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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 up to 5 years
Awards & highlights
No Placebo-Only Group
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.
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.
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 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 5 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 years
Treatment Details
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
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
Temozolomide
2010
Completed Phase 3
~1880
INO-9012
2014
Completed Phase 2
~150
Cemiplimab
2015
Completed Phase 3
~1470
Radiation Therapy
2017
Completed Phase 3
~7250
Find a Location
Who is running the clinical trial?
Inovio PharmaceuticalsLead Sponsor
53 Previous Clinical Trials
4,753 Total Patients Enrolled
Jeffrey Skolnik, MDStudy DirectorInovio Pharmaceuticals
12 Previous Clinical Trials
642 Total Patients Enrolled
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Eligibility Criteria:
This trial includes the following eligibility criteria:- You have had an autoimmune disease that needed strong medications to control it in the past 5 years.You have received or are planning to receive certain types of treatments, such as tumor treatment fields or oncolytic viral treatment. You have also taken part in a clinical trial or used an experimental treatment within the past 28 days.You are allergic to cemiplimab or any of the ingredients in it.You need to have fully recovered from your previous brain surgery, as determined by the doctor in charge of the study.You are able to undergo an MRI scan without any problems or discomfort.You have received treatment with idelalisib in the past.You have had allergic reactions or severe sensitivity to antibody treatments in the past.You have previously received a treatment that blocks the PD-1/PD-Ligand 1 pathway.We agree that during the trial, men will not father a child, and women cannot be or become pregnant
Research Study Groups:
This trial has the following groups:- Group 1: Cohort A: Unmethylated MGMT Promoter
- Group 2: Cohort B: Methylated MGMT Promoter
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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