Combination Immunotherapy + Chemoradiation for Glioblastoma

Recruiting at20 trial locations

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 1 & 2

Waitlist Available

Sponsor: Inovio Pharmaceuticals

No Placebo Group

Trial Summary

What is the purpose of this trial?

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).

Research Team

Jeffrey Skolnik, MD

Principal Investigator

Inovio Pharmaceuticals

Eligibility Criteria

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.

Inclusion Criteria

You need to have fully recovered from your previous brain surgery, as determined by the doctor in charge of the study.

Newly-diagnosed brain cancer with histopathological diagnosis of GBM

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

Exclusion 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.

Treatment Details

Interventions

• Cemiplimab (PD-1/PD-L1 Inhibitor)
• INO-5401 (Cancer Vaccine)
• INO-9012 (Cancer Vaccine)
• Radiation Therapy (Radiation)
• Temozolomide (Alkylating Agent)

Trial Overview 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.

Participant Groups

Group I: Cohort B: Methylated MGMT Promoter Experimental Treatment 5 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 Promoter Experimental Treatment 5 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.

Cemiplimab is already approved in Canada, Brazil for the following indications:

Approved in Canada as Libtayo for:

• Cutaneous squamous cell carcinoma (CSCC)
• Non-small cell lung cancer (NSCLC)

Approved in Brazil as Libtayo for:

• Cutaneous squamous cell carcinoma (CSCC)

Who Is Running the Clinical Trial?

Inovio Pharmaceuticals

Lead Sponsor

Trials

54

Recruited

4,800+