52
Participants
Start Date
May 31, 2018
Primary Completion Date
December 31, 2025
Study Completion Date
December 31, 2025
INO-5401
INO-5401 is a combination of 3 separate DNA plasmids targeting Wilms tumor gene-1 (WT1) antigen, prostate-specific membrane antigen (PSMA) and human telomerase reverse transcriptase (hTERT) genes. Starting on Day 0 three milligrams (mg) of each plasmid will be delivered IM followed by EP using the CELLECTRA® 2000 EP device every three weeks for four doses, and then every 9 weeks until disease progression as defined by immunotherapy Response Assessment in Neuro-Oncology (iRANO), unacceptable toxicity, withdrawal of consent, or death.
INO-9012
INO-9012 is a DNA plasmid for expression of human interleukin-12 (IL-12). Starting on Day 0 one mg plasmid will be delivered IM followed by EP using the CELLECTRA® 2000 EP device every three weeks for four doses, and then every 9 weeks until disease progression as defined by iRANO, unacceptable toxicity, withdrawal of consent, or death.
Cemiplimab
Cemiplimab is an antibody to programmed death-1 (PD-1) protein. Starting on Day 0 cemiplimab will be administered intravenously (IV) every three weeks at a dose of 350 mg per dose in the absence of dose holding, until disease progression as defined by iRANO, unacceptable toxicity, withdrawal of consent, or death.
Radiation Therapy
Radiation therapy (RT) will begin no later than 42 days after surgical intervention, and should start approximately 2 weeks after Day 0. RT will be given for three weeks.
Temozolomide
Temozolomide (TMZ) will be given daily during radiation therapy (RT) at a dose of 75 milligrams per square meter (mg/m\^2).
New York University Langone Medical Center; Perlmutter Cancer Center, New York
Icahn School of Medicine at Mount Sinai, New York
Columbia University Medical Center The Neurological Institute of New York, New York
New York-Presbyterian Hospital/Weill Cornell Medical Center, New York
UPMC Cancer Center Neuro-Oncology; UPMC Cancer Pavilion, Pittsburgh
University of Pennsylvania Health System: Penn Medicine, Philadelphia
University of North Carolina School of Medicine, Chapel Hill
Emory University School of Medicine, Atlanta
University of Miami - Sylvester Comprehensive Cancer Center, Miami
Moffitt Cancer Center, Tampa
Henry Ford Health System, Detroit
Stephenson Cancer Center, Oklahoma City
Baylor College of Medicine, Houston
Texas Oncology, Austin
Huntsman Cancer Institute, Salt Lake City
City of Hope, Duarte
University of California, San Francisco, San Francisco
Stanford University, School of Medicine, Palo Alto
Oregon Health & Science University, Portland
Dana-Farber Cancer Institute, Boston
Rutgers University - Cancer Institute of New Jersey, New Brunswick
Lead Sponsor
Inovio Pharmaceuticals
INDUSTRY