Ignite Creation Date:
2025-12-24 @ 11:43 PM
Ignite Modification Date:
2025-12-25 @ 9:35 PM
Study NCT ID:
NCT04428151
Status:
COMPLETED
Last Update Posted:
2025-12-04
First Post:
2020-06-09
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Lenvatinib (E7080/MK-7902) in Combination With Pembrolizumab (MK-3475) vs. Standard Chemotherapy and Lenvatinib Monotherapy in Participants With Recurrent/Metastatic Head and Neck Squamous Cell Carcinoma That Progressed After Platinum Therapy and Immunotherapy (MK-7902-009/E7080-G000-228/LEAP-009)
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000077195', 'term': 'Squamous Cell Carcinoma of Head and Neck'}, {'id': 'C565324', 'term': 'Parkinson Disease 4, Autosomal Dominant Lewy Body'}], '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': 'C531958', 'term': 'lenvatinib'}, {'id': 'C582435', 'term': 'pembrolizumab'}, {'id': 'D000077143', 'term': 'Docetaxel'}, {'id': 'D000069287', 'term': 'Capecitabine'}, {'id': 'D017239', 'term': 'Paclitaxel'}, {'id': 'D000068818', 'term': 'Cetuximab'}], 'ancestors': [{'id': 'D043823', 'term': 'Taxoids'}, {'id': 'D043822', 'term': 'Cyclodecanes'}, {'id': 'D003516', 'term': 'Cycloparaffins'}, {'id': 'D006840', 'term': 'Hydrocarbons, Alicyclic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D004224', 'term': 'Diterpenes'}, {'id': 'D013729', 'term': 'Terpenes'}, {'id': 'D003841', 'term': 'Deoxycytidine'}, {'id': 'D003562', 'term': 'Cytidine'}, {'id': 'D011741', 'term': 'Pyrimidine Nucleosides'}, {'id': 'D011743', 'term': 'Pyrimidines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D005472', 'term': 'Fluorouracil'}, {'id': 'D014498', 'term': 'Uracil'}, {'id': 'D011744', 'term': 'Pyrimidinones'}, {'id': 'D003853', 'term': 'Deoxyribonucleosides'}, {'id': 'D009705', 'term': 'Nucleosides'}, {'id': 'D009706', 'term': 'Nucleic Acids, Nucleotides, and Nucleosides'}, {'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'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'ClinicalTrialsDisclosure@msd.com', 'phone': '1-800-672-6372', 'title': 'Senior Vice President, Global Clinical Development', 'organization': 'Merck Sharp & Dohme LLC'}, 'certainAgreement': {'otherDetails': 'If publication activity is not directed by the Sponsor, the investigator agrees to submit all manuscripts or abstracts to the Sponsor before submission. This allows the Sponsor to protect proprietary information and to provide comments.', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'Up to approximately 45 months', 'description': 'Serious \\& Other AEs includes participants randomized by primary completion data cut-off who received ≥1 dose of study drug. All-Cause Mortality includes participants randomized by primary completion data cut-off. Per protocol, progression of cancer was not considered an AE unless related to study treatment. MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \\& "Disease progression" not related to study treatment are excluded as AEs. AEs are reported by treatment received.', 'eventGroups': [{'id': 'EG000', 'title': 'Lenvatinib + Pembrolizumab', 'description': 'Participants were treated with the combination of lenvatinib (once daily 20 mg oral dose) plus pembrolizumab (200 mg 30-minute intravenous (IV) infusion on Day 1 of each 21-day cycle for 35 cycles), until centrally verified disease progression, or until a protocol-specified discontinuation criterion was met.', 'otherNumAtRisk': 143, 'deathsNumAtRisk': 144, 'otherNumAffected': 139, 'seriousNumAtRisk': 143, 'deathsNumAffected': 103, 'seriousNumAffected': 86}, {'id': 'EG001', 'title': 'SOC Chemotherapy', 'description': "Participants were treated with investigator's choice of standard of care (SOC) chemotherapy (docetaxel, paclitaxel, cetuximab, or capecitabine) until centrally verified disease progression, or until a protocol-specified discontinuation criterion was met.", 'otherNumAtRisk': 140, 'deathsNumAtRisk': 142, 'otherNumAffected': 135, 'seriousNumAtRisk': 140, 'deathsNumAffected': 42, 'seriousNumAffected': 57}, {'id': 'EG002', 'title': 'Lenvatinib Monotherapy', 'description': 'Participants were treated with lenvatinib monotherapy (once daily 24 mg oral dose) until centrally verified disease progression, or until a protocol-specified discontinuation criterion was met.', 'otherNumAtRisk': 88, 'deathsNumAtRisk': 88, 'otherNumAffected': 80, 'seriousNumAtRisk': 88, 'deathsNumAffected': 50, 'seriousNumAffected': 45}, {'id': 'EG003', 'title': 'SOC Chemotherapy Switched Over to Pembrolizumab+Lenvatinib', 'description': 'Participants who experienced centrally verified progressive disease (PD) on SOC chemotherapy switched over with Sponsor consultation and received a combination of lenvatinib (once daily 20 mg oral dose) plus pembrolizumab (200 mg 30-minute IV infusion on Day 1 of each 21-day cycle for up to 35 cycles) until a protocol-specified discontinuation criterion was met.', 'otherNumAtRisk': 61, 'deathsNumAtRisk': 61, 'otherNumAffected': 55, 'seriousNumAtRisk': 61, 'deathsNumAffected': 44, 'seriousNumAffected': 27}, {'id': 'EG004', 'title': 'SOC Chemotherapy Switched Over to Pembrolizumab', 'description': 'Participants who experienced centrally verified progressive disease (PD) on SOC chemotherapy switched over with Sponsor consultation and received pembrolizumab (200 mg 30-minute IV infusion on Day 1 of each 21-day cycle for up to 35 cycles) until a protocol-specified discontinuation criterion was met.', 'otherNumAtRisk': 1, 'deathsNumAtRisk': 1, 'otherNumAffected': 1, 'seriousNumAtRisk': 1, 'deathsNumAffected': 1, 'seriousNumAffected': 1}, {'id': 'EG005', 'title': 'Lenvatinib Switched Over to Pembrolizumab+Lenvatinib', 'description': 'Participants who experienced centrally verified progressive disease (PD) on lenvatinib monotherapy switched over with Sponsor consultation and received a combination of lenvatinib (once daily 20 mg oral dose) plus pembrolizumab (200 mg 30-minute IV infusion on Day 1 of each 21-day cycle for up to 35 cycles) until a protocol-specified discontinuation criterion was met.', 'otherNumAtRisk': 18, 'deathsNumAtRisk': 18, 'otherNumAffected': 15, 'seriousNumAtRisk': 18, 'deathsNumAffected': 10, 'seriousNumAffected': 6}], 'otherEvents': [{'term': 'Anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 143, 'numEvents': 24, 'numAffected': 20}, {'groupId': 'EG001', 'numAtRisk': 140, 'numEvents': 40, 'numAffected': 37}, {'groupId': 'EG002', 'numAtRisk': 88, 'numEvents': 18, 'numAffected': 13}, {'groupId': 'EG003', 'numAtRisk': 61, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG004', 'numAtRisk': 1, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 18, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Necrotic lymphadenopathy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 143, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 140, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 88, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 61, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 1, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 18, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Ear pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 143, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 140, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 88, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 61, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 1, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 18, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Hypothyroidism', 'stats': [{'groupId': 'EG000', 'numAtRisk': 143, 'numEvents': 52, 'numAffected': 49}, {'groupId': 'EG001', 'numAtRisk': 140, 'numEvents': 12, 'numAffected': 12}, {'groupId': 'EG002', 'numAtRisk': 88, 'numEvents': 28, 'numAffected': 28}, {'groupId': 'EG003', 'numAtRisk': 61, 'numEvents': 15, 'numAffected': 15}, {'groupId': 'EG004', 'numAtRisk': 1, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 18, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Endocrine disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Abdominal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 143, 'numEvents': 5, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 140, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 88, 'numEvents': 11, 'numAffected': 9}, {'groupId': 'EG003', 'numAtRisk': 61, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG004', 'numAtRisk': 1, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 18, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Abdominal pain upper', 'stats': [{'groupId': 'EG000', 'numAtRisk': 143, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 140, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 88, 'numEvents': 9, 'numAffected': 7}, {'groupId': 'EG003', 'numAtRisk': 61, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 1, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 18, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Chapped lips', 'stats': [{'groupId': 'EG000', 'numAtRisk': 143, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 140, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 88, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 61, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 1, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 18, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Constipation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 143, 'numEvents': 28, 'numAffected': 25}, {'groupId': 'EG001', 'numAtRisk': 140, 'numEvents': 38, 'numAffected': 32}, {'groupId': 'EG002', 'numAtRisk': 88, 'numEvents': 24, 'numAffected': 20}, {'groupId': 'EG003', 'numAtRisk': 61, 'numEvents': 7, 'numAffected': 6}, {'groupId': 'EG004', 'numAtRisk': 1, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 18, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 143, 'numEvents': 48, 'numAffected': 38}, {'groupId': 'EG001', 'numAtRisk': 140, 'numEvents': 35, 'numAffected': 26}, {'groupId': 'EG002', 'numAtRisk': 88, 'numEvents': 39, 'numAffected': 25}, {'groupId': 'EG003', 'numAtRisk': 61, 'numEvents': 20, 'numAffected': 15}, {'groupId': 'EG004', 'numAtRisk': 1, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 18, 'numEvents': 5, 'numAffected': 4}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Dry mouth', 'stats': [{'groupId': 'EG000', 'numAtRisk': 143, 'numEvents': 5, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 140, 'numEvents': 5, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 88, 'numEvents': 10, 'numAffected': 10}, {'groupId': 'EG003', 'numAtRisk': 61, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 1, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 18, 'numEvents': 2, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Dyspepsia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 143, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 140, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 88, 'numEvents': 6, 'numAffected': 5}, {'groupId': 'EG003', 'numAtRisk': 61, 'numEvents': 4, 'numAffected': 3}, {'groupId': 'EG004', 'numAtRisk': 1, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 18, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Dysphagia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 143, 'numEvents': 13, 'numAffected': 12}, {'groupId': 'EG001', 'numAtRisk': 140, 'numEvents': 10, 'numAffected': 9}, {'groupId': 'EG002', 'numAtRisk': 88, 'numEvents': 10, 'numAffected': 9}, {'groupId': 'EG003', 'numAtRisk': 61, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 1, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 18, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Gastrooesophageal reflux disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 143, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 140, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 88, 'numEvents': 7, 'numAffected': 7}, {'groupId': 'EG003', 'numAtRisk': 61, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG004', 'numAtRisk': 1, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 18, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 143, 'numEvents': 30, 'numAffected': 26}, {'groupId': 'EG001', 'numAtRisk': 140, 'numEvents': 43, 'numAffected': 31}, {'groupId': 'EG002', 'numAtRisk': 88, 'numEvents': 13, 'numAffected': 12}, {'groupId': 'EG003', 'numAtRisk': 61, 'numEvents': 14, 'numAffected': 12}, {'groupId': 'EG004', 'numAtRisk': 1, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 18, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Odynophagia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 143, 'numEvents': 8, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 140, 'numEvents': 5, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 88, 'numEvents': 6, 'numAffected': 6}, {'groupId': 'EG003', 'numAtRisk': 61, 'numEvents': 4, 'numAffected': 2}, {'groupId': 'EG004', 'numAtRisk': 1, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 18, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Oral pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 143, 'numEvents': 11, 'numAffected': 11}, {'groupId': 'EG001', 'numAtRisk': 140, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 88, 'numEvents': 8, 'numAffected': 6}, {'groupId': 'EG003', 'numAtRisk': 61, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG004', 'numAtRisk': 1, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 18, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Stomatitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 143, 'numEvents': 73, 'numAffected': 52}, {'groupId': 'EG001', 'numAtRisk': 140, 'numEvents': 30, 'numAffected': 28}, {'groupId': 'EG002', 'numAtRisk': 88, 'numEvents': 34, 'numAffected': 26}, {'groupId': 'EG003', 'numAtRisk': 61, 'numEvents': 26, 'numAffected': 21}, {'groupId': 'EG004', 'numAtRisk': 1, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 18, 'numEvents': 2, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 143, 'numEvents': 20, 'numAffected': 18}, {'groupId': 'EG001', 'numAtRisk': 140, 'numEvents': 16, 'numAffected': 13}, {'groupId': 'EG002', 'numAtRisk': 88, 'numEvents': 10, 'numAffected': 10}, {'groupId': 'EG003', 'numAtRisk': 61, 'numEvents': 6, 'numAffected': 5}, {'groupId': 'EG004', 'numAtRisk': 1, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 18, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Asthenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 143, 'numEvents': 33, 'numAffected': 30}, {'groupId': 'EG001', 'numAtRisk': 140, 'numEvents': 46, 'numAffected': 31}, {'groupId': 'EG002', 'numAtRisk': 88, 'numEvents': 26, 'numAffected': 23}, {'groupId': 'EG003', 'numAtRisk': 61, 'numEvents': 7, 'numAffected': 7}, {'groupId': 'EG004', 'numAtRisk': 1, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 18, 'numEvents': 4, 'numAffected': 3}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Cyst', 'stats': [{'groupId': 'EG000', 'numAtRisk': 143, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 140, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 88, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 61, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 1, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 18, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Fatigue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 143, 'numEvents': 38, 'numAffected': 37}, {'groupId': 'EG001', 'numAtRisk': 140, 'numEvents': 24, 'numAffected': 24}, {'groupId': 'EG002', 'numAtRisk': 88, 'numEvents': 23, 'numAffected': 20}, {'groupId': 'EG003', 'numAtRisk': 61, 'numEvents': 13, 'numAffected': 12}, {'groupId': 'EG004', 'numAtRisk': 1, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 18, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Gait disturbance', 'stats': [{'groupId': 'EG000', 'numAtRisk': 143, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 140, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 88, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 61, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 1, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 18, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'General physical health deterioration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 143, 'numEvents': 3, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 140, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 88, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 61, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 1, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 18, 'numEvents': 1, 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disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Upper airway necrosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 143, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 140, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 88, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 61, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 1, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 18, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Angioedema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 143, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 140, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 88, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 61, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 1, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 18, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Rash macular', 'stats': [{'groupId': 'EG000', 'numAtRisk': 143, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 140, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 88, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 61, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 1, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 18, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Arterial haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 143, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 140, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 88, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 61, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 1, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 18, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Embolism', 'stats': [{'groupId': 'EG000', 'numAtRisk': 143, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 140, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 88, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 61, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 1, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 18, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Hypertension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 143, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 140, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 88, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 61, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 1, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 18, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Hypotension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 143, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 140, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 88, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 61, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 1, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 18, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Orthostatic hypotension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 143, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 140, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 88, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 61, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 1, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 18, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Shock haemorrhagic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 143, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 140, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 88, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 61, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 1, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 18, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Overall Survival (OS)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '144', 'groupId': 'OG000'}, {'value': '142', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Lenvatinib + Pembrolizumab', 'description': 'Participants were treated with the combination of lenvatinib (once daily 20 mg oral dose) plus pembrolizumab (200 mg 30-minute intravenous (IV) infusion on Day 1 of each 21-day cycle for 35 cycles), until centrally verified disease progression, or until a protocol-specified discontinuation criterion was met.'}, {'id': 'OG001', 'title': 'SOC Chemotherapy', 'description': "Participants were treated with investigator's choice of standard of care (SOC) chemotherapy (docetaxel, paclitaxel, cetuximab, or capecitabine) until centrally verified disease progression, or until a protocol-specified discontinuation criterion was met."}, {'id': 'OG002', 'title': 'Lenvatinib Monotherapy', 'description': 'Participants were treated with lenvatinib monotherapy (once daily 24 mg oral dose) until centrally verified disease progression, or until a protocol-specified discontinuation criterion was met.'}], 'classes': [{'categories': [{'measurements': [{'value': '8.4', 'groupId': 'OG000', 'lowerLimit': '6.9', 'upperLimit': '10.3'}, {'value': '11.3', 'groupId': 'OG001', 'lowerLimit': '9.8', 'upperLimit': '14.4'}]}]}], 'analyses': [{'pValue': '0.9963', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.48', 'ciLowerLimit': '1.11', 'ciUpperLimit': '1.97', 'pValueComment': 'One-sided p-value based on log-rank test stratified by baseline PD-L1 TPS (\\<50% versus ≥50%) and baseline ECOG performance status (0 versus 1). The reported p-value is nominal.', 'estimateComment': "Based on Cox regression model with Efron's method of tie handling with treatment as a covariate stratified by baseline PD-L1 TPS (\\<50% versus ≥50%) and baseline ECOG performance status (0 versus 1).", 'statisticalMethod': 'Log Rank', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEDIAN', 'timeFrame': 'Up to approximately 45 months', 'description': 'OS was defined as the time from randomization to death due to any cause.', 'unitOfMeasure': 'Months', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis population consisted of all participants who were randomized prior to the primary completion data cut-off. Per protocol, participants who received lenvatinib monotherapy were not analyzed.'}, {'type': 'SECONDARY', 'title': 'Progression-Free Survival (PFS)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '144', 'groupId': 'OG000'}, {'value': '142', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Lenvatinib + Pembrolizumab', 'description': 'Participants were treated with the combination of lenvatinib (once daily 20 mg oral dose) plus pembrolizumab (200 mg 30-minute intravenous (IV) infusion on Day 1 of each 21-day cycle for 35 cycles), until centrally verified disease progression, or until a protocol-specified discontinuation criterion was met.'}, {'id': 'OG001', 'title': 'SOC Chemotherapy', 'description': "Participants were treated with investigator's choice of standard of care (SOC) chemotherapy (docetaxel, paclitaxel, cetuximab, or capecitabine) until centrally verified disease progression, or until a protocol-specified discontinuation criterion was met."}, {'id': 'OG002', 'title': 'Lenvatinib Monotherapy', 'description': 'Participants were treated with lenvatinib monotherapy (once daily 24 mg oral dose) until centrally verified disease progression, or until a protocol-specified discontinuation criterion was met.'}], 'classes': [{'categories': [{'measurements': [{'value': '3.0', 'groupId': 'OG000', 'lowerLimit': '2.8', 'upperLimit': '3.9'}, {'value': '2.8', 'groupId': 'OG001', 'lowerLimit': '2.6', 'upperLimit': '4.0'}]}]}], 'analyses': [{'pValue': '0.4181', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.97', 'ciLowerLimit': '0.74', 'ciUpperLimit': '1.28', 'pValueComment': 'One-sided p-value based on log-rank test stratified by baseline PD-L1 TPS (\\<50% versus ≥50%) and baseline ECOG performance status (0 versus 1). The reported p-value is nominal.', 'estimateComment': "Based on Cox regression model with Efron's method of tie handling with treatment as a covariate stratified by baseline PD-L1 TPS (\\<50% versus ≥50%) and baseline ECOG performance status (0 versus 1).", 'statisticalMethod': 'Log Rank', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEDIAN', 'timeFrame': 'Up to approximately 45 months', 'description': 'PFS was defined as the time from randomization to the first documented progressive disease (PD) or death due to any cause, whichever occurred first. Responses were according to modified Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 as assessed by blinded independent central review (BICR). RECIST 1.1 was modified to follow a maximum of 10 target lesions and a maximum of 5 target lesions per organ. 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 have demonstrated an absolute increase of ≥5 mm. Note: The appearance of one or more new lesions was also considered PD.', 'unitOfMeasure': 'Months', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis population consisted of all participants randomized by the primary completion data cut-off. Per protocol, participants who received lenvatinib monotherapy were not analyzed.'}, {'type': 'SECONDARY', 'title': 'Objective Response Rate (ORR)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '144', 'groupId': 'OG000'}, {'value': '142', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Lenvatinib + Pembrolizumab', 'description': 'Participants were treated with the combination of lenvatinib (once daily 20 mg oral dose) plus pembrolizumab (200 mg 30-minute intravenous (IV) infusion on Day 1 of each 21-day cycle for 35 cycles), until centrally verified disease progression, or until a protocol-specified discontinuation criterion was met.'}, {'id': 'OG001', 'title': 'SOC Chemotherapy', 'description': "Participants were treated with investigator's choice of standard of care (SOC) chemotherapy (docetaxel, paclitaxel, cetuximab, or capecitabine) until centrally verified disease progression, or until a protocol-specified discontinuation criterion was met."}, {'id': 'OG002', 'title': 'Lenvatinib Monotherapy', 'description': 'Participants were treated with lenvatinib monotherapy (once daily 24 mg oral dose) until centrally verified disease progression, or until a protocol-specified discontinuation criterion was met.'}], 'classes': [{'categories': [{'measurements': [{'value': '13.9', 'groupId': 'OG000', 'lowerLimit': '8.7', 'upperLimit': '20.6'}, {'value': '20.4', 'groupId': 'OG001', 'lowerLimit': '14.1', 'upperLimit': '28.0'}]}]}], 'analyses': [{'pValue': '0.9266219', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Difference in Percentage', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-6.5', 'ciLowerLimit': '-15.4', 'ciUpperLimit': '2.3', 'estimateComment': 'Based on Miettinen \\& Nurminen method stratified by baseline PD-L1 TPS (\\<50% versus ≥50%) and baseline ECOG performance status (0 versus 1).', 'statisticalMethod': 'Miettinen & Nurminen', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'One-sided p-value for testing H0: difference in % = 0 versus H1: difference in % \\> 0. The reported p-value is nominal.'}], 'paramType': 'NUMBER', 'timeFrame': 'Up to approximately 45 months', 'description': 'ORR was defined as the percentage of participants who had a confirmed complete response (CR: disappearance of all target lesions) or partial response (PR: At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum of the diameters of target lesions) until progressive disease (PD) or death due to any cause, whichever occurred first. Responses were according to modified RECIST 1.1 as assessed by BICR. RECIST 1.1 was modified to follow a maximum of 10 target lesions and a maximum of 5 target lesions per organ.', 'unitOfMeasure': 'Percentage of Participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis population consisted of all participants randomized by the primary completion data cut-off. Per protocol, participants who received lenvatinib monotherapy were not analyzed.'}, {'type': 'SECONDARY', 'title': 'Duration of Response (DOR)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}, {'value': '29', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Lenvatinib + Pembrolizumab', 'description': 'Participants were treated with the combination of lenvatinib (once daily 20 mg oral dose) plus pembrolizumab (200 mg 30-minute intravenous (IV) infusion on Day 1 of each 21-day cycle for 35 cycles), until centrally verified disease progression, or until a protocol-specified discontinuation criterion was met.'}, {'id': 'OG001', 'title': 'SOC Chemotherapy', 'description': "Participants were treated with investigator's choice of standard of care (SOC) chemotherapy (docetaxel, paclitaxel, cetuximab, or capecitabine) until centrally verified disease progression, or until a protocol-specified discontinuation criterion was met."}, {'id': 'OG002', 'title': 'Lenvatinib Monotherapy', 'description': 'Participants were treated with lenvatinib monotherapy (once daily 24 mg oral dose) until centrally verified disease progression, or until a protocol-specified discontinuation criterion was met.'}], 'classes': [{'categories': [{'measurements': [{'value': '4.1', 'groupId': 'OG000', 'lowerLimit': '3.6', 'upperLimit': '7.9'}, {'value': '5.9', 'groupId': 'OG001', 'lowerLimit': '3.7', 'upperLimit': '11.8'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Up to approximately 45 months', 'description': 'DOR was defined as the time from the first documented evidence of complete response (CR: disappearance of all target lesions) or partial response (PR: At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum of the diameters of target lesions) until progressive disease (PD) or death due to any cause, whichever occurred first. Responses were according to modified RECIST 1.1 as assessed by BICR.', 'unitOfMeasure': 'Months', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis population consisted of all participants randomized by the primary completion data cut-off who experienced a confirmed CR or PR. Per protocol, participants who received lenvatinib monotherapy were not analyzed.'}, {'type': 'SECONDARY', 'title': 'Number of Participants Who Experienced One or More Adverse Events (AEs)', 'timeFrame': 'Up to approximately 5 years', 'description': 'An AE was any untoward medical occurrence in a participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. The number of participants who experience an AE was presented.', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants'}, {'type': 'SECONDARY', 'title': 'Number of Participants Who Discontinued Study Intervention Due to an Adverse Event (AE)', 'timeFrame': 'Up to approximately 5 years', 'description': 'An AE was any untoward medical occurrence in a participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. The number of participants who discontinue study treatment due to an AE was presented.', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Lenvatinib + Pembrolizumab', 'description': 'Participants were treated with the combination of lenvatinib (once daily 20 mg oral dose) plus pembrolizumab (200 mg 30-minute intravenous (IV) infusion on Day 1 of each 21-day cycle for 35 cycles), until centrally verified disease progression, or until a protocol-specified discontinuation criterion was met.'}, {'id': 'FG001', 'title': 'SOC Chemotherapy', 'description': "Participants were treated with investigator's choice of standard of care (SOC) chemotherapy (docetaxel, paclitaxel, cetuximab, or capecitabine) until centrally verified disease progression, or until a protocol-specified discontinuation criterion was met."}, {'id': 'FG002', 'title': 'Lenvatinib Monotherapy', 'description': 'Participants were treated with lenvatinib monotherapy (once daily 24 mg oral dose) until centrally verified disease progression, or until a protocol-specified discontinuation criterion was met.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '144'}, {'groupId': 'FG001', 'numSubjects': '142'}, {'groupId': 'FG002', 'numSubjects': '88'}]}, {'type': 'Treated', 'achievements': [{'groupId': 'FG000', 'numSubjects': '143'}, {'groupId': 'FG001', 'numSubjects': '140'}, {'groupId': 'FG002', 'numSubjects': '88'}]}, {'type': 'Switched Over to Pembrolizumab + Lenvatinib', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '61'}, {'groupId': 'FG002', 'numSubjects': '18'}]}, {'type': 'Switched Over to Pembrolizumab', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '144'}, {'groupId': 'FG001', 'numSubjects': '142'}, {'groupId': 'FG002', 'numSubjects': '88'}]}], 'dropWithdraws': [{'type': 'Death', 'reasons': [{'groupId': 'FG000', 'numSubjects': '100'}, {'groupId': 'FG001', 'numSubjects': '86'}, {'groupId': 'FG002', 'numSubjects': '57'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '2'}, {'groupId': 'FG002', 'numSubjects': '3'}]}, {'type': 'Participant Ongoing in Study', 'reasons': [{'groupId': 'FG000', 'numSubjects': '41'}, {'groupId': 'FG001', 'numSubjects': '53'}, {'groupId': 'FG002', 'numSubjects': '28'}]}]}], 'preAssignmentDetails': 'Protocol-specified final analysis for the results, including participant flow, was performed on 374 participants enrolled within the primary completion data cut-off. Analysis of the remaining 34 participants will be included in the End of Trial analysis.\n\nParticipants who experienced progressive disease in the lenvatinib monotherapy or Standard of Care arms could switch over to receive lenvatinib + pembrolizumab. One participant switched over and received only pembrolizumab.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '144', 'groupId': 'BG000'}, {'value': '142', 'groupId': 'BG001'}, {'value': '88', 'groupId': 'BG002'}, {'value': '374', 'groupId': 'BG003'}]}], 'groups': [{'id': 'BG000', 'title': 'Lenvatinib + Pembrolizumab', 'description': 'Participants were treated with the combination of lenvatinib (once daily 20 mg oral dose) plus pembrolizumab (200 mg 30-minute intravenous (IV) infusion on Day 1 of each 21-day cycle for 35 cycles), until centrally verified disease progression, or until a protocol-specified discontinuation criterion was met.'}, {'id': 'BG001', 'title': 'SOC Chemotherapy', 'description': "Participants were treated with investigator's choice of standard of care (SOC) chemotherapy (docetaxel, paclitaxel, cetuximab, or capecitabine) until centrally verified disease progression, or until a protocol-specified discontinuation criterion was met."}, {'id': 'BG002', 'title': 'Lenvatinib Monotherapy', 'description': 'Participants were treated with lenvatinib monotherapy (once daily 24 mg oral dose) until centrally verified disease progression, or until a protocol-specified discontinuation criterion was met.'}, {'id': 'BG003', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '62.3', 'spread': '9.0', 'groupId': 'BG000'}, {'value': '61.4', 'spread': '10.0', 'groupId': 'BG001'}, {'value': '59.9', 'spread': '9.3', 'groupId': 'BG002'}, {'value': '61.4', 'spread': '9.5', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'Years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '18', 'groupId': 'BG000'}, {'value': '19', 'groupId': 'BG001'}, {'value': '14', 'groupId': 'BG002'}, {'value': '51', 'groupId': 'BG003'}]}, {'title': 'Male', 'measurements': [{'value': '126', 'groupId': 'BG000'}, {'value': '123', 'groupId': 'BG001'}, {'value': '74', 'groupId': 'BG002'}, {'value': '323', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '6', 'groupId': 'BG002'}, {'value': '12', 'groupId': 'BG003'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '139', 'groupId': 'BG000'}, {'value': '137', 'groupId': 'BG001'}, {'value': '82', 'groupId': 'BG002'}, {'value': '358', 'groupId': 'BG003'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '4', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}, {'value': '6', 'groupId': 'BG003'}]}, {'title': 'Asian', 'measurements': [{'value': '35', 'groupId': 'BG000'}, {'value': '40', 'groupId': 'BG001'}, {'value': '25', 'groupId': 'BG002'}, {'value': '100', 'groupId': 'BG003'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}, {'title': 'Black or African American', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}, {'value': '8', 'groupId': 'BG003'}]}, {'title': 'White', 'measurements': [{'value': '104', 'groupId': 'BG000'}, {'value': '96', 'groupId': 'BG001'}, {'value': '57', 'groupId': 'BG002'}, {'value': '257', 'groupId': 'BG003'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '3', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Eastern Cooperative Oncology Group (ECOG) Performance Status', 'classes': [{'categories': [{'title': 'ECOG = 0', 'measurements': [{'value': '52', 'groupId': 'BG000'}, {'value': '58', 'groupId': 'BG001'}, {'value': '32', 'groupId': 'BG002'}, {'value': '142', 'groupId': 'BG003'}]}, {'title': 'ECOG = 1', 'measurements': [{'value': '92', 'groupId': 'BG000'}, {'value': '84', 'groupId': 'BG001'}, {'value': '56', 'groupId': 'BG002'}, {'value': '232', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': 'Randomization of participants in the study was stratified by an ECOG Performance Status of 0 (Fully active, able to carry on all pre-disease performance without restriction) or 1 (Restricted in physically strenuous activity but ambulatory and able to carry out work of a light or sedentary nature).', 'unitOfMeasure': 'Participants'}, {'title': 'Programmed Cell Death Ligand 1 (PD-L1) Status at Baseline', 'classes': [{'categories': [{'title': 'TPS = <50%', 'measurements': [{'value': '121', 'groupId': 'BG000'}, {'value': '120', 'groupId': 'BG001'}, {'value': '74', 'groupId': 'BG002'}, {'value': '315', 'groupId': 'BG003'}]}, {'title': 'TPS = ≥ 50%', 'measurements': [{'value': '23', 'groupId': 'BG000'}, {'value': '22', 'groupId': 'BG001'}, {'value': '14', 'groupId': 'BG002'}, {'value': '59', 'groupId': 'BG003'}]}]}], '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. Randomization of participants in the study was stratified by PD-L1 tumor proportion score (TPS) at baseline (\\<50% or ≥ 50%). Higher percentages of PD-L1 TPS staining correspond to higher positivity of PD-L1 on a tumor.', 'unitOfMeasure': 'Participants'}], 'populationDescription': 'Per protocol, analysis population consisted of all participants randomized by the primary completion data cut-off.'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2024-11-25', 'size': 1108648, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2025-05-05T13:05', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 408}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-08-06', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-11', 'completionDateStruct': {'date': '2025-10-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-11-18', 'studyFirstSubmitDate': '2020-06-09', 'resultsFirstSubmitDate': '2025-05-05', 'studyFirstSubmitQcDate': '2020-06-09', 'lastUpdatePostDateStruct': {'date': '2025-12-04', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2025-05-05', 'studyFirstPostDateStruct': {'date': '2020-06-11', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2025-05-25', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-05-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Overall Survival (OS)', 'timeFrame': 'Up to approximately 45 months', 'description': 'OS was defined as the time from randomization to death due to any cause.'}], 'secondaryOutcomes': [{'measure': 'Progression-Free Survival (PFS)', 'timeFrame': 'Up to approximately 45 months', 'description': 'PFS was defined as the time from randomization to the first documented progressive disease (PD) or death due to any cause, whichever occurred first. Responses were according to modified Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 as assessed by blinded independent central review (BICR). RECIST 1.1 was modified to follow a maximum of 10 target lesions and a maximum of 5 target lesions per organ. 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 have demonstrated an absolute increase of ≥5 mm. Note: The appearance of one or more new lesions was also considered PD.'}, {'measure': 'Objective Response Rate (ORR)', 'timeFrame': 'Up to approximately 45 months', 'description': 'ORR was defined as the percentage of participants who had a confirmed complete response (CR: disappearance of all target lesions) or partial response (PR: At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum of the diameters of target lesions) until progressive disease (PD) or death due to any cause, whichever occurred first. Responses were according to modified RECIST 1.1 as assessed by BICR. RECIST 1.1 was modified to follow a maximum of 10 target lesions and a maximum of 5 target lesions per organ.'}, {'measure': 'Duration of Response (DOR)', 'timeFrame': 'Up to approximately 45 months', 'description': 'DOR was defined as the time from the first documented evidence of complete response (CR: disappearance of all target lesions) or partial response (PR: At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum of the diameters of target lesions) until progressive disease (PD) or death due to any cause, whichever occurred first. Responses were according to modified RECIST 1.1 as assessed by BICR.'}, {'measure': 'Number of Participants Who Experienced One or More Adverse Events (AEs)', 'timeFrame': 'Up to approximately 5 years', 'description': 'An AE was any untoward medical occurrence in a participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. The number of participants who experience an AE was presented.'}, {'measure': 'Number of Participants Who Discontinued Study Intervention Due to an Adverse Event (AE)', 'timeFrame': 'Up to approximately 5 years', 'description': 'An AE was any untoward medical occurrence in a participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. The number of participants who discontinue study treatment due to an AE was presented.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Programmed Cell Death-1 (PD1, PD-1)', 'Programmed Death-Ligand 1 (PDL1, PD-L1)'], 'conditions': ['Squamous Cell Carcinoma of Head and Neck']}, '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'}, {'url': 'https://msd.trialsummaries.com/Study/StudyDetails?id=26315&tenant=MT_MSD_9011', 'label': 'Plain Language Summary'}]}, 'descriptionModule': {'briefSummary': 'Researchers are looking for new ways to treat people with head and neck cancer whose cancer has come back after treatment (recurrent) or whose cancer has spread to other parts of the body (metastatic). Some people with recurrent or metastatic head and neck cancer are treated with chemotherapy and immunotherapy, but the cancer gets worse.\n\nThe goal of this study is to learn if more people who receive lenvatinib and pembrolizumab have a better overall survival rate than people who receive standard chemotherapy treatment.', 'detailedDescription': 'With Amendment 7, participants will discontinue lenvatinib and pembrolizumab and lenvatinib monotherapy, unless discussed with the Sponsor.\n\nA protocol-specified periodic safety review was completed with a data cut-off of 31-May-2024 (Primary Completion Date) and served as the final analysis of the primary outcome measure. Per protocol, 34 participants enrolled after the primary completion date and will be analyzed in the End of Trial analysis.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Pathologically confirmed recurrent (not amenable to curative treatment with local and/or systemic therapies) or metastatic (disseminated) head and neck squamous cell carcinoma (HNSCC) of the oral cavity, oropharynx, hypopharynx, and/or larynx that is considered incurable by local therapies\n* Disease progression at any time during or after treatment with a platinum-containing (e.g., carboplatin or cisplatin) regimen\n* Disease progression on or after treatment with a programmed cell death protein 1/programmed death-ligand 1 monoclonal antibody (anti-PD-1/PD-L1 mAb)\n* Pre-study imaging that demonstrates evidence of disease progression based on investigator review of at least 2 pre-study images per RECIST 1.1, following initiation of treatment with a PD-1/PD-L1 inhibitor\n* Measurable disease by computed tomography scan (CT) or magnetic resonance imaging (MRI) based on Response Criteria in Solid Tumors Version 1.1 (RECIST 1.1) as verified by blinded independent central review (BICR). Tumor lesions situated in a previously irradiated area are considered measurable if progression has been demonstrated in such lesions\n* Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 assessed within 7 days of the first dose of study intervention\n* Male participants are eligible to participate if they agree to the following during the intervention period and for at least 1 week after the last dose of lenvatinib, 3 months after the last dose of capecitabine and paclitaxel, and 6 months after the last dose of docetaxel:\n\n * Refrain from donating sperm\n * Be abstinent from heterosexual intercourse as their preferred and usual lifestyle (abstinent on a long term and persistent basis) and agree to remain abstinent; or must agree to use contraception unless confirmed to be azoospermic\n * Contraceptive use by men should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies\n* A female participant is eligible to participate if she is not pregnant or breastfeeding, and at least one of the following conditions applies:\n\n * Is not a woman of childbearing potential (WOCBP)\n * Is a WOCBP and using a contraceptive method that is highly effective (with a failure rate of \\<1% per year), with low user dependency or be abstinent from heterosexual intercourse as their preferred and usual lifestyle (abstinent on a long term and persistent basis), during the intervention period and for at least 120 days post pembrolizumab or 1 month post lenvatinib, whichever occurs last (Arms 1 and 3), or during the intervention period and for at least 6 months after the last dose of capecitabine, docetaxel, paclitaxel; and 2 months after the last dose of cetuximab (Arm 2)\n * Female participants who randomize to Arm 2 must also agree not to donate or freeze/store eggs during the intervention period and for at least 6 months after the last dose of capecitabine, docetaxel, paclitaxel; and 2 months after the last dose of cetuximab\n* Adequately controlled blood pressure (BP) with or without antihypertensive medications\n* Participants who are hepatitis B surface antigen (HBsAg) positive are eligible if they have received hepatitis B virus (HBV) antiviral therapy for at least 4 weeks and have undetectable HBV viral load prior to randomization\n* Participants with history of hepatitis C virus (HCV) infection are eligible if HCV viral load is undetectable at screening\n* Adequate organ function\n\nExclusion Criteria:\n\n* Disease that is suitable for local therapy administered with curative intent\n* Life expectancy of less than 3 months and/or has rapidly progressing disease in the opinion of the treating investigator\n* History of (noninfectious) pneumonitis/interstitial lung disease that required steroids, or has current pneumonitis/interstitial lung disease\n* Active infection requiring systemic therapy\n* 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 to the first dose of study drug\n* Known active central nervous system (CNS) metastases and/or carcinomatous meningitis\n* Known additional malignancy that is progressing or has required active systemic treatment within the past 3 years, except basal cell carcinoma of the skin, squamous cell carcinoma of the skin, superficial bladder cancer, or carcinoma in situ that have undergone potentially curative therapy\n* Active autoimmune disease that has required systemic treatment in the past 2 years\n* Had an allogeneic tissue/solid organ transplant\n* Known history of human immunodeficiency virus (HIV) infection\n* History of any contraindication or has a severe hypersensitivity to any components of pembrolizumab, lenvatinib or SOC chemotherapy.\n* Pre-existing ≥Grade 3 gastrointestinal or non-gastrointestinal fistula\n* History of a gastrointestinal malabsorption or any other condition or procedure that may affect oral study drug absorption\n* Had major surgery within 3 weeks prior to first dose of study interventions\n* Clinically significant cardiovascular impairment within 12 months of the first dose of study drug\n* Active tuberculosis\n* Has difficulty swallowing capsules or ingesting a suspension orally, or by a feeding tube\n* Prior treatment with lenvatinib\n* Prior chemotherapy, targeted small molecule therapy, or radiation therapy within 2 weeks prior to Study Day 1 or has not recovered from adverse events (AEs) due to a previously administered agent. Participants with endocrine-related AEs Grade ≤2 requiring treatment or hormone replacement may be eligible\n* Has received a live or live attenuated vaccine within 30 days prior to the first dose of study intervention. Note: Administration of killed vaccines is allowed\n* Previously treated with 4 or more systemic regimens given for recurrent/metastatic disease\n* Has received an investigational agent or has used an investigational device within 4 weeks prior to study intervention administration\n* Known psychiatric or substance abuse disorder that would interfere with the participant's ability to cooperate with the requirements of the study"}, 'identificationModule': {'nctId': 'NCT04428151', 'briefTitle': 'Lenvatinib (E7080/MK-7902) in Combination With Pembrolizumab (MK-3475) vs. Standard Chemotherapy and Lenvatinib Monotherapy in Participants With Recurrent/Metastatic Head and Neck Squamous Cell Carcinoma That Progressed After Platinum Therapy and Immunotherapy (MK-7902-009/E7080-G000-228/LEAP-009)', 'organization': {'class': 'INDUSTRY', 'fullName': 'Merck Sharp & Dohme LLC'}, 'officialTitle': 'A Phase 2, Randomized, Open-label Three-arm Clinical Study to Evaluate the Safety and Efficacy of Lenvatinib (E7080/MK-7902) in Combination With Pembrolizumab (MK-3475) Versus Standard of Care Chemotherapy and Lenvatinib Monotherapy in Participants With Recurrent/Metastatic Head and Neck Squamous Cell Carcinoma (R/M HNSCC) That Have Progressed After Platinum Therapy and Immunotherapy (PD-1/PD-L1 Inhibitors) (LEAP-009)', 'orgStudyIdInfo': {'id': '7902-009'}, 'secondaryIdInfos': [{'id': 'LEAP-009', 'type': 'OTHER', 'domain': 'MSD'}, {'id': 'E7080-G000-228', 'type': 'OTHER', 'domain': 'Eisai'}, {'id': 'MK-7902-009', 'type': 'OTHER', 'domain': 'MSD'}, {'id': '2022-500820-31-00', 'type': 'REGISTRY', 'domain': 'EU CT'}, {'id': 'U1111-1278-2707', 'type': 'REGISTRY', 'domain': 'UTN'}, {'id': '2019-000569-19', 'type': 'EUDRACT_NUMBER'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Lenvatinib + Pembrolizumab', 'description': 'Participants will be treated with the combination of lenvatinib (once daily 20 mg oral dose) plus pembrolizumab (200 mg 30-minute intravenous (IV) infusion on Day 1 of each 21-day cycle for 35 cycles), until centrally verified disease progression, or until a protocol-specified discontinuation criterion is met. Participants may receive up to an additional 17 cycles of pembrolizumab as Second Course treatment, with or without lenvatinib.', 'interventionNames': ['Drug: Lenvatinib', 'Biological: Pembrolizumab']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'SOC Chemotherapy', 'description': "Participants will be treated with investigator's choice of standard of care (SOC) chemotherapy (docetaxel, paclitaxel, cetuximab, or capecitabine) until centrally verified disease progression, or until a protocol-specified discontinuation criterion is met.", 'interventionNames': ['Drug: Docetaxel', 'Drug: Capecitabine', 'Drug: Paclitaxel', 'Drug: Cetuximab']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Lenvatinib Monotherapy', 'description': 'Participants will be treated with lenvatinib monotherapy (once daily 24 mg oral dose) until centrally verified disease progression, or until a protocol-specified discontinuation criterion is met.', 'interventionNames': ['Drug: Lenvatinib']}], 'interventions': [{'name': 'Lenvatinib', 'type': 'DRUG', 'otherNames': ['LENVIMA®', 'MK-7902', 'E7080'], 'description': '20 mg once daily, taken as oral capsules', 'armGroupLabels': ['Lenvatinib + Pembrolizumab']}, {'name': 'Pembrolizumab', 'type': 'BIOLOGICAL', 'otherNames': ['KEYTRUDA®', 'MK-3475', 'SCH 900475'], 'description': '200 mg 30-minute IV infusion on day 1 of each 21-day cycle', 'armGroupLabels': ['Lenvatinib + Pembrolizumab']}, {'name': 'Docetaxel', 'type': 'DRUG', 'otherNames': ['TAXOTERE®'], 'description': '75 mg/m\\^2 administered as an IV infusion on day 1 of each 21-day cycle', 'armGroupLabels': ['SOC Chemotherapy']}, {'name': 'Capecitabine', 'type': 'DRUG', 'otherNames': ['Xeloda®'], 'description': '1250 mg/m\\^2 twice daily on days 1-14 of each 21-day cycle, taken as oral tablets', 'armGroupLabels': ['SOC Chemotherapy']}, {'name': 'Paclitaxel', 'type': 'DRUG', 'otherNames': ['Taxol'], 'description': '80 mg/m\\^2 administered as an IV infusion on days 1, 8, and 15 of each 21-day cycle', 'armGroupLabels': ['SOC Chemotherapy']}, {'name': 'Cetuximab', 'type': 'DRUG', 'otherNames': ['ERBITUX®'], 'description': '400 mg/m\\^2 loading dose, followed by 250 mg/m\\^2 administered as an IV infusion on days 1, 8, and 15 of each 21-day cycle', 'armGroupLabels': ['SOC Chemotherapy']}, {'name': 'Lenvatinib', 'type': 'DRUG', 'otherNames': ['LENVIMA®', 'MK-7902', 'E7080'], 'description': '24 mg once daily, taken as oral capsules', 'armGroupLabels': ['Lenvatinib Monotherapy']}]}, 'contactsLocationsModule': {'locations': [{'zip': '91010', 'city': 'Duarte', 'state': 'California', 'country': 'United States', 'facility': 'City of Hope ( Site 1519)', 'geoPoint': {'lat': 34.13945, 'lon': -117.97729}}, {'zip': '90095', 'city': 'Los Angeles', 'state': 'California', 'country': 'United States', 'facility': 'UCLA Hematology/Oncology - Westwood (Building 100) ( Site 1568)', 'geoPoint': {'lat': 34.05223, 'lon': -118.24368}}, {'zip': '06510', 'city': 'New Haven', 'state': 'Connecticut', 'country': 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