Ignite Creation Date:
2025-12-24 @ 2:34 PM
Ignite Modification Date:
2026-02-22 @ 7:23 PM
Study NCT ID:
NCT02551159
Status:
COMPLETED
Last Update Posted:
2021-10-13
First Post:
2015-09-09
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Phase III Open Label Study of MEDI 4736 With/Without Tremelimumab Versus Standard of Care (SOC) in Recurrent/Metastatic Head and Neck Cancer
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['Bulgaria', 'Portugal']}, 'conditionBrowseModule': {'meshes': [{'id': 'D000077195', 'term': 'Squamous Cell Carcinoma of Head and Neck'}], 'ancestors': [{'id': 'D002294', 'term': 'Carcinoma, Squamous Cell'}, {'id': 'D002277', 'term': 'Carcinoma'}, {'id': 'D009375', 'term': 'Neoplasms, Glandular and Epithelial'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D006258', 'term': 'Head and Neck Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C000613593', 'term': 'durvalumab'}, {'id': 'C520704', 'term': 'tremelimumab'}, {'id': 'D000068818', 'term': 'Cetuximab'}, {'id': 'D005472', 'term': 'Fluorouracil'}, {'id': 'D002945', 'term': 'Cisplatin'}, {'id': 'D016190', 'term': 'Carboplatin'}], 'ancestors': [{'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': 'D014498', 'term': 'Uracil'}, {'id': 'D011744', 'term': 'Pyrimidinones'}, {'id': 'D011743', 'term': 'Pyrimidines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D017606', 'term': 'Chlorine Compounds'}, {'id': 'D007287', 'term': 'Inorganic Chemicals'}, {'id': 'D017672', 'term': 'Nitrogen Compounds'}, {'id': 'D017671', 'term': 'Platinum Compounds'}, {'id': 'D056831', 'term': 'Coordination Complexes'}, {'id': 'D009930', 'term': 'Organic Chemicals'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'information.center@astrazeneca.com', 'phone': '1-877-240-9479', 'title': 'Global Clinical Lead', 'organization': 'AstraZeneca Clinical Study Information Center'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': 'Adverse events and serious adverse events will be collected from the time of signature of informed consent throughout the treatment period and including the follow-up period (up to 90 days after the last dose of investigational product or until initiation of another therapy) for an average of approximately 4 years.', 'eventGroups': [{'id': 'EG000', 'title': 'Durvalumab + Tremelimumab', 'description': 'tremelimumab (75 mg) via IV infusion every 4 weeks for a maximum of 4 doses, and durvalumab (1500 mg) via IV infusion every 4 weeks until disease progression', 'otherNumAtRisk': 408, 'deathsNumAtRisk': 413, 'otherNumAffected': 317, 'seriousNumAtRisk': 408, 'deathsNumAffected': 356, 'seriousNumAffected': 168}, {'id': 'EG001', 'title': 'Durvalumab', 'description': 'durvalumab (1500 mg) via IV infusion every 4 weeks until disease progression', 'otherNumAtRisk': 202, 'deathsNumAtRisk': 204, 'otherNumAffected': 153, 'seriousNumAtRisk': 202, 'deathsNumAffected': 176, 'seriousNumAffected': 78}, {'id': 'EG002', 'title': 'Standard of Care (SOC)', 'description': 'either cisplatin (at a dose of 100 mg/m2 of body surface area as an IV infusion) or carboplatin (at an area under the concentration curve of 5 mg/mL/min as an IV infusion) on Day 1 of up to six 3-week cycles, and an infusion of 5-fluorouracil (5FU) (at a dose of 1000 mg/m2/day on Days 1 through 4) every 3 weeks, along with 400 mg/m2 of cetuximab on Cycle 1 Day 1 and 250 mg/m2 weekly for up to 6 cycles and maintenance cetuximab at 250 mg/m2 administered via IV infusion weekly thereafter in patients who achieved stable disease (SD) or better upon completion of chemotherapy until disease progression, toxicity, or withdrawal of consent', 'otherNumAtRisk': 196, 'deathsNumAtRisk': 206, 'otherNumAffected': 182, 'seriousNumAtRisk': 196, 'deathsNumAffected': 171, 'seriousNumAffected': 94}], 'otherEvents': [{'term': 'Anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 408, 'numEvents': 68, 'numAffected': 61}, {'groupId': 'EG001', 'numAtRisk': 202, 'numEvents': 26, 'numAffected': 22}, {'groupId': 'EG002', 'numAtRisk': 196, 'numEvents': 97, 'numAffected': 65}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Leukopenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 408, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 202, 'numEvents': 3, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 196, 'numEvents': 48, 'numAffected': 26}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Neutropenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 408, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 202, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 196, 'numEvents': 103, 'numAffected': 63}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Thrombocytopenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 408, 'numEvents': 24, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 202, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 196, 'numEvents': 76, 'numAffected': 39}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Hyperthyroidism', 'stats': [{'groupId': 'EG000', 'numAtRisk': 408, 'numEvents': 30, 'numAffected': 23}, {'groupId': 'EG001', 'numAtRisk': 202, 'numEvents': 6, 'numAffected': 6}, {'groupId': 'EG002', 'numAtRisk': 196, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Endocrine disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Hypothyroidism', 'stats': [{'groupId': 'EG000', 'numAtRisk': 408, 'numEvents': 79, 'numAffected': 68}, {'groupId': 'EG001', 'numAtRisk': 202, 'numEvents': 23, 'numAffected': 21}, {'groupId': 'EG002', 'numAtRisk': 196, 'numEvents': 7, 'numAffected': 7}], 'organSystem': 'Endocrine disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Constipation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 408, 'numEvents': 72, 'numAffected': 59}, {'groupId': 'EG001', 'numAtRisk': 202, 'numEvents': 25, 'numAffected': 24}, {'groupId': 'EG002', 'numAtRisk': 196, 'numEvents': 68, 'numAffected': 54}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 408, 'numEvents': 113, 'numAffected': 70}, {'groupId': 'EG001', 'numAtRisk': 202, 'numEvents': 20, 'numAffected': 15}, {'groupId': 'EG002', 'numAtRisk': 196, 'numEvents': 96, 'numAffected': 60}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Dysphagia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 408, 'numEvents': 28, 'numAffected': 26}, {'groupId': 'EG001', 'numAtRisk': 202, 'numEvents': 9, 'numAffected': 8}, {'groupId': 'EG002', 'numAtRisk': 196, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 408, 'numEvents': 65, 'numAffected': 52}, {'groupId': 'EG001', 'numAtRisk': 202, 'numEvents': 14, 'numAffected': 13}, {'groupId': 'EG002', 'numAtRisk': 196, 'numEvents': 120, 'numAffected': 74}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Stomatitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 408, 'numEvents': 16, 'numAffected': 14}, {'groupId': 'EG001', 'numAtRisk': 202, 'numEvents': 6, 'numAffected': 6}, {'groupId': 'EG002', 'numAtRisk': 196, 'numEvents': 54, 'numAffected': 40}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 408, 'numEvents': 52, 'numAffected': 34}, {'groupId': 'EG001', 'numAtRisk': 202, 'numEvents': 9, 'numAffected': 8}, {'groupId': 'EG002', 'numAtRisk': 196, 'numEvents': 66, 'numAffected': 39}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Asthenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 408, 'numEvents': 60, 'numAffected': 52}, {'groupId': 'EG001', 'numAtRisk': 202, 'numEvents': 23, 'numAffected': 18}, {'groupId': 'EG002', 'numAtRisk': 196, 'numEvents': 61, 'numAffected': 38}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Fatigue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 408, 'numEvents': 74, 'numAffected': 66}, {'groupId': 'EG001', 'numAtRisk': 202, 'numEvents': 41, 'numAffected': 35}, {'groupId': 'EG002', 'numAtRisk': 196, 'numEvents': 68, 'numAffected': 56}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Mucosal inflammation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 408, 'numEvents': 16, 'numAffected': 15}, {'groupId': 'EG001', 'numAtRisk': 202, 'numEvents': 8, 'numAffected': 6}, {'groupId': 'EG002', 'numAtRisk': 196, 'numEvents': 58, 'numAffected': 43}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Pyrexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 408, 'numEvents': 54, 'numAffected': 48}, {'groupId': 'EG001', 'numAtRisk': 202, 'numEvents': 13, 'numAffected': 12}, {'groupId': 'EG002', 'numAtRisk': 196, 'numEvents': 33, 'numAffected': 21}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Paronychia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 408, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 202, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 196, 'numEvents': 24, 'numAffected': 21}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 408, 'numEvents': 22, 'numAffected': 19}, {'groupId': 'EG001', 'numAtRisk': 202, 'numEvents': 7, 'numAffected': 7}, {'groupId': 'EG002', 'numAtRisk': 196, 'numEvents': 12, 'numAffected': 10}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Aspartate aminotransferase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 408, 'numEvents': 37, 'numAffected': 27}, {'groupId': 'EG001', 'numAtRisk': 202, 'numEvents': 10, 'numAffected': 8}, {'groupId': 'EG002', 'numAtRisk': 196, 'numEvents': 14, 'numAffected': 11}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Lipase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 408, 'numEvents': 27, 'numAffected': 21}, {'groupId': 'EG001', 'numAtRisk': 202, 'numEvents': 8, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 196, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Neutrophil count decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 408, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 202, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 196, 'numEvents': 36, 'numAffected': 24}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Platelet count decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 408, 'numEvents': 5, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 202, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 196, 'numEvents': 47, 'numAffected': 22}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Weight decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 408, 'numEvents': 42, 'numAffected': 39}, {'groupId': 'EG001', 'numAtRisk': 202, 'numEvents': 15, 'numAffected': 13}, {'groupId': 'EG002', 'numAtRisk': 196, 'numEvents': 32, 'numAffected': 26}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Decreased appetite', 'stats': [{'groupId': 'EG000', 'numAtRisk': 408, 'numEvents': 57, 'numAffected': 52}, {'groupId': 'EG001', 'numAtRisk': 202, 'numEvents': 22, 'numAffected': 20}, {'groupId': 'EG002', 'numAtRisk': 196, 'numEvents': 59, 'numAffected': 46}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Hypocalcaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 408, 'numEvents': 7, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 202, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 196, 'numEvents': 27, 'numAffected': 16}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Hypomagnesaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 408, 'numEvents': 11, 'numAffected': 11}, {'groupId': 'EG001', 'numAtRisk': 202, 'numEvents': 6, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 196, 'numEvents': 77, 'numAffected': 45}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Hyponatraemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 408, 'numEvents': 30, 'numAffected': 26}, {'groupId': 'EG001', 'numAtRisk': 202, 'numEvents': 4, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 196, 'numEvents': 14, 'numAffected': 11}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Back pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 408, 'numEvents': 27, 'numAffected': 23}, {'groupId': 'EG001', 'numAtRisk': 202, 'numEvents': 8, 'numAffected': 8}, {'groupId': 'EG002', 'numAtRisk': 196, 'numEvents': 5, 'numAffected': 3}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Pain in extremity', 'stats': [{'groupId': 'EG000', 'numAtRisk': 408, 'numEvents': 6, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 202, 'numEvents': 5, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 196, 'numEvents': 10, 'numAffected': 10}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Dizziness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 408, 'numEvents': 18, 'numAffected': 15}, {'groupId': 'EG001', 'numAtRisk': 202, 'numEvents': 7, 'numAffected': 7}, {'groupId': 'EG002', 'numAtRisk': 196, 'numEvents': 15, 'numAffected': 14}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Insomnia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 408, 'numEvents': 31, 'numAffected': 29}, {'groupId': 'EG001', 'numAtRisk': 202, 'numEvents': 9, 'numAffected': 8}, {'groupId': 'EG002', 'numAtRisk': 196, 'numEvents': 11, 'numAffected': 11}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Cough', 'stats': [{'groupId': 'EG000', 'numAtRisk': 408, 'numEvents': 47, 'numAffected': 44}, {'groupId': 'EG001', 'numAtRisk': 202, 'numEvents': 14, 'numAffected': 14}, {'groupId': 'EG002', 'numAtRisk': 196, 'numEvents': 15, 'numAffected': 13}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Dyspnoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 408, 'numEvents': 40, 'numAffected': 34}, {'groupId': 'EG001', 'numAtRisk': 202, 'numEvents': 5, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 196, 'numEvents': 21, 'numAffected': 18}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Productive cough', 'stats': [{'groupId': 'EG000', 'numAtRisk': 408, 'numEvents': 22, 'numAffected': 19}, {'groupId': 'EG001', 'numAtRisk': 202, 'numEvents': 12, 'numAffected': 12}, {'groupId': 'EG002', 'numAtRisk': 196, 'numEvents': 5, 'numAffected': 5}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Alopecia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 408, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 202, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 196, 'numEvents': 11, 'numAffected': 11}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Dermatitis acneiform', 'stats': [{'groupId': 'EG000', 'numAtRisk': 408, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 202, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 196, 'numEvents': 50, 'numAffected': 36}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Dry skin', 'stats': [{'groupId': 'EG000', 'numAtRisk': 408, 'numEvents': 24, 'numAffected': 23}, {'groupId': 'EG001', 'numAtRisk': 202, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 196, 'numEvents': 34, 'numAffected': 26}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Pruritus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 408, 'numEvents': 61, 'numAffected': 45}, {'groupId': 'EG001', 'numAtRisk': 202, 'numEvents': 13, 'numAffected': 11}, {'groupId': 'EG002', 'numAtRisk': 196, 'numEvents': 18, 'numAffected': 17}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Rash', 'stats': [{'groupId': 'EG000', 'numAtRisk': 408, 'numEvents': 62, 'numAffected': 50}, {'groupId': 'EG001', 'numAtRisk': 202, 'numEvents': 17, 'numAffected': 17}, {'groupId': 'EG002', 'numAtRisk': 196, 'numEvents': 114, 'numAffected': 81}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Skin fissures', 'stats': [{'groupId': 'EG000', 'numAtRisk': 408, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 202, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 196, 'numEvents': 23, 'numAffected': 18}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Hypertension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 408, 'numEvents': 36, 'numAffected': 27}, {'groupId': 'EG001', 'numAtRisk': 202, 'numEvents': 10, 'numAffected': 9}, {'groupId': 'EG002', 'numAtRisk': 196, 'numEvents': 19, 'numAffected': 11}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Hypotension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 408, 'numEvents': 15, 'numAffected': 11}, {'groupId': 'EG001', 'numAtRisk': 202, 'numEvents': 5, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 196, 'numEvents': 16, 'numAffected': 11}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Alanine aminotransferase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 408, 'numEvents': 26, 'numAffected': 23}, {'groupId': 'EG001', 'numAtRisk': 202, 'numEvents': 6, 'numAffected': 6}, {'groupId': 'EG002', 'numAtRisk': 196, 'numEvents': 18, 'numAffected': 14}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 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Progression is defined using Response Evaluation Criteria in Solid Tumours criteria (RECIST v1.1), as ≥20% increase in the sum of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions', 'unitOfMeasure': 'Months', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'PD-L1 TC/IC subgroup'}, {'type': 'SECONDARY', 'title': 'Objective Response Rate (ORR) in the PD-L1 TC/IC High Subgroup', 'denoms': [{'units': 'Participants', 'counts': [{'value': '190', 'groupId': 'OG000'}, {'value': '99', 'groupId': 'OG001'}, {'value': '94', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Durvalumab + Tremelimumab', 'description': 'tremelimumab (75 mg) via IV infusion every 4 weeks for a maximum of 4 doses, and durvalumab (1500 mg) via IV infusion every 4 weeks until disease progression'}, {'id': 'OG001', 'title': 'Durvalumab', 'description': 'durvalumab (1500 mg) via IV infusion every 4 weeks until disease progression'}, {'id': 'OG002', 'title': 'Standard of Care (SOC)', 'description': 'either cisplatin (at a dose of 100 mg/m2 of body surface area as an IV infusion) or carboplatin (at an area under the concentration curve of 5 mg/mL/min as an IV infusion) on Day 1 of up to six 3-week cycles, and an infusion of 5-fluorouracil (5FU) (at a dose of 1000 mg/m2/day on Days 1 through 4) every 3 weeks, along with 400 mg/m2 of cetuximab on Cycle 1 Day 1 and 250 mg/m2 weekly for up to 6 cycles and maintenance cetuximab at 250 mg/m2 administered via IV infusion weekly thereafter in patients who achieved stable disease (SD) or better upon completion of chemotherapy until disease progression, toxicity, or withdrawal of consent'}], 'classes': [{'categories': [{'title': 'Response', 'measurements': [{'value': '48', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}, {'value': '47', 'groupId': 'OG002'}]}, {'title': 'No response', 'measurements': [{'value': '142', 'groupId': 'OG000'}, {'value': '83', 'groupId': 'OG001'}, {'value': '47', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG001', 'OG002'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.19', 'ciLowerLimit': '0.10', 'ciUpperLimit': '0.37', 'pValueComment': '2 sided', 'groupDescription': 'Statistical analysis of number with a response', 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '<0.001', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.34', 'ciLowerLimit': '0.20', 'ciUpperLimit': '0.57', 'pValueComment': '2 sided', 'groupDescription': 'Statistical analysis of number with a response', 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Tumor assessments (per RECIST 1.1) every 6 weeks for the first 24 weeks relative to the date of randomization and then every 8 weeks thereafter, up to approximately 4 years', 'description': 'Number (%) of patients with at least 1 visit response of complete response (CR) or partial response (PR). Per Response Evaluation Criteria in Solid Tumours (RECIST v1.1) for target lesions (TL) and assessed by MRI or CT: CR: Disappearance of all TLs since baseline; PR: \\>= 30% decrease in the sum of diameters of TLs; Overall Response (OR = CR + PR)', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'PD-L1 TC/IC subgroup'}, {'type': 'SECONDARY', 'title': 'Duration of Response (DoR) in the PD-L1 TC/IC High Subgroup', 'denoms': [{'units': 'Participants', 'counts': [{'value': '48', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}, {'value': '47', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Durvalumab + Tremelimumab', 'description': 'tremelimumab (75 mg) via IV infusion every 4 weeks for a maximum of 4 doses, and durvalumab (1500 mg) via IV infusion every 4 weeks until disease progression'}, {'id': 'OG001', 'title': 'Durvalumab', 'description': 'durvalumab (1500 mg) via IV infusion every 4 weeks until disease progression'}, {'id': 'OG002', 'title': 'Standard of Care (SOC)', 'description': 'either cisplatin (at a dose of 100 mg/m2 of body surface area as an IV infusion) or carboplatin (at an area under the concentration curve of 5 mg/mL/min as an IV infusion) on Day 1 of up to six 3-week cycles, and an infusion of 5-fluorouracil (5FU) (at a dose of 1000 mg/m2/day on Days 1 through 4) every 3 weeks, along with 400 mg/m2 of cetuximab on Cycle 1 Day 1 and 250 mg/m2 weekly for up to 6 cycles and maintenance cetuximab at 250 mg/m2 administered via IV infusion weekly thereafter in patients who achieved stable disease (SD) or better upon completion of chemotherapy until disease progression, toxicity, or withdrawal of consent'}], 'classes': [{'categories': [{'measurements': [{'value': '6.5', 'groupId': 'OG000', 'lowerLimit': '4.5', 'upperLimit': '16.1'}, {'value': '12.3', 'comment': 'The upper confidence limit was not calculable because of an insufficient number of participants with events.', 'groupId': 'OG001', 'lowerLimit': '5.6', 'upperLimit': 'NA'}, {'value': '4.2', 'groupId': 'OG002', 'lowerLimit': '3.0', 'upperLimit': '5.7'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Tumor assessments (per RECIST 1.1) every 6 weeks for the first 24 weeks relative to the date of randomization and then every 8 weeks thereafter, up to approximately 4 years', 'description': 'Time from the date of first documented response until the first date of documented progression or death in the absence of disease progression', 'unitOfMeasure': 'Months', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'PD-L1 TC/IC subgroup'}, {'type': 'SECONDARY', 'title': 'Overall Survival (OS) Status in the All-comers (Full Analysis Set)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '413', 'groupId': 'OG000'}, {'value': '204', 'groupId': 'OG001'}, {'value': '206', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Durvalumab + Tremelimumab', 'description': 'tremelimumab (75 mg) via IV infusion every 4 weeks for a maximum of 4 doses, and durvalumab (1500 mg) via IV infusion every 4 weeks until disease progression'}, {'id': 'OG001', 'title': 'Durvalumab', 'description': 'durvalumab (1500 mg) via IV infusion every 4 weeks until disease progression'}, {'id': 'OG002', 'title': 'Standard of Care (SOC)', 'description': 'either cisplatin (at a dose of 100 mg/m2 of body surface area as an IV infusion) or carboplatin (at an area under the concentration curve of 5 mg/mL/min as an IV infusion) on Day 1 of up to six 3-week cycles, and an infusion of 5-fluorouracil (5FU) (at a dose of 1000 mg/m2/day on Days 1 through 4) every 3 weeks, along with 400 mg/m2 of cetuximab on Cycle 1 Day 1 and 250 mg/m2 weekly for up to 6 cycles and maintenance cetuximab at 250 mg/m2 administered via IV infusion weekly thereafter in patients who achieved stable disease (SD) or better upon completion of chemotherapy until disease progression, toxicity, or withdrawal of consent'}], 'classes': [{'categories': [{'title': 'Death', 'measurements': [{'value': '356', 'groupId': 'OG000'}, {'value': '176', 'groupId': 'OG001'}, {'value': '171', 'groupId': 'OG002'}]}, {'title': 'Voluntary Discontinuation by subject', 'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}]}, {'title': 'Alive or lost to follow up', 'measurements': [{'value': '53', 'groupId': 'OG000'}, {'value': '25', 'groupId': 'OG001'}, {'value': '29', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '0.811', 'groupIds': ['OG001', 'OG002'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.03', 'ciLowerLimit': '0.83', 'ciUpperLimit': '1.27', 'pValueComment': '2 sided', 'groupDescription': 'Statistical analysis of number of deaths', 'statisticalMethod': 'Log Rank', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.624', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.04', 'ciLowerLimit': '0.87', 'ciUpperLimit': '1.25', 'groupDescription': 'Statistical analysis of number of deaths', 'statisticalMethod': 'Log Rank', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'From date of randomization until time of final analysis, an average of approximately 4 years', 'description': 'Number of participants with Overall Survival (OS)', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All-comers (Full analysis set)'}, {'type': 'SECONDARY', 'title': 'Overall Survival (OS) Median Duration in the All-comers (Full Analysis Set)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '413', 'groupId': 'OG000'}, {'value': '204', 'groupId': 'OG001'}, {'value': '206', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Durvalumab + Tremelimumab', 'description': 'tremelimumab (75 mg) via IV infusion every 4 weeks for a maximum of 4 doses, and durvalumab (1500 mg) via IV infusion every 4 weeks until disease progression'}, {'id': 'OG001', 'title': 'Durvalumab', 'description': 'durvalumab (1500 mg) via IV infusion every 4 weeks until disease progression'}, {'id': 'OG002', 'title': 'Standard of Care (SOC)', 'description': 'either cisplatin (at a dose of 100 mg/m2 of body surface area as an IV infusion) or carboplatin (at an area under the concentration curve of 5 mg/mL/min as an IV infusion) on Day 1 of up to six 3-week cycles, and an infusion of 5-fluorouracil (5FU) (at a dose of 1000 mg/m2/day on Days 1 through 4) every 3 weeks, along with 400 mg/m2 of cetuximab on Cycle 1 Day 1 and 250 mg/m2 weekly for up to 6 cycles and maintenance cetuximab at 250 mg/m2 administered via IV infusion weekly thereafter in patients who achieved stable disease (SD) or better upon completion of chemotherapy until disease progression, toxicity, or withdrawal of consent'}], 'classes': [{'categories': [{'measurements': [{'value': '10.7', 'groupId': 'OG000', 'lowerLimit': '9.6', 'upperLimit': '12.2'}, {'value': '9.9', 'groupId': 'OG001', 'lowerLimit': '8.9', 'upperLimit': '11.9'}, {'value': '10.3', 'groupId': 'OG002', 'lowerLimit': '9.0', 'upperLimit': '12.1'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'From date of randomization until time of final analysis, an average of approximately 4 years', 'description': 'Time from the date of randomization until death due to any cause (i.e., date of death or censoring - date of randomization + 1)', 'unitOfMeasure': 'Months', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'All-comers (Full analysis set)'}, {'type': 'SECONDARY', 'title': 'Percentage of Patients Alive at 12, 18 and 24 Months in the All-comers (Full Analysis Set)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '413', 'groupId': 'OG000'}, {'value': '204', 'groupId': 'OG001'}, {'value': '206', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Durvalumab + Tremelimumab', 'description': 'tremelimumab (75 mg) via IV infusion every 4 weeks for a maximum of 4 doses, and durvalumab (1500 mg) via IV infusion every 4 weeks until disease progression'}, {'id': 'OG001', 'title': 'Durvalumab', 'description': 'durvalumab (1500 mg) via IV infusion every 4 weeks until disease progression'}, {'id': 'OG002', 'title': 'Standard of Care (SOC)', 'description': 'either cisplatin (at a dose of 100 mg/m2 of body surface area as an IV infusion) or carboplatin (at an area under the concentration curve of 5 mg/mL/min as an IV infusion) on Day 1 of up to six 3-week cycles, and an infusion of 5-fluorouracil (5FU) (at a dose of 1000 mg/m2/day on Days 1 through 4) every 3 weeks, along with 400 mg/m2 of cetuximab on Cycle 1 Day 1 and 250 mg/m2 weekly for up to 6 cycles and maintenance cetuximab at 250 mg/m2 administered via IV infusion weekly thereafter in patients who achieved stable disease (SD) or better upon completion of chemotherapy until disease progression, toxicity, or withdrawal of consent'}], 'classes': [{'title': 'at 12 months', 'categories': [{'measurements': [{'value': '46.5', 'groupId': 'OG000', 'lowerLimit': '41.6', 'upperLimit': '51.2'}, {'value': '42.8', 'groupId': 'OG001', 'lowerLimit': '35.9', 'upperLimit': '49.5'}, {'value': '43.8', 'groupId': 'OG002', 'lowerLimit': '36.8', 'upperLimit': '50.5'}]}]}, {'title': 'at 18 months', 'categories': [{'measurements': [{'value': '30.7', 'groupId': 'OG000', 'lowerLimit': '26.3', 'upperLimit': '35.2'}, {'value': '31.2', 'groupId': 'OG001', 'lowerLimit': '24.9', 'upperLimit': '37.7'}, {'value': '29.7', 'groupId': 'OG002', 'lowerLimit': '23.5', 'upperLimit': '36.1'}]}]}, {'title': 'at 24 months', 'categories': [{'measurements': [{'value': '22.9', 'groupId': 'OG000', 'lowerLimit': '18.9', 'upperLimit': '27.0'}, {'value': '24.7', 'groupId': 'OG001', 'lowerLimit': '18.9', 'upperLimit': '30.8'}, {'value': '23.2', 'groupId': 'OG002', 'lowerLimit': '17.6', 'upperLimit': '29.2'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '12, 18 and 24 months after randomization', 'description': 'Percentage of patients alive', 'unitOfMeasure': '% of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'All-comers (Full analysis set)'}, {'type': 'SECONDARY', 'title': 'Progression Free Survival (PFS) in the All-comers (Full Analysis Set)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '413', 'groupId': 'OG000'}, {'value': '204', 'groupId': 'OG001'}, {'value': '206', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Durvalumab + Tremelimumab', 'description': 'tremelimumab (75 mg) via IV infusion every 4 weeks for a maximum of 4 doses, and durvalumab (1500 mg) via IV infusion every 4 weeks until disease progression'}, {'id': 'OG001', 'title': 'Durvalumab', 'description': 'durvalumab (1500 mg) via IV infusion every 4 weeks until disease progression'}, {'id': 'OG002', 'title': 'Standard of Care (SOC)', 'description': 'either cisplatin (at a dose of 100 mg/m2 of body surface area as an IV infusion) or carboplatin (at an area under the concentration curve of 5 mg/mL/min as an IV infusion) on Day 1 of up to six 3-week cycles, and an infusion of 5-fluorouracil (5FU) (at a dose of 1000 mg/m2/day on Days 1 through 4) every 3 weeks, along with 400 mg/m2 of cetuximab on Cycle 1 Day 1 and 250 mg/m2 weekly for up to 6 cycles and maintenance cetuximab at 250 mg/m2 administered via IV infusion weekly thereafter in patients who achieved stable disease (SD) or better upon completion of chemotherapy until disease progression, toxicity, or withdrawal of consent'}], 'classes': [{'categories': [{'measurements': [{'value': '2.8', 'groupId': 'OG000', 'lowerLimit': '2.6', 'upperLimit': '2.9'}, {'value': '2.8', 'groupId': 'OG001', 'lowerLimit': '2.0', 'upperLimit': '2.8'}, {'value': '5.4', 'groupId': 'OG002', 'lowerLimit': '4.4', 'upperLimit': '5.7'}]}]}], 'analyses': [{'pValue': '0.006', 'groupIds': ['OG001', 'OG002'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.36', 'ciLowerLimit': '1.10', 'ciUpperLimit': '1.68', 'pValueComment': '2 sided', 'statisticalMethod': 'Log Rank', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.008', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.27', 'ciLowerLimit': '1.06', 'ciUpperLimit': '1.53', 'pValueComment': '2 sided', 'statisticalMethod': 'Log Rank', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEDIAN', 'timeFrame': 'Tumor assessments (per RECIST 1.1) every 6 weeks for the first 24 weeks relative to the date of randomization and then every 8 weeks thereafter, up to approximately 4 years', 'description': 'Time from the date of randomization until the date of objective disease progression or death (by any cause in the absence of progression).\n\nProgression is defined using Response Evaluation Criteria in Solid Tumours criteria (RECIST v1.1), as ≥20% increase in the sum of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions', 'unitOfMeasure': 'Months', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'All-comers (Full analysis set)'}, {'type': 'SECONDARY', 'title': 'Objective Response Rate (ORR) in the All-comers (Full Analysis Set)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '413', 'groupId': 'OG000'}, {'value': '204', 'groupId': 'OG001'}, {'value': '206', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Durvalumab + Tremelimumab', 'description': 'tremelimumab (75 mg) via IV infusion every 4 weeks for a maximum of 4 doses, and durvalumab (1500 mg) via IV infusion every 4 weeks until disease progression'}, {'id': 'OG001', 'title': 'Durvalumab', 'description': 'durvalumab (1500 mg) via IV infusion every 4 weeks until disease progression'}, {'id': 'OG002', 'title': 'Standard of Care (SOC)', 'description': 'either cisplatin (at a dose of 100 mg/m2 of body surface area as an IV infusion) or carboplatin (at an area under the concentration curve of 5 mg/mL/min as an IV infusion) on Day 1 of up to six 3-week cycles, and an infusion of 5-fluorouracil (5FU) (at a dose of 1000 mg/m2/day on Days 1 through 4) every 3 weeks, along with 400 mg/m2 of cetuximab on Cycle 1 Day 1 and 250 mg/m2 weekly for up to 6 cycles and maintenance cetuximab at 250 mg/m2 administered via IV infusion weekly thereafter in patients who achieved stable disease (SD) or better upon completion of chemotherapy until disease progression, toxicity, or withdrawal of consent'}], 'classes': [{'categories': [{'title': 'Response', 'measurements': [{'value': '90', 'groupId': 'OG000'}, {'value': '35', 'groupId': 'OG001'}, {'value': '101', 'groupId': 'OG002'}]}, {'title': 'No response', 'measurements': [{'value': '323', 'groupId': 'OG000'}, {'value': '169', 'groupId': 'OG001'}, {'value': '105', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG001', 'OG002'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.21', 'ciLowerLimit': '0.13', 'ciUpperLimit': '0.33', 'pValueComment': '2 sided', 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '<0.001', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.29', 'ciLowerLimit': '0.20', 'ciUpperLimit': '0.41', 'pValueComment': '2 sided', 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Tumor assessments (per RECIST 1.1) every 6 weeks for the first 24 weeks relative to the date of randomization and then every 8 weeks thereafter, up to approximately 4 years', 'description': 'Number (%) of patients with at least 1 visit response of complete response (CR) or partial response (PR). Per Response Evaluation Criteria in Solid Tumours (RECIST v1.1) for target lesions (TL) and assessed by MRI or CT: CR: Disappearance of all TLs since baseline; PR: \\>= 30% decrease in the sum of diameters of TLs; Overall Response (OR = CR + PR)', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All-comers (Full analysis set)'}, {'type': 'SECONDARY', 'title': 'Duration of Response (DoR) in the All-comers (Full Analysis Set)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '90', 'groupId': 'OG000'}, {'value': '35', 'groupId': 'OG001'}, {'value': '101', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Durvalumab + Tremelimumab', 'description': 'tremelimumab (75 mg) via IV infusion every 4 weeks for a maximum of 4 doses, and durvalumab (1500 mg) via IV infusion every 4 weeks until disease progression'}, {'id': 'OG001', 'title': 'Durvalumab', 'description': 'durvalumab (1500 mg) via IV infusion every 4 weeks until disease progression'}, {'id': 'OG002', 'title': 'Standard of Care (SOC)', 'description': 'either cisplatin (at a dose of 100 mg/m2 of body surface area as an IV infusion) or carboplatin (at an area under the concentration curve of 5 mg/mL/min as an IV infusion) on Day 1 of up to six 3-week cycles, and an infusion of 5-fluorouracil (5FU) (at a dose of 1000 mg/m2/day on Days 1 through 4) every 3 weeks, along with 400 mg/m2 of cetuximab on Cycle 1 Day 1 and 250 mg/m2 weekly for up to 6 cycles and maintenance cetuximab at 250 mg/m2 administered via IV infusion weekly thereafter in patients who achieved stable disease (SD) or better upon completion of chemotherapy until disease progression, toxicity, or withdrawal of consent'}], 'classes': [{'categories': [{'measurements': [{'value': '9.2', 'groupId': 'OG000', 'lowerLimit': '6.0', 'upperLimit': '19.6'}, {'value': '11.9', 'groupId': 'OG001', 'lowerLimit': '4.6', 'upperLimit': '17.8'}, {'value': '4.2', 'groupId': 'OG002', 'lowerLimit': '3.7', 'upperLimit': '4.5'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Tumor assessments (per RECIST 1.1) every 6 weeks for the first 24 weeks relative to the date of randomization and then every 8 weeks thereafter, up to approximately 4 years', 'description': 'Time from the date of first documented response until the first date of documented progression or death in the absence of disease progression', 'unitOfMeasure': 'Months', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'All-comers (Full analysis set)'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Durvalumab + Tremelimumab', 'description': 'tremelimumab (75 mg) via IV infusion every 4 weeks for a maximum of 4 doses, and durvalumab (1500 mg) via IV infusion every 4 weeks until disease progression'}, {'id': 'FG001', 'title': 'Durvalumab', 'description': 'durvalumab (1500 mg) via IV infusion every 4 weeks until disease progression'}, {'id': 'FG002', 'title': 'Standard of Care (SOC)', 'description': 'either cisplatin (at a dose of 100 mg/m2 of body surface area as an IV infusion) or carboplatin (at an area under the concentration curve of 5 mg/mL/min as an IV infusion) on Day 1 of up to six 3-week cycles, and an infusion of 5-fluorouracil (5FU) (at a dose of 1000 mg/m2/day on Days 1 through 4) every 3 weeks, along with 400 mg/m2 of cetuximab on Cycle 1 Day 1 and 250 mg/m2 weekly for up to 6 cycles and maintenance cetuximab at 250 mg/m2 administered via IV infusion weekly thereafter in patients who achieved stable disease (SD) or better upon completion of chemotherapy until disease progression, toxicity, or withdrawal of consent'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '413'}, {'groupId': 'FG001', 'numSubjects': '204'}, {'groupId': 'FG002', 'numSubjects': '206'}]}, {'type': 'Full Analysis Set', 'comment': 'All patients randomized', 'achievements': [{'groupId': 'FG000', 'numSubjects': '413'}, {'groupId': 'FG001', 'numSubjects': '204'}, {'groupId': 'FG002', 'numSubjects': '206'}]}, {'type': 'Safety Analysis Set', 'comment': 'All patients who received at least one dose of study treatment', 'achievements': [{'groupId': 'FG000', 'numSubjects': '408'}, {'groupId': 'FG001', 'numSubjects': '202'}, {'groupId': 'FG002', 'numSubjects': '196'}]}, {'type': 'PD-L1 TC/IC High Subgroup Analysis Set', 'comment': 'Patients in the full analysis set with PD-L1 high', 'achievements': [{'groupId': 'FG000', 'numSubjects': '190'}, {'groupId': 'FG001', 'numSubjects': '99'}, {'groupId': 'FG002', 'numSubjects': '94'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '413'}, {'groupId': 'FG001', 'numSubjects': '204'}, {'groupId': 'FG002', 'numSubjects': '206'}]}], 'dropWithdraws': [{'type': 'Death', 'reasons': [{'groupId': 'FG000', 'numSubjects': '352'}, {'groupId': 'FG001', 'numSubjects': '174'}, {'groupId': 'FG002', 'numSubjects': '161'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '8'}, {'groupId': 'FG001', 'numSubjects': '5'}, {'groupId': 'FG002', 'numSubjects': '16'}]}, {'type': 'Patients alive or lost to follow-up at DCO', 'reasons': [{'groupId': 'FG000', 'numSubjects': '53'}, {'groupId': 'FG001', 'numSubjects': '25'}, {'groupId': 'FG002', 'numSubjects': '29'}]}]}], 'recruitmentDetails': 'Patients meeting all the eligibility criteria were randomized 2:1:1 to durvalumab plus tremelimumab combination therapy, durvalumab monotherapy or standard of care.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '413', 'groupId': 'BG000'}, {'value': '204', 'groupId': 'BG001'}, {'value': '206', 'groupId': 'BG002'}, {'value': '823', 'groupId': 'BG003'}]}], 'groups': [{'id': 'BG000', 'title': 'Durvalumab + Tremelimumab', 'description': 'tremelimumab (75 mg) via IV infusion every 4 weeks for a maximum of 4 doses, and durvalumab (1500 mg) via IV infusion every 4 weeks until disease progression'}, {'id': 'BG001', 'title': 'Durvalumab', 'description': 'durvalumab (1500 mg) via IV infusion every 4 weeks until disease progression'}, {'id': 'BG002', 'title': 'Standard of Care (SOC)', 'description': 'either cisplatin (at a dose of 100 mg/m2 of body surface area as an IV infusion) or carboplatin (at an area under the concentration curve of 5 mg/mL/min as an IV infusion) on Day 1 of up to six 3-week cycles, and an infusion of 5-fluorouracil (5FU) (at a dose of 1000 mg/m2/day on Days 1 through 4) every 3 weeks, along with 400 mg/m2 of cetuximab on Cycle 1 Day 1 and 250 mg/m2 weekly for up to 6 cycles and maintenance cetuximab at 250 mg/m2 administered via IV infusion weekly thereafter in patients who achieved stable disease (SD) or better upon completion of chemotherapy until disease progression, toxicity, or withdrawal of consent'}, {'id': 'BG003', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '60.5', 'spread': '9.56', 'groupId': 'BG000'}, {'value': '60.2', 'spread': '10.41', 'groupId': 'BG001'}, {'value': '60.9', 'spread': '9.45', 'groupId': 'BG002'}, {'value': '60.5', 'spread': '9.74', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'Years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '73', 'groupId': 'BG000'}, {'value': '29', 'groupId': 'BG001'}, {'value': '32', 'groupId': 'BG002'}, {'value': '134', 'groupId': 'BG003'}]}, {'title': 'Male', 'measurements': [{'value': '340', 'groupId': 'BG000'}, {'value': '175', 'groupId': 'BG001'}, {'value': '174', 'groupId': 'BG002'}, {'value': '689', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'title': 'White', 'categories': [{'measurements': [{'value': '298', 'groupId': 'BG000'}, {'value': '145', 'groupId': 'BG001'}, {'value': '160', 'groupId': 'BG002'}, {'value': '603', 'groupId': 'BG003'}]}]}, {'title': 'Black or African American', 'categories': [{'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}, {'value': '10', 'groupId': 'BG003'}]}]}, {'title': 'Asian', 'categories': [{'measurements': [{'value': '109', 'groupId': 'BG000'}, {'value': '54', 'groupId': 'BG001'}, {'value': '42', 'groupId': 'BG002'}, {'value': '205', 'groupId': 'BG003'}]}]}, {'title': 'Other', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}, {'value': '4', 'groupId': 'BG003'}]}]}, {'title': 'Missing', 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'Participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2020-06-29', 'size': 2326317, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2021-07-05T05:46', 'hasProtocol': True}, {'date': '2020-12-16', 'size': 1411106, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_001.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2021-07-05T09:00', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 823}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-10-15', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-09', 'completionDateStruct': {'date': '2021-05-21', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-09-16', 'studyFirstSubmitDate': '2015-09-09', 'resultsFirstSubmitDate': '2021-07-05', 'studyFirstSubmitQcDate': '2015-09-15', 'lastUpdatePostDateStruct': {'date': '2021-10-13', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2021-09-16', 'studyFirstPostDateStruct': {'date': '2015-09-16', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2021-10-13', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-07-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Overall Survival (OS) Status in the PD-L1 TC/IC High Subgroup - Durvalumab Versus Standard of Care (SOC)', 'timeFrame': 'From date of randomization until time of final analysis, an average of approximately 4 years', 'description': 'Number of participants with Overall Survival (OS)'}, {'measure': 'Overall Survival (OS) Median Duration in the PD-L1 TC/IC High Subgroup', 'timeFrame': 'From date of randomization until time of final analysis, an average of approximately 4 years', 'description': 'Time from the date of randomization until death due to any cause (i.e., date of death or censoring - date of randomization + 1)'}], 'secondaryOutcomes': [{'measure': 'Overall Survival (OS) Status in the PD-L1 TC/IC High Subgroup - Durvalumab + Tremelimumab Versus Standard of Care (SOC)', 'timeFrame': 'From date of randomization until time of final analysis, an average of approximately 4 years', 'description': 'Number of participants with Overall Survival (OS)'}, {'measure': 'Percentage of Patients Alive at 12, 18 and 24 Months in the PD-L1 TC/IC High Subgroup', 'timeFrame': '12, 18 and 24 months after randomization', 'description': 'Percentage of patients alive'}, {'measure': 'Progression Free Survival (PFS) in the PD-L1 TC/IC High Subgroup', 'timeFrame': 'Tumor assessments (per RECIST 1.1) every 6 weeks for the first 24 weeks relative to the date of randomization and then every 8 weeks thereafter, up to approximately 4 years', 'description': 'Time from the date of randomization until the date of objective disease progression or death (by any cause in the absence of progression). Progression is defined using Response Evaluation Criteria in Solid Tumours criteria (RECIST v1.1), as ≥20% increase in the sum of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions'}, {'measure': 'Objective Response Rate (ORR) in the PD-L1 TC/IC High Subgroup', 'timeFrame': 'Tumor assessments (per RECIST 1.1) every 6 weeks for the first 24 weeks relative to the date of randomization and then every 8 weeks thereafter, up to approximately 4 years', 'description': 'Number (%) of patients with at least 1 visit response of complete response (CR) or partial response (PR). Per Response Evaluation Criteria in Solid Tumours (RECIST v1.1) for target lesions (TL) and assessed by MRI or CT: CR: Disappearance of all TLs since baseline; PR: \\>= 30% decrease in the sum of diameters of TLs; Overall Response (OR = CR + PR)'}, {'measure': 'Duration of Response (DoR) in the PD-L1 TC/IC High Subgroup', 'timeFrame': 'Tumor assessments (per RECIST 1.1) every 6 weeks for the first 24 weeks relative to the date of randomization and then every 8 weeks thereafter, up to approximately 4 years', 'description': 'Time from the date of first documented response until the first date of documented progression or death in the absence of disease progression'}, {'measure': 'Overall Survival (OS) Status in the All-comers (Full Analysis Set)', 'timeFrame': 'From date of randomization until time of final analysis, an average of approximately 4 years', 'description': 'Number of participants with Overall Survival (OS)'}, {'measure': 'Overall Survival (OS) Median Duration in the All-comers (Full Analysis Set)', 'timeFrame': 'From date of randomization until time of final analysis, an average of approximately 4 years', 'description': 'Time from the date of randomization until death due to any cause (i.e., date of death or censoring - date of randomization + 1)'}, {'measure': 'Percentage of Patients Alive at 12, 18 and 24 Months in the All-comers (Full Analysis Set)', 'timeFrame': '12, 18 and 24 months after randomization', 'description': 'Percentage of patients alive'}, {'measure': 'Progression Free Survival (PFS) in the All-comers (Full Analysis Set)', 'timeFrame': 'Tumor assessments (per RECIST 1.1) every 6 weeks for the first 24 weeks relative to the date of randomization and then every 8 weeks thereafter, up to approximately 4 years', 'description': 'Time from the date of randomization until the date of objective disease progression or death (by any cause in the absence of progression).\n\nProgression is defined using Response Evaluation Criteria in Solid Tumours criteria (RECIST v1.1), as ≥20% increase in the sum of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions'}, {'measure': 'Objective Response Rate (ORR) in the All-comers (Full Analysis Set)', 'timeFrame': 'Tumor assessments (per RECIST 1.1) every 6 weeks for the first 24 weeks relative to the date of randomization and then every 8 weeks thereafter, up to approximately 4 years', 'description': 'Number (%) of patients with at least 1 visit response of complete response (CR) or partial response (PR). Per Response Evaluation Criteria in Solid Tumours (RECIST v1.1) for target lesions (TL) and assessed by MRI or CT: CR: Disappearance of all TLs since baseline; PR: \\>= 30% decrease in the sum of diameters of TLs; Overall Response (OR = CR + PR)'}, {'measure': 'Duration of Response (DoR) in the All-comers (Full Analysis Set)', 'timeFrame': 'Tumor assessments (per RECIST 1.1) every 6 weeks for the first 24 weeks relative to the date of randomization and then every 8 weeks thereafter, up to approximately 4 years', 'description': 'Time from the date of first documented response until the first date of documented progression or death in the absence of disease progression'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['programmed cell death ligand 1 (PD-L1), MEDI4736, Cytotoxic T-lymphocyte-associated antigen 4 {CTLA-4}, PFS, SCCHN'], 'conditions': ['Squamous Cell Carcinoma of the Head and Neck']}, 'referencesModule': {'references': [{'pmid': '38430375', 'type': 'DERIVED', 'citation': "Seiwert TY, Wildsmith S, Fayette J, Harrington K, Gillison M, Ahn MJ, Takahashi S, Weiss J, Machiels JP, Baxi S, Baker V, Evans B, Morsli N, Jill Walker, Real K, L'Hernault A, Psyrri A. Outcomes in biomarker-selected subgroups from the KESTREL study of durvalumab and tremelimumab in recurrent or metastatic head and neck squamous cell carcinoma. Cancer Immunol Immunother. 2024 Mar 2;73(4):70. doi: 10.1007/s00262-024-03643-3."}, {'pmid': '33684371', 'type': 'DERIVED', 'citation': 'Hwang M, Seiwert TY. Are taxanes the future for head and neck cancer? Pragmatism in the immunotherapy era. Lancet Oncol. 2021 Apr;22(4):413-415. doi: 10.1016/S1470-2045(21)00121-2. Epub 2021 Mar 5. No abstract available.'}], 'seeAlsoLinks': [{'url': 'https://filehosting-v2.pharmacm.com/api/Attachment/Download?tenantId=80217111&parentIdentifier=D419LC00001&attachmentIdentifier=b4025180-dfd4-4783-a723-cba099a5d9fb&fileName=D419LC00001_-_Protocol_v12__-redact.pdf&versionIdentifier=', 'label': 'Related Info'}, {'url': 'https://filehosting-v2.pharmacm.com/api/Attachment/Download?tenantId=80217111&parentIdentifier=D419LC00001&attachmentIdentifier=0a933c97-43c4-4fdc-8e9f-af78f3808b67&fileName=D419LC00001_-_SAP_v7,0_-_redact.pdf&versionIdentifier=', 'label': 'Related Info'}, {'url': 'https://filehosting-v2.pharmacm.com/api/Attachment/Download?tenantId=80217111&parentIdentifier=D419LC00001&attachmentIdentifier=da78c143-9577-4556-a890-e24f765e4d5f&fileName=D419LC00001_-_CSR_Synposis_-_28Apr2021-redact.pdf&versionIdentifier=', 'label': 'Related Info'}]}, 'descriptionModule': {'briefSummary': 'This is a randomized, open-label, multi-center, 3-arm, global Phase III study to determine the efficacy and safety of MEDI4736 + tremelimumab combination or MEDI4736 monotherapy versus SoC (EXTREME regimen) in the treatment of patients with SCCHN who have not received prior systemic chemotherapy for recurrent or metastatic disease.', 'detailedDescription': 'Patients will be randomized in a 2:1:1 ratio to MEDI4736 + tremelimumab combination therapy, MEDI4736 monotherapy, or SoC. Patients in all arms will continue therapy until progression. Tumor assessments will be performed on computed tomography scans or magnetic resonance imaging scans, preferably with intravenous (IV) contrast. Efficacy for all patients will be assessed by objective tumor assessments every 6 weeks for the first 24 weeks, then every 8 weeks thereafter until treatment discontinuation due to progression or toxicity. All patients will be followed every 3 months for survival after progression is confirmed.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '130 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n1. Age ≥18 years at the time of screening\n2. Documented evidence of recurrent or metastatic SCCHN (oral cavity, oropharynx, hypopharynx, or larynx).\n3. A fresh tumor biopsy for the purpose of screening or an available archival tumor sample. Tumor lesions used for fresh biopsies should not be the same lesions used as RECIST target lesions, unless there are no other lesions suitable for biopsy.\n4. No prior systemic chemotherapy for recurrent or metastatic disease\n5. World Health Organization (WHO)/Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 at enrollment\n6. No prior exposure to immune-mediated therapy,\n\nExclusion Criteria:\n\n1. Histologically or cytologically confirmed head and neck cancer of any other primary anatomic location in the head and neck not specified in the inclusion criteria including patients with SCCHN of unknown primary or non-squamous histologies (eg, nasopharynx or salivary gland)\n2. Tumor progression or recurrence within 6 months of last dose of platinum therapy in the primary treatment setting\n3. Receipt of any radiotherapy or hormonal therapy for cancer treatment within 30 days prior to first dose of study treatment\n4. Active or prior documented autoimmune or inflammatory disorders (including inflammatory bowel disease \\[eg, colitis, Crohn's disease\\], diverticulitis"}, 'identificationModule': {'nctId': 'NCT02551159', 'acronym': 'KESTREL', 'briefTitle': 'Phase III Open Label Study of MEDI 4736 With/Without Tremelimumab Versus Standard of Care (SOC) in Recurrent/Metastatic Head and Neck Cancer', 'organization': {'class': 'INDUSTRY', 'fullName': 'AstraZeneca'}, 'officialTitle': 'A Phase III Randomized, Open-label, Multi-center, Global Study of MEDI4736 Alone or in Combination With Tremelimumab Versus Standard of Care in the Treatment of First-line Recurrent or Metastatic Squamous Cell Head and Neck Cancer Patients', 'orgStudyIdInfo': {'id': 'D419LC00001'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Monotherapy', 'description': 'MEDI4736 monotherapy.', 'interventionNames': ['Biological: MEDI4736']}, {'type': 'EXPERIMENTAL', 'label': 'Combination Therapy', 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