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

Stopped early · Phase 1

Conditions studied: Prostatic Neoplasms

In brief

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

Key facts

Study ID

NCT02616185

Run by

Pfizer

People needed

91

Starts

2015-12-30

Expected to finish

2021-02-23

Last updated by the study team

2023-11-02

Who can join

Age: 18 and older. Sex: male. Healthy volunteers: not accepted.

You may qualify if…

• 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)

You may not qualify if…

• 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

Where it is running

• Banner-University Medical Center Tucson — Tucson, Arizona, United States
• The University of Arizona Cancer Center-North Campus — Tucson, Arizona, United States
• Smilow Cancer Hospital at Yale-New Haven — New Haven, Connecticut, United States
• Smilow Cancer Hospital Phase 1 Unit — New Haven, Connecticut, United States
• National Institutes of Health Clinical Center — Bethesda, Maryland, United States
• GU Research Network — Omaha, Nebraska, United States
• Comprehensive Cancer Centers of Nevada — Las Vegas, Nevada, United States
• Garden State Urology — Morristown, New Jersey, United States
• Morristown Medical Center — Morristown, New Jersey, United States
• Garden State Urology — Rockaway, New Jersey, United States
• Garden State Urology — Whippany, New Jersey, United States
• Northwell Health — Lake Success, New York, United States
• Memorial Sloan-Kettering Cancer Center 53rd Street — New York, New York, United States
• Memorial Sloan Kettering Cancer Center — New York, New York, United States
• Memorial Sloan-Kettering Cancer Center, Sidney Kimmel Center — New York, New York, United States
• Duke University Medical Center — Durham, North Carolina, United States
• UPMC Hillman Cancer Center — Pittsburgh, Pennsylvania, United States
• Seattle Cancer Care Alliance — Seattle, Washington, United States
• University of Washington Medical Center — Seattle, Washington, United States

Full record on ClinicalTrials.gov

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