Ignite Creation Date:
2025-12-24 @ 11:18 PM
Ignite Modification Date:
2026-01-02 @ 4:13 PM
Study NCT ID:
NCT00084656
Status:
COMPLETED
Last Update Posted:
2022-04-14
First Post:
2004-06-10
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Monoclonal Antibody Therapy and Vaccine Therapy in Treating Patients With Resected Stage III or Stage IV Melanoma
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000098943', 'term': 'Uveal Melanoma'}, {'id': 'D008545', 'term': 'Melanoma'}], 'ancestors': [{'id': 'D018358', 'term': 'Neuroendocrine Tumors'}, {'id': 'D017599', 'term': 'Neuroectodermal Tumors'}, {'id': 'D009373', 'term': 'Neoplasms, Germ Cell and Embryonal'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D009380', 'term': 'Neoplasms, Nerve Tissue'}, {'id': 'D018326', 'term': 'Nevi and Melanomas'}, {'id': 'D014604', 'term': 'Uveal Neoplasms'}, {'id': 'D005134', 'term': 'Eye Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D005128', 'term': 'Eye Diseases'}, {'id': 'D014603', 'term': 'Uveal Diseases'}, {'id': 'D012878', 'term': 'Skin Neoplasms'}, {'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000074324', 'term': 'Ipilimumab'}, {'id': 'D014442', 'term': 'Monophenol Monooxygenase'}], 'ancestors': [{'id': 'D061067', 'term': 'Antibodies, Monoclonal, Humanized'}, {'id': 'D000911', 'term': 'Antibodies, Monoclonal'}, {'id': 'D000906', 'term': 'Antibodies'}, {'id': 'D007136', 'term': 'Immunoglobulins'}, {'id': 'D007162', 'term': 'Immunoproteins'}, {'id': 'D001798', 'term': 'Blood Proteins'}, {'id': 'D011506', 'term': 'Proteins'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}, {'id': 'D012712', 'term': 'Serum Globulins'}, {'id': 'D005916', 'term': 'Globulins'}, {'id': 'D004156', 'term': 'Catechol Oxidase'}, {'id': 'D006899', 'term': 'Mixed Function Oxygenases'}, {'id': 'D010105', 'term': 'Oxygenases'}, {'id': 'D010088', 'term': 'Oxidoreductases'}, {'id': 'D004798', 'term': 'Enzymes'}, {'id': 'D045762', 'term': 'Enzymes and Coenzymes'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'Clinical.Trials@bms.com', 'phone': 'Please email:', 'title': 'Bristol-Myers Squibb Study Director', 'organization': 'Bristol-Myers Squibb'}, 'certainAgreement': {'restrictionType': 'LTE60', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'From first dose to 70 days post last dose (up to 3 years)', 'eventGroups': [{'id': 'EG000', 'title': '3.0 MG/KG IPILIMUMAB + PEPTIDES', 'description': 'HLA-A\\*201 positive participants receive ipilimumab at 3 mg/kg/dose as an intravenous (i.v.) infusion every 8 weeks for 12 months for a total of 7 infusions.\n\nPeptides administered at Weeks 1, 3, 5, 7, 9, 11, 17, 21, 25, 33, 41, and 53 for a total of 12 vaccinations.', 'otherNumAtRisk': 25, 'deathsNumAtRisk': 25, 'otherNumAffected': 25, 'seriousNumAtRisk': 25, 'deathsNumAffected': 0, 'seriousNumAffected': 5}, {'id': 'EG001', 'title': '10 MG/KG IPILIMUMAB + PEPTIDES', 'description': 'HLA-A\\*201 positive participants receive ipilimumab at 10 mg/kg/dose as an intravenous (i.v.) infusion every 8 weeks for 12 months for a total of 7 infusions.\n\nPeptides administered at Weeks 1, 3, 5, 7, 9, 11, 17, 21, 25, 33, 41, and 53 for a total of 12 vaccinations.', 'otherNumAtRisk': 25, 'deathsNumAtRisk': 25, 'otherNumAffected': 25, 'seriousNumAtRisk': 25, 'deathsNumAffected': 0, 'seriousNumAffected': 7}, {'id': 'EG002', 'title': '10 MG/KG IPILIMUMAB', 'description': 'HLA-A\\*201 negative participants receive ipilimumab at 10 mg/kg/dose as an intravenous (i.v.) infusion every 8 weeks for 12 months for a total of 7 infusions.', 'otherNumAtRisk': 26, 'deathsNumAtRisk': 26, 'otherNumAffected': 25, 'seriousNumAtRisk': 26, 'deathsNumAffected': 0, 'seriousNumAffected': 10}], 'otherEvents': [{'term': 'Lymph node pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 25, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 26, 'numAffected': 2}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '13.0'}, {'term': 'Lymphadenopathy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 25, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 26, 'numAffected': 3}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '13.0'}, {'term': 'Angina pectoris', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 25, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 26, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '13.0'}, {'term': 'Hypopituitarism', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 25, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 26, 'numAffected': 2}], 'organSystem': 'Endocrine disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '13.0'}, {'term': 'Hypothyroidism', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 25, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 26, 'numAffected': 4}], 'organSystem': 'Endocrine disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '13.0'}, {'term': 'Dry eye', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 25, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 26, 'numAffected': 2}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '13.0'}, {'term': 'Eye pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 25, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 26, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '13.0'}, {'term': 'Eye pruritus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 25, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 26, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '13.0'}, {'term': 'Lacrimation increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 25, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 26, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '13.0'}, {'term': 'Ocular hyperaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 25, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 26, 'numAffected': 2}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '13.0'}, {'term': 'Photophobia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 25, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 26, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '13.0'}, {'term': 'Vision blurred', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 25, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 26, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '13.0'}, {'term': 'Abdominal discomfort', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 25, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 26, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '13.0'}, {'term': 'Abdominal distension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 25, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 26, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '13.0'}, {'term': 'Abdominal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 25, 'numAffected': 12}, {'groupId': 'EG002', 'numAtRisk': 26, 'numAffected': 10}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '13.0'}, {'term': 'Abdominal pain upper', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 25, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 26, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '13.0'}, {'term': 'Colitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 25, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 26, 'numAffected': 4}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '13.0'}, {'term': 'Constipation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 25, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 26, 'numAffected': 6}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '13.0'}, {'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numAffected': 15}, {'groupId': 'EG001', 'numAtRisk': 25, 'numAffected': 16}, {'groupId': 'EG002', 'numAtRisk': 26, 'numAffected': 20}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '13.0'}, {'term': 'Flatulence', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 25, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 26, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '13.0'}, {'term': 'Gastrooesophageal reflux disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 25, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 26, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '13.0'}, {'term': 'Haemorrhoids', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 25, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 26, 'numAffected': 4}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '13.0'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 25, 'numAffected': 9}, {'groupId': 'EG002', 'numAtRisk': 26, 'numAffected': 12}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '13.0'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 25, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 26, 'numAffected': 6}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '13.0'}, {'term': 'Chills', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 25, 'numAffected': 6}, {'groupId': 'EG002', 'numAtRisk': 26, 'numAffected': 8}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '13.0'}, {'term': 'Face oedema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 25, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 26, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '13.0'}, {'term': 'Fatigue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numAffected': 24}, {'groupId': 'EG001', 'numAtRisk': 25, 'numAffected': 19}, {'groupId': 'EG002', 'numAtRisk': 26, 'numAffected': 20}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '13.0'}, {'term': 'Granuloma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numAffected': 13}, {'groupId': 'EG001', 'numAtRisk': 25, 'numAffected': 21}, {'groupId': 'EG002', 'numAtRisk': 26, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '13.0'}, {'term': 'Influenza like illness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numAffected': 14}, {'groupId': 'EG001', 'numAtRisk': 25, 'numAffected': 7}, {'groupId': 'EG002', 'numAtRisk': 26, 'numAffected': 2}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '13.0'}, {'term': 'Injection site erythema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 25, 'numAffected': 7}, {'groupId': 'EG002', 'numAtRisk': 26, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '13.0'}, {'term': 'Injection site nodule', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numAffected': 14}, {'groupId': 'EG001', 'numAtRisk': 25, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 26, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '13.0'}, {'term': 'Injection site pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numAffected': 17}, {'groupId': 'EG001', 'numAtRisk': 25, 'numAffected': 13}, {'groupId': 'EG002', 'numAtRisk': 26, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '13.0'}, {'term': 'Injection site pruritus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 25, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 26, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '13.0'}, {'term': 'Injection site rash', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 25, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 26, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '13.0'}, {'term': 'Injection site reaction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numAffected': 25}, {'groupId': 'EG001', 'numAtRisk': 25, 'numAffected': 11}, {'groupId': 'EG002', 'numAtRisk': 26, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '13.0'}, {'term': 'Injection site swelling', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 25, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 26, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '13.0'}, {'term': 'Injection site vesicles', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 25, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 26, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '13.0'}, {'term': 'Irritability', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 25, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 26, 'numAffected': 2}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '13.0'}, {'term': 'Non-cardiac chest pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 25, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 26, 'numAffected': 2}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '13.0'}, {'term': 'Oedema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 25, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 26, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '13.0'}, {'term': 'Oedema peripheral', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 25, 'numAffected': 9}, {'groupId': 'EG002', 'numAtRisk': 26, 'numAffected': 3}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '13.0'}, {'term': 'Pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 25, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 26, 'numAffected': 2}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '13.0'}, {'term': 'Pyrexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numAffected': 12}, {'groupId': 'EG001', 'numAtRisk': 25, 'numAffected': 10}, {'groupId': 'EG002', 'numAtRisk': 26, 'numAffected': 8}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '13.0'}, {'term': 'Hypersensitivity', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 25, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 26, 'numAffected': 0}], 'organSystem': 'Immune system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '13.0'}, {'term': 'Nasopharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 25, 'numAffected': 6}, {'groupId': 'EG002', 'numAtRisk': 26, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '13.0'}, {'term': 'Oral candidiasis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 25, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 26, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '13.0'}, {'term': 'Sinusitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 25, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 26, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '13.0'}, {'term': 'Upper respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 25, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 26, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '13.0'}, {'term': 'Urinary tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 25, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 26, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '13.0'}, {'term': 'Fall', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 25, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 26, 'numAffected': 2}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '13.0'}, {'term': 'Procedural pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 25, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 26, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '13.0'}, {'term': 'Alanine aminotransferase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 25, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 26, 'numAffected': 3}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '13.0'}, {'term': 'Aspartate aminotransferase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 25, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 26, 'numAffected': 2}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '13.0'}, {'term': 'Blood 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'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '13.0'}, {'term': 'Colitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 25, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 26, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '13.0'}, {'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 25, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 26, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '13.0'}, {'term': 'Diarrhoea haemorrhagic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 25, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 26, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '13.0'}, {'term': 'Duodenitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 25, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 26, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '13.0'}, {'term': 'Gastritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 25, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 26, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '13.0'}, {'term': 'Gastrointestinal perforation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 25, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 26, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '13.0'}, {'term': 'Ileus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 25, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 26, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '13.0'}, {'term': 'Megacolon', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 25, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 26, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '13.0'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 25, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 26, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '13.0'}, {'term': 'Oesophagitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 25, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 26, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '13.0'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 25, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 26, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '13.0'}, {'term': 'Fatigue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 25, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 26, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '13.0'}, {'term': 'Hernia obstructive', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 25, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 26, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '13.0'}, {'term': 'Injection site reaction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 25, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 26, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '13.0'}, {'term': 'Pyrexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 25, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 26, 'numAffected': 2}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '13.0'}, {'term': 'Autoimmune hepatitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 25, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 26, 'numAffected': 1}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '13.0'}, {'term': 'Cholecystitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 25, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 26, 'numAffected': 1}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '13.0'}, {'term': 'Blood corticotrophin decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 25, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 26, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '13.0'}, {'term': 'Dehydration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 25, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 26, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '13.0'}, {'term': 'Hypercalcaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 25, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 26, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '13.0'}, {'term': 'Hyponatraemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 25, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 26, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '13.0'}, {'term': 'Arthritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 25, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 26, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '13.0'}, {'term': 'Back pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 25, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 26, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '13.0'}, {'term': 'Myalgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 25, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 26, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '13.0'}, {'term': 'Cerebral infarction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 25, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 26, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '13.0'}, {'term': 'Cerebral ischaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 25, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 26, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '13.0'}, {'term': 'Azotaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 25, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 26, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '13.0'}, {'term': 'Pulmonary embolism', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 25, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 26, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '13.0'}, {'term': 'Rash', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 25, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 26, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '13.0'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Percentage of Participants With Immune-related Adverse Events (irAEs)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'OG000'}, {'value': '25', 'groupId': 'OG001'}, {'value': '26', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': '3.0 MG/KG IPILIMUMAB + PEPTIDES', 'description': 'HLA-A\\*201 positive participants receive ipilimumab at 3 mg/kg/dose as an intravenous (i.v.) infusion every 8 weeks for 12 months for a total of 7 infusions.\n\nPeptides administered at Weeks 1, 3, 5, 7, 9, 11, 17, 21, 25, 33, 41, and 53 for a total of 12 vaccinations.'}, {'id': 'OG001', 'title': '10 MG/KG IPILIMUMAB + PEPTIDES', 'description': 'HLA-A\\*201 positive participants receive ipilimumab at 10 mg/kg/dose as an intravenous (i.v.) infusion every 8 weeks for 12 months for a total of 7 infusions.\n\nPeptides administered at Weeks 1, 3, 5, 7, 9, 11, 17, 21, 25, 33, 41, and 53 for a total of 12 vaccinations.'}, {'id': 'OG002', 'title': '10 MG/KG IPILIMUMAB', 'description': 'HLA-A\\*201 negative participants receive ipilimumab at 10 mg/kg/dose as an intravenous (i.v.) infusion every 8 weeks for 12 months for a total of 7 infusions.'}], 'classes': [{'categories': [{'measurements': [{'value': '80.0', 'groupId': 'OG000', 'lowerLimit': '62.5', 'upperLimit': '91.8'}, {'value': '72.0', 'groupId': 'OG001', 'lowerLimit': '53.8', 'upperLimit': '86.1'}, {'value': '65.4', 'groupId': 'OG002', 'lowerLimit': '47.4', 'upperLimit': '80.6'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Between first dose and 70 days after last dose of study therapy (up to 3 years including maintenance phase)', 'description': 'Percentage of participants who experienced an irAE during the course of the study defined by the induction of Grade 1, Grade 2, or acceptable Grade 3 drug-related irAEs.\n\nFor the purposes of this trial, acceptable drug-related irAEs are skin-related immune-mediated adverse events \\< or = Grade 3 (potentially reversible inflammation \\< Grade 4 that can be attributable to a local antitumor reaction that could potentially be a therapeutic response will also be considered an acceptable irAE).\n\nNote: The confidence interval was calculated using the Clopper Pearson method', 'unitOfMeasure': 'Percentage of participants', 'dispersionType': '90% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'All treated participants'}, {'type': 'PRIMARY', 'title': 'Time to Disease Relapse', 'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'OG000'}, {'value': '26', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': '10 MG/KG IPILIMUMAB + PEPTIDES', 'description': 'HLA-A\\*201 positive participants receive ipilimumab at 10 mg/kg/dose as an intravenous (i.v.) infusion every 8 weeks for 12 months for a total of 7 infusions.\n\nPeptides administered at Weeks 1, 3, 5, 7, 9, 11, 17, 21, 25, 33, 41, and 53 for a total of 12 vaccinations.'}, {'id': 'OG001', 'title': '10 MG/KG IPILIMUMAB', 'description': 'HLA-A\\*201 negative participants receive ipilimumab at 10 mg/kg/dose as an intravenous (i.v.) infusion every 8 weeks for 12 months for a total of 7 infusions.'}], 'classes': [{'categories': [{'measurements': [{'value': 'NA', 'comment': 'insufficient number of events to achieve median value determination and upper limit', 'groupId': 'OG000', 'lowerLimit': '10.38', 'upperLimit': 'NA'}, {'value': 'NA', 'comment': 'insufficient number of events to achieve median value determination and upper limit', 'groupId': 'OG001', 'lowerLimit': '7.59', 'upperLimit': 'NA'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'up to 3 years', 'description': 'To determine the time (months) from first dose to disease relapse.\n\nTime to disease relapse is defined from the start of treatment to the first occurrence of any new lesion (reported by the investigator on physical exam or diagnostic imaging assessments that are attributed to metastatic melanoma) or death. Participants who neither relapse nor died will be censored on the date of their last tumor evaluation.\n\nMedian estimated using Kaplan-Meier method; A two-sided 95% CI for median in each treatment group was computed via the log-log transformation method.', 'unitOfMeasure': 'Months', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'All treated participants for the 10 mg/kg ipilimumab arms of the study only'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Drug-related irAEs of Any Grade', 'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'OG000'}, {'value': '25', 'groupId': 'OG001'}, {'value': '26', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': '3.0 MG/KG IPILIMUMAB + PEPTIDES', 'description': 'HLA-A\\*201 positive participants receive ipilimumab at 3 mg/kg/dose as an intravenous (i.v.) infusion every 8 weeks for 12 months for a total of 7 infusions.\n\nPeptides administered at Weeks 1, 3, 5, 7, 9, 11, 17, 21, 25, 33, 41, and 53 for a total of 12 vaccinations.'}, {'id': 'OG001', 'title': '10 MG/KG IPILIMUMAB + PEPTIDES', 'description': 'HLA-A\\*201 positive participants receive ipilimumab at 10 mg/kg/dose as an intravenous (i.v.) infusion every 8 weeks for 12 months for a total of 7 infusions.\n\nPeptides administered at Weeks 1, 3, 5, 7, 9, 11, 17, 21, 25, 33, 41, and 53 for a total of 12 vaccinations.'}, {'id': 'OG002', 'title': '10 MG/KG IPILIMUMAB', 'description': 'HLA-A\\*201 negative participants receive ipilimumab at 10 mg/kg/dose as an intravenous (i.v.) infusion every 8 weeks for 12 months for a total of 7 infusions.'}], 'classes': [{'categories': [{'measurements': [{'value': '24', 'groupId': 'OG000'}, {'value': '24', 'groupId': 'OG001'}, {'value': '24', 'groupId': 'OG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Between first dose and 70 days after last dose of study therapy (up to 3 years including maintenance phase)', 'description': 'The number of participants who experienced a drug-related irAE of any grade over the course of the study.\n\nNote: The confidence interval was calculated using the Clopper Pearson method', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All treated participants'}, {'type': 'SECONDARY', 'title': 'Immunologic Response to the Dose Regimen', 'denoms': [{'units': 'Participants', 'counts': [{'value': '24', 'groupId': 'OG000'}, {'value': '21', 'groupId': 'OG001'}, {'value': '21', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': '3.0 MG/KG IPILIMUMAB + PEPTIDES', 'description': 'HLA-A\\*201 positive participants receive ipilimumab at 3 mg/kg/dose as an intravenous (i.v.) infusion every 8 weeks for 12 months for a total of 7 infusions.\n\nPeptides administered at Weeks 1, 3, 5, 7, 9, 11, 17, 21, 25, 33, 41, and 53 for a total of 12 vaccinations.'}, {'id': 'OG001', 'title': '10 MG/KG IPILIMUMAB + PEPTIDES', 'description': 'HLA-A\\*201 positive participants receive ipilimumab at 10 mg/kg/dose as an intravenous (i.v.) infusion every 8 weeks for 12 months for a total of 7 infusions.\n\nPeptides administered at Weeks 1, 3, 5, 7, 9, 11, 17, 21, 25, 33, 41, and 53 for a total of 12 vaccinations.'}, {'id': 'OG002', 'title': '10 MG/KG IPILIMUMAB', 'description': 'HLA-A\\*201 negative participants receive ipilimumab at 10 mg/kg/dose as an intravenous (i.v.) infusion every 8 weeks for 12 months for a total of 7 infusions.'}], 'classes': [{'title': 'HAHA positive at baseline', 'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'HAHA positive', 'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}]}]}, {'title': 'HAHA negative', 'categories': [{'measurements': [{'value': '19', 'groupId': 'OG000'}, {'value': '19', 'groupId': 'OG001'}, {'value': '20', 'groupId': 'OG002'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'up to 3 years', 'description': 'The secondary objective was to determine the immunologic response to the dosing regimen, via Human Anti-Human Antibody (HAHA) Assessment, displayed by number of participants observed as HAHA positive or negative.\n\nNote: If participant had at least one post-baseline HAHA result with increase in titer over pre-study, the participant is counted as HAHA Positive.\n\nA participant with all negative post-baseline results is counted as HAHA negative.', 'unitOfMeasure': 'Number of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All Treated Subjects with Baseline and at Least one Post-Baseline HAHA Assessment'}, {'type': 'SECONDARY', 'title': 'Number of Participants Experiencing Hematology-related Lab Abnormalities', 'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'OG000'}, {'value': '25', 'groupId': 'OG001'}, {'value': '26', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': '3.0 MG/KG IPILIMUMAB + PEPTIDES', 'description': 'HLA-A\\*201 positive participants receive ipilimumab at 3 mg/kg/dose as an intravenous (i.v.) infusion every 8 weeks for 12 months for a total of 7 infusions.\n\nPeptides administered at Weeks 1, 3, 5, 7, 9, 11, 17, 21, 25, 33, 41, and 53 for a total of 12 vaccinations.'}, {'id': 'OG001', 'title': '10 MG/KG IPILIMUMAB + PEPTIDES', 'description': 'HLA-A\\*201 positive participants receive ipilimumab at 10 mg/kg/dose as an intravenous (i.v.) infusion every 8 weeks for 12 months for a total of 7 infusions.\n\nPeptides administered at Weeks 1, 3, 5, 7, 9, 11, 17, 21, 25, 33, 41, and 53 for a total of 12 vaccinations.'}, {'id': 'OG002', 'title': '10 MG/KG IPILIMUMAB', 'description': 'HLA-A\\*201 negative participants receive ipilimumab at 10 mg/kg/dose as an intravenous (i.v.) infusion every 8 weeks for 12 months for a total of 7 infusions.'}], 'classes': [{'title': 'White blood cells, grade 1-4', 'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'White blood cells, grade 3-4', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'Absolute Neutrophil Count, grade 1-4', 'categories': [{'measurements': [{'value': '6', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}]}]}, {'title': 'Absolute Neutrophil Count, grade 3-4', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'Platelet Count, grade 1-4', 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}]}]}, {'title': 'Platelet Count, grade 3-4', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'Hemoglobin, grade 1-4', 'categories': [{'measurements': [{'value': '8', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}, {'value': '15', 'groupId': 'OG002'}]}]}, {'title': 'Hemoglobin, grade 3-4', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'Lymphocytes, grade 1-4', 'categories': [{'measurements': [{'value': '19', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}, {'value': '17', 'groupId': 'OG002'}]}]}, {'title': 'Lymphocytes, grade 3-4', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Between first dose and 70 days after last dose of study therapy (up to 3 years including maintenance phase)', 'description': 'The number of participants who experienced a Hematology-related laboratory abnormality (grade 1-4 and grade 3-4 categories, grade 4 being the worst) during the course of the study.\n\nLaboratory tests were graded using the NCI Common Terminology Criteria for Adverse Events (CTCAE), version 3.0.', 'unitOfMeasure': 'Number of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All treated participants'}, {'type': 'SECONDARY', 'title': 'Number of Participants Experiencing Serum Chemistry-related Lab Abnormalities', 'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'OG000'}, {'value': '25', 'groupId': 'OG001'}, {'value': '26', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': '3.0 MG/KG IPILIMUMAB + PEPTIDES', 'description': 'HLA-A\\*201 positive participants receive ipilimumab at 3 mg/kg/dose as an intravenous (i.v.) infusion every 8 weeks for 12 months for a total of 7 infusions.\n\nPeptides administered at Weeks 1, 3, 5, 7, 9, 11, 17, 21, 25, 33, 41, and 53 for a total of 12 vaccinations.'}, {'id': 'OG001', 'title': '10 MG/KG IPILIMUMAB + PEPTIDES', 'description': 'HLA-A\\*201 positive participants receive ipilimumab at 10 mg/kg/dose as an intravenous (i.v.) infusion every 8 weeks for 12 months for a total of 7 infusions.\n\nPeptides administered at Weeks 1, 3, 5, 7, 9, 11, 17, 21, 25, 33, 41, and 53 for a total of 12 vaccinations.'}, {'id': 'OG002', 'title': '10 MG/KG IPILIMUMAB', 'description': 'HLA-A\\*201 negative participants receive ipilimumab at 10 mg/kg/dose as an intravenous (i.v.) infusion every 8 weeks for 12 months for a total of 7 infusions.'}], 'classes': [{'title': 'alanine aminotransferase (ALT), grade 1-4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'OG000'}, {'value': '25', 'groupId': 'OG001'}, {'value': '25', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '7', 'groupId': 'OG002'}]}]}, {'title': 'alanine aminotransferase (ALT), grade 3-4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'OG000'}, {'value': '25', 'groupId': 'OG001'}, {'value': '25', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}]}]}, {'title': 'aspartate aminotransferase (AST), grade 1-4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'OG000'}, {'value': '25', 'groupId': 'OG001'}, {'value': '25', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '9', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '7', 'groupId': 'OG002'}]}]}, {'title': 'aspartate aminotransferase (AST), grade 3-4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'OG000'}, {'value': '25', 'groupId': 'OG001'}, {'value': '25', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}]}]}, {'title': 'Total Bilirubin, grade 1-4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'OG000'}, {'value': '25', 'groupId': 'OG001'}, {'value': '25', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}]}]}, {'title': 'Total Bilirubin, grade 3-4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'OG000'}, {'value': '25', 'groupId': 'OG001'}, {'value': '25', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}]}]}, {'title': 'Alkaline Phosphatase, grade 1-4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'OG000'}, {'value': '25', 'groupId': 'OG001'}, {'value': '25', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}]}]}, {'title': 'Alkaline Phosphatase, grade 3-4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'OG000'}, {'value': '25', 'groupId': 'OG001'}, {'value': '25', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'Amylase, grade 1-4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'OG000'}, {'value': '25', 'groupId': 'OG001'}, {'value': '26', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}, {'value': '10', 'groupId': 'OG002'}]}]}, {'title': 'Amylase, grade 3-4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'OG000'}, {'value': '25', 'groupId': 'OG001'}, {'value': '26', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'Lipase, grade 1-4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'OG000'}, {'value': '25', 'groupId': 'OG001'}, {'value': '26', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}, {'value': '10', 'groupId': 'OG002'}]}]}, {'title': 'Lipase, grade 3-4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'OG000'}, {'value': '25', 'groupId': 'OG001'}, {'value': '26', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '4', 'groupId': 'OG002'}]}]}, {'title': 'Creatinine, grade 1-4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'OG000'}, {'value': '25', 'groupId': 'OG001'}, {'value': '26', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}]}]}, {'title': 'Creatinine, grade 3-4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'OG000'}, {'value': '25', 'groupId': 'OG001'}, {'value': '26', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Between first dose and 70 days after last dose of study therapy (up to 3 years including maintenance phase)', 'description': 'The number of participants who experienced a Serum Chemistry-related laboratory abnormality (grade 1-4 and grade 3-4 categories, grade 4 being the worst) during the course of the study.\n\nLaboratory tests were graded using the NCI Common Terminology Criteria for Adverse Events (CTCAE), version 3.0.', 'unitOfMeasure': 'Number of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All treated participants'}, {'type': 'SECONDARY', 'title': 'Time to Disease Relapse', 'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': '3.0 MG/KG IPILIMUMAB + PEPTIDES', 'description': 'HLA-A\\*201 positive participants receive ipilimumab at 3 mg/kg/dose as an intravenous (i.v.) infusion every 8 weeks for 12 months for a total of 7 infusions.\n\nPeptides administered at Weeks 1, 3, 5, 7, 9, 11, 17, 21, 25, 33, 41, and 53 for a total of 12 vaccinations.'}], 'classes': [{'categories': [{'measurements': [{'value': 'NA', 'comment': 'insufficient number of events to achieve median value determination and upper limit', 'groupId': 'OG000', 'lowerLimit': '15.80', 'upperLimit': 'NA'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'up to 3 years', 'description': 'To determine the time (months) from first dose to disease relapse.\n\nTime to disease relapse is defined from the start of treatment to the first occurrence of any new lesion (reported by the investigator on physical exam or diagnostic imaging assessments that are attributed to metastatic melanoma) or death. Participants who neither relapse nor died will be censored on the date of their last tumor evaluation.\n\nMedian estimated using Kaplan-Meier method; A two-sided 95% CI for median in each treatment group was computed via the log-log transformation method.', 'unitOfMeasure': 'Months', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'All treated participants for the 3 mg/kg ipilimumab arm of the study only'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': '3.0 MG/KG IPILIMUMAB + PEPTIDES', 'description': 'HLA-A\\*201 positive participants receive ipilimumab at 3 mg/kg/dose as an intravenous (i.v.) infusion every 8 weeks for 12 months for a total of 7 infusions.\n\nPeptides administered at Weeks 1, 3, 5, 7, 9, 11, 17, 21, 25, 33, 41, and 53 for a total of 12 vaccinations.'}, {'id': 'FG001', 'title': '10 MG/KG IPILIMUMAB + PEPTIDES', 'description': 'HLA-A\\*201 positive participants receive ipilimumab at 10 mg/kg/dose as an intravenous (i.v.) infusion every 8 weeks for 12 months for a total of 7 infusions.\n\nPeptides administered at Weeks 1, 3, 5, 7, 9, 11, 17, 21, 25, 33, 41, and 53 for a total of 12 vaccinations.'}, {'id': 'FG002', 'title': '10 MG/KG IPILIMUMAB', 'description': 'HLA-A\\*201 negative participants receive ipilimumab at 10 mg/kg/dose as an intravenous (i.v.) infusion every 8 weeks for 12 months for a total of 7 infusions.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '25'}, {'groupId': 'FG001', 'numSubjects': '25'}, {'groupId': 'FG002', 'numSubjects': '26'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '25'}, {'groupId': 'FG001', 'numSubjects': '25'}, {'groupId': 'FG002', 'numSubjects': '26'}]}], 'dropWithdraws': [{'type': 'Other reasons', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '12'}, {'groupId': 'FG002', 'numSubjects': '11'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '15'}, {'groupId': 'FG001', 'numSubjects': '4'}, {'groupId': 'FG002', 'numSubjects': '4'}]}, {'type': 'Disease relapse', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '9'}, {'groupId': 'FG002', 'numSubjects': '10'}]}, {'type': 'Disease progression', 'reasons': [{'groupId': 'FG000', 'numSubjects': '9'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '1'}]}]}], 'preAssignmentDetails': '77 participants enrolled, 76 treated. 1 not treated due to protocol violation.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'BG000'}, {'value': '25', 'groupId': 'BG001'}, {'value': '26', 'groupId': 'BG002'}, {'value': '76', 'groupId': 'BG003'}]}], 'groups': [{'id': 'BG000', 'title': '3.0 MG/KG IPILIMUMAB + PEPTIDES', 'description': 'HLA-A\\*201 positive participants receive ipilimumab at 3 mg/kg/dose as an intravenous (i.v.) infusion every 8 weeks for 12 months for a total of 7 infusions.\n\nPeptides administered at Weeks 1, 3, 5, 7, 9, 11, 17, 21, 25, 33, 41, and 53 for a total of 12 vaccinations.'}, {'id': 'BG001', 'title': '10 MG/KG IPILIMUMAB + PEPTIDES', 'description': 'HLA-A\\*201 positive participants receive ipilimumab at 10 mg/kg/dose as an intravenous (i.v.) infusion every 8 weeks for 12 months for a total of 7 infusions.\n\nPeptides administered at Weeks 1, 3, 5, 7, 9, 11, 17, 21, 25, 33, 41, and 53 for a total of 12 vaccinations.'}, {'id': 'BG002', 'title': '10 MG/KG IPILIMUMAB', 'description': 'HLA-A\\*201 negative participants receive ipilimumab at 10 mg/kg/dose as an intravenous (i.v.) infusion every 8 weeks for 12 months for a total of 7 infusions.'}, {'id': 'BG003', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '54.7', 'spread': '15.25', 'groupId': 'BG000'}, {'value': '53.3', 'spread': '10.34', 'groupId': 'BG001'}, {'value': '51.5', 'spread': '14.06', 'groupId': 'BG002'}, {'value': '53.1', 'spread': '13.28', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'Years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '12', 'groupId': 'BG000'}, {'value': '10', 'groupId': 'BG001'}, {'value': '9', 'groupId': 'BG002'}, {'value': '31', 'groupId': 'BG003'}]}, {'title': 'Male', 'measurements': [{'value': '13', 'groupId': 'BG000'}, {'value': '15', 'groupId': 'BG001'}, {'value': '17', 'groupId': 'BG002'}, {'value': '45', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'categories': [{'title': 'Hispanic', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}]}, {'title': 'White', 'measurements': [{'value': '25', 'groupId': 'BG000'}, {'value': '25', 'groupId': 'BG001'}, {'value': '25', 'groupId': 'BG002'}, {'value': '75', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 77}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2004-05-31', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-04', 'completionDateStruct': {'date': '2009-10-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-04-13', 'studyFirstSubmitDate': '2004-06-10', 'resultsFirstSubmitDate': '2022-03-21', 'studyFirstSubmitQcDate': '2004-06-10', 'lastUpdatePostDateStruct': {'date': '2022-04-14', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2022-04-13', 'studyFirstPostDateStruct': {'date': '2004-06-11', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2022-04-14', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2009-10-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Percentage of Participants With Immune-related Adverse Events (irAEs)', 'timeFrame': 'Between first dose and 70 days after last dose of study therapy (up to 3 years including maintenance phase)', 'description': 'Percentage of participants who experienced an irAE during the course of the study defined by the induction of Grade 1, Grade 2, or acceptable Grade 3 drug-related irAEs.\n\nFor the purposes of this trial, acceptable drug-related irAEs are skin-related immune-mediated adverse events \\< or = Grade 3 (potentially reversible inflammation \\< Grade 4 that can be attributable to a local antitumor reaction that could potentially be a therapeutic response will also be considered an acceptable irAE).\n\nNote: The confidence interval was calculated using the Clopper Pearson method'}, {'measure': 'Time to Disease Relapse', 'timeFrame': 'up to 3 years', 'description': 'To determine the time (months) from first dose to disease relapse.\n\nTime to disease relapse is defined from the start of treatment to the first occurrence of any new lesion (reported by the investigator on physical exam or diagnostic imaging assessments that are attributed to metastatic melanoma) or death. Participants who neither relapse nor died will be censored on the date of their last tumor evaluation.\n\nMedian estimated using Kaplan-Meier method; A two-sided 95% CI for median in each treatment group was computed via the log-log transformation method.'}], 'secondaryOutcomes': [{'measure': 'Number of Participants With Drug-related irAEs of Any Grade', 'timeFrame': 'Between first dose and 70 days after last dose of study therapy (up to 3 years including maintenance phase)', 'description': 'The number of participants who experienced a drug-related irAE of any grade over the course of the study.\n\nNote: The confidence interval was calculated using the Clopper Pearson method'}, {'measure': 'Immunologic Response to the Dose Regimen', 'timeFrame': 'up to 3 years', 'description': 'The secondary objective was to determine the immunologic response to the dosing regimen, via Human Anti-Human Antibody (HAHA) Assessment, displayed by number of participants observed as HAHA positive or negative.\n\nNote: If participant had at least one post-baseline HAHA result with increase in titer over pre-study, the participant is counted as HAHA Positive.\n\nA participant with all negative post-baseline results is counted as HAHA negative.'}, {'measure': 'Number of Participants Experiencing Hematology-related Lab Abnormalities', 'timeFrame': 'Between first dose and 70 days after last dose of study therapy (up to 3 years including maintenance phase)', 'description': 'The number of participants who experienced a Hematology-related laboratory abnormality (grade 1-4 and grade 3-4 categories, grade 4 being the worst) during the course of the study.\n\nLaboratory tests were graded using the NCI Common Terminology Criteria for Adverse Events (CTCAE), version 3.0.'}, {'measure': 'Number of Participants Experiencing Serum Chemistry-related Lab Abnormalities', 'timeFrame': 'Between first dose and 70 days after last dose of study therapy (up to 3 years including maintenance phase)', 'description': 'The number of participants who experienced a Serum Chemistry-related laboratory abnormality (grade 1-4 and grade 3-4 categories, grade 4 being the worst) during the course of the study.\n\nLaboratory tests were graded using the NCI Common Terminology Criteria for Adverse Events (CTCAE), version 3.0.'}, {'measure': 'Time to Disease Relapse', 'timeFrame': 'up to 3 years', 'description': 'To determine the time (months) from first dose to disease relapse.\n\nTime to disease relapse is defined from the start of treatment to the first occurrence of any new lesion (reported by the investigator on physical exam or diagnostic imaging assessments that are attributed to metastatic melanoma) or death. Participants who neither relapse nor died will be censored on the date of their last tumor evaluation.\n\nMedian estimated using Kaplan-Meier method; A two-sided 95% CI for median in each treatment group was computed via the log-log transformation method.'}]}, 'conditionsModule': {'keywords': ['stage III melanoma', 'stage IV melanoma', 'ciliary body and choroid melanoma, medium/large size', 'extraocular extension melanoma', 'iris melanoma', 'recurrent melanoma', 'recurrent intraocular melanoma', 'metastatic intraocular melanoma'], 'conditions': ['Intraocular Melanoma', 'Melanoma (Skin)']}, 'referencesModule': {'references': [{'pmid': '32161584', 'type': 'DERIVED', 'citation': 'Garg SK, Ott MJ, Mostofa AGM, Chen Z, Chen YA, Kroeger J, Cao B, Mailloux AW, Agrawal A, Schaible BJ, Sarnaik A, Weber JS, Berglund AE, Mule JJ, Markowitz J. Multi-Dimensional Flow Cytometry Analyses Reveal a Dichotomous Role for Nitric Oxide in Melanoma Patients Receiving Immunotherapy. Front Immunol. 2020 Feb 25;11:164. doi: 10.3389/fimmu.2020.00164. eCollection 2020.'}, {'pmid': '21106722', 'type': 'DERIVED', 'citation': 'Sarnaik AA, Yu B, Yu D, Morelli D, Hall M, Bogle D, Yan L, Targan S, Solomon J, Nichol G, Yellin M, Weber JS. Extended dose ipilimumab with a peptide vaccine: immune correlates associated with clinical benefit in patients with resected high-risk stage IIIc/IV melanoma. Clin Cancer Res. 2011 Feb 15;17(4):896-906. doi: 10.1158/1078-0432.CCR-10-2463. Epub 2010 Nov 24.'}]}, 'descriptionModule': {'briefSummary': 'RATIONALE: Monoclonal antibodies can locate tumor cells and either kill them or deliver tumor-killing substances to them without harming normal cells. Vaccines may make the body build an immune response to kill tumor cells. Combining the vaccines with Montanide ISA-51 may cause a stronger immune response and kill more tumor cells. Giving monoclonal antibody therapy together with vaccine therapy may be an effective treatment for stage III or stage IV melanoma.\n\nPURPOSE: This phase II trial is studying how well giving monoclonal antibody therapy together with vaccine therapy works in treating patients with resected stage III or stage IV melanoma.', 'detailedDescription': 'OBJECTIVES:\n\nPrimary\n\n* Achieve at least a 40% autoimmune breakthrough event rate, as defined by the induction of grade 1, grade 2, or acceptable grade 3 drug-related autoimmune adverse events, in patients with resected stage III or IV melanoma treated with anti-cytotoxic T-lymphocyte-associated antigen-4 monoclonal antibody (MDX-010) and peptide vaccine comprising tyrosinase, gp100 antigen, and MART-1 antigen emulsified in Montanide ISA-51.\n\nSecondary\n\n* Determine the incidence of drug-related autoimmune adverse events of any grade in patients treated with this regimen.\n* Determine the time to disease relapse in patients treated with this regimen.\n* Determine the immunologic response in patients treated with this regimen.\n\nOUTLINE: This is an open-label study.\n\nPatients receive anti-cytotoxic T-lymphocyte-associated antigen-4 monoclonal antibody (MDX-010) IV over 90 minutes on day 1 of weeks 1, 9, 17, 25, 33, 41, and 53 and peptide vaccine comprising tyrosinase, gp100 antigen, and MART-1 antigen emulsified in Montanide ISA-51 subcutaneously on day 1 of weeks 1, 3, 5, 7, 9, 11, 17, 21, 25, 33, 41, and 53.\n\nPatients are followed every 3 months for 2 years, every 6 months for 2 years, and then annually thereafter.\n\nPROJECTED ACCRUAL: A total of 25 patients will be accrued for this study.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '120 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "DISEASE CHARACTERISTICS:\n\n* Histologically confirmed melanoma\n\n * Stage III (≥ 3 positive lymph nodes) or stage IV disease\n * Mucosal or ocular melanoma allowed\n* Completely resected within the past 6 months\n* Patients with stage III resected melanoma rendered free of disease may have failed, been ineligible for, or refused prior treatment with interferon alfa\n* Positive staining of tumor tissue for at least one of the following:\n\n * Antibody HMB-45 for gp100\n * Antibody HMB-45 for tyrosinase\n * Antibody HMB-45 for MART-1\n* HLA-A\\*0201 positive by DNA allele-specific polymerase chain reaction assay\n\nPATIENT CHARACTERISTICS:\n\nAge\n\n* 18 and over\n\nPerformance status\n\n* ECOG 0-1\n\nLife expectancy\n\n* At least 6 months\n\nHematopoietic\n\n* WBC ≥ 2,500/mm\\^3\n* Absolute neutrophil count ≥ 1,500/mm\\^3\n* Platelet count ≥ 100,000/mm\\^3\n* Hematocrit ≥ 30%\n* Hemoglobin ≥ 10 g/dL\n\nHepatic\n\n* AST ≤ 3 times upper limit of normal (ULN)\\*\n* Bilirubin ≤ ULN\\* (\\< 3.0 mg/dL for patients with Gilbert's syndrome)\n* No significant hepatic disease that would preclude study participation\n* Hepatitis B surface antigen negative\n* Hepatitis C antibody negative NOTE: \\* Unless attributable to disease\n\nRenal\n\n* Creatinine ≤ 2.0 mg/dL\n* No significant renal disease that would preclude study participation\n\nCardiovascular\n\n* No significant cardiac disease that would preclude study participation\n\nPulmonary\n\n* No significant pulmonary disease that would preclude study participation\n\nImmunologic\n\n* No history of any of the following:\n\n * Inflammatory bowel disease or any other autoimmune bowel disease\n * Systemic lupus erythematosus\n * Rheumatoid arthritis\n * Autoimmune ocular disease\n* No systemic hypersensitivity to Montanide ISA-51 or any vaccine component\n* No active infection requiring therapy\n* HIV negative\n\nOther\n\n* No other malignancy within the past 5 years except adequately treated basal cell or squamous cell skin cancer, superficial bladder cancer, or carcinoma in situ of the cervix\n* No significant gastrointestinal disease that would preclude study participation\n* No significant psychiatric disease that would preclude study participation\n* No other medical condition that would preclude study participation\n* Not pregnant or nursing\n* Negative pregnancy test\n* Fertile patients must use effective contraception during and for at least 4 months after study participation\n\nPRIOR CONCURRENT THERAPY:\n\nBiologic therapy\n\n* See Disease Characteristics\n* No prior anti-cytotoxic T-lymphocyte-associated antigen-4 monoclonal antibody (MDX-010)\n* No prior gp100 antigen, MART-1 antigen, or tyrosinase peptide\n* At least 4 weeks since prior immunotherapy for melanoma and recovered\n* No other concurrent immunotherapy\n\nChemotherapy\n\n* At least 4 weeks since prior chemotherapy for melanoma (6 weeks for nitrosoureas) and recovered\n* No concurrent chemotherapy\n\nEndocrine therapy\n\n* At least 4 weeks since prior hormonal therapy for melanoma and recovered\n* At least 4 weeks since prior systemic, inhaled, or topical corticosteroids\n* No concurrent systemic, inhaled, or topical corticosteroids\n\nRadiotherapy\n\n* At least 4 weeks since prior radiotherapy for melanoma and recovered\n\nSurgery\n\n* See Disease Characteristics\n* At least 4 weeks since prior surgery for melanoma and recovered\n\nOther\n\n* No concurrent immunosuppressive agents (e.g., cyclosporine and its analog)\n* Concurrent analgesic therapy allowed provided the dose is stable for the past 14 days"}, 'identificationModule': {'nctId': 'NCT00084656', 'briefTitle': 'Monoclonal Antibody Therapy and Vaccine Therapy in Treating Patients With Resected Stage III or Stage IV Melanoma', 'organization': {'class': 'INDUSTRY', 'fullName': 'Bristol-Myers Squibb'}, 'officialTitle': 'An Extended Dosing, Two-phase Study of MDX-010 as Monotherapy or in Combination With Tyrosinase/gp100/MART-1 Peptides Emulsified With Montanide ISA 51 VG in the Treatment of Subjects With Resected Stage III or Stage IV Melanoma', 'orgStudyIdInfo': {'id': 'CDR0000365467'}, 'secondaryIdInfos': [{'id': 'P30CA076292', 'link': 'https://reporter.nih.gov/quickSearch/P30CA076292', 'type': 'NIH'}, {'id': 'P30CA014089', 'link': 'https://reporter.nih.gov/quickSearch/P30CA014089', 'type': 'NIH'}, {'id': 'MCC-15241', 'type': 'OTHER', 'domain': 'Moffitt Cancer Center'}, {'id': 'MDX010-16', 'type': 'OTHER', 'domain': 'Medarex'}, {'id': 'NCI-6446', 'type': 'OTHER', 'domain': 'National Cancer Institute'}, {'id': 'CA184-016', 'type': 'OTHER', 'domain': 'BMS'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Arm 1', 'interventionNames': ['Biological: ipilimumab', 'Biological: Tyrosinase/gp100/MART-1 Peptides']}], 'interventions': [{'name': 'ipilimumab', 'type': 'BIOLOGICAL', 'description': 'IV over 90 mins on day 1, wks 1,9,17,25,33,41,53 Dose: 3 mg/kg (Part I), 10 mg/kg (Part II)', 'armGroupLabels': ['Arm 1']}, {'name': 'Tyrosinase/gp100/MART-1 Peptides', 'type': 'BIOLOGICAL', 'description': '(All subjects in Part I and HLA-A\\*0201 positive subjects only in Part II): SC, day 1 of wks 1,3,5,7,9,11,17, 21,25,33,41,53 Dose: 1 mg peptide emulsified in 1 mL Montanide ISA 51 VG.)', 'armGroupLabels': ['Arm 1']}]}, 'contactsLocationsModule': {'locations': [{'zip': '33612-9497', 'city': 'Tampa', 'state': 'Florida', 'country': 'United States', 'facility': 'H. Lee Moffitt Cancer Center and Research Institute at University of South Florida', 'geoPoint': {'lat': 27.94752, 'lon': -82.45843}}], 'overallOfficials': [{'name': 'Bristol-Myers Squibb', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Bristol-Myers Squibb'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Bristol-Myers Squibb', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'National Cancer Institute (NCI)', 'class': 'NIH'}], 'responsibleParty': {'type': 'SPONSOR'}}}}