INO-5401 and INO-9012 Delivered by Electroporation (EP) in Combination With Cemiplimab (REGN2810) in Newly-Diagnosed Glioblastoma (GBM)

PHASE1/PHASE2Active, not recruitingINTERVENTIONAL
Enrollment

52

Participants

Timeline

Start Date

May 31, 2018

Primary Completion Date

December 31, 2025

Study Completion Date

December 31, 2025

Conditions
Glioblastoma
Interventions
BIOLOGICAL

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.

BIOLOGICAL

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.

BIOLOGICAL

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

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.

DRUG

Temozolomide

Temozolomide (TMZ) will be given daily during radiation therapy (RT) at a dose of 75 milligrams per square meter (mg/m\^2).

Trial Locations (21)

10016

New York University Langone Medical Center; Perlmutter Cancer Center, New York

10029

Icahn School of Medicine at Mount Sinai, New York

10032

Columbia University Medical Center The Neurological Institute of New York, New York

10065

New York-Presbyterian Hospital/Weill Cornell Medical Center, New York

15232

UPMC Cancer Center Neuro-Oncology; UPMC Cancer Pavilion, Pittsburgh

19104

University of Pennsylvania Health System: Penn Medicine, Philadelphia

27599

University of North Carolina School of Medicine, Chapel Hill

30322

Emory University School of Medicine, Atlanta

33136

University of Miami - Sylvester Comprehensive Cancer Center, Miami

33612

Moffitt Cancer Center, Tampa

48202

Henry Ford Health System, Detroit

73104

Stephenson Cancer Center, Oklahoma City

77030

Baylor College of Medicine, Houston

78705

Texas Oncology, Austin

84112

Huntsman Cancer Institute, Salt Lake City

91010

City of Hope, Duarte

94143

University of California, San Francisco, San Francisco

94304

Stanford University, School of Medicine, Palo Alto

97239

Oregon Health & Science University, Portland

02215

Dana-Farber Cancer Institute, Boston

08901

Rutgers University - Cancer Institute of New Jersey, New Brunswick

Sponsors
All Listed Sponsors
lead

Inovio Pharmaceuticals

INDUSTRY

NCT03491683 - INO-5401 and INO-9012 Delivered by Electroporation (EP) in Combination With Cemiplimab (REGN2810) in Newly-Diagnosed Glioblastoma (GBM) | Biotech Hunter | Biotech Hunter