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



Status:Recruiting
Conditions:Prostate Cancer
Therapuetic Areas:Oncology
Healthy:No
Age Range:18 - Any
Updated:12/19/2018
Start Date:December 30, 2015
End Date:March 15, 2021
Contact:Pfizer CT.gov Call Center
Email:ClinicalTrials.gov_Inquiries@pfizer.com
Phone:1-800-718-1021

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A Phase 1 Study To Evaluate The Safety, Pharmacokinetics And Pharmacodynamics Of Escalating Doses Of A Vaccine-Based Immunotherapy Regimen (VBIR) For Prostate Cancer (PF-06753512)

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

- 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
We found this trial at
13
sites
9000 Rockville Pike
Bethesda, Maryland 20892
301-496-2563
National Institutes of Health Clinical Center The National Institutes of Health (NIH) Clinical Center in...
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825 Eastlake Ave E
Seattle, Washington 98109
(206) 288-7222
Seattle Cancer Care Alliance Seattle Cancer Care Alliance (SCCA) is a cancer treatment center that...
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Seattle, WA
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Bethesda, Maryland 20892
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Durham, North Carolina 27710
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Durham, NC
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2301 Erwin Rd
Durham, North Carolina 27710
919-684-8111
Duke Univ Med Ctr As a world-class academic and health care system, Duke Medicine strives...
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Durham, NC
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9280 W. Sunset Road Suite 100
Las Vegas, Nevada 89148
702.952.1251
Comprehensive Cancer Centers of Nevada Comprehensive Cancer Centers of Nevada (CCCN) is the award-winning multidisciplinary...
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Las Vegas, NV
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New Haven, Connecticut 06520
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1275 York Ave
New York, New York 10021
(212) 639-2000
Memorial Sloan Kettering Cancer Center Memorial Sloan Kettering Cancer Center — the world's oldest and...
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New York, NY
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Omaha, Nebraska 68130
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Omaha, NE
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Pittsburgh, Pennsylvania 15232
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1959 NE Pacific St
Seattle, Washington 98195
(206) 598-3300
University of Washington Medical Center University of Washington Medical Center is one of the nation's...
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Seattle, WA
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