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

Running, not enrolling · Phase 1/Phase 2

Conditions studied: Glioblastoma

In brief

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).

Key facts

Study ID

NCT03491683

Run by

Inovio Pharmaceuticals

People needed

52

Starts

2018-05-31

Expected to finish

2026-12-31

Last updated by the study team

2026-05-04

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Newly-diagnosed brain cancer with histopathological diagnosis of GBM;
• Karnofsky Performance Status (KPS) rating of >/=70 at baseline;
• Receive dexamethasone equivalent dose </=2 mg per day, stable or decreased for >/= three days prior to Day 0;
• Recovery from the effects of prior GBM surgery as defined by the Investigator;
• Electrocardiogram (ECG) with no clinically significant findings as assessed by the Investigator;
• Adequate organ function as demonstrated by hematological, renal, hepatic laboratory assessments;
• Agree that during the trial, men will not father a child, and women cannot be or become pregnant. Participants must be of non-child bearing potential or agree to use one highly effective or combined contraceptive methods that result in a failure rate of <1% per year during the treatment period and at least through week 12 after last dose;
• Ability to tolerate magnetic resonance imaging (MRI).

You may not qualify if…

• Presence of greater than 1 cm x 1 cm residual tumor enhancement on postoperative MRI;
• Multifocal disease or leptomeningeal disease (LM) disease on post-operative MRI;
• Not scheduled to start radiation within 42 days of surgical resection of tumor;
• Dexamethasone equivalent dose >2 mg per day;
• Prior treatment with an agent that blocks the PD-1/PD-Ligand 1 pathway;
• Receipt of previous approved or investigative immune modulatory agent within 28 days of receiving the first dose of treatment;
• Prior treatment with idelalisib;
• Past, current or planned treatment with tumor treatment fields; oncolytic viral treatment; or prior exposure to an investigational agent or device within 28 days of receiving the first dose of treatment;
• Allergy or hypersensitivity to cemiplimab or to any of its excipients;
• History of documented allergic reactions or acute hypersensitivity reaction attributed to antibody treatments;
• Ongoing or recent (within 5 years) evidence of autoimmune disease that required treatment with systemic immunosuppressive treatments;
• Diagnosis of immunodeficiency or treatment with systemic immunosuppressive therapy within 28 days prior to the first dose of trial treatment, other than dexamethasone for the underlying disease under investigation, as noted in the inclusion criteria;
• History of clinically significant, medically unstable disease which, in the judgment of the investigator, would jeopardize the safety of the subject, interfere with trial assessments or endpoint evaluation, or otherwise impact the validity of the trial results.

Where it is running

• 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

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.