INO-5401 for Glioblastoma

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
GlioblastomaINO-5401 - Biological
Eligibility
18+
All Sexes
What conditions do you have?
Select

Study Summary

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

Treatment Effectiveness

Study Objectives

1 Primary · 5 Secondary · Reporting Duration: At Month 18

At Month 18
Overall survival at 18 months (OS18)
Month 24
Percentage of Participants with Adverse Events (AEs)
Month 18
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
Change from Baseline in T-Cell Phenotypes in PBMCs

Trial Safety

Trial Design

2 Treatment Groups

Cohort B: Methylated MGMT Promoter
1 of 2
Cohort A: Unmethylated MGMT Promoter
1 of 2

Experimental Treatment

52 Total Participants · 2 Treatment Groups

Primary Treatment: INO-5401 · No Placebo Group · Phase 1 & 2

Cohort B: Methylated MGMT PromoterExperimental Group · 5 Interventions: Cemiplimab, INO-9012, Radiation Therapy, INO-5401, Temozolomide · Intervention Types: Biological, Biological, Radiation, Biological, Drug
Cohort A: Unmethylated MGMT PromoterExperimental Group · 5 Interventions: Cemiplimab, INO-9012, Radiation Therapy, INO-5401, Temozolomide · Intervention Types: Biological, Biological, Radiation, Biological, Drug
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Cemiplimab
FDA approved
Rocakinogene sifuplasmid
Not yet FDA approved
Radiation Therapy
2005
Completed Phase 3
~7010
Temozolomide
FDA approved

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: at month 18

Who is running the clinical trial?

Inovio PharmaceuticalsLead Sponsor
52 Previous Clinical Trials
4,715 Total Patients Enrolled
Jeffrey Skolnik, MDStudy DirectorInovio Pharmaceuticals
12 Previous Clinical Trials
641 Total Patients Enrolled

Eligibility Criteria

Age 18+ · All Participants · 8 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
Receive dexamethasone oral equivalent dose of <=2 mg per day for three days before Day 0.
The patient has fully recovered from the effects of the prior surgery.
We agree that during the trial, men will not father a child, and women cannot be or become pregnant
Having the ability to tolerate MRI scans.
MGMT promoter methylation A person has been diagnosed with brain cancer
The Karnofsky Performance Status (KPS) rating of >/=70 at the baseline means that the person's health is relatively good.
No clinically significant abnormalities were found on the subjects' electrocardiograms.
meeting at least 3 out of 4 following criteria: The person has adequate organ function as demonstrated by hematological, renal, hepatic laboratory assessments

Who else is applying?

What state do they live in?
California100.0%
What portion of applicants met pre-screening criteria?
Met criteria100.0%