A Phase 1 Study To Evaluate Escalating Doses Of A Vaccine-Based Immunotherapy Regimen For Prostate Cancer (PrCa VBIR)
NCT ID: NCT02616185
Last Updated: 2023-11-02
Study Results
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View full resultsBasic Information
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TERMINATED
PHASE1
91 participants
INTERVENTIONAL
2015-12-30
2021-02-23
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SEQUENTIAL
TREATMENT
NONE
Study Groups
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Dose Escalation
PF-06753512
PF-06755992
PF-06755992 will be administered on Day 1 of Cycles 1 and 2.
PF-06755990
PF-06755990 will be administered using a device on Day 29, 57 and 85 of each cycle.
TDS-IM Electroporation Device
TDS-IM electroporation device and associated supplies will be used for PF-06755990 administration
Tremelimumab
PF-06753388 will be administered every 28 days.
PF-06801591
PF-06801591 will be administered every 28 days.
PF-06753512
Combination of adenovirus (AdC68) + plasmid DNA (pDNA) + tremelimumab
Interventions
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PF-06755992
PF-06755992 will be administered on Day 1 of Cycles 1 and 2.
PF-06755990
PF-06755990 will be administered using a device on Day 29, 57 and 85 of each cycle.
TDS-IM Electroporation Device
TDS-IM electroporation device and associated supplies will be used for PF-06755990 administration
Tremelimumab
PF-06753388 will be administered every 28 days.
PF-06801591
PF-06801591 will be administered every 28 days.
PF-06753512
Combination of adenovirus (AdC68) + plasmid DNA (pDNA) + tremelimumab
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
MALE
No
Sponsors
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Pfizer
INDUSTRY
Responsible Party
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Principal Investigators
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Pfizer CT.gov Call Center
Role: STUDY_DIRECTOR
Pfizer
Locations
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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
Countries
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References
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Autio KA, Higano CS, Nordquist L, Appleman LJ, Zhang T, Zhu XH, Babiker H, Vogelzang NJ, Prasad SM, Schweizer MT, Madan RA, Billotte S, Cavazos N, Bogg O, Li R, Chan K, Cho H, Kaneda M, Wang IM, Zheng J, Tang SY, Hollingsworth R, Kern KA, Petrylak DP. First-in-human, phase 1 study of PF-06753512, a vaccine-based immunotherapy regimen (VBIR), in non-metastatic hormone-sensitive biochemical recurrence and metastatic castration-resistant prostate cancer (mCRPC). J Immunother Cancer. 2023 Mar;11(3):e005702. doi: 10.1136/jitc-2022-005702.
Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Related Links
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To obtain contact information for a study center near you, click here.
Other Identifiers
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PRCA VBIR FIP STUDY
Identifier Type: OTHER
Identifier Source: secondary_id
B7791001
Identifier Type: -
Identifier Source: org_study_id
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