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PD-1/PD-L1 Inhibitor

Combination Immunotherapy + Chemoradiation for Glioblastoma

Phase 1 & 2
Waitlist Available
Research Sponsored by Inovio Pharmaceuticals
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up at month 18
Awards & highlights

Study Summary

This trial is testing a new combination of drugs to treat glioblastoma, a type of brain cancer.

Who is the study for?
This trial is for adults with newly-diagnosed glioblastoma who've recovered from initial surgery, have a Karnofsky Performance Status of 70 or above, can tolerate MRIs, and have stable organ function. They must not be pregnant or fathering children and agree to use effective contraception. Excluded are those with recent autoimmune disease treatment, certain allergies, multifocal brain cancer, immunodeficiency, unstable diseases that could affect the trial's integrity.Check my eligibility
What is being tested?
The study tests INO-5401 and INO-9012 combined with cemiplimab (REGN2810), radiation therapy, and temozolomide chemotherapy in patients with new glioblastoma. It aims to assess safety and immune response as well as early signs of effectiveness in treating this aggressive brain cancer.See study design
What are the potential side effects?
Potential side effects may include reactions related to the immune system such as inflammation in various organs due to cemiplimab; skin reactions at electroporation sites; typical chemotherapy-related issues like nausea; fatigue from radiation therapy; blood count changes affecting immunity.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~at month 18
This trial's timeline: 3 weeks for screening, Varies for treatment, and at month 18 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Percentage of Participants with Adverse Events (AEs)
Secondary outcome measures
Change from Baseline in Antigen-Specific Humoral Response
Change from Baseline in Interferon-gamma Secreting T Lymphocytes in Peripheral Blood Mononuclear Cells (PBMCs)
Change from Baseline in T Cell Receptor (TCR) Subtypes in PBMCs
+2 more

Trial Design

2Treatment groups
Experimental Treatment
Group I: Cohort B: Methylated MGMT PromoterExperimental Treatment5 Interventions
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.
Group II: Cohort A: Unmethylated MGMT PromoterExperimental Treatment5 Interventions
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.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Cemiplimab
2015
Completed Phase 3
~1340
INO-9012
2014
Completed Phase 2
~150
Radiation Therapy
2017
Completed Phase 3
~7250
Temozolomide
2010
Completed Phase 3
~1930

Find a Location

Who is running the clinical trial?

Inovio PharmaceuticalsLead Sponsor
53 Previous Clinical Trials
4,787 Total Patients Enrolled
Jeffrey Skolnik, MDStudy DirectorInovio Pharmaceuticals
12 Previous Clinical Trials
642 Total Patients Enrolled

Media Library

Cemiplimab (PD-1/PD-L1 Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT03491683 — Phase 1 & 2
Glioblastoma Research Study Groups: Cohort A: Unmethylated MGMT Promoter, Cohort B: Methylated MGMT Promoter
Glioblastoma Clinical Trial 2023: Cemiplimab Highlights & Side Effects. Trial Name: NCT03491683 — Phase 1 & 2
Cemiplimab (PD-1/PD-L1 Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03491683 — Phase 1 & 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is this research being conducted in more than one country?

"This study is currently being administered at Huntsman Cancer Institute in Salt Lake City, Utah, Emory University School of Medicine in Atlanta, Georgia, and New york-Presbyterian Hospital/Weill Cornell Medical Center in New York, New York. In addition to these locations, there are 21 other trial sites."

Answered by AI

How many people are being given the chance to participate in this research?

"As of right now, this study is not looking for any more participants. The clinical trial was first posted on May 31st 2018 and the listing was last updated on October 7th 2020. If you are interested in other studies, there are 458 trials for glioblastoma and 282 for INO-5401 that are currently enrolling patients."

Answered by AI

Are we still able to enroll in this particular clinical trial?

"As can be seen on clinicaltrials.gov, this study is not presently looking for new patients to enroll. Although the study was last updated on 10/7/2022, it is not currently active. There are, however, 740 other trials which are still recruiting participants."

Answered by AI

Has this research been conducted before?

"As of now, there are 282 active studies for INO-5401 being conducted in 50 countries and 1103 cities. The first study was sponsored by Schering-Plough back in 2002. That initial trial had 60 participants and completed its Phase 2 drug approval stage. In the 18 years since that first study, 406 more trials have been conducted."

Answered by AI

Could you explain the most common reason why people use INO-5401?

"Other than nitrosourea treatment, INO-5401 can be used to treat advance directives, malignant neoplasms, and refractory advanced mycosis fungoides."

Answered by AI

Are there other examples of INO-5401 being tested in a laboratory setting?

"As of now, there are 282 active clinical trials researching INO-5401 with 29 trials in Phase 3. While most of the trials for INO-5401 are running out of Seoul, Songpa, there are 6609 locations running trials for INO-5401."

Answered by AI

Who else is applying?

What state do they live in?
California
What portion of applicants met pre-screening criteria?
Met criteria
~8 spots leftby Apr 2025