Combination Immunotherapy + Chemoradiation for Glioblastoma
What You Need to Know Before You Apply
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).
Will I have to stop taking my current medications?
The trial does not specify if you need to stop taking your current medications. However, you cannot have had certain immune treatments or investigational agents within 28 days before starting the trial, and you must be on a stable or decreasing dose of dexamethasone.
Is the combination of immunotherapy and chemoradiation safe for humans?
Research shows that temozolomide, when used with radiation therapy, has a lower toxicity profile compared to older chemotherapy drugs and is generally well-tolerated in patients with glioblastoma. Studies have focused on finding the maximum safe dose of this combination, indicating ongoing efforts to ensure its safety in humans.12345
What makes the combination immunotherapy and chemoradiation treatment for glioblastoma unique?
This treatment is unique because it combines immunotherapy (which helps the immune system fight cancer) with chemoradiation (a mix of chemotherapy and radiation therapy) using drugs like Cemiplimab and Temozolomide. This approach aims to enhance the body's immune response while directly targeting cancer cells, potentially offering a more effective treatment for glioblastoma compared to traditional methods.36789
What data supports the effectiveness of the treatment for glioblastoma?
Research shows that combining temozolomide (a chemotherapy drug) with radiotherapy can improve outcomes for patients with glioblastoma, a type of brain cancer. Temozolomide is known to be effective in treating high-grade gliomas and is being studied for its potential to enhance the effects of radiotherapy in newly diagnosed cases.37101112
Who Is on the Research Team?
Jeffrey Skolnik, MD
Principal Investigator
Inovio Pharmaceuticals
Are You a Good Fit for This Trial?
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
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive INO-5401 and INO-9012 delivered by electroporation in combination with cemiplimab, radiation, and temozolomide
Chemotherapy
Participants continue to receive temozolomide for up to six additional cycles following radiation therapy, if clinically indicated
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- Cemiplimab
- INO-5401
- INO-9012
- Radiation Therapy
- Temozolomide
Cemiplimab is already approved in European Union, United States, Canada, Brazil for the following indications:
- Cutaneous squamous cell carcinoma (CSCC)
- Non-small cell lung cancer (NSCLC)
- Cutaneous squamous cell carcinoma (CSCC)
- Basal cell carcinoma (BCC)
- Non-small cell lung cancer (NSCLC)
- Cutaneous squamous cell carcinoma (CSCC)
- Non-small cell lung cancer (NSCLC)
- Cutaneous squamous cell carcinoma (CSCC)
Find a Clinic Near You
Who Is Running the Clinical Trial?
Inovio Pharmaceuticals
Lead Sponsor