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Brief Title: Trial to Evaluate Safety and Immunogenicity of INO-5150 Alone or With INO-9012 in Men With Prostate Cancer
Official Title: Phase I, Open-label Trial to Evaluate the Safety and Immunogenicity of INO-5150 Alone or in Combination With INO-9012 in Men With Biochemically Relapsed (PSA) Prostate Cancer
Study ID: NCT02514213
Brief Summary: This is a phase I, open-label trial to evaluate the safety and immunogenicity of INO 5150 alone or in combination with INO-9012 when delivered intramuscularly (IM) followed by electroporation (EP) in men with biochemically relapsed prostate cancer.
Detailed Description: Phase I, open label study of INO-5150 (DNA plasmids encoding prostate specific antigen (PSA) and prostate specific membrane antigen (PSMA)) alone or co-administered with INO-9012 (IL-12 plasmid) delivered intramuscularly followed by EP using the CELLECTRA®-5P device in adult males with biochemically relapsed prostate cancer following definitive local therapy (e.g. prostatectomy, external beam radiation, or brachytherapy). Four injections will be administered to approximately 60 eligible subjects who consent to participate in the study. Subjects will be monitored for safety and immunogenicity through Week 72.
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: MALE
Healthy Volunteers: No
Chesapeake Urology Research Associates, Baltimore, Maryland, United States
Karmanos Cancer Institute, Detroit, Michigan, United States
GU Research Network, LLC/ Urology Cancer Center, Omaha, Nebraska, United States
Weill Cornell Medical College, New York, New York, United States
University of North Carolina Lineberger Cancer Center, Chapel Hill, North Carolina, United States
Cleveland Clinic, Cleveland, Ohio, United States
Sidney Kimmel Cancer Center - Thomas Jefferson University, Philadelphia, Pennsylvania, United States
UPMC, Pittsburgh, Pennsylvania, United States
Carolina Urologic Research Center, Myrtle Beach, South Carolina, United States
Seattle Cancer Care Alliance, Seattle, Washington, United States
Name: Ildi Csiki, MD, PH.D.
Affiliation: Inovio Pharmaceuticals
Role: STUDY_DIRECTOR