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show-jargon-definitions"><div class="h3 alert alert-danger text-center">This study is in progress, not accepting new patients</div><h1 id="summary--title"> INO-5401 and INO-9012 Delivered by Electroporation (EP) in Combination With Cemiplimab (REGN2810) in Newly-Diagnosed Glioblastoma (GBM) </h1><p class="h3 hide-long-content">a study on <span class="comma-list"><span class="comma-list-item"> <a href="../astrocytoma">Astrocytoma</a></span><span class="comma-list-item"> <a href="../glioblastoma">Glioblastoma</a></span><span class="comma-list-item"> <a href="../glioma">Glioma</a></span></span></p></div><div id="trial-details-container"><div id="key-points" class="trial-details-block"><div class="row"> <div class="col"><h2 class="sr-only h3">Summary</h2><dl id="key-points-bullets" class="row"><dt class="d-none d-sm-block col-sm-1 col-lg-2"> <i class="fa fa-user fa-lg fa-fw" aria-hidden="true"></i> <span class="sr-only">Eligibility</span></dt><dd class="col-12 col-sm-11 col-lg-10"> <strong>for people ages 18 years and up</strong> (<a href="#eligibility">full criteria</a>) </dd><dt class="d-none d-sm-block col-sm-1 col-lg-2"> <i class="fa fa-map-marker fa-lg fa-fw" aria-hidden="true"></i> <span class="sr-only">Location</span></dt><dd class="col-12 col-sm-11 col-lg-10"> <a href="#location"> at San Francisco, California and other locations </a> </dd><dt class="d-none d-sm-block col-sm-1 col-lg-2"> <i class="fa fa-calendar fa-lg fa-fw" aria-hidden="true"></i> <span class="sr-only">Dates</span></dt><dd class="col-12 col-sm-11 col-lg-10"><div> study started <span itemscope itemtype="https://schema.org/WebPage"><time itemprop="dateCreated" datetime="2018-05-31">May 2018</time></span></div><div> completion around <time datetime="2024-12-31">December 31, 2024</time></div><div itemscope itemtype="https://schema.org/WebPage" aria-hidden="true" class="d-none"><meta itemprop="datePublished" content="2018-04-09"></div></dd></dl></div> </div></div><div id="description" class="trial-details-block"><h2 class="h3">Description</h2><div class="show-jargon-definitions"><h3 class="h4">Summary</h3><div class="hide-long-content"><p>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 <a href="../glioblastoma" class="trial--link-to-condition-in-text">glioblastoma</a> (GBM).</p></div><h3 class="h4">Official Title</h3><p class="hide-long-content">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)</p><h3 class="h4">Details</h3><div class="hide-long-content"><p>This is a phase 1/2, open-label, multi-center trial to evaluate safety, immunogenicity and preliminary efficacy of INO-5401 and INO-9012 in combination with cemiplimab in subjects with newly-diagnosed <a href="../glioblastoma" class="trial--link-to-condition-in-text">glioblastoma</a> (GBM). INO-5401 and INO-9012 will be delivered by intramuscular (IM) injection followed by electroporation (EP) in combination with cemiplimab and chemoradiation and radiation. There will be 2 cohorts in this trial. Cohort A will be participants with a tumor with an unmethylated O6-methylguanine-deoxyribonucleic acid (DNA) methyltransferase (MGMT) promoter. Cohort B will be participants with a tumor with a MGMT methylated promoter or who have indeterminate MGMT status. Both cohorts will receive INO-5401 and INO-9012 and cemiplimab at the same doses and on the same dosing schedule, and both cohorts will receive radiation and temozolomide (TMZ), if clinically indicated.</p></div><h3 class="h4">Keywords</h3><p class=" hide-long-content"><span> <a href="../glioblastoma" class="trial--link-to-condition-in-text">Glioblastoma</a></span>, <span> <a href="../immunotherapy" class="trial--link-to-condition-in-text">immunotherapy</a></span>, <span> DNA therapy</span>, <span> checkpoint inhibitor</span>, <span> Temozolomide</span>, <span> Cemiplimab</span>, <span> INO-5401</span>, <span> INO-9012</span>, <span> Radiation Therapy</span>, <span> Unmethylated MGMT Promoter</span>, <span> Methylated MGMT Promoter</span></p></div></div><div id="eligibility" class="trial-details-block show-jargon-definitions"><h2 class="h3">Eligibility</h2><div class="hide-long-content"><div class="row"><div class="col-12 col-lg-6"><h3 class="h4 mt-0"> <i class="fa fa-check-square-o" aria-hidden="true"></i> You can join if… </h3><div><p><strong>Open to people ages 18 years and up</strong></p><ul><li>Newly-diagnosed <a href="../brain-cancer" class="trial--link-to-condition-in-text">brain cancer</a> with histopathological diagnosis of GBM;</li><li>Karnofsky Performance Status (KPS) rating of >/=70 at baseline;</li><li>Receive dexamethasone equivalent dose </=2 mg per day, stable or decreased for >/= three days prior to Day 0;</li><li>Recovery from the effects of prior GBM surgery as defined by the Investigator;</li><li>Electrocardiogram (ECG) with no clinically significant findings as assessed by the Investigator;</li><li>Adequate organ function as demonstrated by hematological, renal, hepatic laboratory assessments;</li><li>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;</li><li>Ability to tolerate magnetic resonance imaging (MRI).</li></ul></div></div><div class="col-12 col-lg-6"><h3 class="h4 mt-0"> <i class="fa fa-ban" aria-hidden="true"></i> You CAN'T join if... </h3><div><ul><li>Presence of greater than 1 cm x 1 cm residual tumor enhancement on postoperative MRI;</li><li>Multifocal disease or <a href="../leptomeningeal-disease" class="trial--link-to-condition-in-text">leptomeningeal disease</a> (LM) disease on post-operative MRI;</li><li>Not scheduled to start radiation within 42 days of surgical resection of tumor;</li><li>Dexamethasone equivalent dose >2 mg per day;</li><li>Prior treatment with an agent that blocks the PD-1/PD-Ligand 1 pathway;</li><li>Receipt of previous approved or investigative immune modulatory agent within 28 days of receiving the first dose of treatment;</li><li>Prior treatment with idelalisib;</li><li>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;</li><li>Allergy or hypersensitivity to cemiplimab or to any of its <a href="../excipient" class="trial--link-to-condition-in-text">excipients</a>;</li><li>History of documented allergic reactions or acute hypersensitivity reaction attributed to antibody treatments;</li><li>Ongoing or recent (within 5 years) evidence of <a href="../autoimmune-disease" class="trial--link-to-condition-in-text">autoimmune disease</a> that required treatment with systemic immunosuppressive treatments;</li><li>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;</li><li>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.</li></ul></div></div></div></div></div><div id="location" class="trial-details-block"><h2 class="h3">Locations</h2><ul id="locations-list" class="hide-long-content "><li class="location location-is-institutional" itemprop="address" itemscope itemtype="https://schema.org/PostalAddress"><span class="location-name" itemprop="name">UCSF</span><br><span class="location-address comma-list comma-list--without-and"><span class="comma-list-item" itemprop="addressLocality"> San Francisco</span><span class="comma-list-item" itemprop="addressRegion"> California</span><span class="comma-list-item" itemprop="postalCode"> 94143</span><span class="comma-list-item" itemprop="addressCountry"> United States</span></span></li><li class="location " itemprop="address" itemscope itemtype="https://schema.org/PostalAddress"><span class="location-name" itemprop="name">Stanford University, School of Medicine</span><br><span class="location-address comma-list comma-list--without-and"><span class="comma-list-item" itemprop="addressLocality"> Palo Alto</span><span class="comma-list-item" itemprop="addressRegion"> California</span><span class="comma-list-item" itemprop="postalCode"> 94304</span><span class="comma-list-item" itemprop="addressCountry"> United States</span></span></li></ul></div><div id="details" class="trial-details-block"><h2 class="h3">Details</h2><dl class="row"><dt class="col-sm-3 text-sm-right">Status</dt><dd class="col-sm-9"> in progress, not accepting new patients </dd><dt class="col-sm-3 text-sm-right">Start Date</dt><dd class="col-sm-9"><time datetime="2018-05-31">May 2018</time></dd><dt class="col-sm-3 text-sm-right">Completion Date</dt><dd class="col-sm-9"><time datetime="2024-12-31">December 31, 2024</time> (estimated)</dd><dt class="col-sm-3 text-sm-right">Sponsor</dt><dd class="col-sm-9">Inovio Pharmaceuticals</dd><dt class="col-sm-3 text-sm-right">ID</dt><dd class="col-sm-9"> <a href="https://clinicaltrials.gov/ct2/show/NCT03491683" class="trial--link-to-clinicaltrials-gov" target="_blank" rel="noopener nofollow" title="ClinicalTrials.gov identifier">NCT03491683</a> </dd><dt class="col-sm-3 text-sm-right">Phase</dt><dd class="col-sm-9">Phase 1/2 research study</dd><dt class="col-sm-3 text-sm-right">Study Type</dt><dd class="col-sm-9">Interventional</dd><dt class="col-sm-3 text-sm-right">Participants</dt><dd class="col-sm-9">About 52 people participating</dd><dt class="col-sm-3 text-sm-right">Last Updated</dt><dd class="col-sm-9"><span itemscope itemtype="https://schema.org/WebPage"><time itemprop="dateModified" datetime="2024-10-10">October 10, 2024</time></span></dd></dl></div><div id="faq" class="trial-details-block d-print-none" role="complementary"><h2 class="h3">Frequently Asked Questions</h2><ul><li><a href="../about/how-clinical-trials-work">How Do Clinical Trials Work?</a></li><li><a href="../about/what-to-expect">What to Expect</a></li><li><a href="../about/who-can-join">Who Can Join</a></li><li><a href="../about/our-researchers">Our Researchers</a></li></ul></div></div> </div><div class="col-md-3 text-center offset-lg-1 d-none d-md-block d-print-none" id="secondary-column"> <div id="sidebar"></div> </div></div> </div> <script type="application/ld+json"> [{"@context":"https://schema.org/","@type":"MedicalTrial","additionalType":"Product","alternateName":"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 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