Suspended

INO-5401 and INO-9012 with Cemiplimab for Newly-Diagnosed Glioblastoma

Study Aim

This study aims to evaluate the safety of INO-5401 and INO-9012 combined with Cemiplimab in newly-diagnosed Glioblastoma patients, by observing the percentage of participants who experience adverse events.

What is being tested

INO-5401

+ INO-9012

+ Cemiplimab

BiologicalRadiationDrug

Who is being recruted

Astrocytoma+7

+ Glioblastoma

+ Glioma

Over 18 Years

+20 Eligibility Criteria

See all eligibility criteria

How is the trial designed

Treatment Study

Phase 1 & 2

Interventional

Study Start: May 2018

See protocol details

Summary

Principal SponsorInovio Pharmaceuticals

Last updated: March 20, 2026

Sourced from a government-validated database.Claim as a partner

Study start date: May 31, 2018

Actual date on which the first participant was enrolled.

This clinical trial is an open-label, multi-center study in its first and second phases. It aims to evaluate the safety, immune response, and initial effectiveness of INO-5401 and INO-9012 in combination with cemiplimab for treating newly-diagnosed glioblastoma (GBM), a type of brain tumor. The trial is designed for two groups of participants: those with an unmethylated O6-methylguanine-deoxyribonucleic acid (DNA) methyltransferase (MGMT) promoter in their tumor (Cohort A), and those with a methylated MGMT promoter or indeterminate MGMT status (Cohort B). The study is crucial as it explores a potential new treatment approach for GBM, which could improve patient care and address current challenges in managing this condition.

Official TitleAn 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)

NCT03491683

Principal SponsorInovio Pharmaceuticals

Last updated: March 20, 2026

Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.

Design Details

52 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.

Conditions

Criteria

Any sex

Biological sex of participants that are eligible to enroll.

Over 18 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

AstrocytomaGlioblastomaGliomaNeoplasmsNeoplasms by Histologic TypeNeoplasms, Germ Cell and EmbryonalNeoplasms, Glandular and EpithelialNeoplasms, Nerve TissueNeuroectodermal TumorsNeoplasms, Neuroepithelial

Criteria

8 inclusion criteria required to participate

Newly-diagnosed brain cancer with histopathological diagnosis of GBM

Karnofsky Performance Status (KPS) rating of >=70 at baseline

Ability to tolerate magnetic resonance imaging (MRI)

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

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12 exclusion criteria prevent from participating

Multifocal disease or leptomeningeal disease (LM) disease on post-operative MRI

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

Dexamethasone equivalent dose >2 mg per day

Allergy or hypersensitivity to cemiplimab or to any of its excipients

Show More Criteria

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.

Treatment Groups

Study Objectives

2 intervention groups are designated in this study

This study does not include a placebo group

Treatment Groups

Group I

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.

Group II

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.

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 21 locations

Suspended

City of Hope

Duarte, United StatesOpen City of Hope in Google Maps

Suspended

Stanford University, School of Medicine

Palo Alto, United States

Suspended

University of California, San Francisco

San Francisco, United States

Suspended

University of Miami - Sylvester Comprehensive Cancer Center

Miami, United States

Suspended21 Study Centers