New combo therapy targets aggressive brain cancer
NCT ID NCT03491683
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This early-phase trial tests whether adding two experimental DNA vaccines (INO-5401 and INO-9012) and an immunotherapy drug (cemiplimab) to standard radiation and chemotherapy is safe and helps people with newly-diagnosed glioblastoma, a fast-growing brain cancer. About 52 adults with good performance status and low steroid use are enrolled. The main goal is safety; researchers also measure immune response and survival at 18 months.
Why investors are watching
Inovio Pharmaceuticals is testing its DNA medicines INO-5401 and INO-9012, given with an electric pulse device, alongside the immunotherapy cemiplimab and standard radiation and chemotherapy, in people newly diagnosed with glioblastoma, an aggressive brain cancer. For a micro-cap company, this Phase 1/2 trial of 52 participants is a key test of whether Inovio's platform can work in a hard-to-treat tumor. A clear signal of safety or disease control would matter more to this company's future than it would for a large drugmaker.
If it works: A positive result could show that Inovio's approach is safe and active in glioblastoma, supporting further development of its DNA medicine platform. That could strengthen the company's position with partners or investors.
If it fails: Trials in glioblastoma often fail, and this one is small and early. A poor safety profile, weak efficacy, or a delay in results could hurt the company's credibility and financial runway, given its small size.
AI-written from the trial record. Speculative, and not investment advice.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 1/2
Runs two stages together: safety and dose first, then whether the treatment works.
- Participants
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52 people
The number who actually took part.
- Started
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May 2018
- Expected to finish
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Dec 2026
An estimate. End dates often move.
- Lead sponsor
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A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * 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). Exclusion Criteria: * 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.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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Baylor College of Medicine
Houston, Texas, 77030, United States
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City of Hope
Duarte, California, 91010, United States
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Columbia University Medical Center The Neurological Institute of New York
New York, New York, 10032, United States
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Dana-Farber Cancer Institute
Boston, Massachusetts, 02215, United States
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Emory University School of Medicine
Atlanta, Georgia, 30322, United States
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Henry Ford Health System
Detroit, Michigan, 48202, United States
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Huntsman Cancer Institute
Salt Lake City, Utah, 84112, United States
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Icahn School of Medicine at Mount Sinai
New York, New York, 10029, United States
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Moffitt Cancer Center
Tampa, Florida, 33612, United States
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New York University Langone Medical Center; Perlmutter Cancer Center
New York, New York, 10016, United States
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New York-Presbyterian Hospital/Weill Cornell Medical Center
New York, New York, 10065, United States
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Oregon Health & Science University
Portland, Oregon, 97239, United States
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Rutgers University - Cancer Institute of New Jersey
New Brunswick, New Jersey, 08901, United States
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Stanford University, School of Medicine
Palo Alto, California, 94304, United States
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Stephenson Cancer Center
Oklahoma City, Oklahoma, 73104, United States
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Texas Oncology
Austin, Texas, 78705, United States
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UPMC Cancer Center Neuro-Oncology; UPMC Cancer Pavilion
Pittsburgh, Pennsylvania, 15232, United States
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University of California, San Francisco
San Francisco, California, 94143, United States
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University of Miami - Sylvester Comprehensive Cancer Center
Miami, Florida, 33136, United States
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University of North Carolina School of Medicine
Chapel Hill, North Carolina, 27599, United States
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University of Pennsylvania Health System: Penn Medicine
Philadelphia, Pennsylvania, 19104, United States
More trials for these conditions
Other studies related to the condition(s) this trial covers.
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- Can an existing drug boost bevacizumab against recurrent brain cancer?
- One extra radiation dose after standard brain cancer therapy: can it boost the immune system?
- Radioactive tracer lights up Oxygen-Starved brain tumors
- Can a common virus vaccine help fight brain cancer?
- Radioactive tiles target brain tumors in frail patients