GlioblastomaPhase 1/2NCT03491683
INO-5401 and INO-9012 Delivered by Electroporation (EP) in Combination With Cemiplimab (REGN2810) in Newly-Diagnosed Glioblastoma (GBM)
A Phase 1/2 study testing INO-5401, INO-9012 and Cemiplimab in people with Glioblastoma, run by Inovio Pharmaceuticals at 21 sites in United States.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Glioblastoma
- What is being tested?
- INO-5401, INO-9012 and Cemiplimab
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 52 participants
- Where
- 21 sitesUnited States
- Study dates
- 31 May 2018to 31 Dec 2027
- Phase
- Phase 1/2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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).
Who cannot join
- 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;
Show all 13Show fewer
- 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.
Trial locations and contacts
21 sites in 1 country.
21 sites in 1 country
United States21 sites
Emory University School of Medicine
Atlanta, Georgia, 30322
Texas Oncology
Austin, Texas, 78705
Dana-Farber Cancer Institute
Boston, Massachusetts, 02215
University of North Carolina School of Medicine
Chapel Hill, North Carolina, 27599
Henry Ford Health System
Detroit, Michigan, 48202
City of Hope
Duarte, California, 91010
Baylor College of Medicine
Houston, Texas, 77030
University of Miami - Sylvester Comprehensive Cancer Center
Miami, Florida, 33136
Rutgers University - Cancer Institute of New Jersey
New Brunswick, New Jersey, 08901
New York University Langone Medical Center; Perlmutter Cancer Center
New York, New York, 10016
Icahn School of Medicine at Mount Sinai
New York, New York, 10029
Columbia University Medical Center The Neurological Institute of New York
New York, New York, 10032
New York-Presbyterian Hospital/Weill Cornell Medical Center
New York, New York, 10065
Stephenson Cancer Center
Oklahoma City, Oklahoma, 73104
Stanford University, School of Medicine
Palo Alto, California, 94304
University of Pennsylvania Health System: Penn Medicine
Philadelphia, Pennsylvania, 19104
UPMC Cancer Center Neuro-Oncology; UPMC Cancer Pavilion
Pittsburgh, Pennsylvania, 15232
Oregon Health & Science University
Portland, Oregon, 97239
Huntsman Cancer Institute
Salt Lake City, Utah, 84112
University of California, San Francisco
San Francisco, California, 94143
Moffitt Cancer Center
Tampa, Florida, 33612
About this study
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)
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).
Read the 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.
- Conditions
- Glioblastoma
- Being tested
- INO-5401, INO-9012, Cemiplimab, Radiation Therapy, Temozolomide
- Keywords
- Glioblastoma, immunotherapy, DNA therapy, checkpoint inhibitor
- Medical subject headings
- Glioblastoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
INO-5401Biological
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-9012Biological
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.
CemiplimabBiological
Also called REGN2810
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 TherapyRadiation
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.
TemozolomideDrug
Temozolomide (TMZ) will be given daily during radiation therapy (RT) at a dose of 75 milligrams per square meter (mg/m^2).
| Study group | Role | What they receive |
|---|---|---|
| Cohort A: Unmethylated MGMT Promoter | Experimental | Cohort A will include participants with a glioblastoma tumor with an unmethylated MGMT promoter. Participants will receive INO-5401 and INO-9012 and cemiplimab as well as radiation and temozolomide (TMZ; only during radiation therapy), if clinically indicated. Receives: Biological: INO-5401; Biological: INO-9012; Biological: Cemiplimab; Radiation: Radiation Therapy; Drug: Temozolomide |
| Cohort B: Methylated MGMT Promoter | Experimental | Cohort B will include participants with a glioblastoma tumor with a methylated MGMT promoter or with indeterminate MGMT status. Participants will receive INO-5401 and INO-9012 and cemiplimab as well as radiation and temozolomide (TMZ), if clinically indicated. Participants will continue to receive TMZ following radiation therapy, for up to six additional cycles, if clinically indicated. Receives: Biological: INO-5401; Biological: INO-9012; Biological: Cemiplimab; Radiation: Radiation Therapy; Drug: Temozolomide |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Participants with Adverse Events (AEs)
Measured: From Day 0 to 30 days after the last dose of study treatment (non-serious AEs) and to 6 months after the last dose of study treatment (immune-related AEs, AEs of special interest and serious AEs) up to approximately 24 months
Secondary outcomes (5)
Overall survival at 18 months (OS18)
Measured: At Month 18
Change from Baseline in Interferon-gamma Secreting T Lymphocytes in Peripheral Blood Mononuclear Cells (PBMCs)
Measured: From Day 0 to last dose of study treatment up to approximately 18 months
Change from Baseline in T-Cell Phenotypes in PBMCs
Measured: From Day 0 to last dose of study treatment up to approximately 18 months
Change from Baseline in T Cell Receptor (TCR) Subtypes in PBMCs
Measured: From Day 0 to last dose of study treatment up to approximately 18 months
Change from Baseline in Antigen-Specific Humoral Response
Measured: From Day 0 to last dose of study treatment up to approximately 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Apr 2018
- Study start31 May 2018
- Primary completion31 Dec 2027 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for GlioblastomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 52 participants (actual)
Sponsor and investigators
- Lead sponsor
- Inovio Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Jeffrey Skolnik, MD, Study director, Inovio Pharmaceuticals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03491683
- Sponsor's protocol ID
- GBM-001
- Status last verified
- Oct 2026
- First submitted
- 2 Apr 2018
- Last updated
- 22 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 22 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT03491683
- Acronym / sponsor ID
- GBM-001
- Conditions
- Glioblastoma
- Keywords
- Glioblastoma, immunotherapy, DNA therapy, checkpoint inhibitor
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 52 participants (actual)
- Lead sponsor
- Inovio PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- 31 May 2018 (actual)
- Primary completion
- 31 Dec 2027 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 9 Apr 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cohort A: Unmethylated MGMT Promoter | Experimental | Biological: INO-5401, Biological: INO-9012, Biological: Cemiplimab, Radiation: Radiation Therapy, Drug: TemozolomideCohort A will include participants with a glioblastoma tumor with an unmethylated MGMT promoter. Participants will receive INO-5401 and INO-9012 and cemiplimab as well as radiation and temozolomide (TMZ; only during radiation therapy), if clinically indicated. |
| Cohort B: Methylated MGMT Promoter | Experimental | Biological: INO-5401, Biological: INO-9012, Biological: Cemiplimab, Radiation: Radiation Therapy, Drug: TemozolomideCohort B will include participants with a glioblastoma tumor with a methylated MGMT promoter or with indeterminate MGMT status. Participants will receive INO-5401 and INO-9012 and cemiplimab as well as radiation and temozolomide (TMZ), if clinically indicated. Participants will continue to receive TMZ following radiation therapy, for up to six additional cycles, if clinically indicated. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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;
Key exclusion criteria (13 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| INO-5401INO-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 | Cohort A: Unmethylated MGMT Promoter, Cohort B: Methylated MGMT Promoter |
| INO-9012INO-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 | Cohort A: Unmethylated MGMT Promoter, Cohort B: Methylated MGMT Promoter |
| CemiplimabAlso: REGN2810Cemiplimab 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. | Biological | Cohort A: Unmethylated MGMT Promoter, Cohort B: Methylated MGMT Promoter |
| Radiation TherapyRadiation 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. | Radiation | Cohort A: Unmethylated MGMT Promoter, Cohort B: Methylated MGMT Promoter |
| TemozolomideTemozolomide (TMZ) will be given daily during radiation therapy (RT) at a dose of 75 milligrams per square meter (mg/m^2). | Drug | Cohort A: Unmethylated MGMT Promoter, Cohort B: Methylated MGMT Promoter |
Primary outcome
Percentage of Participants with Adverse Events (AEs)
Time frame: From Day 0 to 30 days after the last dose of study treatment (non-serious AEs) and to 6 months after the last dose of study treatment (immune-related AEs, AEs of special interest and serious AEs) up to approximately 24 months
5 secondary outcomes
Overall survival at 18 months (OS18)
Time frame: At Month 18
Change from Baseline in Interferon-gamma Secreting T Lymphocytes in Peripheral Blood Mononuclear Cells (PBMCs)
Time frame: From Day 0 to last dose of study treatment up to approximately 18 months
Change from Baseline in T-Cell Phenotypes in PBMCs
Time frame: From Day 0 to last dose of study treatment up to approximately 18 months
Change from Baseline in T Cell Receptor (TCR) Subtypes in PBMCs
Time frame: From Day 0 to last dose of study treatment up to approximately 18 months
Change from Baseline in Antigen-Specific Humoral Response
Time frame: From Day 0 to last dose of study treatment up to approximately 18 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Oct 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jeffrey Skolnik, MD study director
Inovio Pharmaceuticals
21 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing INO-5401, INO-9012 and Cemiplimab in people with Glioblastoma, run by Inovio Pharmaceuticals at 21 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 22 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 21 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of Participants with Adverse Events (AEs) (time frame: From Day 0 to 30 days after the last dose of study treatment (non-serious AEs) and to 6 months after the last dose of study treatment (immune-related AEs, AEs of special interest and serious AEs) up to approximately 24 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Oct 2026.