Viewing Study NCT02705105

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Ignite Creation Date: 2025-12-25 @ 3:30 AM
Ignite Modification Date: 2026-02-25 @ 10:05 PM
Study NCT ID: NCT02705105
Status: COMPLETED
Last Update Posted: 2024-04-25
First Post: 2016-02-24
Is NOT Gene Therapy: True
Has Adverse Events: True
Brief Title: Study of Mogamulizumab + Nivolumab in Subjects w/Locally Advanced or Metastatic Solid Tumors
Sponsor:
Organization:
Overview Dates Organization Conditions Design Enrollment Locations Outcomes Modules Raw JSON

Raw JSON

{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D002277', 'term': 'Carcinoma'}, {'id': 'D006528', 'term': 'Carcinoma, Hepatocellular'}], 'ancestors': [{'id': 'D009375', 'term': 'Neoplasms, Glandular and Epithelial'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D000230', 'term': 'Adenocarcinoma'}, {'id': 'D008113', 'term': 'Liver Neoplasms'}, {'id': 'D004067', 'term': 'Digestive System Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D008107', 'term': 'Liver Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C549035', 'term': 'mogamulizumab'}, {'id': 'D000077594', 'term': 'Nivolumab'}], 'ancestors': [{'id': 'D061067', 'term': 'Antibodies, Monoclonal, Humanized'}, {'id': 'D000911', 'term': 'Antibodies, Monoclonal'}, {'id': 'D000906', 'term': 'Antibodies'}, {'id': 'D007136', 'term': 'Immunoglobulins'}, {'id': 'D007162', 'term': 'Immunoproteins'}, {'id': 'D001798', 'term': 'Blood Proteins'}, {'id': 'D011506', 'term': 'Proteins'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}, {'id': 'D012712', 'term': 'Serum Globulins'}, {'id': 'D005916', 'term': 'Globulins'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'kkd.clintrial.82@kyowakirin.com', 'phone': '609-919-1100', 'title': 'Kyowa Kirin Pharmaceutical Development', 'organization': 'Kyowa Kirin Pharmaceutical Development'}, 'certainAgreement': {'restrictionType': 'GT60', 'piSponsorEmployee': False, 'restrictiveAgreement': True}, 'limitationsAndCaveats': {'description': 'A decision was made by the Sponsor and Collaborator (BMS) in March of 2018 to stop enrollment in Phase 2 of study despite not all cohorts having reached the Stage 1 target enrollment.'}}, 'adverseEventsModule': {'timeFrame': 'From the date of informed consent to 100 days after the last dose of IMP.', 'eventGroups': [{'id': 'EG000', 'title': 'All in Phase 1 Cohort', 'description': 'All subjects in dose-finding cohort', 'otherNumAtRisk': 4, 'deathsNumAtRisk': 4, 'otherNumAffected': 4, 'seriousNumAtRisk': 4, 'deathsNumAffected': 0, 'seriousNumAffected': 2}, {'id': 'EG001', 'title': 'NSCLC, Squamous Cell', 'description': 'Subjects in expansion cohort with squamous cell NSCLC', 'otherNumAtRisk': 5, 'deathsNumAtRisk': 5, 'otherNumAffected': 5, 'seriousNumAtRisk': 5, 'deathsNumAffected': 0, 'seriousNumAffected': 2}, {'id': 'EG002', 'title': 'NSCLC, Nonsquamous, PD-L1 Non-Expressing', 'description': 'Subjects in expansion cohort with non-expressing, nonsquamous, PD-L1 NSCLC', 'otherNumAtRisk': 4, 'deathsNumAtRisk': 4, 'otherNumAffected': 4, 'seriousNumAtRisk': 4, 'deathsNumAffected': 0, 'seriousNumAffected': 3}, {'id': 'EG003', 'title': 'Squamous Cell Carcinoma of Head and Neck', 'description': 'Subjects in expansion cohort with head \\& neck squamous cell carcinoma', 'otherNumAtRisk': 10, 'deathsNumAtRisk': 10, 'otherNumAffected': 10, 'seriousNumAtRisk': 10, 'deathsNumAffected': 0, 'seriousNumAffected': 6}, {'id': 'EG004', 'title': 'Colorectal Carcinoma, Non-MSI High', 'description': 'Subjects in expansion cohort with colorectal carcinoma', 'otherNumAtRisk': 29, 'deathsNumAtRisk': 29, 'otherNumAffected': 28, 'seriousNumAtRisk': 29, 'deathsNumAffected': 1, 'seriousNumAffected': 18}, {'id': 'EG005', 'title': 'Ovarian/Fallopian Tube/Primary Peritoneal Carcinoma', 'description': 'Subjects in expansion cohort with ovarian cancer, primary peritoneal cancer, or fallopian tube carcinoma', 'otherNumAtRisk': 21, 'deathsNumAtRisk': 21, 'otherNumAffected': 21, 'seriousNumAtRisk': 21, 'deathsNumAffected': 0, 'seriousNumAffected': 11}, {'id': 'EG006', 'title': 'Hepatocellular Carcinoma (HCC)', 'description': 'Subjects in expansion cohort with hepatocellular carcinoma', 'otherNumAtRisk': 24, 'deathsNumAtRisk': 24, 'otherNumAffected': 24, 'seriousNumAtRisk': 24, 'deathsNumAffected': 2, 'seriousNumAffected': 17}, {'id': 'EG007', 'title': 'Pancreatic Adenocarcinoma', 'description': 'Subjects in expansion cohort with pancreatic adenocarcinoma', 'otherNumAtRisk': 17, 'deathsNumAtRisk': 17, 'otherNumAffected': 17, 'seriousNumAtRisk': 17, 'deathsNumAffected': 3, 'seriousNumAffected': 11}], 'otherEvents': [{'term': 'Anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4, 'numEvents': 5, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 5, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 10, 'numEvents': 5, 'numAffected': 4}, {'groupId': 'EG004', 'numAtRisk': 29, 'numEvents': 16, 'numAffected': 7}, {'groupId': 'EG005', 'numAtRisk': 21, 'numEvents': 6, 'numAffected': 4}, {'groupId': 'EG006', 'numAtRisk': 24, 'numEvents': 18, 'numAffected': 10}, {'groupId': 'EG007', 'numAtRisk': 17, 'numEvents': 7, 'numAffected': 7}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.1)'}, {'term': 'Coagulopathy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 10, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 29, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 21, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 24, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 17, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.1)'}, {'term': 'Febrile neutropenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 10, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 29, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 21, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG006', 'numAtRisk': 24, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 17, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.1)'}, {'term': 'Thrombocytopenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 10, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 29, 'numEvents': 2, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 21, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 24, 'numEvents': 9, 'numAffected': 6}, {'groupId': 'EG007', 'numAtRisk': 17, 'numEvents': 2, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.1)'}, {'term': 'Atrial fibrillation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 5, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 10, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 29, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 21, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 24, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 17, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.1)'}, {'term': 'Atrioventricular block first degree', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 10, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 29, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 21, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 24, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 17, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.1)'}, {'term': 'Bradycardia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 5, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 10, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 29, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 21, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 24, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 17, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.1)'}, {'term': 'Palpitations', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 10, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 29, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 21, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 24, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 17, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.1)'}, {'term': 'Pericardial effusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 4, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 10, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 29, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 21, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 24, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 17, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.1)'}, {'term': 'Sinus bradycardia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 10, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 29, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 21, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 24, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG007', 'numAtRisk': 17, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.1)'}, {'term': 'Sinus tachycardia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 10, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 29, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 21, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 24, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 17, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.1)'}, {'term': 'Tachycardia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 4, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 10, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 29, 'numEvents': 7, 'numAffected': 6}, {'groupId': 'EG005', 'numAtRisk': 21, 'numEvents': 2, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 24, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG007', 'numAtRisk': 17, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.1)'}, {'term': 'Ear pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 10, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG004', 'numAtRisk': 29, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 21, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 24, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 17, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.1)'}, {'term': 'Tinnitus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 10, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 29, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 21, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 24, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG007', 'numAtRisk': 17, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.1)'}, {'term': 'Hypothyroidism', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 5, 'numEvents': 2, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 10, 'numEvents': 4, 'numAffected': 3}, {'groupId': 'EG004', 'numAtRisk': 29, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG005', 'numAtRisk': 21, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 24, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG007', 'numAtRisk': 17, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Endocrine disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.1)'}, {'term': 'Eye swelling', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 10, 'numEvents': 2, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 29, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 21, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 24, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 17, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.1)'}, {'term': 'Lacrimation increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 10, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 29, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 21, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG006', 'numAtRisk': 24, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 17, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.1)'}, {'term': 'Vision blurred', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 4, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 10, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 29, 'numEvents': 2, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 21, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG006', 'numAtRisk': 24, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 17, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.1)'}, {'term': 'Abdominal discomfort', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 5, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 10, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 29, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 21, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG006', 'numAtRisk': 24, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 17, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.1)'}, {'term': 'Abdominal distension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 10, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 29, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG005', 'numAtRisk': 21, 'numEvents': 8, 'numAffected': 8}, {'groupId': 'EG006', 'numAtRisk': 24, 'numEvents': 5, 'numAffected': 5}, {'groupId': 'EG007', 'numAtRisk': 17, 'numEvents': 3, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.1)'}, {'term': 'Abdominal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 4, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 10, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG004', 'numAtRisk': 29, 'numEvents': 13, 'numAffected': 9}, {'groupId': 'EG005', 'numAtRisk': 21, 'numEvents': 10, 'numAffected': 7}, {'groupId': 'EG006', 'numAtRisk': 24, 'numEvents': 9, 'numAffected': 9}, {'groupId': 'EG007', 'numAtRisk': 17, 'numEvents': 6, 'numAffected': 5}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 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'BG007'}, {'value': '6', 'groupId': 'BG008'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}, {'value': '7', 'groupId': 'BG003'}, {'value': '25', 'groupId': 'BG004'}, {'value': '18', 'groupId': 'BG005'}, {'value': '21', 'groupId': 'BG006'}, {'value': '16', 'groupId': 'BG007'}, {'value': '99', 'groupId': 'BG008'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '2', 'groupId': 'BG003'}, {'value': '2', 'groupId': 'BG004'}, {'value': '2', 'groupId': 'BG005'}, {'value': '2', 'groupId': 'BG006'}, {'value': '0', 'groupId': 'BG007'}, {'value': '9', 'groupId': 'BG008'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '0', 'groupId': 'BG006'}, {'value': '0', 'groupId': 'BG007'}, {'value': '0', 'groupId': 'BG008'}]}, {'title': 'Asian', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '1', 'groupId': 'BG005'}, {'value': '1', 'groupId': 'BG006'}, {'value': '1', 'groupId': 'BG007'}, {'value': '3', 'groupId': 'BG008'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '0', 'groupId': 'BG006'}, {'value': '0', 'groupId': 'BG007'}, {'value': '0', 'groupId': 'BG008'}]}, {'title': 'Black or African American', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '4', 'groupId': 'BG004'}, {'value': '3', 'groupId': 'BG005'}, {'value': '3', 'groupId': 'BG006'}, {'value': '0', 'groupId': 'BG007'}, {'value': '13', 'groupId': 'BG008'}]}, {'title': 'White', 'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}, {'value': '10', 'groupId': 'BG003'}, {'value': '24', 'groupId': 'BG004'}, {'value': '17', 'groupId': 'BG005'}, {'value': '20', 'groupId': 'BG006'}, {'value': '16', 'groupId': 'BG007'}, {'value': '97', 'groupId': 'BG008'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '0', 'groupId': 'BG006'}, {'value': '0', 'groupId': 'BG007'}, {'value': '0', 'groupId': 'BG008'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '1', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '0', 'groupId': 'BG006'}, {'value': '0', 'groupId': 'BG007'}, {'value': '1', 'groupId': 'BG008'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}, {'value': '10', 'groupId': 'BG003'}, {'value': '29', 'groupId': 'BG004'}, {'value': '21', 'groupId': 'BG005'}, {'value': '24', 'groupId': 'BG006'}, {'value': '17', 'groupId': 'BG007'}, {'value': '114', 'groupId': 'BG008'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}], 'populationDescription': 'Patients in Phase 2 were enrolled into 7 cohorts by tumor type.'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2018-09-28', 'size': 1086115, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_002.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2022-07-27T13:50', 'hasProtocol': True}, {'date': '2018-12-06', 'size': 727131, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_001.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2020-02-11T14:13', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1', 'PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 114}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-02', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-04', 'dispFirstSubmitDate': '2019-09-06', 'completionDateStruct': {'date': '2018-10-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-04-23', 'studyFirstSubmitDate': '2016-02-24', 'dispFirstSubmitQcDate': '2019-09-06', 'resultsFirstSubmitDate': '2020-05-19', 'studyFirstSubmitQcDate': '2016-03-04', 'dispFirstPostDateStruct': {'date': '2019-09-16', 'type': 'ACTUAL'}, 'lastUpdatePostDateStruct': {'date': '2024-04-25', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2020-05-19', 'studyFirstPostDateStruct': {'date': '2016-03-10', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2020-06-04', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-08-22', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Maximum Tolerated Dose (MTD)', 'timeFrame': 'From the first dose of study medications until 14 days after the last dose of study medication', 'description': 'The MTD was defined as one dose level below the dose level of the cohort where ≥ one-third of the subjects experienced a dose-limiting toxicity (DLT)'}, {'measure': 'Number of Subjects Experiencing Dose-limiting Toxicity', 'timeFrame': 'From the first dose of study medications until 14 days after the last dose of study medication', 'description': 'combination of mogamulizumab and nivolumab'}], 'secondaryOutcomes': [{'measure': 'Objective Tumor Response Rate According to RECIST', 'timeFrame': 'From baseline to every 12 weeks, until data cut off', 'description': 'To evaluate the anti-tumor activity of the combination of mogamulizumab and nivolumab based on the Response Evaluation Criteria in Solid Tumors (RECIST) v. 1.1.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Metastatic Solid Tumors', 'Advanced Solid Tumors', 'KW-0761', 'ONO-4538/BMS-936558', 'Anti-tumor', 'Mogamulizumab', 'Nivolumab', 'Oncology', 'HCC', 'Hepatocellular carcinoma'], 'conditions': ['Solid Tumor', 'Cancer', 'Carcinoma', 'Hepatocellular Carcinoma', 'HCC']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to characterize the safety and tolerability and determine the maximum tolerated dose (MTD) or the recommended fixed dose of the combinations of mogamulizumab and nivolumab in subjects with locally advanced or metastatic solid tumors.', 'detailedDescription': 'This is a multicenter, Phase 1/2 open-label, dose-finding and cohort expansion study of the anti-CCR4 antibody mogamulizumab in combination therapy with the anti-PD-1 antibody nivolumab in adult subjects with locally advanced or metastatic solid tumors.\n\nPhase 1 will identify the maximum tolerated dose (MTD) or the highest protocol-defined dose in absence of exceeding the MTD, of the combination regimen of mogamulizumab and nivolumab subjects. Phase 1 will enroll up to 12 subjects. Phase 2 will explore the safety, efficacy and anti-tumor activity of the highest tolerated dose of the combination regimen. Phase 2 will enroll up to 184 subjects.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria\n\n* Subject is age 18 years or older;\n* Subject must have histologically or cytologically confirmed solid tumor;\n* Subject must have locally advanced or metastatic solid tumor;\n* Subjects who have progressed or have been intolerant to any standard treatment regimen or refused standard treatment, or for which adequate standard therapy does not exist.\n* Subjects who have evaluable lesion per guideline of Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1.\n* Subject has an Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0 or 1;\n* If the subject is a woman of child-bearing potential or man who is sexually active with woman of child-bearing potential, the subject agrees to use adequate contraception from signing of the ICF, for the duration of study participation; and for 23 weeks after the last dose of IMP for women or 31 weeks after the last dose of IMP for men;\n* Subjects who have adequate hematological, renal, hepatic and respiratory functions defined.\n* The subject is willing to undergo tumor biopsy during the Screening period, or if the tumor is inaccessible for biopsy, archived tumor material must be available for submission;\n* Subjects who voluntarily signed and dated Institutional Review Board approved informed consent form in accordance with regulatory and institutional guidelines.\n\nHepatocellular Carcinoma Inclusion Criteria:\n\n* Histologically confirmed hepatocellular carcinoma not amenable for management with curative intent by surgery or local therapeutic measure;\n* Subject must have received sorafenib treatment and either:\n\n * have had documented radiographic or symptomatic progression during or after sorafenib therapy; OR\n * be intolerant of sorafenib (defined as Grade 2 drug-related adverse event which 1) persisted in spite of comprehensive supportive therapy according to institutional standards AND 2) persisted or recurred after sorafenib treatment interruption of at least 7 days and dose reduction by one dose level (to 400 mg once daily) AND/OR Grade 3 drug-related adverse event which 1) persisted in spite of comprehensive supportive therapy according to institutional standards OR 2) persisted or recurred after sorafenib treatment interruption of at least 7 days and dose reduction by one dose level (to 400 mg once daily); OR must have documented refusal of sorafenib;\n* Subject has Child-Pugh score of ≤6, i.e., Child-Pugh A (Appendix 2);\n* INR ≤ 2.3 or Prothrombin time (PT) ≤ 6 seconds above control;\n* Subject has HBV DNA viral load undetectable or \\< 100 IU/mL at screening. If subject has detectable HBsAg, HBeAg, or HBV DNA (indicating ongoing viral replication of hepatitis B, he/she must be on antiviral therapy per regional standard of care guidelines prior to initiation of study therapy. If not on antiviral therapy at screening, then the subject must initiate treatment per regional standard of care guidelines prior to C1D1 and must be willing to continue antiviral therapy while on study treatment.\n\nExclusion Criteria\n\n* Female subject who is pregnant or breast-feeding, or any subject expecting to conceive or father a child during this study;\n* Subjects with uncontrolled and significant inter-current illness.\n* Subjects has psychiatric illness/social situations that in the opinion of the investigator would limit compliance with study requirements;\n* Subject has primary central nervous system (CNS) tumor or known CNS metastases and/or history of CNS metastases and/or carcinomatous meningitis; Exception: Subjects are eligible if CNS metastases are adequately treated and subjects are neurologically returned to baseline (except for residual signs or symptoms related to the CNS treatment) for at least 4 weeks prior to enrollment. In addition, subjects must be off corticosteroids for 4 weeks prior to enrollment.\n* Subject has received prior therapy for cancer or major surgery within 28 days, or 42 days for nitrosourea or mitomycin C, prior to Cycle 1 Day 1, or 14 days for tamoxifen;\n* Subject has received radiotherapy or radiosurgery within 14 days prior to Cycle 1 Day 1;\n* Subject has been previously treated with an anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CD137, or anti-CTLA-4 antibody or any other antibody or drug specifically targeting T-cell co-stimulation or checkpoint pathways;\n* Subject has been previously treated with mogamulizumab;\n* Subject has a history of allergy or hypersensitivity to study drug components;\n* Subject has received a live, attenuated vaccine within 28 days prior to Cycle 1 Day 1;\n* Subject has a history of organ transplant or allogeneic bone marrow transplant;\n* Subject has any unresolved toxicity Grade \\> 1 from previous anti-cancer therapy\n* Subject use of immunosuppressive medication within 14 days before Cycle 1 Day 1.\n* Subjects who have known active autoimmune disease or a history of autoimmune disease which may affect vital organ function or require immune suppressive treatment including systemic corticosteroids;\n* Subjects who have history of toxic epidermal necrolysis or Stevens-Johnson syndrome;\n* Subjects who have a history of inflammatory bowel disease, Crohn's disease, ulcerative colitis, or Wegener's granulomatosis;\n* Subject has primary or acquired immunodeficiency or known history of testing positive for human immunodeficiency virus (HIV) or known acquired immunodeficiency syndrome;\n* Subject who tests positive for hepatitis B surface antigen (HBVsAg) or hepatitis C RNA indicating acute or chronic infection except for subjects with hepatocellular carcinoma;\n* Subject has another active malignancy requiring concurrent intervention;\n* Subject who is receiving any other investigational agents;\n* Subject has another condition that, in the opinion of the Investigator and/or Sponsor, would interfere with evaluation of the IMP or interpretation of subject safety or study results;\n* Subject has a history of pneumonitis or interstitial lung disease.\n\nHepatocellular Carcinoma Exclusion Criterion:\n\n* Any history of hepatic encephalopathy\n* Any prior (within 1 year) or current clinically significant ascites as measured by physical examination and that requires paracentesis for control;\n* Active coinfection with both hepatitis B (i.e., HBVsAg and/or hepatitis B DNA) and hepatitis C (i.e., hepatitic C RNA)\n* Hepatitis D infection in subjects with hepatitis B\n* Any history of clinically meaningful variceal bleeding within the last three months."}, 'identificationModule': {'nctId': 'NCT02705105', 'briefTitle': 'Study of Mogamulizumab + Nivolumab in Subjects w/Locally Advanced or Metastatic Solid Tumors', 'organization': {'class': 'INDUSTRY', 'fullName': 'Kyowa Kirin Co., Ltd.'}, 'officialTitle': 'Open-label, Multicenter, Phase 1/2 Study of Mogamulizumab in Combination With Nivolumab in Subjects With Locally Advanced or Metastatic Solid Tumors', 'orgStudyIdInfo': {'id': '0761-014'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Dose-Finding Cohort', 'description': 'Cycle 1 Days 1, 8, 15, and 22: Dose Level 1 of Mogamulizumab + Nivolumab Subsequent Cycles Days 1 and 15: Dose Level 1 of Mogamulizumab + Nivolumab\n\nIf \\>1 patient has a DLT at first dose level, then the following cohort will be enrolled:\n\nCycle 1 Days 1, 8, 15, and 22: Optional Dose Level of Mogamulizumab + Nivolumab Subsequent Cycles Days 1 and 15: Optional Dose Level of Mogamulizumab + Nivolumab', 'interventionNames': ['Biological: Mogamulizumab + Nivolumab']}, {'type': 'EXPERIMENTAL', 'label': 'Expansion Cohort', 'description': 'Cycle 1 Days 1, 8, 15, and 22: Maximum Tolerated Dose of Mogamulizumab + Nivolumab Subsequent Cycles Days 1 and 15: Maximum Tolerated Dose of Mogamulizumab + Nivolumab\n\nSubjects will be separated further into cohorts by tumor type', 'interventionNames': ['Biological: Mogamulizumab + Nivolumab']}], 'interventions': [{'name': 'Mogamulizumab + Nivolumab', 'type': 'BIOLOGICAL', 'otherNames': ['Mogamulizumab: KW-0761, Nivolumab: ONO-4538/BMS-936558'], 'description': 'i.v. administration', 'armGroupLabels': ['Dose-Finding Cohort', 'Expansion Cohort']}]}, 'contactsLocationsModule': {'locations': [{'zip': '85234', 'city': 'Gilbert', 'state': 'Arizona', 'country': 'United States', 'geoPoint': {'lat': 33.35283, 'lon': -111.78903}}, {'zip': '94904', 'city': 'Greenbrae', 'state': 'California', 'country': 'United States', 'geoPoint': {'lat': 37.94854, 'lon': -122.5247}}, {'zip': '90033', 'city': 'Los Angeles', 'state': 'California', 'country': 'United States', 'geoPoint': {'lat': 34.05223, 'lon': -118.24368}}, {'zip': '32224', 'city': 'Jacksonville', 'state': 'Florida', 'country': 'United States', 'geoPoint': {'lat': 30.33218, 'lon': -81.65565}}, {'zip': '30912', 'city': 'Augusta', 'state': 'Georgia', 'country': 'United States', 'geoPoint': {'lat': 33.47097, 'lon': -81.97484}}, {'zip': '60637', 'city': 'Chicago', 'state': 'Illinois', 'country': 'United States', 'geoPoint': {'lat': 41.85003, 'lon': -87.65005}}, {'zip': '21205', 'city': 'Baltimore', 'state': 'Maryland', 'country': 'United States', 'geoPoint': {'lat': 39.29038, 'lon': -76.61219}}, {'zip': '49007', 'city': 'Kalamazoo', 'state': 'Michigan', 'country': 'United States', 'geoPoint': {'lat': 42.29171, 'lon': -85.58723}}, {'zip': '08854', 'city': 'Piscataway', 'state': 'New Jersey', 'country': 'United States', 'geoPoint': {'lat': 40.49927, 'lon': -74.39904}}, {'zip': '87106', 'city': 'Albuquerque', 'state': 'New Mexico', 'country': 'United States', 'geoPoint': {'lat': 35.08449, 'lon': -106.65114}}, {'zip': '27534', 'city': 'Goldsboro', 'state': 'North Carolina', 'country': 'United States', 'geoPoint': {'lat': 35.38488, 'lon': -77.99277}}, {'zip': '43210', 'city': 'Columbus', 'state': 'Ohio', 'country': 'United States', 'geoPoint': {'lat': 39.96118, 'lon': -82.99879}}, {'zip': '97213', 'city': 'Portland', 'state': 'Oregon', 'country': 'United States', 'geoPoint': {'lat': 45.52345, 'lon': -122.67621}}, {'zip': '19111-2497', 'city': 'Philadelphia', 'state': 'Pennsylvania', 'country': 'United States', 'geoPoint': {'lat': 39.95238, 'lon': -75.16362}}, {'zip': '77030', 'city': 'Houston', 'state': 'Texas', 'country': 'United States', 'geoPoint': {'lat': 29.76328, 'lon': -95.36327}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Kyowa Kirin, Inc.', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'Bristol-Myers Squibb', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}