Principal Investigator
Enrollment Status
Clinical Trial ID
Clinical Trial Summary
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).
Phase
Phase 1/Phase 2
Funding Agency/Sponsor
Industrial
Disease
Neurological Cancer
Enrollment Eligibility
Inclusion Criteria:
- Newly-diagnosed brain cancer with histopathological diagnosis of GBM;
- Karnofsky Performance Status (KPS) rating of >/=70 at baseline;
- Receive dexamethasone equivalent dose /=
three days prior to Day 0;
- Recovery from the effects of prior GBM surgery as defined by the Investigator;
- Electrocardiogram (ECG) with no clinically significant findings as assessed by the
Investigator;
- Adequate organ function as demonstrated by hematological, renal, hepatic laboratory
assessments;
- Agree that during the trial, men will not father a child, and women cannot be or
become pregnant. Participants must be of non-child bearing potential or agree to use
one highly effective or combined contraceptive methods that result in a failure rate
of <1% per year during the treatment period and at least through week 12 after last
dose;
- Ability to tolerate magnetic resonance imaging (MRI).
Exclusion Criteria:
- Presence of greater than 1 cm x 1 cm residual tumor enhancement on postoperative MRI;
- Multifocal disease or leptomeningeal disease (LM) disease on post-operative MRI;
- Not scheduled to start radiation within 42 days of surgical resection of tumor;
- Dexamethasone equivalent dose >2 mg per day;
- Prior treatment with an agent that blocks the PD-1/PD-Ligand 1 pathway;
- Receipt of previous approved or investigative immune modulatory agent within 28 days
of receiving the first dose of treatment;
- Prior treatment with idelalisib;
- Past, current or planned treatment with tumor treatment fields; oncolytic viral
treatment; or prior exposure to an investigational agent or device within 28 days of
receiving the first dose of treatment;
- Allergy or hypersensitivity to cemiplimab or to any of its excipients;
- History of documented allergic reactions or acute hypersensitivity reaction attributed
to antibody treatments;
- Ongoing or recent (within 5 years) evidence of autoimmune disease that required
treatment with systemic immunosuppressive treatments;
- Diagnosis of immunodeficiency or treatment with systemic immunosuppressive therapy
within 28 days prior to the first dose of trial treatment, other than dexamethasone
for the underlying disease under investigation, as noted in the inclusion criteria;
- History of clinically significant, medically unstable disease which, in the judgment
of the investigator, would jeopardize the safety of the subject, interfere with trial
assessments or endpoint evaluation, or otherwise impact the validity of the trial
results.