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Clinical Trial 19582

Cancer Type: Neurologic Oncology
Interventions:INO-5401; INO-9012; REGN2810 (Cemiplimab); Temodal (Temozolomide); Temozolomide

Study Type: Treatment
Phase of Study: Phase I/II
Investigators:

  • Peter Forsyth

Call 813-745-6100
or 1-800-679-0775
Overview

Study Title

An Open-Label, Multi-Center Trial of INO-5401 and INO-9012 Delivered by Electroporation (EP) in Combination with REGN2810 in Subjects with Newly-Diagnosed Glioblastoma (GBM)

Summary

Objective

PRIMARY OBJECTIVE To evaluate the safety and tolerability of INO-5401 and INO-9012 delivered by IM injection followed by EP with CELLECTRA 2000 in combination with REGN2810 in adult subjects with newly-diagnosed GBM. PRIMARY ENDPOINT(S) AND ASSESSMENTS 1. Incidence of AEs, graded per CTCAE v4.03, and classified by system organ class, preferred term, severity, and relationship to trial treatment. 2. Clinically significant changes in safety laboratory parameters from baseline. SECONDARY OBJECTIVE(S) 1. To evaluate preliminary clinical efficacy of INO-5401 and INO-9012 delivered by IM injection followed by EP with CELLECTRA 2000 in combination with REGN2810 in adult subjects with newly-diagnosed GBM. 2. To evaluate preliminary immunogenicity of INO-5401 and INO-9012 delivered by IM injection followed by EP with CELLECTRA 2000 in combination with REGN2810 in adult subjects with newly-diagnosed GBM. SECONDARY ENDPOINT(S) AND ASSESSMENTS 1. Overall survival at 18 months (OS18). 2. Antigen-specific cellular immune responses assessed by: Interferon-£^ secreting T lymphocytes in peripheral blood mononuclear cells (PBMC) by ELISpot, T-cell phenotype (e.g. activation and cytolytic cell, myeloid derived suppressor cell frequency (MDSC)) in PBMC by Flow Cytometry, T cell receptor (TCR) sequencing from PBMCs to assess diversity and putative antigen specificity 3. Antigen-specific humoral responses (e.g. B cell activation/antibody secretion). EXPLORATORY OBJECTIVE(S) 1. To explore correlative association between clinical efficacy and tumor genetics and/or biomarkers. 2. To further evaluate efficacy of INO-5401 and INO-9012 delivered by IM injection followed by EP with CELLECTRA 2000 in combination with REGN2810 and hypofractionated RT in adult subjects with newly-diagnosed GBM.

Inclusion Criteria

  • Newly-diagnosed brain cancer with histopathological diagnosis of Gioblastoma (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 > 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.