Spots Global Cancer Trial Database for INO-5401 and INO-9012 Delivered by Electroporation (EP) in Combination With Cemiplimab (REGN2810) in Newly-Diagnosed Glioblastoma (GBM)
The following info and data is provided "as is" to help patients around the globe.
We do not endorse or review these studies in any way.
Trial Identification
Brief Title: INO-5401 and INO-9012 Delivered by Electroporation (EP) in Combination With Cemiplimab (REGN2810) in Newly-Diagnosed Glioblastoma (GBM)
Official Title: An Open-Label, Multi-Center Trial of INO-5401 and INO-9012 Delivered by Electroporation (EP) in Combination With REGN2810 in Subjects With Newly-Diagnosed Glioblastoma (GBM)
Study ID: NCT03491683
Conditions
Study Description
Brief Summary: Phase 1/2 trial to evaluate safety, immunogenicity and preliminary efficacy of INO-5401 and INO-9012 in combination with cemiplimab (REGN2810), with radiation and chemotherapy, in subjects with newly-diagnosed glioblastoma (GBM).
Detailed Description: This is a phase 1/2, open-label, multi-center trial to evaluate safety, immunogenicity and preliminary efficacy of INO-5401 and INO-9012 in combination with cemiplimab in subjects with newly-diagnosed glioblastoma (GBM). INO-5401 and INO-9012 will be delivered by intramuscular (IM) injection followed by electroporation (EP) in combination with cemiplimab and chemoradiation and radiation. There will be 2 cohorts in this trial. Cohort A will be participants with a tumor with an unmethylated O6-methylguanine-deoxyribonucleic acid (DNA) methyltransferase (MGMT) promoter. Cohort B will be participants with a tumor with a MGMT methylated promoter or who have indeterminate MGMT status. Both cohorts will receive INO-5401 and INO-9012 and cemiplimab at the same doses and on the same dosing schedule, and both cohorts will receive radiation and temozolomide (TMZ), if clinically indicated.
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
City of Hope, Duarte, California, United States
Stanford University, School of Medicine, Palo Alto, California, United States
University of California, San Francisco, San Francisco, California, United States
University of Miami - Sylvester Comprehensive Cancer Center, Miami, Florida, United States
Moffitt Cancer Center, Tampa, Florida, United States
Emory University School of Medicine, Atlanta, Georgia, United States
Dana-Farber Cancer Institute, Boston, Massachusetts, United States
Henry Ford Health System, Detroit, Michigan, United States
Rutgers University - Cancer Institute of New Jersey, New Brunswick, New Jersey, United States
New York University Langone Medical Center; Perlmutter Cancer Center, New York, New York, United States
Icahn School of Medicine at Mount Sinai, New York, New York, United States
Columbia University Medical Center The Neurological Institute of New York, New York, New York, United States
New York-Presbyterian Hospital/Weill Cornell Medical Center, New York, New York, United States
University of North Carolina School of Medicine, Chapel Hill, North Carolina, United States
Stephenson Cancer Center, Oklahoma City, Oklahoma, United States
Oregon Health & Science University, Portland, Oregon, United States
University of Pennsylvania Health System: Penn Medicine, Philadelphia, Pennsylvania, United States
UPMC Cancer Center Neuro-Oncology; UPMC Cancer Pavilion, Pittsburgh, Pennsylvania, United States
Texas Oncology, Austin, Texas, United States
Baylor College of Medicine, Houston, Texas, United States
Huntsman Cancer Institute, Salt Lake City, Utah, United States
Contact Details
Name: Jeffrey Skolnik, MD
Affiliation: Inovio Pharmaceuticals
Role: STUDY_DIRECTOR
Take Control of Your Skin and Body Changes Today.
Try out Spots for free, set up only takes 2 mins.
Join others from around the world:
