Viewing Study NCT04396860


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Study NCT ID: NCT04396860
Status: ACTIVE_NOT_RECRUITING
Last Update Posted: 2025-12-18
First Post: 2020-05-20
Is NOT Gene Therapy: True
Has Adverse Events: True

Brief Title: Testing the Use of the Immunotherapy Drugs Ipilimumab and Nivolumab Plus Radiation Therapy Compared to the Usual Treatment (Temozolomide and Radiation Therapy) for Newly Diagnosed MGMT Unmethylated Glioblastoma
Sponsor:
Organization:

Raw JSON

{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D018316', 'term': 'Gliosarcoma'}], 'ancestors': [{'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': 'D009369', 'term': 'Neoplasms'}, {'id': 'D009375', 'term': 'Neoplasms, Glandular and Epithelial'}, {'id': 'D009380', 'term': 'Neoplasms, Nerve Tissue'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D009682', 'term': 'Magnetic Resonance Spectroscopy'}, {'id': 'D003287', 'term': 'Contrast Media'}, {'id': 'D000074324', 'term': 'Ipilimumab'}, {'id': 'D060908', 'term': 'CTLA-4 Antigen'}, {'id': 'D000077594', 'term': 'Nivolumab'}, {'id': 'D011878', 'term': 'Radiotherapy'}, {'id': 'D011827', 'term': 'Radiation'}, {'id': 'D000077204', 'term': 'Temozolomide'}], 'ancestors': [{'id': 'D013057', 'term': 'Spectrum Analysis'}, {'id': 'D002623', 'term': 'Chemistry Techniques, Analytical'}, {'id': 'D008919', 'term': 'Investigative Techniques'}, {'id': 'D064907', 'term': 'Diagnostic Uses of Chemicals'}, {'id': 'D020228', 'term': 'Pharmacologic Actions'}, {'id': 'D020164', 'term': 'Chemical Actions and Uses'}, {'id': 'D020313', 'term': 'Specialty Uses of Chemicals'}, {'id': 'D061067', 'term': 'Antibodies, Monoclonal, Humanized'}, {'id': 'D000911', 'term': 'Antibodies, Monoclonal'}, {'id': 'D000906', 'term': 'Antibodies'}, {'id': 'D007136', 'term': 'Immunoglobulins'}, {'id': 'D007162', 'term': 'Immunoproteins'}, {'id': 'D001798', 'term': 'Blood Proteins'}, {'id': 'D011506', 'term': 'Proteins'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}, {'id': 'D012712', 'term': 'Serum Globulins'}, {'id': 'D005916', 'term': 'Globulins'}, {'id': 'D000082102', 'term': 'Immune Checkpoint Proteins'}, {'id': 'D061025', 'term': 'Costimulatory and Inhibitory T-Cell Receptors'}, {'id': 'D011971', 'term': 'Receptors, Immunologic'}, {'id': 'D011956', 'term': 'Receptors, Cell Surface'}, {'id': 'D008565', 'term': 'Membrane Proteins'}, {'id': 'D000945', 'term': 'Antigens, Differentiation, T-Lymphocyte'}, {'id': 'D000943', 'term': 'Antigens, Differentiation'}, {'id': 'D000954', 'term': 'Antigens, Surface'}, {'id': 'D000941', 'term': 'Antigens'}, {'id': 'D001685', 'term': 'Biological Factors'}, {'id': 'D015415', 'term': 'Biomarkers'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D055585', 'term': 'Physical Phenomena'}, {'id': 'D003606', 'term': 'Dacarbazine'}, {'id': 'D014226', 'term': 'Triazenes'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D007093', 'term': 'Imidazoles'}, {'id': 'D001393', 'term': 'Azoles'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'seiferheldw@nrgoncology.org', 'phone': '2155743208', 'title': 'Wendy Seiferheld', 'organization': 'NRG Oncology'}, 'certainAgreement': {'restrictionType': 'LTE60', 'piSponsorEmployee': False, 'restrictiveAgreement': True}, 'limitationsAndCaveats': {'description': 'This phase II/III trial did not proceed to the phase III component, per the protocol. Therefore, only phase II outcome measures are reported.'}}, 'adverseEventsModule': {'timeFrame': 'Randomization to date of last known follow-up. Maximum follow-up time was 19.3 months.', 'description': 'All-cause mortality was assessed in randomized participants. Adverse events were assessed in randomized participants who started protocol treatment and were assessed for adverse events.', 'eventGroups': [{'id': 'EG000', 'title': 'Arm I (Radiation Therapy, Temozolomide)', 'description': 'Patients undergo radiation therapy for 5 days per week (Monday-Friday) for a total of 30 fractions over 6 weeks and simultaneously receive temozolomide PO daily for 6 weeks. After radiation, patients may wear the Optune device at the discretion of the patient and their treating physician. Beginning 1 month after radiation therapy, patients receive temozolomide on days 1-5. Treatment repeats every 28 days for up to 12 cycles at the discretion of the treating investigator in the absence of disease progression or unacceptable toxicity. Patients also undergo contrast-enhanced brain MRI throughout the trial.', 'otherNumAtRisk': 74, 'deathsNumAtRisk': 80, 'otherNumAffected': 70, 'seriousNumAtRisk': 74, 'deathsNumAffected': 41, 'seriousNumAffected': 29}, {'id': 'EG001', 'title': 'Arm II (Radiation Therapy, Ipilimumab, Nivolumab)', 'description': 'Patients undergo radiation therapy for 5 days per week (Monday-Friday) for a total of 30 fractions over 6 weeks. Starting on the first day of radiation, patients also receive ipilimumab IV over 90 minutes Q4W for 4 doses and nivolumab IV over 30 minutes every 2 weeks until disease progression. Patients also undergo contrast-enhanced brain MRI throughout the trial.', 'otherNumAtRisk': 78, 'deathsNumAtRisk': 79, 'otherNumAffected': 70, 'seriousNumAtRisk': 78, 'deathsNumAffected': 37, 'seriousNumAffected': 45}], 'otherEvents': [{'term': 'Anemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 74, 'numAffected': 21}, {'groupId': 'EG001', 'numAtRisk': 78, 'numAffected': 26}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (5.0)'}, {'term': 'Sinus tachycardia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 74, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 78, 'numAffected': 4}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (5.0)'}, {'term': 'Tinnitus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 74, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 78, 'numAffected': 2}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (5.0)'}, {'term': 'Hyperthyroidism', 'stats': [{'groupId': 'EG000', 'numAtRisk': 74, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 78, 'numAffected': 7}], 'organSystem': 'Endocrine disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (5.0)'}, {'term': 'Hypothyroidism', 'stats': [{'groupId': 'EG000', 'numAtRisk': 74, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 78, 'numAffected': 9}], 'organSystem': 'Endocrine disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (5.0)'}, {'term': 'Blurred vision', 'stats': [{'groupId': 'EG000', 'numAtRisk': 74, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 78, 'numAffected': 8}], 'organSystem': 'Eye disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (5.0)'}, {'term': 'Dry eye', 'stats': [{'groupId': 'EG000', 'numAtRisk': 74, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 78, 'numAffected': 6}], 'organSystem': 'Eye disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (5.0)'}, {'term': 'Eye disorders - Other', 'stats': [{'groupId': 'EG000', 'numAtRisk': 74, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 78, 'numAffected': 8}], 'organSystem': 'Eye disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (5.0)'}, {'term': 'Abdominal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 74, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 78, 'numAffected': 7}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (5.0)'}, {'term': 'Colitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 74, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 78, 'numAffected': 4}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (5.0)'}, {'term': 'Constipation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 74, 'numAffected': 34}, {'groupId': 'EG001', 'numAtRisk': 78, 'numAffected': 16}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (5.0)'}, {'term': 'Diarrhea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 74, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 78, 'numAffected': 23}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (5.0)'}, {'term': 'Dry mouth', 'stats': [{'groupId': 'EG000', 'numAtRisk': 74, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 78, 'numAffected': 6}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (5.0)'}, {'term': 'Dysphagia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 74, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 78, 'numAffected': 4}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (5.0)'}, {'term': 'Mucositis oral', 'stats': [{'groupId': 'EG000', 'numAtRisk': 74, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 78, 'numAffected': 5}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (5.0)'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 74, 'numAffected': 32}, {'groupId': 'EG001', 'numAtRisk': 78, 'numAffected': 30}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (5.0)'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 74, 'numAffected': 12}, {'groupId': 'EG001', 'numAtRisk': 78, 'numAffected': 16}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (5.0)'}, {'term': 'Chills', 'stats': [{'groupId': 'EG000', 'numAtRisk': 74, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 78, 'numAffected': 8}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (5.0)'}, {'term': 'Edema face', 'stats': [{'groupId': 'EG000', 'numAtRisk': 74, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 78, 'numAffected': 6}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (5.0)'}, {'term': 'Edema limbs', 'stats': [{'groupId': 'EG000', 'numAtRisk': 74, 'numAffected': 12}, {'groupId': 'EG001', 'numAtRisk': 78, 'numAffected': 9}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (5.0)'}, {'term': 'Fatigue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 74, 'numAffected': 51}, {'groupId': 'EG001', 'numAtRisk': 78, 'numAffected': 50}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (5.0)'}, {'term': 'Fever', 'stats': [{'groupId': 'EG000', 'numAtRisk': 74, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 78, 'numAffected': 9}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (5.0)'}, {'term': 'Gait disturbance', 'stats': [{'groupId': 'EG000', 'numAtRisk': 74, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 78, 'numAffected': 13}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (5.0)'}, {'term': 'Malaise', 'stats': [{'groupId': 'EG000', 'numAtRisk': 74, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 78, 'numAffected': 4}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (5.0)'}, {'term': 'Non-cardiac chest pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 74, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 78, 'numAffected': 4}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (5.0)'}, {'term': 'Pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 74, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 78, 'numAffected': 7}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (5.0)'}, {'term': 'Infections and infestations - Other', 'stats': [{'groupId': 'EG000', 'numAtRisk': 74, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 78, 'numAffected': 6}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (5.0)'}, {'term': 'Thrush', 'stats': [{'groupId': 'EG000', 'numAtRisk': 74, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 78, 'numAffected': 8}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (5.0)'}, {'term': 'Urinary tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 74, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 78, 'numAffected': 4}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (5.0)'}, {'term': 'Dermatitis radiation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 74, 'numAffected': 16}, {'groupId': 'EG001', 'numAtRisk': 78, 'numAffected': 13}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (5.0)'}, {'term': 'Fall', 'stats': [{'groupId': 'EG000', 'numAtRisk': 74, 'numAffected': 10}, {'groupId': 'EG001', 'numAtRisk': 78, 'numAffected': 5}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (5.0)'}, {'term': 'Infusion related reaction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 74, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 78, 'numAffected': 4}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (5.0)'}, {'term': 'Alanine aminotransferase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 74, 'numAffected': 16}, {'groupId': 'EG001', 'numAtRisk': 78, 'numAffected': 23}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (5.0)'}, {'term': 'Alkaline phosphatase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 74, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 78, 'numAffected': 6}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (5.0)'}, {'term': 'Aspartate aminotransferase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 74, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 78, 'numAffected': 22}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (5.0)'}, {'term': 'Blood bilirubin increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 74, 'numAffected': 10}, {'groupId': 'EG001', 'numAtRisk': 78, 'numAffected': 3}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (5.0)'}, {'term': 'Blood lactate dehydrogenase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 74, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 78, 'numAffected': 4}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (5.0)'}, {'term': 'Creatinine increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 74, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 78, 'numAffected': 8}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (5.0)'}, {'term': 'Investigations - Other', 'stats': [{'groupId': 'EG000', 'numAtRisk': 74, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 78, 'numAffected': 4}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (5.0)'}, {'term': 'Lipase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 74, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 78, 'numAffected': 4}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (5.0)'}, {'term': 'Lymphocyte count decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 74, 'numAffected': 34}, {'groupId': 'EG001', 'numAtRisk': 78, 'numAffected': 18}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (5.0)'}, {'term': 'Neutrophil count decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 74, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 78, 'numAffected': 9}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (5.0)'}, {'term': 'Platelet count decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 74, 'numAffected': 24}, {'groupId': 'EG001', 'numAtRisk': 78, 'numAffected': 11}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (5.0)'}, {'term': 'Thyroid stimulating hormone increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 74, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 78, 'numAffected': 4}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (5.0)'}, {'term': 'Weight loss', 'stats': [{'groupId': 'EG000', 'numAtRisk': 74, 'numAffected': 10}, {'groupId': 'EG001', 'numAtRisk': 78, 'numAffected': 18}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (5.0)'}, {'term': 'White blood cell decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 74, 'numAffected': 14}, {'groupId': 'EG001', 'numAtRisk': 78, 'numAffected': 12}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (5.0)'}, {'term': 'Anorexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 74, 'numAffected': 24}, {'groupId': 'EG001', 'numAtRisk': 78, 'numAffected': 24}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (5.0)'}, {'term': 'Dehydration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 74, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 78, 'numAffected': 8}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (5.0)'}, {'term': 'Hypercalcemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 74, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 78, 'numAffected': 4}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (5.0)'}, {'term': 'Hyperglycemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 74, 'numAffected': 23}, {'groupId': 'EG001', 'numAtRisk': 78, 'numAffected': 26}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (5.0)'}, {'term': 'Hyperkalemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 74, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 78, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (5.0)'}, {'term': 'Hypernatremia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 74, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 78, 'numAffected': 2}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (5.0)'}, {'term': 'Hypoalbuminemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 74, 'numAffected': 10}, {'groupId': 'EG001', 'numAtRisk': 78, 'numAffected': 13}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (5.0)'}, {'term': 'Hypocalcemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 74, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 78, 'numAffected': 7}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (5.0)'}, {'term': 'Hypoglycemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 74, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 78, 'numAffected': 2}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (5.0)'}, {'term': 'Hypokalemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 74, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 78, 'numAffected': 13}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (5.0)'}, {'term': 'Hyponatremia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 74, 'numAffected': 13}, {'groupId': 'EG001', 'numAtRisk': 78, 'numAffected': 20}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (5.0)'}, {'term': 'Arthralgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 74, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 78, 'numAffected': 5}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (5.0)'}, {'term': 'Back pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 74, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 78, 'numAffected': 9}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (5.0)'}, {'term': 'Generalized muscle weakness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 74, 'numAffected': 11}, {'groupId': 'EG001', 'numAtRisk': 78, 'numAffected': 18}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (5.0)'}, {'term': 'Muscle weakness lower limb', 'stats': [{'groupId': 'EG000', 'numAtRisk': 74, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 78, 'numAffected': 4}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (5.0)'}, {'term': 'Musculoskeletal and connective tissue disorder - Other', 'stats': [{'groupId': 'EG000', 'numAtRisk': 74, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 78, 'numAffected': 3}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (5.0)'}, {'term': 'Myalgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 74, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 78, 'numAffected': 3}], 'organSystem': 'Musculoskeletal and connective 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complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (5.0)'}, {'term': 'Alanine aminotransferase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 74, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 78, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (5.0)'}, {'term': 'Blood bilirubin increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 74, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 78, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (5.0)'}, {'term': 'Platelet count decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 74, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 78, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (5.0)'}, {'term': 'White blood cell decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 74, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 78, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (5.0)'}, {'term': 'Dehydration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 74, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 78, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (5.0)'}, {'term': 'Hyperglycemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 74, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 78, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (5.0)'}, {'term': 'Hypokalemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 74, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 78, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (5.0)'}, {'term': 'Hyponatremia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 74, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 78, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (5.0)'}, {'term': 'Generalized muscle weakness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 74, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 78, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (5.0)'}, {'term': 'Muscle weakness lower limb', 'stats': [{'groupId': 'EG000', 'numAtRisk': 74, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 78, 'numAffected': 2}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (5.0)'}, {'term': 'Rhabdomyolysis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 74, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 78, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (5.0)'}, {'term': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps) - Other', 'stats': [{'groupId': 'EG000', 'numAtRisk': 74, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 78, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (5.0)'}, {'term': 'Ataxia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 74, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 78, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (5.0)'}, {'term': 'Cognitive disturbance', 'stats': [{'groupId': 'EG000', 'numAtRisk': 74, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 78, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (5.0)'}, {'term': 'Dizziness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 74, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 78, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (5.0)'}, {'term': 'Dysgeusia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 74, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 78, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (5.0)'}, {'term': 'Dysphasia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 74, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 78, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (5.0)'}, {'term': 'Edema cerebral', 'stats': [{'groupId': 'EG000', 'numAtRisk': 74, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 78, 'numAffected': 3}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (5.0)'}, {'term': 'Encephalopathy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 74, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 78, 'numAffected': 5}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (5.0)'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 74, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 78, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (5.0)'}, {'term': 'Hydrocephalus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 74, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 78, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (5.0)'}, {'term': 'Intracranial hemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 74, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 78, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (5.0)'}, {'term': 'Muscle weakness left-sided', 'stats': [{'groupId': 'EG000', 'numAtRisk': 74, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 78, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (5.0)'}, {'term': 'Nervous system disorders - Other', 'stats': [{'groupId': 'EG000', 'numAtRisk': 74, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 78, 'numAffected': 2}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (5.0)'}, {'term': 'Paresthesia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 74, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 78, 'numAffected': 2}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (5.0)'}, {'term': 'Seizure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 74, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 78, 'numAffected': 10}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (5.0)'}, {'term': 'Stroke', 'stats': [{'groupId': 'EG000', 'numAtRisk': 74, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 78, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (5.0)'}, {'term': 'Syncope', 'stats': [{'groupId': 'EG000', 'numAtRisk': 74, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 78, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (5.0)'}, {'term': 'Anxiety', 'stats': [{'groupId': 'EG000', 'numAtRisk': 74, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 78, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (5.0)'}, {'term': 'Confusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 74, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 78, 'numAffected': 3}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (5.0)'}, {'term': 'Delirium', 'stats': [{'groupId': 'EG000', 'numAtRisk': 74, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 78, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (5.0)'}, {'term': 'Mania', 'stats': [{'groupId': 'EG000', 'numAtRisk': 74, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 78, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (5.0)'}, {'term': 'Bladder perforation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 74, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 78, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (5.0)'}, {'term': 'Dyspnea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 74, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 78, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (5.0)'}, {'term': 'Hypoxia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 74, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 78, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (5.0)'}, {'term': 'Pneumonitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 74, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 78, 'numAffected': 2}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (5.0)'}, {'term': 'Rash maculo-papular', 'stats': [{'groupId': 'EG000', 'numAtRisk': 74, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 78, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (5.0)'}, {'term': 'Hypotension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 74, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 78, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (5.0)'}, {'term': 'Thromboembolic event', 'stats': [{'groupId': 'EG000', 'numAtRisk': 74, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 78, 'numAffected': 6}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (5.0)'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Progression-free Survival (PFS) (Phase II)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '80', 'groupId': 'OG000'}, {'value': '79', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Arm I (Radiation Therapy, Temozolomide)', 'description': 'Patients undergo radiation therapy for 5 days per week (Monday-Friday) for a total of 30 fractions over 6 weeks and simultaneously receive temozolomide PO daily for 6 weeks. After radiation, patients may wear the Optune device at the discretion of the patient and their treating physician. Beginning 1 month after radiation therapy, patients receive temozolomide on days 1-5. Treatment repeats every 28 days for up to 12 cycles at the discretion of the treating investigator in the absence of disease progression or unacceptable toxicity. Patients also undergo contrast-enhanced brain MRI throughout the trial.'}, {'id': 'OG001', 'title': 'Arm II (Radiation Therapy, Ipilimumab, Nivolumab)', 'description': 'Patients undergo radiation therapy for 5 days per week (Monday-Friday) for a total of 30 fractions over 6 weeks. Starting on the first day of radiation, patients also receive ipilimumab IV over 90 minutes Q4W for 4 doses and nivolumab IV over 30 minutes every 2 weeks until disease progression. Patients also undergo contrast-enhanced brain MRI throughout the trial.'}], 'classes': [{'categories': [{'measurements': [{'value': '8.5', 'groupId': 'OG000', 'lowerLimit': '7.1', 'upperLimit': '10.4'}, {'value': '7.7', 'groupId': 'OG001', 'lowerLimit': '6.5', 'upperLimit': '8.5'}]}]}], 'analyses': [{'pValue': '0.96', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.47', 'ciLowerLimit': '0.98', 'ciUpperLimit': '2.21', 'estimateComment': 'Reference level = Arm 1', 'groupDescription': 'For the phase II endpoint, observation of 100 PFS events among the 150 randomized patients (from both arms) provides 95% statistical power to detect an improvement in median PFS from 5.7 months in the control arm to 9.7 months in the experimental arm, corresponding to a hazard reduction of 42% (hazard ratio 0.58) at one-sided significance level of 0.15 (and 87% power for hazard ratio of 0.65 at this same alpha).', 'statisticalMethod': 'Log Rank', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Stratified log-rank'}], 'paramType': 'MEDIAN', 'timeFrame': 'From randomization to date of progression, death, or last known follow-up, whichever occurs first. Maximum follow-up time was 19.3 months.', 'description': 'Disease progression was confirmed by central review and defined using an adaptation of the Response Assessment in Neuro-Oncology criteria (Wen et al, J Clin Oncol. 2010 Apr 10;28(11):1963-72. doi: 10.1200/JCO.2009.26.3541. Epub 2010 Mar 15) with modification such that the first MRI performed following completion of radiotherapy is the baseline MRI for determination of radiographic disease. Progression-free survival time is defined as time from randomization to the date of first progression, death, or the last progression assessment with no documented progression (censored). Progression-free survival rates were estimated using the Kaplan-Meier method.', 'unitOfMeasure': 'months', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Randomized participants'}, {'type': 'PRIMARY', 'title': 'Overall Survival (OS) (Phase III)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Arm I (Radiation Therapy, Temozolomide)', 'description': 'Patients undergo radiation therapy for 5 days per week (Monday-Friday) for a total of 30 fractions over 6 weeks and simultaneously receive temozolomide PO daily for 6 weeks. After radiation, patients may wear the Optune device at the discretion of the patient and their treating physician. Beginning 1 month after radiation therapy, patients receive temozolomide on days 1-5. Treatment repeats every 28 days for up to 12 cycles at the discretion of the treating investigator in the absence of disease progression or unacceptable toxicity. Patients also undergo contrast-enhanced brain MRI throughout the trial.'}, {'id': 'OG001', 'title': 'Arm II (Radiation Therapy, Ipilimumab, Nivolumab)', 'description': 'Patients undergo radiation therapy for 5 days per week (Monday-Friday) for a total of 30 fractions over 6 weeks. Starting on the first day of radiation, patients also receive ipilimumab IV over 90 minutes Q4W for 4 doses and nivolumab IV over 30 minutes every 2 weeks until disease progression. Patients also undergo contrast-enhanced brain MRI throughout the trial.'}], 'timeFrame': 'From randomization to date of death or last known follow-up. Maximum follow-up time was 19.3 months.', 'description': 'Overall survival time is defined as time from randomization to the date of death from any cause or last known follow-up (censored). Overall survival rates were to be estimated by the Kaplan-Meier method.', 'reportingStatus': 'POSTED', 'populationDescription': 'Study did not continue to the Phase III component.'}, {'type': 'SECONDARY', 'title': 'PFS for the Entire Cohort (Phase II/III)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Arm I (Radiation Therapy, Temozolomide)', 'description': 'Patients undergo radiation therapy for 5 days per week (Monday-Friday) for a total of 30 fractions over 6 weeks and simultaneously receive temozolomide PO daily for 6 weeks. After radiation, patients may wear the Optune device at the discretion of the patient and their treating physician. Beginning 1 month after radiation therapy, patients receive temozolomide on days 1-5. Treatment repeats every 28 days for up to 12 cycles at the discretion of the treating investigator in the absence of disease progression or unacceptable toxicity. Patients also undergo contrast-enhanced brain MRI throughout the trial.'}, {'id': 'OG001', 'title': 'Arm II (Radiation Therapy, Ipilimumab, Nivolumab)', 'description': 'Patients undergo radiation therapy for 5 days per week (Monday-Friday) for a total of 30 fractions over 6 weeks. Starting on the first day of radiation, patients also receive ipilimumab IV over 90 minutes Q4W for 4 doses and nivolumab IV over 30 minutes every 2 weeks until disease progression. Patients also undergo contrast-enhanced brain MRI throughout the trial.'}], 'timeFrame': 'From randomization to date of progression, death, or last known follow-up. Maximum follow-up time was 19.3 months.', 'description': 'Disease progression was confirmed by central review and defined using an adaptation of the Response Assessment in Neuro-Oncology criteria (Wen et al, J Clin Oncol. 2010 Apr 10;28(11):1963-72. doi: 10.1200/JCO.2009.26.3541. Epub 2010 Mar 15) with modification such that the first MRI performed following completion of radiotherapy is the baseline MRI for determination of radiographic disease. Progression-free survival time is defined as time from randomization to the date of first progression, death, or the last progression assessment with no documented progression (censored). Progression-free survival rates were estimated using the Kaplan-Meier method.', 'reportingStatus': 'POSTED', 'populationDescription': 'Study did not continue to the Phase III component.'}, {'type': 'SECONDARY', 'title': 'Overall Survival at 2 Years', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Arm I (Radiation Therapy, Temozolomide)', 'description': 'Patients undergo radiation therapy for 5 days per week (Monday-Friday) for a total of 30 fractions over 6 weeks and simultaneously receive temozolomide PO daily for 6 weeks. After radiation, patients may wear the Optune device at the discretion of the patient and their treating physician. Beginning 1 month after radiation therapy, patients receive temozolomide on days 1-5. Treatment repeats every 28 days for up to 12 cycles at the discretion of the treating investigator in the absence of disease progression or unacceptable toxicity. Patients also undergo contrast-enhanced brain MRI throughout the trial.'}, {'id': 'OG001', 'title': 'Arm II (Radiation Therapy, Ipilimumab, Nivolumab)', 'description': 'Patients undergo radiation therapy for 5 days per week (Monday-Friday) for a total of 30 fractions over 6 weeks. Starting on the first day of radiation, patients also receive ipilimumab IV over 90 minutes Q4W for 4 doses and nivolumab IV over 30 minutes every 2 weeks until disease progression. Patients also undergo contrast-enhanced brain MRI throughout the trial.'}], 'timeFrame': 'From randomization to two years', 'description': 'Overall survival time is defined as time from randomization to the date of death from any cause or last known follow-up (censored). Two-year survival rates were to be estimated by the Kaplan-Meier method.', 'reportingStatus': 'POSTED', 'populationDescription': 'Study did not continue to the Phase III component.'}, {'type': 'SECONDARY', 'title': 'Number of Participants by Highest Grade Adverse Event Reported', 'denoms': [{'units': 'Participants', 'counts': [{'value': '74', 'groupId': 'OG000'}, {'value': '78', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Arm I (Radiation Therapy, Temozolomide)', 'description': 'Patients undergo radiation therapy for 5 days per week (Monday-Friday) for a total of 30 fractions over 6 weeks and simultaneously receive temozolomide PO daily for 6 weeks. After radiation, patients may wear the Optune device at the discretion of the patient and their treating physician. Beginning 1 month after radiation therapy, patients receive temozolomide on days 1-5. Treatment repeats every 28 days for up to 12 cycles at the discretion of the treating investigator in the absence of disease progression or unacceptable toxicity. Patients also undergo contrast-enhanced brain MRI throughout the trial.'}, {'id': 'OG001', 'title': 'Arm II (Radiation Therapy, Ipilimumab, Nivolumab)', 'description': 'Patients undergo radiation therapy for 5 days per week (Monday-Friday) for a total of 30 fractions over 6 weeks. Starting on the first day of radiation, patients also receive ipilimumab IV over 90 minutes Q4W for 4 doses and nivolumab IV over 30 minutes every 2 weeks until disease progression. Patients also undergo contrast-enhanced brain MRI throughout the trial.'}], 'classes': [{'title': 'Grade 1', 'categories': [{'measurements': [{'value': '6', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Grade 2', 'categories': [{'measurements': [{'value': '19', 'groupId': 'OG000'}, {'value': '21', 'groupId': 'OG001'}]}]}, {'title': 'Grade 3', 'categories': [{'measurements': [{'value': '38', 'groupId': 'OG000'}, {'value': '38', 'groupId': 'OG001'}]}]}, {'title': 'Grade 4', 'categories': [{'measurements': [{'value': '9', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}]}]}, {'title': 'Grade 5', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'From randomization to date of last known follow-up. Maximum follow-up time was 19.3 months.', 'description': 'Common Terminology Criteria for Adverse Events (version 5.0) grades adverse event severity from 1=mild to 5=death. Summary data is provided in this outcome measure; see Adverse Events Module for specific adverse event data.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Randomized participants who started protocol treatment and were assessed for adverse events.'}, {'type': 'SECONDARY', 'title': 'Change in MD Anderson Symptom Inventory for Brain Tumor (MDASI-BT) at Six Months (Patient Reported Outcomes)', 'timeFrame': 'Up to 2 years', 'description': 'The MD Anderson Symptom Inventory for brain tumor (MDASI-BT) is a 28-item multi-symptom patient-reported outcome measure assessing the severity of symptoms experienced by cancer patients and the interference with daily living caused by these symptoms, with 9 items specific to brain tumors. Each item ranges from 0 (best condition) to 10 (worst condition). A subscale score is the average of the subscale items, given that a specified minimum numbers of items were completed.', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants', 'anticipatedPostingDate': '2026-04'}, {'type': 'SECONDARY', 'title': 'Neurocognitive Function (NCF)', 'timeFrame': 'Up to 2 years', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants', 'anticipatedPostingDate': '2026-04'}, {'type': 'SECONDARY', 'title': 'Selected Patient-Reported Outcomes Version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE) Items', 'timeFrame': 'Up to 2 years', 'description': "Questions refer to the participants' experiences for the past 7 days of a given symptom in terms of frequency (never, rarely, occasionally, frequently, almost constantly), severity (none, mild, moderate, severe, very severe), interference with usual or daily activities (not at all, a little bit, somewhat, quite a bit, very much).", 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants', 'anticipatedPostingDate': '2026-04'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'OS (if the Study Discontinues in Phase II)', 'timeFrame': 'At the end of phase II of study', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Tumor Biomarker Analyses', 'timeFrame': 'Up to 4 years', 'description': 'Will assess PD-L1 expression and mutational burden expression specifically.', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'MGMT Protein Expression', 'timeFrame': 'Up to 4 years', 'description': 'Will assess the prognostic value of MGMT protein expression (in terms of predicting clinical outcomes such as PFS, OS, and 2-year OS rate) in the two treatment arms, separately. In addition, will evaluate if MGMT protein expression may be predictive of differential treatment effects between the two treatment arms. Correlation methods and survival modeling will be used to address these questions.', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Arm I (Radiation Therapy, Temozolomide)', 'description': 'Patients undergo radiation therapy for 5 days per week (Monday-Friday) for a total of 30 fractions over 6 weeks and simultaneously receive temozolomide PO daily for 6 weeks. After radiation, patients may wear the Optune device at the discretion of the patient and their treating physician. Beginning 1 month after radiation therapy, patients receive temozolomide on days 1-5. Treatment repeats every 28 days for up to 12 cycles at the discretion of the treating investigator in the absence of disease progression or unacceptable toxicity. Patients also undergo contrast-enhanced brain MRI throughout the trial.'}, {'id': 'FG001', 'title': 'Arm II (Radiation Therapy, Ipilimumab, Nivolumab)', 'description': 'Patients undergo radiation therapy for 5 days per week (Monday-Friday) for a total of 30 fractions over 6 weeks. Starting on the first day of radiation, patients also receive ipilimumab IV over 90 minutes Q4W for 4 doses and nivolumab IV over 30 minutes every 2 weeks until disease progression. Patients also undergo contrast-enhanced brain MRI throughout the trial.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '80'}, {'groupId': 'FG001', 'numSubjects': '79'}]}, {'type': 'Randomized', 'achievements': [{'groupId': 'FG000', 'numSubjects': '80'}, {'groupId': 'FG001', 'numSubjects': '79'}]}, {'type': 'Adverse Event Population', 'comment': 'Randomized, started protocol treatment, and assessed for adverse events', 'achievements': [{'groupId': 'FG000', 'numSubjects': '74'}, {'groupId': 'FG001', 'numSubjects': '78'}]}, {'type': 'COMPLETED', 'comment': 'Participants contributing data to results are considered to have completed the study.', 'achievements': [{'groupId': 'FG000', 'numSubjects': '80'}, {'groupId': 'FG001', 'numSubjects': '79'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}], 'preAssignmentDetails': 'Screening required central pathology review confirmation of glioblastoma histology and unmethylated MGMT promotor status in order to proceed to randomization. Of 374 patients registered, 159 patients were randomized.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '80', 'groupId': 'BG000'}, {'value': '79', 'groupId': 'BG001'}, {'value': '159', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Arm I (Radiation Therapy, Temozolomide)', 'description': 'Patients undergo radiation therapy for 5 days per week (Monday-Friday) for a total of 30 fractions over 6 weeks and simultaneously receive temozolomide PO daily for 6 weeks. After radiation, patients may wear the Optune device at the discretion of the patient and their treating physician. Beginning 1 month after radiation therapy, patients receive temozolomide on days 1-5. Treatment repeats every 28 days for up to 12 cycles at the discretion of the treating investigator in the absence of disease progression or unacceptable toxicity. Patients also undergo contrast-enhanced brain MRI throughout the trial.\n\nContrast-enhanced Magnetic Resonance Imaging: Undergo contrast-enhanced brain MRI\n\nNovoTTF-100A Device: Wear Optune device\n\nQuality-of-Life Assessment: Ancillary studies\n\nQuestionnaire Administration: Ancillary studies\n\nRadiation Therapy: Undergo radiation therapy\n\nTemozolomide: Given PO'}, {'id': 'BG001', 'title': 'Arm II (Radiation Therapy, Ipilimumab, Nivolumab)', 'description': 'Patients undergo radiation therapy for 5 days per week (Monday-Friday) for a total of 30 fractions over 6 weeks. Starting on the first day of radiation, patients also receive ipilimumab IV over 90 minutes Q4W for 4 doses and nivolumab IV over 30 minutes every 2 weeks until disease progression. Patients also undergo contrast-enhanced brain MRI throughout the trial.\n\nContrast-enhanced Magnetic Resonance Imaging: Undergo contrast-enhanced brain MRI\n\nIpilimumab: Given IV\n\nNivolumab: Given IV\n\nQuality-of-Life Assessment: Ancillary studies\n\nQuestionnaire Administration: Ancillary studies\n\nRadiation Therapy: Undergo radiation therapy'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '59.5', 'groupId': 'BG000', 'lowerLimit': '28', 'upperLimit': '77'}, {'value': '61', 'groupId': 'BG001', 'lowerLimit': '35', 'upperLimit': '79'}, {'value': '60', 'groupId': 'BG002', 'lowerLimit': '28', 'upperLimit': '79'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'years', 'dispersionType': 'FULL_RANGE'}, {'title': 'Age, Customized', 'classes': [{'categories': [{'title': '≤ 49', 'measurements': [{'value': '15', 'groupId': 'BG000'}, {'value': '9', 'groupId': 'BG001'}, {'value': '24', 'groupId': 'BG002'}]}, {'title': '50 -59', 'measurements': [{'value': '25', 'groupId': 'BG000'}, {'value': '27', 'groupId': 'BG001'}, {'value': '52', 'groupId': 'BG002'}]}, {'title': '60 -69', 'measurements': [{'value': '30', 'groupId': 'BG000'}, {'value': '27', 'groupId': 'BG001'}, {'value': '57', 'groupId': 'BG002'}]}, {'title': '≥ 70', 'measurements': [{'value': '10', 'groupId': 'BG000'}, {'value': '16', 'groupId': 'BG001'}, {'value': '26', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '26', 'groupId': 'BG000'}, {'value': '28', 'groupId': 'BG001'}, {'value': '54', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '54', 'groupId': 'BG000'}, {'value': '51', 'groupId': 'BG001'}, {'value': '105', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '7', 'groupId': 'BG000'}, {'value': '9', 'groupId': 'BG001'}, {'value': '16', 'groupId': 'BG002'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '73', 'groupId': 'BG000'}, {'value': '69', 'groupId': 'BG001'}, {'value': '142', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Asian', 'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '7', 'groupId': 'BG002'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Black or African American', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}]}, {'title': 'White', 'measurements': [{'value': '71', 'groupId': 'BG000'}, {'value': '69', 'groupId': 'BG001'}, {'value': '140', 'groupId': 'BG002'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '9', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Karnofsky performance status (KPS)', 'classes': [{'categories': [{'title': '70', 'measurements': [{'value': '10', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '16', 'groupId': 'BG002'}]}, {'title': '80', 'measurements': [{'value': '24', 'groupId': 'BG000'}, {'value': '22', 'groupId': 'BG001'}, {'value': '46', 'groupId': 'BG002'}]}, {'title': '90', 'measurements': [{'value': '37', 'groupId': 'BG000'}, {'value': '36', 'groupId': 'BG001'}, {'value': '73', 'groupId': 'BG002'}]}, {'title': '100', 'measurements': [{'value': '9', 'groupId': 'BG000'}, {'value': '15', 'groupId': 'BG001'}, {'value': '24', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': '70 = Cares for self, unable to carry on normal activity or to do active work; 80 = Normal activity with effort, some signs or symptoms of disease; 90 = Able to carry on normal activity, minor signs or symptoms of disease; 100 = Normal no complaints, no evidence of disease.', 'unitOfMeasure': 'Participants'}, {'title': 'Extent of resection', 'classes': [{'categories': [{'title': 'Biopsy', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}, {'title': 'Subtotal', 'measurements': [{'value': '28', 'groupId': 'BG000'}, {'value': '27', 'groupId': 'BG001'}, {'value': '55', 'groupId': 'BG002'}]}, {'title': 'Total (gross)', 'measurements': [{'value': '51', 'groupId': 'BG000'}, {'value': '52', 'groupId': 'BG001'}, {'value': '103', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Neurologic function', 'classes': [{'categories': [{'title': 'No symptoms', 'measurements': [{'value': '22', 'groupId': 'BG000'}, {'value': '37', 'groupId': 'BG001'}, {'value': '59', 'groupId': 'BG002'}]}, {'title': 'Minor symptoms', 'measurements': [{'value': '44', 'groupId': 'BG000'}, {'value': '27', 'groupId': 'BG001'}, {'value': '71', 'groupId': 'BG002'}]}, {'title': 'Moderate symptoms (fully active)', 'measurements': [{'value': '11', 'groupId': 'BG000'}, {'value': '10', 'groupId': 'BG001'}, {'value': '21', 'groupId': 'BG002'}]}, {'title': 'Moderate symptoms (required assistance)', 'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '8', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Recursive partitioning analysis (RPA) class', 'classes': [{'categories': [{'title': 'III', 'measurements': [{'value': '9', 'groupId': 'BG000'}, {'value': '7', 'groupId': 'BG001'}, {'value': '16', 'groupId': 'BG002'}]}, {'title': 'IV', 'measurements': [{'value': '58', 'groupId': 'BG000'}, {'value': '58', 'groupId': 'BG001'}, {'value': '116', 'groupId': 'BG002'}]}, {'title': 'V', 'measurements': [{'value': '13', 'groupId': 'BG000'}, {'value': '14', 'groupId': 'BG001'}, {'value': '27', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': '* Class III: age \\< 50 and KPS 90-100.\n* Class IV: age \\< 50 and KPS \\< 90; OR age ≥ 50 and KPS 70-100 and partially or total resected with no worse than minor neurologic function impairment.\n* Class V: age ≥ 50 and KPS 70-100 and underwent prior partial or total tumor resection with worse than minor neurologic function impairment; OR age ≥ 50 and KPS \\<70.', 'unitOfMeasure': 'Participants'}, {'title': 'Intent to use Optune', 'classes': [{'title': 'No', 'categories': [{'measurements': [{'value': '42', 'groupId': 'BG000'}, {'value': '41', 'groupId': 'BG001'}, {'value': '83', 'groupId': 'BG002'}]}]}, {'title': 'Yes', 'categories': [{'measurements': [{'value': '38', 'groupId': 'BG000'}, {'value': '38', 'groupId': 'BG001'}, {'value': '76', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}], 'populationDescription': 'Randomized participants'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2023-01-17', 'size': 3770756, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_001.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2024-05-28T10:03', 'hasProtocol': True}, {'date': '2023-01-17', 'size': 344276, 'label': 'Informed Consent Form', 'hasIcf': True, 'hasSap': False, 'filename': 'ICF_002.pdf', 'typeAbbrev': 'ICF', 'uploadDate': '2025-05-08T12:51', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2', 'PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 159}}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2020-09-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-09', 'completionDateStruct': {'date': '2026-09-11', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-12-03', 'studyFirstSubmitDate': '2020-05-20', 'resultsFirstSubmitDate': '2024-04-09', 'studyFirstSubmitQcDate': '2020-05-20', 'lastUpdatePostDateStruct': {'date': '2025-12-18', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2024-04-09', 'studyFirstPostDateStruct': {'date': '2020-05-21', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2024-05-01', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-01-13', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'OS (if the Study Discontinues in Phase II)', 'timeFrame': 'At the end of phase II of study'}, {'measure': 'Tumor Biomarker Analyses', 'timeFrame': 'Up to 4 years', 'description': 'Will assess PD-L1 expression and mutational burden expression specifically.'}, {'measure': 'MGMT Protein Expression', 'timeFrame': 'Up to 4 years', 'description': 'Will assess the prognostic value of MGMT protein expression (in terms of predicting clinical outcomes such as PFS, OS, and 2-year OS rate) in the two treatment arms, separately. In addition, will evaluate if MGMT protein expression may be predictive of differential treatment effects between the two treatment arms. Correlation methods and survival modeling will be used to address these questions.'}], 'primaryOutcomes': [{'measure': 'Progression-free Survival (PFS) (Phase II)', 'timeFrame': 'From randomization to date of progression, death, or last known follow-up, whichever occurs first. Maximum follow-up time was 19.3 months.', 'description': 'Disease progression was confirmed by central review and defined using an adaptation of the Response Assessment in Neuro-Oncology criteria (Wen et al, J Clin Oncol. 2010 Apr 10;28(11):1963-72. doi: 10.1200/JCO.2009.26.3541. Epub 2010 Mar 15) with modification such that the first MRI performed following completion of radiotherapy is the baseline MRI for determination of radiographic disease. Progression-free survival time is defined as time from randomization to the date of first progression, death, or the last progression assessment with no documented progression (censored). Progression-free survival rates were estimated using the Kaplan-Meier method.'}, {'measure': 'Overall Survival (OS) (Phase III)', 'timeFrame': 'From randomization to date of death or last known follow-up. Maximum follow-up time was 19.3 months.', 'description': 'Overall survival time is defined as time from randomization to the date of death from any cause or last known follow-up (censored). Overall survival rates were to be estimated by the Kaplan-Meier method.'}], 'secondaryOutcomes': [{'measure': 'PFS for the Entire Cohort (Phase II/III)', 'timeFrame': 'From randomization to date of progression, death, or last known follow-up. Maximum follow-up time was 19.3 months.', 'description': 'Disease progression was confirmed by central review and defined using an adaptation of the Response Assessment in Neuro-Oncology criteria (Wen et al, J Clin Oncol. 2010 Apr 10;28(11):1963-72. doi: 10.1200/JCO.2009.26.3541. Epub 2010 Mar 15) with modification such that the first MRI performed following completion of radiotherapy is the baseline MRI for determination of radiographic disease. Progression-free survival time is defined as time from randomization to the date of first progression, death, or the last progression assessment with no documented progression (censored). Progression-free survival rates were estimated using the Kaplan-Meier method.'}, {'measure': 'Overall Survival at 2 Years', 'timeFrame': 'From randomization to two years', 'description': 'Overall survival time is defined as time from randomization to the date of death from any cause or last known follow-up (censored). Two-year survival rates were to be estimated by the Kaplan-Meier method.'}, {'measure': 'Number of Participants by Highest Grade Adverse Event Reported', 'timeFrame': 'From randomization to date of last known follow-up. Maximum follow-up time was 19.3 months.', 'description': 'Common Terminology Criteria for Adverse Events (version 5.0) grades adverse event severity from 1=mild to 5=death. Summary data is provided in this outcome measure; see Adverse Events Module for specific adverse event data.'}, {'measure': 'Change in MD Anderson Symptom Inventory for Brain Tumor (MDASI-BT) at Six Months (Patient Reported Outcomes)', 'timeFrame': 'Up to 2 years', 'description': 'The MD Anderson Symptom Inventory for brain tumor (MDASI-BT) is a 28-item multi-symptom patient-reported outcome measure assessing the severity of symptoms experienced by cancer patients and the interference with daily living caused by these symptoms, with 9 items specific to brain tumors. Each item ranges from 0 (best condition) to 10 (worst condition). A subscale score is the average of the subscale items, given that a specified minimum numbers of items were completed.'}, {'measure': 'Neurocognitive Function (NCF)', 'timeFrame': 'Up to 2 years'}, {'measure': 'Selected Patient-Reported Outcomes Version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE) Items', 'timeFrame': 'Up to 2 years', 'description': "Questions refer to the participants' experiences for the past 7 days of a given symptom in terms of frequency (never, rarely, occasionally, frequently, almost constantly), severity (none, mild, moderate, severe, very severe), interference with usual or daily activities (not at all, a little bit, somewhat, quite a bit, very much)."}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Gliosarcoma', 'MGMT-Unmethylated Glioblastoma']}, 'referencesModule': {'references': [{'pmid': '40779733', 'type': 'DERIVED', 'citation': 'Lassman AB, Polley MC, Iwamoto FM, Sloan AE, Wang TJC, Aldape KD, Wefel JS, Gondi V, Gutierrez AN, Manasawala MH, Gilbert MR, Sulman EP, Wolchok JD, Green RM, Neil EC, Lukas RV, Goldlust SA, Snuderl M, Galbraith K, Dignam JJ, Won M, Mehta MP. Dual Immune Check Point Blockade in MGMT-Unmethylated Newly Diagnosed Glioblastoma: NRG Oncology BN007, a Randomized Phase II/III Clinical Trial. J Clin Oncol. 2025 Sep 20;43(27):3032-3040. doi: 10.1200/JCO-25-00618. Epub 2025 Aug 8.'}, {'pmid': '32691060', 'type': 'DERIVED', 'citation': 'Woroniecka K, Fecci PE. Immuno-synergy? Neoantigen vaccines and checkpoint blockade in glioblastoma. Neuro Oncol. 2020 Sep 29;22(9):1233-1234. doi: 10.1093/neuonc/noaa170. No abstract available.'}]}, 'descriptionModule': {'briefSummary': "This phase II/III trial compares the usual treatment with radiation therapy and temozolomide to radiation therapy in combination with immunotherapy with ipilimumab and nivolumab in treating patients with newly diagnosed MGMT unmethylated glioblastoma. Radiation therapy uses high energy photons to kill tumor and shrink tumors. Chemotherapy drugs, such as temozolomide, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Temozolomide, may not work as well for the treatment of tumors that have the unmethylated MGMT. Immunotherapy with monoclonal antibodies called immune checkpoint inhibitors, such as ipilimumab and nivolumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. It is possible that immune checkpoint inhibitors may work better at time of first diagnosis as opposed to when tumor comes back. Giving radiation therapy with ipilimumab and nivolumab may lengthen the time without brain tumor returning or growing and may extend patients' life compared to usual treatment with radiation therapy and temozolomide.", 'detailedDescription': 'PRIMARY OBJECTIVES:\n\nI. To determine if adding ipilimumab and nivolumab to radiotherapy significantly prolongs progression-free survival (PFS) versus adding temozolomide to radiotherapy in patients with newly diagnosed glioblastoma (GBM) without MGMT promoter methylation. (Phase II) II. To determine if adding ipilimumab and nivolumab to radiotherapy significantly prolongs overall survival (OS) versus adding temozolomide to radiotherapy in patients with newly diagnosed GBM without MGMT promoter methylation. (Phase III)\n\nSECONDARY OBJECTIVES:\n\nI. To determine if adding ipilimumab and nivolumab to radiotherapy significantly prolongs PFS versus adding temozolomide to radiotherapy in patients with newly diagnosed GBM without MGMT promoter methylation for the phase III part of the study.\n\nII. To determine if adding ipilimumab and nivolumab to radiotherapy significantly increases the 2-year OS rate versus adding temozolomide to radiotherapy in patients with newly diagnosed GBM without MGMT promoter methylation.\n\nIII. To evaluate the safety of adding ipilimumab and nivolumab to radiotherapy via comparative frequency between arms of specific adverse events of interest and frequency summaries for all adverse event types.\n\nIV. To evaluate the effect of adding ipilimumab and nivolumab to radiotherapy versus adding temozolomide to radiotherapy on patient reported outcomes (PROs), as measured by the MD Anderson Symptom Inventory - Brain Tumor (MDASI-BT) in patients with newly diagnosed GBM without MGMT promoter methylation.\n\nV. To evaluate the effect of adding ipilimumab and nivolumab to radiotherapy versus adding temozolomide to radiotherapy on selected Patient Reported Outcomes-Common Terminology Criteria for Adverse Events (PRO-CTCAE) items in patients with newly diagnosed GBM without MGMT promoter methylation.\n\nVI. To evaluate the impact of adding ipilimumab and nivolumab to radiotherapy versus adding temozolomide to radiotherapy on neurocognitive function (NCF) in patients with newly diagnosed GBM without MGMT promoter methylation.\n\nEXPLORATORY OBJECTIVES:\n\nI. To explore biomarkers in pre-treatment archival tumor tissue that may predict efficacy of ipilimumab and nivolumab as measured by OS, PFS, and 2-year OS rate, such as but not limited to:\n\nIa. PDL1 expression; Ib. Mutational burden. II. To explore (in the two treatment separately) whether the MGMT protein expression correlates with clinical outcomes including OS, PFS, and 2-year OS rate.\n\nIII. To evaluate if MGMT protein expression may be predictive of differential treatment effects between the two treatment arms.\n\nOUTLINE: Patients are randomized to 1 of 2 arms.\n\nARM 1: Patients undergo radiation therapy for 5 days per week (Monday-Friday) for a total of 30 fractions over 6 weeks and simultaneously receive temozolomide orally (PO) daily for 6 weeks. After radiation, patients may wear the Optune device at the discretion of the patient and their treating physician. Beginning 1 month after radiation therapy, patients receive temozolomide on days 1-5. Treatment repeats every 28 days for up to 12 cycles at the discretion of the treating investigator in the absence of disease progression or unacceptable toxicity. Patients also undergo contrast-enhanced brain magnetic resonance imaging (MRI) throughout the trial.\n\nARM 2: Patients undergo radiation therapy for 5 days per week (Monday-Friday) for a total of 30 fractions over 6 weeks. Starting on the first day of radiation, patients also receive ipilimumab intravenously (IV) over 90 minutes once every 4 weeks (Q4W) for 4 doses and nivolumab IV over 30 minutes every 2 weeks until disease progression. Patients also undergo contrast-enhanced brain MRI throughout the trial.\n\nAfter completion of study treatment, patients are followed up every 3 months for year 1, then every 4 months for year 2, and then every 6 months thereafter.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* PRIOR TO STEP 1 REGISTRATION:\n* No known IDH mutation. (If tested before step 1 registration, patients known to have IDH mutation in the tumor on local or other testing are ineligible and should not be registered)\n* Availability of formalin-fixed paraffin-embedded (FFPE) tumor tissue block and hematoxylin \\& eosin (H\\&E) stained slide to be sent for central pathology review for confirmation of histology and MGMT promoter methylation status. Note that tissue for central pathology review and central MGMT assessment must be received by the New York University (NYU) Center for Biospecimen Research and Development (CBRD) on or before postoperative calendar day 23. If tissue cannot be received by postoperative calendar day 23, then patients may NOT enroll on this trial as central pathology review will not be complete in time for the patient to start treatment no later than 6 weeks following surgery. Results of central pathology review and central MGMT analysis will generally be conveyed to NRG Oncology within 10 business days of receipt of tissue. Note: In the event of an additional tumor resection(s), tissue must be received within 23 days of the most recent resection and the latest resection must have been performed within 30 days after the initial resection. Surgical resection (partial or complete) is required; a limited biopsy is not allowed because it will not provide sufficient tissue for MGMT analysis\n\n * Note: The central pathology review and central MGMT results determine eligibility. Therefore, patients may be offered the opportunity to consent REGARDLESS of local pathology and MGMT results, and consent can occur BEFORE local pathology interpretation is finalized and BEFORE local MGMT testing is conducted\n* Contrast-enhanced brain MRI within 3 days after surgery\n\n * MRI with Axial T2 weighted FLAIR {preferred} or T2 turbo spin echo (TSE)/fast spin echo (FSE) and 3-dimensional (3D) contrast-enhanced T1 sequences are required\n * 3D pre contrast-enhanced T1 sequences are strongly suggested\n* Women of childbearing potential (WOCBP) and men who are sexually active with WOCBP must be willing to use an adequate method of contraception hormonal or barrier method of birth control; or abstinence during and after treatment\n* The patient or a legally authorized representative must provide study-specific informed consent prior to study entry\n* PRIOR TO STEP 2 REGISTRATION:\n* Histopathologically proven diagnosis of glioblastoma (or gliosarcoma as a subtype of glioblastoma) confirmed by central pathology review\n\n * Note: diagnoses of "Molecular glioblastoma" per the Consortium to Inform Molecular and Practical Approaches to Central Nervous System (CNS) Tumor Taxonomy (c-IMPACT-NOW) criteria or "CNS grade 4" per the World Health Organization (WHO) 2021 criteria are NOT relevant\n* MGMT promoter without methylation confirmed by central pathology review. Note: Patients with tissue that is insufficient or inadequate for analysis, fails MGMT testing, or has indeterminate or methylated MGMT promoter are excluded.\n\n * Note: central pathology review and central MGMT results determine eligibility; local pathology or MGMT results cannot be used for eligibility/randomization\n * Note: patients with methylated MGMT may be considered for enrollment on NRG-BN011\n* IDH mutation testing by at least one method (such as immunohistochemistry for IDH1 R132H) must be performed as part of standard of care and no mutation must be found (i.e IDH wildtype). (If a mutation is identified then the patient will be ineligible and must be registered as ineligible at step 2.)\n\n * Note: this test is not being performed in real time as part of central review and will not be provided to sites from a centrally performed test\n* History/physical examination within 28 days prior to step 2 registration\n* Karnofsky Performance Status (KPS) \\>= 70 within 28 days prior to step 2 registration\n* Neurologic function assessment within 28 days prior to step 2 registration\n* Age \\>= 18 years\n* Hemoglobin \\>= 10 g/dl (Note: the use of transfusion or other intervention to achieve hemoglobin \\[Hgb\\] \\>= 10.0 g/dl is acceptable) (within 7 days prior to step 2 registration)\n* Leukocytes \\>= 2,000/mm\\^3 (within 7 days prior to step 2 registration)\n* Absolute neutrophil count \\>= 1,500/mm\\^3 (within 7 days prior to step 2 registration)\n* Platelets \\>= 100,000/mm\\^3 (within 7 days prior to step 2 registration)\n* Total bilirubin =\\< 1.5 x institutional/lab upper limit of normal (ULN) (within 7 days prior to step 2 registration)\n* Aspartate transaminase (AST) (serum glutamic-oxaloacetic transaminase \\[SGOT\\]) =\\< 2.5 x ULN (within 7 days prior to step 2 registration)\n* Alanine transferase (ALT) (serum glutamate pyruvate transaminase \\[SGPT\\]) =\\< 2.5 x ULN (within 7 days prior to step 2 registration)\n* Serum creatinine =\\< 1.5 x ULN OR creatinine clearance (CrCl) \\>= 50 mL/min (if using the Cockcroft-Gault formula) (within 7 days prior to step 2 registration)\n* For patients with evidence of chronic hepatitis B virus (HBV) infection, the HBV viral load must be undetectable on suppressive therapy, if indicated. Patients with a history of hepatitis C virus (HCV) infection must have been treated and cured. For patients with HCV infection who are currently on treatment, they are eligible if they have an undetectable HCV viral load\n* For women of childbearing potential (WOCBP), negative serum or urine pregnancy test within 7 days prior to step 2 registration. Note that it may need to be repeated if not also within 3 days prior to treatment start\n\n * Women of childbearing potential (WOCBP) is defined as any female who has experienced menarche and who has not undergone surgical sterilization (hysterectomy or bilateral oophorectomy) or who is not postmenopausal. Menopause is defined clinically as 12 months of amenorrhea in a woman over 45 in the absence of other biological or physiological causes\n\nExclusion Criteria:\n\n* Prior therapy for tumor except for resection. For example, prior chemotherapy, immunotherapy, or targeted therapy for GBM or lower grade glioma is disallowed (including but not limited to temozolomide, lomustine, bevacizumab, any viral therapy, ipilimumab or other CTLA-4 antibody, PD-1 antibody, CD-137 agonist, CD40 antibody, PDL-1 or 2 antibody, vaccine therapy, polio or similar viral injection as treatment for the tumor, and/or any other antibody or drug specifically targeting T-cell co-stimulation or immune checkpoint pathways) as is prior Laser interstitial thermal therapy (LITT), Gliadel wafer, radiotherapy, radiosurgery, gamma knife, cyber knife, vaccine or other immunotherapy, brachytherapy, or convection enhanced delivery;\n\n * Note that 5-aminolevulinic acid (ALA)-mediated fluorescent guided resection (FGR) photodynamic therapy (PDT) or fluorescein administered prior to/during surgery to aid resection is not exclusionary and is not considered a chemotherapy or intracerebral agent\n* Current or planned treatment with any other investigational agents for the study cancer\n* Definitive clinical or radiologic evidence of metastatic disease outside the brain\n* Prior invasive malignancy (except non-melanomatous skin cancer, cervical cancer in situ and melanoma in situ) unless disease free for a minimum of 2 years\n* Prior radiotherapy to the head or neck that would result in overlap of radiation therapy fields\n* Pregnancy and nursing females due to the potential teratogenic effects and potential risk for adverse events in nursing infants\n* History of severe hypersensitivity reaction to any monoclonal antibody\n* History of allergic reactions attributed to compounds of similar chemical or biologic composition to ipilimumab, nivolumab, or temozolomide\n* On any dose of any systemically administered (oral, rectal, intravenous) corticosteroid within 3 days prior to step 2 registration. Inhaled, topical, and ocular corticosteroids are allowed without limitation but must be recorded. Note that treatment with systemically administered corticosteroid after initiating study treatment is allowed as needed\n* Patients with known immune impairment who may be unable to respond to anti-CTLA 4 antibody\n* History of interstitial lung disease including but not limited to sarcoidosis or pneumonitis\n* Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, defined as New York Heart Association functional classification III/IV (Note: Patients with known history or current symptoms of cardiac disease, or history of treatment with cardiotoxic agents, should have a clinical risk assessment of cardiac function using the New York Heart Association functional classification), unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements\n* Known history of testing positive for human immunodeficiency virus (HIV) or known acquired immunodeficiency syndrome (AIDS)\n* Patients with active autoimmune disease or history of autoimmune disease that might recur, which may affect vital organ function or require immune suppressive treatment including systemic corticosteroids, are excluded, as are patients on active immunosuppressive therapy. These include but are not limited to: patients with a history of immune-related neurologic disease, CNS or motor neuropathy, multiple sclerosis, autoimmune (demyelinating) neuropathy, Guillain-Barre syndrome, myasthenia gravis; systemic autoimmune disease such as autoimmune vasculitis \\[e.g., Wegener\'s Granulomatosis\\]), systemic lupus erythematosus (SLE), connective tissue diseases (e.g., systemic progressive sclerosis), scleroderma, inflammatory bowel disease (IBD), Crohn\'s, ulcerative colitis, hepatitis; and patients with a history of toxic epidermal necrolysis (TEN), Stevens-Johnson syndrome, or phospholipid syndrome, Hashimoto\'s thyroiditis, autoimmune hepatitis are excluded because of the risk of recurrence or exacerbation of disease\n\n * Exceptions: patients with a history of the following conditions are not excluded, unless receiving active immunosuppressive therapy:\n\n * Vitiligo\n * Type I diabetes\n * Rheumatoid arthritis and other arthropathies\n * Sjogren\'s syndrome and psoriasis controlled with topical medication and patients with positive serology, such as antinuclear antibodies (ANA)\n\n * Anti-thyroid antibodies should be evaluated for the presence of target organ involvement and potential need for systemic treatment but should otherwise be eligible\n* Patients who have evidence of active or acute diverticulitis, intra-abdominal abscess, gastrointestinal (GI) obstruction and abdominal carcinomatosis which are known risk factors for bowel perforation are also excluded\n* Current or planned therapy with warfarin'}, 'identificationModule': {'nctId': 'NCT04396860', 'briefTitle': 'Testing the Use of the Immunotherapy Drugs Ipilimumab and Nivolumab Plus Radiation Therapy Compared to the Usual Treatment (Temozolomide and Radiation Therapy) for Newly Diagnosed MGMT Unmethylated Glioblastoma', 'organization': {'class': 'NIH', 'fullName': 'National Cancer Institute (NCI)'}, 'officialTitle': 'A Randomized Phase II/III Open-Label Study of Ipilimumab and Nivolumab Versus Temozolomide in Patients With Newly Diagnosed MGMT (Tumor O-6-Methylguanine DNA Methyltransferase) Unmethylated Glioblastoma', 'orgStudyIdInfo': {'id': 'NCI-2020-03404'}, 'secondaryIdInfos': [{'id': 'NCI-2020-03404', 'type': 'REGISTRY', 'domain': 'CTRP (Clinical Trial Reporting Program)'}, {'id': 'NRG-BN007', 'type': 'OTHER', 'domain': 'NRG Oncology'}, {'id': 'NRG-BN007', 'type': 'OTHER', 'domain': 'CTEP'}, {'id': 'U10CA180868', 'link': 'https://reporter.nih.gov/quickSearch/U10CA180868', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Arm I (radiation therapy, temozolomide)', 'description': 'Patients undergo radiation therapy for 5 days per week (Monday-Friday) for a total of 30 fractions over 6 weeks and simultaneously receive temozolomide PO daily for 6 weeks. After radiation, patients may wear the Optune device at the discretion of the patient and their treating physician. Beginning 1 month after radiation therapy, patients receive temozolomide on days 1-5. Treatment repeats every 28 days for up to 12 cycles at the discretion of the treating investigator in the absence of disease progression or unacceptable toxicity. Patients also undergo contrast-enhanced brain MRI throughout the trial.', 'interventionNames': ['Procedure: Contrast-enhanced Magnetic Resonance Imaging', 'Device: NovoTTF-100A Device', 'Other: Quality-of-Life Assessment', 'Other: Questionnaire Administration', 'Radiation: Radiation Therapy', 'Drug: Temozolomide']}, {'type': 'EXPERIMENTAL', 'label': 'Arm II (radiation therapy, ipilimumab, nivolumab)', 'description': 'Patients undergo radiation therapy for 5 days per week (Monday-Friday) for a total of 30 fractions over 6 weeks. Starting on the first day of radiation, patients also receive ipilimumab IV over 90 minutes Q4W for 4 doses and nivolumab IV over 30 minutes every 2 weeks until disease progression. Patients also undergo contrast-enhanced brain MRI throughout the trial.', 'interventionNames': ['Procedure: Contrast-enhanced Magnetic Resonance Imaging', 'Biological: Ipilimumab', 'Biological: Nivolumab', 'Other: Quality-of-Life Assessment', 'Other: Questionnaire Administration', 'Radiation: Radiation Therapy']}], 'interventions': [{'name': 'Contrast-enhanced Magnetic Resonance Imaging', 'type': 'PROCEDURE', 'otherNames': ['CONTRAST ENHANCED MRI', 'Contrast-enhanced MRI', 'MRI With Contrast'], 'description': 'Undergo contrast-enhanced brain MRI', 'armGroupLabels': ['Arm I (radiation therapy, temozolomide)', 'Arm II (radiation therapy, ipilimumab, nivolumab)']}, {'name': 'Ipilimumab', 'type': 'BIOLOGICAL', 'otherNames': ['Anti-Cytotoxic T-Lymphocyte-Associated Antigen-4 Monoclonal Antibody', 'BMS 734016', 'BMS-734016', 'BMS734016', 'Ipilimumab Biosimilar CS1002', 'MDX 010', 'MDX-010', 'MDX-CTLA4', 'MDX010', 'Yervoy'], 'description': 'Given IV', 'armGroupLabels': ['Arm II (radiation therapy, ipilimumab, nivolumab)']}, {'name': 'Nivolumab', 'type': 'BIOLOGICAL', 'otherNames': ['ABP 206', 'BCD-263', 'BMS 936558', 'BMS-936558', 'BMS936558', 'CMAB819', 'MDX 1106', 'MDX-1106', 'MDX1106', 'NIVO', 'Nivolumab Biosimilar ABP 206', 'Nivolumab Biosimilar BCD-263', 'Nivolumab Biosimilar CMAB819', 'ONO 4538', 'ONO-4538', 'ONO4538', 'Opdivo'], 'description': 'Given IV', 'armGroupLabels': ['Arm II (radiation therapy, ipilimumab, nivolumab)']}, {'name': 'NovoTTF-100A Device', 'type': 'DEVICE', 'otherNames': ['NovoTTF-100A', 'NovoTTF-100A System', 'NovoTTF-100A system (Optune)', 'NovoTTFields', 'NovoTumor Treatment Fields', 'Optune', 'Optune Device'], 'description': 'Wear Optune device', 'armGroupLabels': ['Arm I (radiation therapy, temozolomide)']}, {'name': 'Quality-of-Life Assessment', 'type': 'OTHER', 'otherNames': ['Quality of Life Assessment'], 'description': 'Ancillary studies', 'armGroupLabels': ['Arm I (radiation therapy, temozolomide)', 'Arm II (radiation therapy, ipilimumab, nivolumab)']}, {'name': 'Questionnaire Administration', 'type': 'OTHER', 'description': 'Ancillary studies', 'armGroupLabels': ['Arm I (radiation therapy, temozolomide)', 'Arm II (radiation therapy, ipilimumab, nivolumab)']}, {'name': 'Radiation Therapy', 'type': 'RADIATION', 'otherNames': ['Cancer Radiotherapy', 'Energy Type', 'ENERGY_TYPE', 'Irradiate', 'Irradiated', 'Irradiation', 'Radiation', 'Radiation Therapy, NOS', 'Radiotherapeutics', 'Radiotherapy', 'RT', 'Therapy, Radiation'], 'description': 'Undergo radiation therapy', 'armGroupLabels': ['Arm I (radiation therapy, temozolomide)', 'Arm II (radiation therapy, ipilimumab, nivolumab)']}, {'name': 'Temozolomide', 'type': 'DRUG', 'otherNames': ['CCRG-81045', 'Gliotem', 'Imidazo[5,1-d]-1,2,3,5-tetrazine-8-carboxamide, 3, 4-dihydro-3-methyl-4-oxo-', 'M & B 39831', 'M and B 39831', 'Methazolastone', 'RP-46161', 'SCH 52365', 'Temcad', 'Temizole', 'Temodal', 'Temodar', 'Temomedac', 'TMZ'], 'description': 'Given PO', 'armGroupLabels': ['Arm I (radiation therapy, temozolomide)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '35233', 'city': 'Birmingham', 'state': 'Alabama', 'country': 'United States', 'facility': 'University of Alabama at Birmingham Cancer Center', 'geoPoint': {'lat': 33.52066, 'lon': -86.80249}}, {'zip': '72205', 'city': 'Little Rock', 'state': 'Arkansas', 'country': 'United States', 'facility': 'University of Arkansas for Medical Sciences', 'geoPoint': {'lat': 34.74648, 'lon': -92.28959}}, {'zip': '92806', 'city': 'Anaheim', 'state': 'California', 'country': 'United States', 'facility': 'Kaiser Permanente-Anaheim', 'geoPoint': {'lat': 33.83529, 'lon': -117.9145}}, {'zip': '95602', 'city': 'Auburn', 'state': 'California', 'country': 'United States', 'facility': 'Sutter Auburn Faith Hospital', 'geoPoint': {'lat': 38.89657, 'lon': -121.07689}}, {'zip': '95603', 'city': 'Auburn', 'state': 'California', 'country': 'United States', 'facility': 'Sutter Cancer Centers Radiation 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Medical Center', 'geoPoint': {'lat': 38.77456, 'lon': -75.13935}}, {'zip': '19967', 'city': 'Millville', 'state': 'Delaware', 'country': 'United States', 'facility': 'Beebe South Coastal Health Campus', 'geoPoint': {'lat': 38.54956, 'lon': -75.12324}}, {'zip': '19713', 'city': 'Newark', 'state': 'Delaware', 'country': 'United States', 'facility': 'Delaware Clinical and Laboratory Physicians PA', 'geoPoint': {'lat': 39.68372, 'lon': -75.74966}}, {'zip': '19713', 'city': 'Newark', 'state': 'Delaware', 'country': 'United States', 'facility': 'Helen F Graham Cancer Center', 'geoPoint': {'lat': 39.68372, 'lon': -75.74966}}, {'zip': '19713', 'city': 'Newark', 'state': 'Delaware', 'country': 'United States', 'facility': 'Medical Oncology Hematology Consultants PA', 'geoPoint': {'lat': 39.68372, 'lon': -75.74966}}, {'zip': '19718', 'city': 'Newark', 'state': 'Delaware', 'country': 'United States', 'facility': 'Christiana Care Health System-Christiana Hospital', 'geoPoint': {'lat': 39.68372, 'lon': -75.74966}}, {'zip': '19971', 'city': 'Rehoboth Beach', 'state': 'Delaware', 'country': 'United States', 'facility': 'Beebe Health Campus', 'geoPoint': {'lat': 38.72095, 'lon': -75.07601}}, {'zip': '32207', 'city': 'Jacksonville', 'state': 'Florida', 'country': 'United States', 'facility': 'Baptist MD Anderson Cancer Center', 'geoPoint': {'lat': 30.33218, 'lon': -81.65565}}, {'zip': '32803', 'city': 'Orlando', 'state': 'Florida', 'country': 'United States', 'facility': 'AdventHealth Orlando', 'geoPoint': {'lat': 28.53834, 'lon': -81.37924}}, {'zip': '30912', 'city': 'Augusta', 'state': 'Georgia', 'country': 'United States', 'facility': 'Augusta University Medical Center', 'geoPoint': {'lat': 33.47097, 'lon': -81.97484}}, {'zip': '31404', 'city': 'Savannah', 'state': 'Georgia', 'country': 'United States', 'facility': 'Memorial Health University Medical Center', 'geoPoint': {'lat': 32.08354, 'lon': -81.09983}}, {'zip': '31405', 'city': 'Savannah', 'state': 'Georgia', 'country': 'United States', 'facility': "Lewis Cancer and Research Pavilion at Saint Joseph's/Candler", 'geoPoint': {'lat': 32.08354, 'lon': -81.09983}}, {'zip': '31792', 'city': 'Thomasville', 'state': 'Georgia', 'country': 'United States', 'facility': 'Lewis Hall Singletary Oncology Center', 'geoPoint': {'lat': 30.83658, 'lon': -83.97878}}, {'zip': '96813', 'city': 'Honolulu', 'state': 'Hawaii', 'country': 'United States', 'facility': 'Hawaii Cancer Care Inc - Waterfront Plaza', 'geoPoint': {'lat': 21.30694, 'lon': -157.85833}}, {'zip': '96813', 'city': 'Honolulu', 'state': 'Hawaii', 'country': 'United States', 'facility': 'Island Urology', 'geoPoint': {'lat': 21.30694, 'lon': -157.85833}}, {'zip': '96813', 'city': 'Honolulu', 'state': 'Hawaii', 'country': 'United States', 'facility': "Queen's Cancer Cenrer - POB I", 'geoPoint': {'lat': 21.30694, 'lon': -157.85833}}, {'zip': '96813', 'city': 'Honolulu', 'state': 'Hawaii', 'country': 'United States', 'facility': "Queen's Medical Center", 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'state': 'Hawaii', 'country': 'United States', 'facility': 'Kapiolani Medical Center for Women and Children', 'geoPoint': {'lat': 21.30694, 'lon': -157.85833}}, {'zip': '96734', 'city': 'Kailua', 'state': 'Hawaii', 'country': 'United States', 'facility': 'Castle Medical Center', 'geoPoint': {'lat': 21.40241, 'lon': -157.74054}}, {'zip': '96766', 'city': 'Lihue', 'state': 'Hawaii', 'country': 'United States', 'facility': 'Wilcox Memorial Hospital and Kauai Medical Clinic', 'geoPoint': {'lat': 21.98121, 'lon': -159.3721}}, {'zip': '96701', 'city': '‘Aiea', 'state': 'Hawaii', 'country': 'United States', 'facility': 'Hawaii Cancer Care - Westridge', 'geoPoint': {'lat': 21.38222, 'lon': -157.93361}}, {'zip': '96701', 'city': '‘Aiea', 'state': 'Hawaii', 'country': 'United States', 'facility': 'Pali Momi Medical Center', 'geoPoint': {'lat': 21.38222, 'lon': -157.93361}}, {'zip': '96701', 'city': '‘Aiea', 'state': 'Hawaii', 'country': 'United States', 'facility': "Queen's Cancer Center - Pearlridge", 'geoPoint': {'lat': 21.38222, 'lon': -157.93361}}, {'zip': '96701', 'city': '‘Aiea', 'state': 'Hawaii', 'country': 'United States', 'facility': 'The Cancer Center of Hawaii-Pali Momi', 'geoPoint': {'lat': 21.38222, 'lon': -157.93361}}, {'zip': '83712', 'city': 'Boise', 'state': 'Idaho', 'country': 'United States', 'facility': "Saint Luke's Cancer Institute - Boise", 'geoPoint': {'lat': 43.6135, 'lon': -116.20345}}, {'zip': '83605', 'city': 'Caldwell', 'state': 'Idaho', 'country': 'United States', 'facility': 'Saint Alphonsus Cancer Care Center-Caldwell', 'geoPoint': {'lat': 43.66294, 'lon': -116.68736}}, {'zip': '83619', 'city': 'Fruitland', 'state': 'Idaho', 'country': 'United States', 'facility': "Saint Luke's Cancer Institute - Fruitland", 'geoPoint': {'lat': 44.00766, 'lon': -116.91655}}, {'zip': '83642', 'city': 'Meridian', 'state': 'Idaho', 'country': 'United States', 'facility': "Saint Luke's Cancer Institute - Meridian", 'geoPoint': {'lat': 43.61211, 'lon': 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