Ignite Creation Date:
2025-12-24 @ 8:02 PM
Ignite Modification Date:
2026-02-23 @ 4:55 AM
Study NCT ID:
NCT04199104
Status:
COMPLETED
Last Update Posted:
2025-04-23
First Post:
2019-12-12
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
A Study of Pembrolizumab (MK-3475) With or Without Lenvatinib (E7080/MK-7902) as First Line (1L) Intervention in a Programmed Cell Death-ligand 1 (PD-L1) Selected Population With Recurrent or Metastatic Head and Neck Squamous Cell Carcinoma (R/M HNSCC) (MK-7902-010) (KEYNOTE-010)
Sponsor:
Organization:
Raw JSON
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This allows the Sponsor to protect proprietary information and to provide comments.', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'Up to ~ 37 months', 'description': 'All-cause mortality (ACM) was analyzed in all randomized participants. Safety analyses were conducted in all randomized participants who received at least 1 dose of study intervention. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA 26.0 preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.', 'eventGroups': [{'id': 'EG000', 'title': 'Pembrolizumab + Lenvatinib First Course', 'description': 'Participants were administered Pembrolizumab 200mg by intravenous IV infusion on Day 1 of each 21-day cycle (Q3W) plus Lenvatinib 20 mg orally once a day (QD).', 'otherNumAtRisk': 254, 'deathsNumAtRisk': 256, 'otherNumAffected': 244, 'seriousNumAtRisk': 254, 'deathsNumAffected': 152, 'seriousNumAffected': 152}, {'id': 'EG001', 'title': 'Pembrolizumab + Placebo', 'description': 'Participants were administered lenvatinib-matching placebo orally once a day (QD) plus pembrolizumab 200 mg by intravenous (IV) infusion on Day 1 of each 21-day cycle (Q3W).', 'otherNumAtRisk': 253, 'deathsNumAtRisk': 255, 'otherNumAffected': 221, 'seriousNumAtRisk': 253, 'deathsNumAffected': 138, 'seriousNumAffected': 89}, {'id': 'EG002', 'title': 'Pembrolizumab + Lenvatinib Second Course', 'description': 'Pembrolizumab was administered 200mg by intravenous IV infusion on Day 1 of each 21-day cycle (Q3W) for 17 cycles (\\~ 1 year) and Lenvatinib/Placebo at the last dose level was continued during second course at investigators discretion.', 'otherNumAtRisk': 2, 'deathsNumAtRisk': 2, 'otherNumAffected': 2, 'seriousNumAtRisk': 2, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 254, 'numEvents': 95, 'numAffected': 65}, {'groupId': 'EG001', 'numAtRisk': 253, 'numEvents': 73, 'numAffected': 51}, {'groupId': 'EG002', 'numAtRisk': 2, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Ear pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 254, 'numEvents': 6, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 253, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 2, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Hyperthyroidism', 'stats': [{'groupId': 'EG000', 'numAtRisk': 254, 'numEvents': 22, 'numAffected': 19}, {'groupId': 'EG001', 'numAtRisk': 253, 'numEvents': 10, 'numAffected': 10}, {'groupId': 'EG002', 'numAtRisk': 2, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Endocrine disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Hypothyroidism', 'stats': [{'groupId': 'EG000', 'numAtRisk': 254, 'numEvents': 145, 'numAffected': 124}, {'groupId': 'EG001', 'numAtRisk': 253, 'numEvents': 49, 'numAffected': 43}, {'groupId': 'EG002', 'numAtRisk': 2, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Endocrine disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Bowel movement irregularity', 'stats': [{'groupId': 'EG000', 'numAtRisk': 254, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 253, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 2, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Constipation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 254, 'numEvents': 73, 'numAffected': 56}, {'groupId': 'EG001', 'numAtRisk': 253, 'numEvents': 55, 'numAffected': 46}, {'groupId': 'EG002', 'numAtRisk': 2, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 254, 'numEvents': 111, 'numAffected': 71}, {'groupId': 'EG001', 'numAtRisk': 253, 'numEvents': 45, 'numAffected': 33}, {'groupId': 'EG002', 'numAtRisk': 2, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Dry mouth', 'stats': [{'groupId': 'EG000', 'numAtRisk': 254, 'numEvents': 18, 'numAffected': 17}, {'groupId': 'EG001', 'numAtRisk': 253, 'numEvents': 19, 'numAffected': 18}, {'groupId': 'EG002', 'numAtRisk': 2, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Dyspepsia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 254, 'numEvents': 22, 'numAffected': 14}, {'groupId': 'EG001', 'numAtRisk': 253, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 2, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Dysphagia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 254, 'numEvents': 39, 'numAffected': 35}, {'groupId': 'EG001', 'numAtRisk': 253, 'numEvents': 15, 'numAffected': 14}, {'groupId': 'EG002', 'numAtRisk': 2, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Flatulence', 'stats': [{'groupId': 'EG000', 'numAtRisk': 254, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 253, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 2, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 254, 'numEvents': 83, 'numAffected': 62}, {'groupId': 'EG001', 'numAtRisk': 253, 'numEvents': 27, 'numAffected': 25}, {'groupId': 'EG002', 'numAtRisk': 2, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Oral pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 254, 'numEvents': 34, 'numAffected': 29}, {'groupId': 'EG001', 'numAtRisk': 253, 'numEvents': 7, 'numAffected': 6}, {'groupId': 'EG002', 'numAtRisk': 2, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Stomatitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 254, 'numEvents': 73, 'numAffected': 53}, {'groupId': 'EG001', 'numAtRisk': 253, 'numEvents': 12, 'numAffected': 12}, {'groupId': 'EG002', 'numAtRisk': 2, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 254, 'numEvents': 48, 'numAffected': 33}, {'groupId': 'EG001', 'numAtRisk': 253, 'numEvents': 16, 'numAffected': 14}, {'groupId': 'EG002', 'numAtRisk': 2, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Asthenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 254, 'numEvents': 32, 'numAffected': 26}, {'groupId': 'EG001', 'numAtRisk': 253, 'numEvents': 30, 'numAffected': 25}, {'groupId': 'EG002', 'numAtRisk': 2, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Fatigue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 254, 'numEvents': 91, 'numAffected': 80}, {'groupId': 'EG001', 'numAtRisk': 253, 'numEvents': 44, 'numAffected': 41}, {'groupId': 'EG002', 'numAtRisk': 2, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Mucosal inflammation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 254, 'numEvents': 35, 'numAffected': 25}, {'groupId': 'EG001', 'numAtRisk': 253, 'numEvents': 10, 'numAffected': 7}, {'groupId': 'EG002', 'numAtRisk': 2, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Pyrexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 254, 'numEvents': 22, 'numAffected': 20}, {'groupId': 'EG001', 'numAtRisk': 253, 'numEvents': 24, 'numAffected': 19}, {'groupId': 'EG002', 'numAtRisk': 2, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'COVID-19', 'stats': [{'groupId': 'EG000', 'numAtRisk': 254, 'numEvents': 17, 'numAffected': 16}, {'groupId': 'EG001', 'numAtRisk': 253, 'numEvents': 13, 'numAffected': 13}, {'groupId': 'EG002', 'numAtRisk': 2, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 254, 'numEvents': 26, 'numAffected': 25}, {'groupId': 'EG001', 'numAtRisk': 253, 'numEvents': 12, 'numAffected': 11}, {'groupId': 'EG002', 'numAtRisk': 2, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Urinary tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 254, 'numEvents': 16, 'numAffected': 13}, {'groupId': 'EG001', 'numAtRisk': 253, 'numEvents': 15, 'numAffected': 13}, {'groupId': 'EG002', 'numAtRisk': 2, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Alanine aminotransferase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 254, 'numEvents': 49, 'numAffected': 36}, {'groupId': 'EG001', 'numAtRisk': 253, 'numEvents': 27, 'numAffected': 21}, {'groupId': 'EG002', 'numAtRisk': 2, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Amylase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 254, 'numEvents': 20, 'numAffected': 14}, {'groupId': 'EG001', 'numAtRisk': 253, 'numEvents': 21, 'numAffected': 14}, {'groupId': 'EG002', 'numAtRisk': 2, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Aspartate aminotransferase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 254, 'numEvents': 56, 'numAffected': 37}, {'groupId': 'EG001', 'numAtRisk': 253, 'numEvents': 30, 'numAffected': 23}, {'groupId': 'EG002', 'numAtRisk': 2, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Blood alkaline phosphatase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 254, 'numEvents': 15, 'numAffected': 13}, {'groupId': 'EG001', 'numAtRisk': 253, 'numEvents': 21, 'numAffected': 19}, {'groupId': 'EG002', 'numAtRisk': 2, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Blood bilirubin increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 254, 'numEvents': 20, 'numAffected': 17}, {'groupId': 'EG001', 'numAtRisk': 253, 'numEvents': 9, 'numAffected': 7}, {'groupId': 'EG002', 'numAtRisk': 2, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Blood creatinine increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 254, 'numEvents': 27, 'numAffected': 26}, {'groupId': 'EG001', 'numAtRisk': 253, 'numEvents': 6, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 2, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Blood thyroid stimulating hormone increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 254, 'numEvents': 21, 'numAffected': 16}, {'groupId': 'EG001', 'numAtRisk': 253, 'numEvents': 7, 'numAffected': 7}, {'groupId': 'EG002', 'numAtRisk': 2, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Lipase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 254, 'numEvents': 36, 'numAffected': 30}, {'groupId': 'EG001', 'numAtRisk': 253, 'numEvents': 28, 'numAffected': 17}, {'groupId': 'EG002', 'numAtRisk': 2, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Lymphocyte count decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 254, 'numEvents': 57, 'numAffected': 30}, {'groupId': 'EG001', 'numAtRisk': 253, 'numEvents': 33, 'numAffected': 20}, {'groupId': 'EG002', 'numAtRisk': 2, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Platelet count decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 254, 'numEvents': 42, 'numAffected': 31}, {'groupId': 'EG001', 'numAtRisk': 253, 'numEvents': 13, 'numAffected': 8}, {'groupId': 'EG002', 'numAtRisk': 2, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Weight decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 254, 'numEvents': 72, 'numAffected': 65}, {'groupId': 'EG001', 'numAtRisk': 253, 'numEvents': 41, 'numAffected': 39}, {'groupId': 'EG002', 'numAtRisk': 2, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'White blood cell count decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 254, 'numEvents': 33, 'numAffected': 16}, {'groupId': 'EG001', 'numAtRisk': 253, 'numEvents': 16, 'numAffected': 10}, {'groupId': 'EG002', 'numAtRisk': 2, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Decreased appetite', 'stats': [{'groupId': 'EG000', 'numAtRisk': 254, 'numEvents': 69, 'numAffected': 57}, {'groupId': 'EG001', 'numAtRisk': 253, 'numEvents': 24, 'numAffected': 23}, {'groupId': 'EG002', 'numAtRisk': 2, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Hypercalcaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 254, 'numEvents': 13, 'numAffected': 11}, {'groupId': 'EG001', 'numAtRisk': 253, 'numEvents': 20, 'numAffected': 18}, {'groupId': 'EG002', 'numAtRisk': 2, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Hyperglycaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 254, 'numEvents': 22, 'numAffected': 14}, {'groupId': 'EG001', 'numAtRisk': 253, 'numEvents': 12, 'numAffected': 11}, {'groupId': 'EG002', 'numAtRisk': 2, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Hyperkalaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 254, 'numEvents': 20, 'numAffected': 18}, {'groupId': 'EG001', 'numAtRisk': 253, 'numEvents': 8, 'numAffected': 7}, {'groupId': 'EG002', 'numAtRisk': 2, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Hypoalbuminaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 254, 'numEvents': 45, 'numAffected': 34}, {'groupId': 'EG001', 'numAtRisk': 253, 'numEvents': 25, 'numAffected': 23}, {'groupId': 'EG002', 'numAtRisk': 2, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Hypokalaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 254, 'numEvents': 29, 'numAffected': 22}, {'groupId': 'EG001', 'numAtRisk': 253, 'numEvents': 11, 'numAffected': 9}, {'groupId': 'EG002', 'numAtRisk': 2, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Hypomagnesaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 254, 'numEvents': 29, 'numAffected': 22}, {'groupId': 'EG001', 'numAtRisk': 253, 'numEvents': 9, 'numAffected': 7}, {'groupId': 'EG002', 'numAtRisk': 2, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Hyponatraemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 254, 'numEvents': 71, 'numAffected': 44}, {'groupId': 'EG001', 'numAtRisk': 253, 'numEvents': 36, 'numAffected': 28}, {'groupId': 'EG002', 'numAtRisk': 2, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Hypophosphataemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 254, 'numEvents': 16, 'numAffected': 14}, {'groupId': 'EG001', 'numAtRisk': 253, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 2, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Arthralgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 254, 'numEvents': 52, 'numAffected': 40}, {'groupId': 'EG001', 'numAtRisk': 253, 'numEvents': 25, 'numAffected': 18}, {'groupId': 'EG002', 'numAtRisk': 2, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Musculoskeletal chest pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 254, 'numEvents': 8, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 253, 'numEvents': 5, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 2, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Neck pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 254, 'numEvents': 18, 'numAffected': 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'OG000', 'lowerLimit': '40.6', 'upperLimit': '53.2'}, {'value': '27.5', 'groupId': 'OG001', 'lowerLimit': '22.1', 'upperLimit': '33.4'}]}]}], 'analyses': [{'pValue': '0.0000019', 'groupIds': ['OG000', 'OG001'], 'paramType': 'point estimate', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '19.3', 'ciLowerLimit': '11.2', 'ciUpperLimit': '27.3', 'statisticalMethod': 'Miettinen and Nurminen method', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'NUMBER', 'timeFrame': 'Up to ~ 37 months', 'description': 'ORR is defined as the percentage of participants who had a Complete Response (CR: Disappearance of all target lesions) or a Partial Response (PR: At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters) per RECIST 1.1 modified to follow a maximum of 10 target lesions and a maximum of 5 target lesions per organ. The percentage of participants who experienced a CR or PR based on modified RECIST 1.1 is presented.', 'unitOfMeasure': 'Percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized participants were included from the intention to treat (ITT) participants. Participants were included in the treatment group to which they were randomized.'}, {'type': 'PRIMARY', 'title': 'Progression Free Survival (PFS) Per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) as Assessed by Blinded Independent Central Review (BICR).', 'denoms': [{'units': 'Participants', 'counts': [{'value': '256', 'groupId': 'OG000'}, {'value': '255', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Pembrolizumab + Lenvatinib', 'description': 'Participants were administered Pembrolizumab 200mg by intravenous IV infusion on Day 1 of each 21-day cycle (Q3W) plus Lenvatinib 20 mg orally once a day (QD)'}, {'id': 'OG001', 'title': 'Pembrolizumab + Placebo', 'description': 'Participants were administered lenvatinib-matching placebo orally once a day (QD) plus pembrolizumab 200 mg by intravenous (IV) infusion on Day 1 of each 21-day cycle (Q3W).'}], 'classes': [{'categories': [{'measurements': [{'value': '7.0', 'groupId': 'OG000', 'lowerLimit': '5.6', 'upperLimit': '8.0'}, {'value': '2.8', 'groupId': 'OG001', 'lowerLimit': '2.6', 'upperLimit': '4.1'}]}]}], 'analyses': [{'pValue': '0.0001129', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.68', 'ciLowerLimit': '0.55', 'ciUpperLimit': '0.83', 'statisticalMethod': 'Regression, Cox', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEDIAN', 'timeFrame': 'Up to ~ 37 months', 'description': 'PFS is defined as the time from randomization to the first documented progressive disease (PD) or death due to any cause, whichever occurs first. Per RECIST 1.1, PD was defined as ≥20% increase in the sum of diameters of target lesions. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of ≥5 mm. Note: The appearance of one or more new lesions is also considered PD.', 'unitOfMeasure': 'Months', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized participants included in the ITT participants. Participants were included in the treatment group to which they were randomized.'}, {'type': 'PRIMARY', 'title': 'Overall Survival (OS)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '256', 'groupId': 'OG000'}, {'value': '255', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Pembrolizumab + Lenvatinib', 'description': 'Participants were administered Pembrolizumab 200mg by intravenous IV infusion on Day 1 of each 21-day cycle (Q3W) plus Lenvatinib 20 mg orally once a day (QD)'}, {'id': 'OG001', 'title': 'Pembrolizumab + Placebo', 'description': 'Participants were administered lenvatinib-matching placebo orally once a day (QD) plus pembrolizumab 200 mg by intravenous (IV) infusion on Day 1 of each 21-day cycle (Q3W).'}], 'classes': [{'categories': [{'measurements': [{'value': '15.0', 'groupId': 'OG000', 'lowerLimit': '13.2', 'upperLimit': '17.0'}, {'value': '17.9', 'groupId': 'OG001', 'lowerLimit': '13.8', 'upperLimit': '21.6'}]}]}], 'analyses': [{'pValue': '0.8819584', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.15', 'ciLowerLimit': '0.91', 'ciUpperLimit': '1.45', 'statisticalMethod': 'Regression, Cox', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEDIAN', 'timeFrame': 'Up to ~ 37 months', 'description': 'OS is the time from randomization to death due to any cause.', 'unitOfMeasure': 'Months', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized participants included in the ITT participants. Participants were included in the treatment group to which they were randomized.'}, {'type': 'SECONDARY', 'title': 'Duration of Response (DOR)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '120', 'groupId': 'OG000'}, {'value': '70', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Pembrolizumab + Lenvatinib', 'description': 'Participants were administered Pembrolizumab 200mg by intravenous IV infusion on Day 1 of each 21-day cycle (Q3W) plus Lenvatinib 20 mg orally once a day (QD)'}, {'id': 'OG001', 'title': 'Pembrolizumab + Placebo', 'description': 'Participants were administered lenvatinib-matching placebo orally once a day (QD) plus pembrolizumab 200 mg by intravenous (IV) infusion on Day 1 of each 21-day cycle (Q3W).'}], 'classes': [{'categories': [{'measurements': [{'value': '10.1', 'groupId': 'OG000', 'lowerLimit': '8.3', 'upperLimit': '13.9'}, {'value': 'NA', 'comment': 'Median and upper limit not reached at time of data cut-off due to insufficient number of responding participants with relapse.', 'groupId': 'OG001', 'lowerLimit': '11.9', 'upperLimit': 'NA'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Up to ~ 37 months', 'description': 'For participants who demonstrate a confirmed complete response (CR: Disappearance of all target lesions) or confirmed Partial Response (PR: At least a 30% decrease in the sum of diameters of target lesions) per RECIST 1.1, DOR is defined as the time from first documented evidence of CR or PR until disease progression or death.', 'unitOfMeasure': 'Months', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized participants included in the ITT participants who demonstrated at least a partial response. Participants were included in the treatment group to which they were randomized.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants Who Experienced an Adverse Event (AE)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '254', 'groupId': 'OG000'}, {'value': '253', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Pembrolizumab + Lenvatinib', 'description': 'Participants were administered Pembrolizumab 200mg by intravenous IV infusion on Day 1 of each 21-day cycle (Q3W) plus Lenvatinib 20 mg orally once a day (QD)'}, {'id': 'OG001', 'title': 'Pembrolizumab + Placebo', 'description': 'Participants were administered lenvatinib-matching placebo orally once a day (QD) plus pembrolizumab 200 mg by intravenous (IV) infusion on Day 1 of each 21-day cycle (Q3W).'}], 'classes': [{'categories': [{'measurements': [{'value': '99.21', 'groupId': 'OG000'}, {'value': '96.84', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Up to ~ 37 months', 'description': 'An adverse event (AE) is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study.', 'unitOfMeasure': 'Percentage of Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety analyses was conducted in the all-participants-as-treated (APaT) population, which consisted of all randomized participants who received at least one dose of study treatment. Participants were included in the treatment group corresponding to the study treatment they actually received.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants Who Discontinued Study Drug Due to an AE', 'denoms': [{'units': 'Participants', 'counts': [{'value': '254', 'groupId': 'OG000'}, {'value': '253', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Pembrolizumab + Lenvatinib', 'description': 'Participants were administered Pembrolizumab 200mg by intravenous IV infusion on Day 1 of each 21-day cycle (Q3W) plus Lenvatinib 20 mg orally once a day (QD)'}, {'id': 'OG001', 'title': 'Pembrolizumab + Placebo', 'description': 'Participants were administered lenvatinib-matching placebo orally once a day (QD) plus pembrolizumab 200 mg by intravenous (IV) infusion on Day 1 of each 21-day cycle (Q3W).'}], 'classes': [{'categories': [{'measurements': [{'value': '43.7', 'groupId': 'OG000'}, {'value': '15.02', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Up to ~ 34 months', 'description': 'An adverse event (AE) is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study.', 'unitOfMeasure': 'Percentage of Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety analyses was conducted in the APaT population, which consisted of all randomized participants who received at least one dose of study treatment. Participants were included in the treatment group corresponding to the study treatment they actually received.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Pembrolizumab + Lenvatinib', 'description': 'Participants were administered Pembrolizumab 200mg by intravenous IV infusion on Day 1 of each 21-day cycle (Q3W) plus Lenvatinib 20 mg orally once a day (QD)'}, {'id': 'FG001', 'title': 'Pembrolizumab + Placebo', 'description': 'Participants were administered lenvatinib-matching placebo orally once a day (QD) plus pembrolizumab 200 mg by intravenous (IV) infusion on Day 1 of each 21-day cycle (Q3W).'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '256'}, {'groupId': 'FG001', 'numSubjects': '255'}]}, {'type': 'Treated', 'achievements': [{'groupId': 'FG000', 'numSubjects': '254'}, {'groupId': 'FG001', 'numSubjects': '253'}]}, {'type': 'Received Second Course', 'achievements': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '256'}, {'groupId': 'FG001', 'numSubjects': '255'}]}], 'dropWithdraws': [{'type': 'Death', 'reasons': [{'groupId': 'FG000', 'numSubjects': '148'}, {'groupId': 'FG001', 'numSubjects': '134'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '4'}]}, {'type': 'Participants Ongoing', 'reasons': [{'groupId': 'FG000', 'numSubjects': '103'}, {'groupId': 'FG001', 'numSubjects': '116'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '256', 'groupId': 'BG000'}, {'value': '255', 'groupId': 'BG001'}, {'value': '511', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Pembrolizumab + Lenvatinib', 'description': 'Participants were administered Pembrolizumab 200mg by intravenous IV infusion on Day 1 of each 21-day cycle (Q3W) plus Lenvatinib 20 mg orally once a day (QD)'}, {'id': 'BG001', 'title': 'Pembrolizumab + Placebo', 'description': 'Participants were administered lenvatinib-matching placebo orally once a day (QD) plus pembrolizumab 200 mg by intravenous (IV) infusion on Day 1 of each 21-day cycle (Q3W).'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '64.0', 'spread': '8.8', 'groupId': 'BG000'}, {'value': '62.7', 'spread': '9.6', 'groupId': 'BG001'}, {'value': '63.4', 'spread': '9.2', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'Years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '37', 'groupId': 'BG000'}, {'value': '42', 'groupId': 'BG001'}, {'value': '79', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '219', 'groupId': 'BG000'}, {'value': '213', 'groupId': 'BG001'}, {'value': '432', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '33', 'groupId': 'BG000'}, {'value': '43', 'groupId': 'BG001'}, {'value': '76', 'groupId': 'BG002'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '205', 'groupId': 'BG000'}, {'value': '198', 'groupId': 'BG001'}, {'value': '403', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '18', 'groupId': 'BG000'}, {'value': '14', 'groupId': 'BG001'}, {'value': '32', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '7', 'groupId': 'BG001'}, {'value': '9', 'groupId': 'BG002'}]}, {'title': 'Asian', 'measurements': [{'value': '67', 'groupId': 'BG000'}, {'value': '80', 'groupId': 'BG001'}, {'value': '147', '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': '2', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}]}, {'title': 'White', 'measurements': [{'value': '168', 'groupId': 'BG000'}, {'value': '147', 'groupId': 'BG001'}, {'value': '315', 'groupId': 'BG002'}]}, {'title': 'More than one race', 'measurements': [{'value': '17', 'groupId': 'BG000'}, {'value': '19', 'groupId': 'BG001'}, {'value': '36', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Programmed Cell Death Ligand 1 (PD-L1) Tumor Expression', 'classes': [{'categories': [{'title': '<50%', 'measurements': [{'value': '192', 'groupId': 'BG000'}, {'value': '191', 'groupId': 'BG001'}, {'value': '383', 'groupId': 'BG002'}]}, {'title': '>=50%', 'measurements': [{'value': '64', 'groupId': 'BG000'}, {'value': '64', 'groupId': 'BG001'}, {'value': '128', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': 'Participants were assessed for their PD- L1 tumor expression level by immunohistochemistry assay using tumor tissue from a newly obtained biopsy. PD-L1 expression analyses were restricted to only tumor cells with TPS (tumor proportion scoring) \\<50% vs ≥50%.', 'unitOfMeasure': 'Participants'}, {'title': 'Human Papilloma Virus (HPV) Status', 'classes': [{'categories': [{'title': 'Positive', 'measurements': [{'value': '57', 'groupId': 'BG000'}, {'value': '58', 'groupId': 'BG001'}, {'value': '115', 'groupId': 'BG002'}]}, {'title': 'Negative', 'measurements': [{'value': '199', 'groupId': 'BG000'}, {'value': '197', 'groupId': 'BG001'}, {'value': '396', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': 'HPV status for oropharynx cancer as determined by immunohistochemistry (positive or negative); HPV status for participants without oropharynx cancer (eg, cancers of the oral cavity, hypopharynx and larynx) is considered HPV negative.', 'unitOfMeasure': 'Participants'}, {'title': 'Eastern Cooperative Oncology Group (ECOG Status of 0 vs 1)', 'classes': [{'categories': [{'title': 'ECOG 0', 'measurements': [{'value': '122', 'groupId': 'BG000'}, {'value': '115', 'groupId': 'BG001'}, {'value': '237', 'groupId': 'BG002'}]}, {'title': 'ECOG 1', 'measurements': [{'value': '134', 'groupId': 'BG000'}, {'value': '140', 'groupId': 'BG001'}, {'value': '274', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': 'Participants were stratified on basis of their ECOG status of 0 vs 1. The ECOG status 0 meant fully active, able to carry on all pre-disease performance without restriction, whereas an ECOG status 1 meant restricted in physically strenuous activity but ambulatory and able to carry out work of a light or sedentary nature.', 'unitOfMeasure': 'Participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2023-10-19', 'size': 1429816, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2024-05-09T11:16', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 511}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-02-05', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-04', 'completionDateStruct': {'date': '2025-03-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-04-16', 'studyFirstSubmitDate': '2019-12-12', 'resultsFirstSubmitDate': '2024-05-09', 'studyFirstSubmitQcDate': '2019-12-12', 'lastUpdatePostDateStruct': {'date': '2025-04-23', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2024-06-21', 'studyFirstPostDateStruct': {'date': '2019-12-13', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2024-07-16', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-05-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Objective Response Rate (ORR) Per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) as Assessed by Blinded Independent Central Review (BICR)', 'timeFrame': 'Up to ~ 37 months', 'description': 'ORR is defined as the percentage of participants who had a Complete Response (CR: Disappearance of all target lesions) or a Partial Response (PR: At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters) per RECIST 1.1 modified to follow a maximum of 10 target lesions and a maximum of 5 target lesions per organ. The percentage of participants who experienced a CR or PR based on modified RECIST 1.1 is presented.'}, {'measure': 'Progression Free Survival (PFS) Per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) as Assessed by Blinded Independent Central Review (BICR).', 'timeFrame': 'Up to ~ 37 months', 'description': 'PFS is defined as the time from randomization to the first documented progressive disease (PD) or death due to any cause, whichever occurs first. Per RECIST 1.1, PD was defined as ≥20% increase in the sum of diameters of target lesions. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of ≥5 mm. Note: The appearance of one or more new lesions is also considered PD.'}, {'measure': 'Overall Survival (OS)', 'timeFrame': 'Up to ~ 37 months', 'description': 'OS is the time from randomization to death due to any cause.'}], 'secondaryOutcomes': [{'measure': 'Duration of Response (DOR)', 'timeFrame': 'Up to ~ 37 months', 'description': 'For participants who demonstrate a confirmed complete response (CR: Disappearance of all target lesions) or confirmed Partial Response (PR: At least a 30% decrease in the sum of diameters of target lesions) per RECIST 1.1, DOR is defined as the time from first documented evidence of CR or PR until disease progression or death.'}, {'measure': 'Percentage of Participants Who Experienced an Adverse Event (AE)', 'timeFrame': 'Up to ~ 37 months', 'description': 'An adverse event (AE) is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study.'}, {'measure': 'Percentage of Participants Who Discontinued Study Drug Due to an AE', 'timeFrame': 'Up to ~ 34 months', 'description': 'An adverse event (AE) is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['head and neck squamous cell carcinoma', 'pembrolizumab', 'lenvatinib', 'PD-L1'], 'conditions': ['Head and Neck Squamous Cell Carcinoma']}, 'referencesModule': {'references': [{'pmid': '33300372', 'type': 'DERIVED', 'citation': 'Taylor MH, Schmidt EV, Dutcus C, Pinheiro EM, Funahashi Y, Lubiniecki G, Rasco D. The LEAP program: lenvatinib plus pembrolizumab for the treatment of advanced solid tumors. Future Oncol. 2021 Feb;17(6):637-648. doi: 10.2217/fon-2020-0937. Epub 2020 Dec 10.'}], 'seeAlsoLinks': [{'url': 'https://www.merckclinicaltrials.com/', 'label': 'Merck Clinical Trials Information'}]}, 'descriptionModule': {'briefSummary': 'This is a study of pembrolizumab (MK-3475) with or without lenvatinib (E7080/MK-7902) as a first line intervention in a PD-L1 selected population with participants with recurrent or metastatic head and neck squamous cell carcinoma.\n\nHypotheses include:\n\n* Pembrolizumab + lenvatinib is superior to pembrolizumab + placebo with respect to Objective Response Rate (ORR) per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) by blinded independent central review (BICR).\n* Pembrolizumab + lenvatinib is superior to pembrolizumab + placebo with respect to Progression Free Survival (PFS) per RECIST 1.1 as assessed by BICR.\n* Pembrolizumab + lenvatinib is superior to pembrolizumab + placebo with respect to overall survival (OS).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Has histologically confirmed diagnosis of R/M HNSCC that is considered incurable by local therapies.\n\nNote: Participants with newly-diagnosed HNSCC must be M1/Stage IV.\n\n* Has a primary tumor location of oropharynx, oral cavity, hypopharynx, or larynx.\n\nNote: Primary tumor site of nasopharynx (any histology) or unknown primary tumor (including p16+ unknown primary) are not eligible.\n\nContraceptive use by men should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies. If the contraception requirements in the local label for any of the study interventions is more stringent than the requirements above, the local label requirements are to be followed.\n\n* Male participants agree to use approved contraception during the treatment period for at least 7 days after the last dose of lenvatinib/placebo, or refrain from heterosexual intercourse during this period\n* Female participants are not pregnant or breastfeeding, and are not a woman of childbearing potential (WOCBP), OR are a WOCBP that agrees to use contraception during the treatment period (or 14 days prior to the initiation of study treatment for oral contraception) and for at least 120 days post pembrolizumab, or 30 days post lenvatinib/placebo, whichever occurs last\n* Has measurable disease per RECIST 1.1 as assessed by BICR. Note: Lesions situated in a previously irradiated area are considered measurable if progression has been shown in such lesions.\n* Participants with oropharyngeal cancer must have results from testing of human papillomavirus HPV status.\n* Has an Eastern Cooperative Oncology Group (ECOG) performance score of 0 to 1.\n* Have adequately controlled blood pressure with or without antihypertensive medications.\n* Has adequate organ function.\n\nExclusion Criteria:\n\n* Has a history of any contraindication or has a severe hypersensitivity to any components of pembrolizumab (≥Grade 3) or lenvatinib.\n* Has pre-existing ≥Grade 3 gastrointestinal or non-gastrointestinal fistula.\n* Has a history of a gastrointestinal condition or procedure that, in the opinion of the investigator, may affect oral study drug absorption.\n* Has clinically significant cardiovascular impairment within 12 months of the first dose of study intervention, such as history of congestive heart failure greater than New York Heart Association (NYHA) Class II, unstable angina, myocardial infarction or cerebrovascular accident/transient ischemic attack (TIA)/stroke, cardiac revascularization, or cardiac arrhythmia associated with hemodynamic instability.\n* Has disease that is suitable for local therapy administered with curative intent.\n* Had PD within 6 months of completion of curatively intended systemic treatment for locoregionally advanced HNSCC.\n* Has had major surgery within 3 weeks before to first dose of study interventions.\n* Has difficulty swallowing capsules or ingesting a suspension orally or by a feeding tube.\n* Has received prior therapy with lenvatinib or pembrolizumab.\n* Received last dose of systemic therapy for locoregionally advanced disease less than 6 months before signing consent.\n* Has received prior therapy with an anti-PD-1, anti-PD-L1, or anti PD-L2 agent or with an agent directed to another stimulatory or co-inhibitory T-cell receptor (e.g., CTLA-4, OX-40, CD137).\n* Has received prior systemic anticancer therapy including investigational agents within 4 weeks before randomization.\n* Has received prior radiotherapy within 2 weeks of start of study intervention.\n* Has received a live vaccine within 30 days before the first dose of study intervention. Administration of killed vaccines is allowed.\n* Received an investigational agent or has used an investigational device within 4 weeks prior to study intervention-administration.\n* Has a diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy (in dosing exceeding 10 mg daily of prednisone equivalent) or any other form of immunosuppressive therapy within 7 days prior the first dose of study intervention.\n* Has a known additional malignancy that is progressing or has required active treatment within the past 3 years.\n\nNote: Participants with basal cell carcinoma of the skin, squamous cell carcinoma of the skin, or carcinoma in situ (e.g., breast carcinoma, cervical cancer in situ) that have undergone potentially curative therapy are not excluded.\n\n* Has known active central nervous system (CNS) metastases and/or carcinomatous meningitis.\n* Has an active autoimmune disease that has required systemic treatment in past 2 years. Replacement therapy (e.g., thyroxine, insulin, or physiologic corticosteroid) is allowed.\n* Has a history of (non-infectious) pneumonitis that required steroids or has current pneumonitis.\n* Has an active infection requiring systemic therapy. (e.g., tuberculosis, known viral or bacterial infections, etc.).\n* Has a known history of human immunodeficiency virus (HIV) infection.\n* Has a known history of hepatitis B (defined as HBsAg reactive) or known active hepatitis C virus (defined as HCV ribonucleic acid (RNA) \\[qualitative\\] is detected) infection.\n* Is pregnant or breastfeeding or expecting to conceive or father children within the projected duration of the study, starting with the screening visit through 120 days after the last dose of study intervention.\n* Has had an allogenic tissue/solid organ transplant.\n* Has a known psychiatric or substance abuse disorder that would interfere with the participant's ability to cooperate with the requirements of the study."}, 'identificationModule': {'nctId': 'NCT04199104', 'briefTitle': 'A Study of Pembrolizumab (MK-3475) With or Without Lenvatinib (E7080/MK-7902) as First Line (1L) Intervention in a Programmed Cell Death-ligand 1 (PD-L1) Selected Population With Recurrent or Metastatic Head and Neck Squamous Cell Carcinoma (R/M HNSCC) (MK-7902-010) (KEYNOTE-010)', 'organization': {'class': 'INDUSTRY', 'fullName': 'Merck Sharp & Dohme LLC'}, 'officialTitle': 'A Phase 3, Randomized, Placebo-controlled, Double-blind Clinical Study of Pembrolizumab (MK-3475) With or Without Lenvatinib (E7080/MK-7902) to Evaluate the Safety and Efficacy of Pembrolizumab and Lenvatinib as 1L Intervention in a PD-L1 Selected Population of Participants With Recurrent or Metastatic Head and Neck Squamous Cell Carcinoma (R/M HNSCC) (LEAP-010).', 'orgStudyIdInfo': {'id': '7902-010'}, 'secondaryIdInfos': [{'id': 'MK-7902-010', 'type': 'OTHER', 'domain': 'MSD'}, {'id': 'LEAP-10', 'type': 'OTHER', 'domain': 'MSD'}, {'id': '205240', 'type': 'REGISTRY', 'domain': 'JAPIC-CTI'}, {'id': '2019-003717-34', 'type': 'EUDRACT_NUMBER'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Pembrolizumab with Lenvatinib', 'description': 'Participants receive lenvatinib 20 mg orally once a day (QD) plus pembrolizumab 200 mg by intravenous (IV) infusion on Day 1 of each 21-day cycle (Q3W). Pembrolizumab will be administered for up to 35 cycles (approximately 24 months). Lenvatinib will be administered until progressive disease or unacceptable toxicity.', 'interventionNames': ['Drug: Lenvatinib', 'Biological: Pembrolizumab']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Pembrolizumab with Placebo', 'description': 'Participants receive lenvatinib-matching placebo orally once a day (QD) plus pembrolizumab 200 mg by intravenous (IV) infusion on Day 1 of each 21-day cycle (Q3W). Pembrolizumab will be administered for up to 35 cycles (approximately 24 months).', 'interventionNames': ['Biological: Pembrolizumab', 'Drug: Placebo']}], 'interventions': [{'name': 'Lenvatinib', 'type': 'DRUG', 'otherNames': ['E7080', 'MK-7902', 'LENVIMA®'], 'description': 'Lenvatinib, 20 mg (two 10-mg oral capsules) administered QD', 'armGroupLabels': ['Pembrolizumab with Lenvatinib']}, {'name': 'Pembrolizumab', 'type': 'BIOLOGICAL', 'otherNames': ['MK-3475', 'Keytruda®'], 'description': 'Pembrolizumab (MK-3475), 200 mg, every 3 weeks (Q3W) by intravenous (IV) infusion for up to 35 3-week cycles', 'armGroupLabels': ['Pembrolizumab with Lenvatinib', 'Pembrolizumab with Placebo']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'Lenvatinib-matching placebo, oral capsules, administered once daily (QD)', 'armGroupLabels': ['Pembrolizumab with Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '93720', 'city': 'Fresno', 'state': 'California', 'country': 'United States', 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