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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: Active

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

Arizona

Tucson
Banner University Medical Center - Tucson
Status: ACTIVE

Connecticut

New Haven
Yale University
Status: ACTIVE

Maryland

Bethesda
National Institutes of Health Clinical Center
Status: ADMINISTRATIVELY_COMPLETE
Contact: Ravi A. Madan
Phone: 301-496-3493

Michigan

Detroit
Wayne State University / Karmanos Cancer Institute
Status: WITHDRAWN
Contact: Ulka N. Vaishampayan
Phone: 313-576-9363

New York

New York
Memorial Sloan Kettering Cancer Center
Status: ACTIVE

North Carolina

Durham
Duke University Medical Center
Status: ACTIVE

Pennsylvania

Philadelphia
Thomas Jefferson University Hospital
Status: WITHDRAWN
Contact: William Kevin Kelly
Phone: 215-955-6084
Pittsburgh
University of Pittsburgh Cancer Institute (UPCI)
Status: ACTIVE

Washington

Seattle
Fred Hutch / University of Washington Cancer Consortium
Status: TEMPORARILY_CLOSED_TO_ACCRUAL

Trial Phase Phase I

Trial Type Treatment

Lead Organization
Pfizer

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