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

TerminatedPhase 1

Sponsor: Pfizer

Conditions: Prostatic Neoplasms

Interventions: PF-06755992, PF-06755990, TDS-IM Electroporation Device, Tremelimumab, PF-06801591

Countries: United States

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

Eligibility overview

Sex: MALE

Age: 18 Years to —

Healthy volunteers: No

Study type: INTERVENTIONAL

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
* 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

Locations (19)

Tucson, Arizona, United States
Tucson, Arizona, United States
New Haven, Connecticut, United States
New Haven, Connecticut, United States
Bethesda, Maryland, United States
Omaha, Nebraska, United States
Las Vegas, Nevada, United States
Morristown, New Jersey, United States
Morristown, New Jersey, United States
Rockaway, New Jersey, United States
Whippany, New Jersey, United States
Lake Success, New York, United States
New York, New York, United States
New York, New York, United States
New York, New York, United States
Durham, North Carolina, United States
Pittsburgh, Pennsylvania, United States
Seattle, Washington, United States
Seattle, Washington, United States