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

Status: Active

Description

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

Eligibility Criteria

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

Locations & Contacts

Connecticut

New Haven
Yale University
Status: Active
Name Not Available

New York

New York
Memorial Sloan Kettering Cancer Center
Status: Active
Name Not Available

North Carolina

Durham
Duke University Medical Center
Status: Active
Name Not Available

Pennsylvania

Pittsburgh
University of Pittsburgh Cancer Institute (UPCI)
Status: Active
Name Not Available

Washington

Seattle
Fred Hutch / University of Washington Cancer Consortium
Status: Active
Name Not Available

Trial Phase & Type

Trial Phase

Phase I

Trial Type

Treatment

Lead Organization

Lead Organization
Pfizer

Trial IDs

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