Ignite Creation Date:
2025-12-24 @ 7:44 PM
Ignite Modification Date:
2026-04-25 @ 7:50 AM
Study NCT ID:
NCT03223103
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2025-09-10
First Post:
2017-07-18
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Safety and Immunogenicity of Personalized Genomic Vaccine and Tumor Treating Fields (TTFields) to Treat Glioblastoma
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D005909', 'term': 'Glioblastoma'}, {'id': 'D001932', 'term': 'Brain Neoplasms'}, {'id': 'D009369', 'term': 'Neoplasms'}], 'ancestors': [{'id': 'D001254', 'term': 'Astrocytoma'}, {'id': 'D005910', 'term': 'Glioma'}, {'id': 'D018302', 'term': 'Neoplasms, Neuroepithelial'}, {'id': 'D017599', 'term': 'Neuroectodermal Tumors'}, {'id': 'D009373', 'term': 'Neoplasms, Germ Cell and Embryonal'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009375', 'term': 'Neoplasms, Glandular and Epithelial'}, {'id': 'D009380', 'term': 'Neoplasms, Nerve Tissue'}, {'id': 'D016543', 'term': 'Central Nervous System Neoplasms'}, {'id': 'D009423', 'term': 'Nervous System Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C019531', 'term': 'poly ICLC'}, {'id': 'D010455', 'term': 'Peptides'}], 'ancestors': [{'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 13}}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2018-03-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-09', 'completionDateStruct': {'date': '2029-05-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-09-03', 'studyFirstSubmitDate': '2017-07-18', 'studyFirstSubmitQcDate': '2017-07-18', 'lastUpdatePostDateStruct': {'date': '2025-09-10', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2017-07-19', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2029-05-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Overall Response', 'timeFrame': '2 years after treatment initiation', 'description': 'Overall Response will be determined as measured by Immunotherapy Response Assessment in Neuro-oncology (iRANO) criteria. Response Criteria will be summarized as either: Complete response, Partial response, Stable Disease, or Progressive Disease. The number/percentage of patients with each response type will be summarized.'}], 'primaryOutcomes': [{'measure': 'Dose-limiting toxicities (DLT)', 'timeFrame': 'long term, up to 10 years after treatment initiation', 'description': 'Safety and Tolerability of the personalized treatment regimen will be assessed in tandem using the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) Version 4.03. NCI-CTCAE is a standard system for grading and reporting adverse events (AEs) in cancer clinical trials to document the occurrence and severity of AEs, with grades ranging from 1 (mild) to 5 (death). DLTs will be summarized and reported.'}, {'measure': 'Feasibility of Personalized MTA vaccine administration', 'timeFrame': 'Up to 42 weeks after treatment initiation', 'description': 'Feasibility of the personalized MTA vaccine will be defined as the successful administration of at least one (1) dose to subjects following tissue sample acquisition and will be expressed as the proportion or percentage subjects enrolled in the study who have successfully been administered at least one dose of the personalized MTA vaccine.'}], 'secondaryOutcomes': [{'measure': 'Progression Free Survival (PFS)', 'timeFrame': '6 months after diagnosis', 'description': 'PFS will be determined by the percentage of patients whose disease remains stable, without disease progression or death, from the time diagnosis until 6 months after diagnosis.'}, {'measure': 'Overall Survival (OS)', 'timeFrame': '1 year, 2 years, 5 years, and 10 years after diagnosis', 'description': 'Overall Survival will be determined by from the time of diagnosis to the time of death, or up to 10 years. OS will be summarized as the percentage of patients who reach the 1-year, 2-year, 5-year, and 10-year milestones.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'keywords': ['Brain cancer', 'Glioblastoma', 'Personalized vaccine', 'Polyinosinic-polycytidylic acid (Poly-ICLC)', 'Immunotherapy', 'Cancer', 'NovoTTF-200A', 'Optune', 'GBM', 'immunogenicity'], 'conditions': ['Glioblastoma']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to use precision medicine in the form of a vaccine, a mutation-derived tumor antigen vaccine (MTA-based vaccine) in combination with standard care treatment of glioblastoma (GBM) and Tumor Treating Fields (TTFields).\n\nThe study is designed to determine whether this treatment combination is well tolerated and safe.', 'detailedDescription': "This is a single-arm, single institution phase 1a / 1b study to test the safety, tolerability, and immunogenicity of MTA-based personalized vaccine in patients with newly diagnosed GBM along with the use of continual TTFields. MTA-based personalized vaccine is prepared in the laboratory with several peptides based on each patient's own tumor sequence.\n\nThe vaccine is given after the radiation and chemotherapy portion of the treatment, in the maintenance phase of temozolomide in conjunction with the TTFields."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age ≥ 18\n* Histological confirmation of GBM (WHO grade IV).\n* Stable disease after treatment of radiation with concurrent chemotherapy. If the disease is not stable or progresses while in the study the patient is allowed to continue the study receiving the vaccine if the tumor gets controlled by other modality treatment(s)\n* Must have received maximal debulking surgery and undergo radiotherapy concomitant with Temozolomide (45-70Gy)\n* Life expectancy \\> 16 weeks\n* Performance status of 0-2 as determined by Eastern Cooperative Oncology Group (ECOG) and/or Karnofsky Performance Status (KPS) 70-100\n* First vaccine treatment start date at least 4 weeks out but not more than 8 weeks from the last dose of concomitant Temozolomide or radiotherapy\n* Must have archival tumor tissue that is sufficient quantity and quality for sequencing\n* Have adequate bone marrow function\n* Requires Dexamethasone ≤ 4mg daily on a stable dose\n* Acceptable hematologic, hepatic, and renal function and these tests must be performed within 14 days prior to study\n* Must be deemed competent to give informed consent\n* Must agree to use two effective forms of contraception beginning at least four (4) weeks prior to study entry, and continuing to do so for the duration of participation in the study\n\nExclusion Criteria:\n\n* Progression of disease at time of screening\n* Implanted pacemaker, programmable shunts, defibrillator, deep brain stimulator, other implanted electronic devices in the brain, or documented clinically significant arrhythmias\n* Infra-tentorial tumor or multifocal disease\n* History of hypersensitivity reaction to Temozolomide or a history of hypersensitivity to Decarbazine (DTIC)\n* Receiving any other investigational agents. Patient is allowed to get another investigational agent and to continue receiving the vaccine only if the disease progresses while in the study and the other investigational agent is a reasonable choice to treat the patient\n* Active cancer at the time of screening\n* Prior history of unrelated neoplastic disease, and having received systemic therapy for the secondary malignancy within the twelve (12) month period preceding the screening evaluation.\n* History of Human Immunodeficiency Virus/Acquired Immunodeficiency Syndrome (HIV/AIDS), chronic hepatitis B or hepatitis C or is otherwise reasonably suspected to meet criteria for the diagnosis of a known congenital or acquired disorder causing systemic immunosuppression\n* History of, or is reasonably suspected to meet criteria for the diagnosis of a known congenital or acquired disorder causing systemic immunosuppression; or the subject is currently receiving any drug or supplement which is known to be associated with systemic immune suppression including those drugs which are prescribed for solid organ or stem cell transplant, autoimmune/inflammatory disorders, or other related medical conditions\n* History of, or is reasonably suspected to meet criteria for the diagnosis of a systemic auto-immune/inflammatory disease or other autoimmune disorder with the exception of: Vitiligo, diabetes, or thyroid dysfunction\n* Less than 18 years of age, or otherwise unable to give informed consent due to minor status\n* Prisoner, as defined by \\[45 CFR 46.303(c)\\]\n* Cognitively impaired, and unable to give informed consent\n* Pregnant, as defined by a presumptive sign of pregnancy such as missed menses or a positive pregnancy test \\[45 CFR 46.203(b)\\]\n* Requires or is likely to require more than a 2-week course of corticosteroids of \\>4mg'}, 'identificationModule': {'nctId': 'NCT03223103', 'briefTitle': 'Safety and Immunogenicity of Personalized Genomic Vaccine and Tumor Treating Fields (TTFields) to Treat Glioblastoma', 'organization': {'class': 'OTHER', 'fullName': 'Albert Einstein College of Medicine'}, 'officialTitle': 'Phase I Study of Tumor Treatment Fields and a Personalized Mutation-derived Tumor Vaccine in Patients With Newly Diagnosed Glioblastoma (GCO 17-0566)', 'orgStudyIdInfo': {'id': '2022-13817'}, 'secondaryIdInfos': [{'id': '16-089', 'type': 'OTHER', 'domain': 'PRMC'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Mutation-derived tumor vaccine', 'description': 'MTA-based Personalized Vaccine (peptides + Poly-ICLC with Tumor Treating Fields', 'interventionNames': ['Drug: Poly-ICLC', 'Device: Tumor Treating Fields', 'Biological: Peptides']}], 'interventions': [{'name': 'Poly-ICLC', 'type': 'DRUG', 'otherNames': ['Hiltonol®'], 'description': 'Poly-ICLC 100mcg per peptide per dose', 'armGroupLabels': ['Mutation-derived tumor vaccine']}, {'name': 'Tumor Treating Fields', 'type': 'DEVICE', 'otherNames': ['Optune®'], 'description': 'an FDA approved treatment for patients with recurrent GBM and newly diagnosed GBM', 'armGroupLabels': ['Mutation-derived tumor vaccine']}, {'name': 'Peptides', 'type': 'BIOLOGICAL', 'otherNames': ['Personalized peptides'], 'description': 'synthetic long peptides (SLP) as vaccine substrate', 'armGroupLabels': ['Mutation-derived tumor vaccine']}]}, 'contactsLocationsModule': {'locations': [{'zip': '10461', 'city': 'The Bronx', 'state': 'New York', 'country': 'United States', 'facility': 'Albert Einstein College of Medicine', 'geoPoint': {'lat': 40.84985, 'lon': -73.86641}}], 'overallOfficials': [{'name': 'Adilia Hormigo, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Albert Einstein College of Medicine'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Adilia Hormigo', 'class': 'OTHER'}, 'collaborators': [{'name': 'NovoCure Ltd.', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Adilia Hormigo', 'investigatorAffiliation': 'Albert Einstein College of Medicine'}}}}