide, abiraterone), no metastasis to the liver or brain
Study sponsor and potential other locations can be found on ClinicalTrials.gov for NCT02616185.
