Ignite Creation Date:
2025-12-25 @ 2:42 AM
Ignite Modification Date:
2025-12-26 @ 1:21 AM
Study NCT ID:
NCT03445533
Status:
TERMINATED
Last Update Posted:
2022-11-08
First Post:
2018-02-13
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
A Study of Tilsotolimod in Combo With Ipilimumab vs Ipilimumab Alone in Subjects With Anti-PD-1 Refractory Melanoma
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'firstMcpInfo': {'postDateStruct': {'date': '2022-09-15', 'type': 'ACTUAL'}}}}, 'conditionBrowseModule': {'meshes': [{'id': 'D008545', 'term': 'Melanoma'}, {'id': 'D009362', 'term': 'Neoplasm Metastasis'}, {'id': 'C563326', 'term': 'Diabetes Mellitus, Insulin-Dependent, 12'}, {'id': 'D012878', 'term': 'Skin Neoplasms'}], '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': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}, {'id': 'D009385', 'term': 'Neoplastic Processes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000074324', 'term': 'Ipilimumab'}, {'id': 'C000723013', 'term': 'tilsotolimod'}], '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': 'lcolfer@iderapharma.com', 'phone': '484-348-1605', 'title': 'Head of Clinical Operations', 'organization': 'Idera Pharmaceuticals, Inc.'}, 'certainAgreement': {'otherDetails': "There IS an agreement between the Principal Investigator and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.", 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'Adverse events were collected from the signing of informed consent, through the duration of active study treatment (10 weeks active study for participants assigned to Arm A OR 24 weeks active study for participants assigned to Arm B) and then for 90 days after the last dose of study treatment. All-Cause Mortality was assessed for up to 36 months.', 'description': 'Definitions aligned with FDA and ICH requirements.\n\nThe grading of adverse events utilized the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v4.03, which were defined as:\n\nGrade 1 = Mild, Grade 2 = Moderate, Grade 3 = Severe, Grade 4 = Life-threatening, and Grade 5 = Death', 'eventGroups': [{'id': 'EG000', 'title': 'Arm A: Ipilimumab', 'description': 'ipilimumab 3 mg/kg intravenous\n\nipilimumab: Arm A: 4 doses administered intravenously at a dose of 3 mg/kg over 90 minutes on Weeks 1, 4, 7, and 10.', 'otherNumAtRisk': 243, 'deathsNumAtRisk': 243, 'otherNumAffected': 218, 'seriousNumAtRisk': 243, 'deathsNumAffected': 166, 'seriousNumAffected': 108}, {'id': 'EG001', 'title': 'Arm B: IMO-2125 (Tilsotolimod) Plus Ipilimumab', 'description': 'IMO-2125 by intratumoral injection plus ipilimumab 3 mg/kg intravenous\n\nTilsotolimod with ipilimumab: IMO-2125 intratumoral injection administered as 9 doses on Weeks 1, 2, 3, 5, 8, 11, 16, 20, and 24. WITH (Arm B): Ipilimumab administered as 4 doses on Weeks 2, 5, 8, and 11. in combination with tilsotolimod.', 'otherNumAtRisk': 238, 'deathsNumAtRisk': 238, 'otherNumAffected': 226, 'seriousNumAtRisk': 238, 'deathsNumAffected': 165, 'seriousNumAffected': 119}], 'otherEvents': [{'term': 'Anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 243, 'numEvents': 57, 'numAffected': 31}, {'groupId': 'EG001', 'numAtRisk': 238, 'numEvents': 61, 'numAffected': 37}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (23.0)'}, {'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 243, 'numEvents': 85, 'numAffected': 61}, {'groupId': 'EG001', 'numAtRisk': 238, 'numEvents': 108, 'numAffected': 70}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (23.0)'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 243, 'numEvents': 56, 'numAffected': 48}, {'groupId': 'EG001', 'numAtRisk': 238, 'numEvents': 67, 'numAffected': 54}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (23.0)'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 243, 'numEvents': 35, 'numAffected': 30}, {'groupId': 'EG001', 'numAtRisk': 238, 'numEvents': 40, 'numAffected': 35}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (23.0)'}, {'term': 'Constipation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 243, 'numEvents': 24, 'numAffected': 23}, {'groupId': 'EG001', 'numAtRisk': 238, 'numEvents': 23, 'numAffected': 21}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (23.0)'}, {'term': 'Abdominal Pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 243, 'numEvents': 14, 'numAffected': 13}, {'groupId': 'EG001', 'numAtRisk': 238, 'numEvents': 24, 'numAffected': 21}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (23.0)'}, {'term': 'Dry Mouth', 'stats': [{'groupId': 'EG000', 'numAtRisk': 243, 'numEvents': 13, 'numAffected': 13}, {'groupId': 'EG001', 'numAtRisk': 238, 'numEvents': 14, 'numAffected': 13}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (23.0)'}, {'term': 'Abdominal Pain Upper', 'stats': [{'groupId': 'EG000', 'numAtRisk': 243, 'numEvents': 17, 'numAffected': 15}, {'groupId': 'EG001', 'numAtRisk': 238, 'numEvents': 8, 'numAffected': 8}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (23.0)'}, {'term': 'Asthenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 243, 'numEvents': 60, 'numAffected': 52}, {'groupId': 'EG001', 'numAtRisk': 238, 'numEvents': 110, 'numAffected': 79}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (23.0)'}, {'term': 'Pyrexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 243, 'numEvents': 42, 'numAffected': 28}, {'groupId': 'EG001', 'numAtRisk': 238, 'numEvents': 211, 'numAffected': 102}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (23.0)'}, {'term': 'Fatigue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 243, 'numEvents': 44, 'numAffected': 35}, {'groupId': 'EG001', 'numAtRisk': 238, 'numEvents': 75, 'numAffected': 48}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (23.0)'}, {'term': 'Chills', 'stats': [{'groupId': 'EG000', 'numAtRisk': 243, 'numEvents': 7, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 238, 'numEvents': 120, 'numAffected': 75}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (23.0)'}, {'term': 'Influenza Like Illness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 243, 'numEvents': 7, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 238, 'numEvents': 61, 'numAffected': 30}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (23.0)'}, {'term': 'Injection Site Pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 243, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 238, 'numEvents': 30, 'numAffected': 22}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (23.0)'}, {'term': 'Hepatocellular Injury', 'stats': [{'groupId': 'EG000', 'numAtRisk': 243, 'numEvents': 11, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 238, 'numEvents': 15, 'numAffected': 14}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (23.0)'}, {'term': 'Cholestasis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 243, 'numEvents': 6, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 238, 'numEvents': 14, 'numAffected': 13}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (23.0)'}, {'term': 'Aspartate Aminotransferase Increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 243, 'numEvents': 25, 'numAffected': 18}, {'groupId': 'EG001', 'numAtRisk': 238, 'numEvents': 54, 'numAffected': 32}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (23.0)'}, {'term': 'Alanine Aminotransferase Increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 243, 'numEvents': 27, 'numAffected': 18}, {'groupId': 'EG001', 'numAtRisk': 238, 'numEvents': 51, 'numAffected': 31}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (23.0)'}, {'term': 'Weight Decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 243, 'numEvents': 15, 'numAffected': 12}, {'groupId': 'EG001', 'numAtRisk': 238, 'numEvents': 33, 'numAffected': 25}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (23.0)'}, {'term': 'Blood Alkaline Phosphate Increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 243, 'numEvents': 9, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 238, 'numEvents': 19, 'numAffected': 16}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (23.0)'}, {'term': 'Gamma-glutamyltransferase Increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 243, 'numEvents': 5, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 238, 'numEvents': 23, 'numAffected': 16}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (23.0)'}, {'term': 'Decreased Appetite', 'stats': [{'groupId': 'EG000', 'numAtRisk': 243, 'numEvents': 46, 'numAffected': 42}, {'groupId': 'EG001', 'numAtRisk': 238, 'numEvents': 49, 'numAffected': 45}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (23.0)'}, {'term': 'Hypokalaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 243, 'numEvents': 16, 'numAffected': 14}, {'groupId': 'EG001', 'numAtRisk': 238, 'numEvents': 26, 'numAffected': 18}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (23.0)'}, {'term': 'Hyponatraemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 243, 'numEvents': 8, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 238, 'numEvents': 16, 'numAffected': 14}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (23.0)'}, {'term': 'Arthralgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 243, 'numEvents': 20, 'numAffected': 18}, {'groupId': 'EG001', 'numAtRisk': 238, 'numEvents': 24, 'numAffected': 18}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (23.0)'}, {'term': 'Back Pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 243, 'numEvents': 18, 'numAffected': 17}, {'groupId': 'EG001', 'numAtRisk': 238, 'numEvents': 12, 'numAffected': 12}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (23.0)'}, {'term': 'Pain in Extremity', 'stats': [{'groupId': 'EG000', 'numAtRisk': 243, 'numEvents': 13, 'numAffected': 12}, {'groupId': 'EG001', 'numAtRisk': 238, 'numEvents': 13, 'numAffected': 11}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (23.0)'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 243, 'numEvents': 20, 'numAffected': 15}, {'groupId': 'EG001', 'numAtRisk': 238, 'numEvents': 60, 'numAffected': 43}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (23.0)'}, {'term': 'Insomnia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 243, 'numEvents': 14, 'numAffected': 14}, {'groupId': 'EG001', 'numAtRisk': 238, 'numEvents': 11, 'numAffected': 11}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (23.0)'}, {'term': 'Cough', 'stats': [{'groupId': 'EG000', 'numAtRisk': 243, 'numEvents': 16, 'numAffected': 14}, {'groupId': 'EG001', 'numAtRisk': 238, 'numEvents': 19, 'numAffected': 19}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (23.0)'}, {'term': 'Dyspnoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 243, 'numEvents': 13, 'numAffected': 11}, {'groupId': 'EG001', 'numAtRisk': 238, 'numEvents': 20, 'numAffected': 17}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (23.0)'}, {'term': 'Pruritus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 243, 'numEvents': 70, 'numAffected': 60}, {'groupId': 'EG001', 'numAtRisk': 238, 'numEvents': 72, 'numAffected': 57}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (23.0)'}, {'term': 'Rash', 'stats': [{'groupId': 'EG000', 'numAtRisk': 243, 'numEvents': 32, 'numAffected': 22}, {'groupId': 'EG001', 'numAtRisk': 238, 'numEvents': 30, 'numAffected': 22}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (23.0)'}, {'term': 'Vitiligo', 'stats': [{'groupId': 'EG000', 'numAtRisk': 243, 'numEvents': 4, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 238, 'numEvents': 17, 'numAffected': 15}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (23.0)'}, {'term': 'Erythema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 243, 'numEvents': 6, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 238, 'numEvents': 14, 'numAffected': 12}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (23.0)'}, {'term': 'Hypotension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 243, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 238, 'numEvents': 13, 'numAffected': 12}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (23.0)'}], 'seriousEvents': [{'term': 'Anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 243, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 238, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (23.0)'}, {'term': 'Disseminated Intravascular Coagulation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 243, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 238, 'numEvents': 3, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (23.0)'}, {'term': 'Lymph Node Pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 243, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 238, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (23.0)'}, {'term': 'Microcytic Anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 243, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 238, 'numEvents': 2, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (23.0)'}, {'term': 'Neutropenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 243, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 238, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (23.0)'}, {'term': 'Thrombocytopenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 243, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 238, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (23.0)'}, {'term': 'Cardiogenic Shock', 'stats': [{'groupId': 'EG000', 'numAtRisk': 243, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 238, 'numEvents': 5, 'numAffected': 2}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (23.0)'}, {'term': 'Angina Pectoris', 'stats': [{'groupId': 'EG000', 'numAtRisk': 243, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 238, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (23.0)'}, {'term': 'Atrial Flutter', 'stats': [{'groupId': 'EG000', 'numAtRisk': 243, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 238, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (23.0)'}, {'term': 'Cardiac Arrest', 'stats': [{'groupId': 'EG000', 'numAtRisk': 243, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 238, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (23.0)'}, {'term': 'Cardiac Failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 243, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 238, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (23.0)'}, {'term': 'Cardiovascular Disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 243, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 238, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (23.0)'}, {'term': 'Coronary Artery Occlusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 243, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 238, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (23.0)'}, {'term': 'Immune-mediated Myocarditis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 243, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 238, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (23.0)'}, {'term': 'Myocarditis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 243, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 238, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (23.0)'}, {'term': 'Pericardial Effusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 243, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 238, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (23.0)'}, {'term': 'Hypophysitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 243, 'numEvents': 7, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 238, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Endocrine disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (23.0)'}, {'term': 'Adrenal Insufficiency', 'stats': [{'groupId': 'EG000', 'numAtRisk': 243, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 238, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Endocrine disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (23.0)'}, {'term': 'Adrenocortical Insufficiency Acute', 'stats': [{'groupId': 'EG000', 'numAtRisk': 243, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 238, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Endocrine disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (23.0)'}, {'term': 'Adrenocorticotropic Hormone Deficiency', 'stats': [{'groupId': 'EG000', 'numAtRisk': 243, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 238, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Endocrine disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (23.0)'}, {'term': 'Lymphocytic Hypophysitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 243, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 238, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Endocrine disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (23.0)'}, {'term': 'Retinal Detachment', 'stats': [{'groupId': 'EG000', 'numAtRisk': 243, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 238, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (23.0)'}, {'term': 'Colitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 243, 'numEvents': 17, 'numAffected': 13}, {'groupId': 'EG001', 'numAtRisk': 238, 'numEvents': 10, 'numAffected': 10}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 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1}, {'groupId': 'EG001', 'numAtRisk': 238, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (23.0)'}, {'term': 'Acute Kidney Injury', 'stats': [{'groupId': 'EG000', 'numAtRisk': 243, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 238, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (23.0)'}, {'term': 'Immune-mediated Nephritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 243, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 238, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (23.0)'}, {'term': 'Autoimmune Nephritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 243, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 238, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (23.0)'}, {'term': 'Cystitis Hemorrhagic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 243, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 238, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (23.0)'}, {'term': 'Immune-mediated Renal Disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 243, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 238, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (23.0)'}, {'term': 'Urinary Retention', 'stats': [{'groupId': 'EG000', 'numAtRisk': 243, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 238, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (23.0)'}, {'term': 'Pneumonitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 243, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 238, 'numEvents': 5, 'numAffected': 5}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (23.0)'}, {'term': 'Pulmonary Embolism', 'stats': [{'groupId': 'EG000', 'numAtRisk': 243, 'numEvents': 5, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 238, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (23.0)'}, {'term': 'Dyspnoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 243, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 238, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (23.0)'}, {'term': 'Acute Respiratory Failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 243, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 238, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (23.0)'}, {'term': 'Immune-mediated Pneumonitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 243, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 238, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (23.0)'}, {'term': 'Lung Disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 243, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 238, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (23.0)'}, {'term': 'Pleural Effusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 243, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 238, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (23.0)'}, {'term': 'Eczema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 243, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 238, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (23.0)'}, {'term': 'Pemphigoid', 'stats': [{'groupId': 'EG000', 'numAtRisk': 243, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 238, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (23.0)'}, {'term': 'Rash Maculo-papular', 'stats': [{'groupId': 'EG000', 'numAtRisk': 243, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 238, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (23.0)'}, {'term': 'Rash Pruritic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 243, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 238, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (23.0)'}, {'term': 'Hypotension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 243, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 238, 'numEvents': 6, 'numAffected': 3}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (23.0)'}, {'term': 'Deep Vein Thrombosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 243, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 238, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (23.0)'}, {'term': 'Haematoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 243, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 238, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (23.0)'}, {'term': 'Jugular Vein Thrombosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 243, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 238, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (23.0)'}, {'term': 'Phlebitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 243, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 238, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (23.0)'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Summary of Independent Reviewer-Assessed Objective Response Rate (ORR) by RECIST v1.1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '243', 'groupId': 'OG000'}, {'value': '238', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Arm A: Ipilimumab', 'description': 'ipilimumab 3 mg/kg intravenous\n\nIpilimumab: Arm A: 4 doses administered intravenously at a dose of 3 mg/kg over 90 minutes on Weeks 1, 4, 7, and 10.'}, {'id': 'OG001', 'title': 'Arm B: IMO-2125 Plus Ipilimumab', 'description': 'IMO-2125 by intratumoral injection plus ipilimumab 3 mg/kg intravenous\n\nTilsotolimod with Ipilimumab: IMO-2125 intratumoral injection administered as 9 doses on Weeks 1, 2, 3, 5, 8, 11, 16, 20, and 24. WITH (Arm B): Ipilimumab administered as 4 doses on Weeks 2, 5, 8, and 11. in combination with tilsotolimod'}], 'classes': [{'categories': [{'title': 'Complete Response', 'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}, {'title': 'Partial Response', 'measurements': [{'value': '20', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}]}, {'title': 'Stable Disease', 'measurements': [{'value': '45', 'groupId': 'OG000'}, {'value': '61', 'groupId': 'OG001'}]}, {'title': 'Progressive Disease', 'measurements': [{'value': '110', 'groupId': 'OG000'}, {'value': '89', 'groupId': 'OG001'}]}, {'title': 'Not Evaluable', 'measurements': [{'value': '67', 'groupId': 'OG000'}, {'value': '67', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.9394', 'groupIds': ['OG000', 'OG001'], 'pValueComment': 'p-value was calculated for percentage difference (B-A) using a Cochran-Mantel-Haenszel (CMH) test stratified by metastasis stage and BRAF mutation.', 'groupDescription': 'The ORR was defined as a percentage of subjects meeting criteria of CR and PR to calculate the p-value.', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'ORR and OS comprise a primary endpoint family; both have a priori hypotheses and were tested for statistical significance.'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Response is measured from the date of randomization, until disease progression, death, or start of new anti-cancer therapy (up to 36 months).', 'description': "The ORR for evaluable participants was calculated using the participant's best overall response (BOR).\n\nPer Response Evaluation Criteria in Solid Tumors (RECIST v1.1) for target lesions as assessed by MRI, CT or X-ray: Complete Response (CR) - disappearance of all target lesions; Partial Response (PR) - \\>=30% decrease from baseline of the sum of diameters of all target lesions; Stable Disease (SD) - does not qualify for CR, PR or Progression; Progressive Disease (PD) - 20% increase in the sum of diameters of target lesions.\n\nThe calculation is derived from measuring the diameter (mm) of the target lesion at baseline and comparing target lesion diameter (mm) at intervals during treatment and/or post-treatment. Based on the percent of tumor decrease or increase, the appropriate category is assigned.", 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All percentages were based on the number of participants in the Intent-to-Treat (ITT) analysis set within each group. Participants with no disease assessment in the study were included in the Not Evaluable category under Best Overall Response.'}, {'type': 'PRIMARY', 'title': 'Summary of Overall Survival', 'denoms': [{'units': 'Participants', 'counts': [{'value': '243', 'groupId': 'OG000'}, {'value': '238', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Arm A: Ipilimumab', 'description': 'ipilimumab 3 mg/kg intravenous\n\nIpilimumab: Arm A: 4 doses administered intravenously at a dose of 3 mg/kg over 90 minutes on Weeks 1, 4, 7, and 10.'}, {'id': 'OG001', 'title': 'Arm B: IMO-2125 Plus Ipilimumab', 'description': 'IMO-2125 by intratumoral injection plus ipilimumab 3 mg/kg intravenous\n\nTilsotolimod with Ipilimumab: IMO-2125 intratumoral injection administered as 9 doses on Weeks 1, 2, 3, 5, 8, 11, 16, 20, and 24. WITH (Arm B): Ipilimumab administered as 4 doses on Weeks 2, 5, 8, and 11. in combination with tilsotolimod'}], 'classes': [{'categories': [{'title': 'Died', 'measurements': [{'value': '166', 'groupId': 'OG000'}, {'value': '165', 'groupId': 'OG001'}]}, {'title': 'Alive (Censored)', 'measurements': [{'value': '77', 'groupId': 'OG000'}, {'value': '73', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.6775', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Cox Proportional Hazard', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.955', 'ciLowerLimit': '0.770', 'ciUpperLimit': '1.186', 'pValueComment': 'The p-value was calculated using the log rank test stratified by metastasis stage and BRAF mutation.', 'estimateComment': 'Hazard ratio and 95% CI (B/A) are estimated using a Cox proportional hazards model stratified by metastasis stage and BRAF mutation.', 'statisticalMethod': 'Log Rank', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'ORR and OS comprise a primary endpoint family; both have a priori hypotheses. ORR will be tested first followed by OS.'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'OS is measured from the date of randomization to the date of death from any cause (up to 36 months).', 'description': 'Efficacy measured by overall survival (OS) was defined as the number of participants alive compared to the number of participants that died by treatment group.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All percentages were based on the number of participants in the Intent-to-Treat (ITT) analysis set within each group.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Arm A: Ipilimumab', 'description': 'ipilimumab 3 mg/kg intravenous\n\nipilimumab: Arm A: 4 doses administered intravenously at a dose of 3 mg/kg over 90 minutes on Weeks 1, 4, 7, and 10.'}, {'id': 'FG001', 'title': 'Arm B: IMO-2125 (Tilsotolimod) Plus Ipilimumab', 'description': 'IMO-2125 by intratumoral injection plus ipilimumab 3 mg/kg intravenous\n\nTilsotolimod with ipilimumab: IMO-2125 intratumoral injection administered as 9 doses on Weeks 1, 2, 3, 5, 8, 11, 16, 20, and 24. WITH (Arm B): Ipilimumab administered as 4 doses on Weeks 2, 5, 8, and 11. in combination with tilsotolimod.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '243'}, {'groupId': 'FG001', 'numSubjects': '238'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '115'}, {'groupId': 'FG001', 'numSubjects': '45'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '128'}, {'groupId': 'FG001', 'numSubjects': '193'}]}], 'dropWithdraws': [{'type': 'Progressive Disease', 'reasons': [{'groupId': 'FG000', 'numSubjects': '48'}, {'groupId': 'FG001', 'numSubjects': '81'}]}, {'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '60'}, {'groupId': 'FG001', 'numSubjects': '64'}]}, {'type': 'Death', 'reasons': [{'groupId': 'FG000', 'numSubjects': '9'}, {'groupId': 'FG001', 'numSubjects': '19'}]}, {'type': 'Miscellaneous', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '16'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '4'}]}, {'type': 'Physician Decision', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '3'}]}, {'type': 'Sponsor Decision', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'Never Received any Study Treatment', 'reasons': [{'groupId': 'FG000', 'numSubjects': '7'}, {'groupId': 'FG001', 'numSubjects': '4'}]}]}], 'recruitmentDetails': 'The global Phase 3 study was conducted at academic cancer centers across 11 countries. Participating countries included United States, Australia, Canada, Czech Republic, France, Germany, Italy, Netherlands, Spain, Sweden, and United Kingdom.', 'preAssignmentDetails': 'The study was an open-label comparison of ipilimumab with and without intratumoral IMO-2125 (tilsotolimod) in participants with advanced melanoma who had disease progression while on or after PD-1 directed therapy. Study participants were randomized 1:1 to ipilimumab alone (Arm A) or ipilimumab with tilsotolimod given intratumorally (Arm B). Randomization was stratified on the duration of prior anti-PD-1 therapy, metastasis stage, and BRAF mutation status.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '243', 'groupId': 'BG000'}, {'value': '238', 'groupId': 'BG001'}, {'value': '481', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Arm A: Ipilimumab', 'description': 'ipilimumab 3 mg/kg intravenous\n\nIpilimumab: Arm A: 4 doses administered intravenously at a dose of 3 mg/kg over 90 minutes on Weeks 1, 4, 7, and 10.'}, {'id': 'BG001', 'title': 'Arm B: IMO-2125 Plus Ipilimumab', 'description': 'IMO-2125 by intratumoral injection plus ipilimumab 3 mg/kg intravenous\n\nTilsotolimod with Ipilimumab: IMO-2125 intratumoral injection administered as 9 doses on Weeks 1, 2, 3, 5, 8, 11, 16, 20, and 24. WITH (Arm B): Ipilimumab administered as 4 doses on Weeks 2, 5, 8, and 11. in combination with tilsotolimod'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '64.3', 'spread': '13.73', 'groupId': 'BG000'}, {'value': '64.3', 'spread': '13.28', 'groupId': 'BG001'}, {'value': '64.3', 'spread': '13.49', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '116', 'groupId': 'BG000'}, {'value': '105', 'groupId': 'BG001'}, {'value': '221', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '127', 'groupId': 'BG000'}, {'value': '133', 'groupId': 'BG001'}, {'value': '260', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '11', 'groupId': 'BG002'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '211', 'groupId': 'BG000'}, {'value': '187', 'groupId': 'BG001'}, {'value': '398', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '27', 'groupId': 'BG000'}, {'value': '45', 'groupId': 'BG001'}, {'value': '72', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}, {'title': 'Asian', 'measurements': [{'value': '6', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '7', 'groupId': 'BG002'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}, {'title': 'Black or African American', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}]}, {'title': 'White', 'measurements': [{'value': '207', 'groupId': 'BG000'}, {'value': '187', 'groupId': 'BG001'}, {'value': '394', 'groupId': 'BG002'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '27', 'groupId': 'BG000'}, {'value': '44', 'groupId': 'BG001'}, {'value': '71', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'Canada', 'categories': [{'measurements': [{'value': '9', 'groupId': 'BG000'}, {'value': '11', 'groupId': 'BG001'}, {'value': '20', 'groupId': 'BG002'}]}]}, {'title': 'Netherlands', 'categories': [{'measurements': [{'value': '9', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '11', 'groupId': 'BG002'}]}]}, {'title': 'Sweden', 'categories': [{'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '5', 'groupId': 'BG002'}]}]}, {'title': 'United States', 'categories': [{'measurements': [{'value': '23', 'groupId': 'BG000'}, {'value': '23', 'groupId': 'BG001'}, {'value': '46', 'groupId': 'BG002'}]}]}, {'title': 'Czechia', 'categories': [{'measurements': [{'value': '11', 'groupId': 'BG000'}, {'value': '19', 'groupId': 'BG001'}, {'value': '30', 'groupId': 'BG002'}]}]}, {'title': 'Italy', 'categories': [{'measurements': [{'value': '53', 'groupId': 'BG000'}, {'value': '40', 'groupId': 'BG001'}, {'value': '93', 'groupId': 'BG002'}]}]}, {'title': 'United Kingdom', 'categories': [{'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '5', 'groupId': 'BG002'}]}]}, {'title': 'Australia', 'categories': [{'measurements': [{'value': '10', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '14', 'groupId': 'BG002'}]}]}, {'title': 'France', 'categories': [{'measurements': [{'value': '71', 'groupId': 'BG000'}, {'value': '97', 'groupId': 'BG001'}, {'value': '168', 'groupId': 'BG002'}]}]}, {'title': 'Germany', 'categories': [{'measurements': [{'value': '24', 'groupId': 'BG000'}, {'value': '14', 'groupId': 'BG001'}, {'value': '38', 'groupId': 'BG002'}]}]}, {'title': 'Spain', 'categories': [{'measurements': [{'value': '29', 'groupId': 'BG000'}, {'value': '22', 'groupId': 'BG001'}, {'value': '51', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Baseline Melanoma Characteristics', 'classes': [{'categories': [{'title': 'Primary Histology - Cutaneous', 'measurements': [{'value': '210', 'groupId': 'BG000'}, {'value': '203', 'groupId': 'BG001'}, {'value': '413', 'groupId': 'BG002'}]}, {'title': 'Primary Histology - Mucosal', 'measurements': [{'value': '14', 'groupId': 'BG000'}, {'value': '12', 'groupId': 'BG001'}, {'value': '26', 'groupId': 'BG002'}]}, {'title': 'Primary Histology - Other', 'measurements': [{'value': '18', 'groupId': 'BG000'}, {'value': '23', 'groupId': 'BG001'}, {'value': '41', 'groupId': 'BG002'}]}, {'title': 'Primary Histology - Missing', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Baseline Melanoma Staging', 'classes': [{'categories': [{'title': 'IIIA', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}, {'title': 'IIIB', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}]}, {'title': 'IIIC', 'measurements': [{'value': '20', 'groupId': 'BG000'}, {'value': '35', 'groupId': 'BG001'}, {'value': '55', 'groupId': 'BG002'}]}, {'title': 'IVM1A', 'measurements': [{'value': '36', 'groupId': 'BG000'}, {'value': '24', 'groupId': 'BG001'}, {'value': '60', 'groupId': 'BG002'}]}, {'title': 'IVM1B', 'measurements': [{'value': '46', 'groupId': 'BG000'}, {'value': '24', 'groupId': 'BG001'}, {'value': '70', 'groupId': 'BG002'}]}, {'title': 'IVM1C', 'measurements': [{'value': '137', 'groupId': 'BG000'}, {'value': '147', 'groupId': 'BG001'}, {'value': '284', 'groupId': 'BG002'}]}, {'title': 'Other', 'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '9', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': 'Measure Description: Physician assessed and determined based on American Joint Committee on Cancer (AJCC) Staging System for Melanoma, Seventh Edition, which determines the stage (I-V) based on the TNM classification. T refers to tumor size, N refers to nearby lymph nodes and M represents metastasized (spread) to other parts of the body. This staging number is obtained as a sum of the TNM classification. The lower the number, the lower the cancer stage and the better the prognosis for the patient. The higher the stage, the worse the prognosis for the patient.', 'unitOfMeasure': 'Participants'}, {'title': 'Baseline Elevated LDH (lactate dehydrogenase)', 'classes': [{'categories': [{'title': 'Yes', 'measurements': [{'value': '124', 'groupId': 'BG000'}, {'value': '126', 'groupId': 'BG001'}, {'value': '250', 'groupId': 'BG002'}]}, {'title': 'No', 'measurements': [{'value': '112', 'groupId': 'BG000'}, {'value': '106', 'groupId': 'BG001'}, {'value': '218', 'groupId': 'BG002'}]}, {'title': 'Unknown', 'measurements': [{'value': '7', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '13', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'ECOG Performance Status', 'classes': [{'categories': [{'title': '0', 'measurements': [{'value': '146', 'groupId': 'BG000'}, {'value': '150', 'groupId': 'BG001'}, {'value': '296', 'groupId': 'BG002'}]}, {'title': '1', 'measurements': [{'value': '96', 'groupId': 'BG000'}, {'value': '87', 'groupId': 'BG001'}, {'value': '183', 'groupId': 'BG002'}]}, {'title': '2', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}]}, {'title': '3', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': '4', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': '5', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': "The Eastern Cooperative Oncology Group (ECOG) Performance Status Scale describes a patient's level of functioning in terms of their ability to care for themself, daily activity, and physical ability (walking, working, etc.). Scale grades are from 0 (fully active) best to 5 (dead) worst and are determined by physician assessment of the patient.\n\nGrade:\n\n0 - Fully active\n\n1. \\- Restricted in physically strenuous activity\n2. \\- Ambulatory, but unable to work\n3. \\- Limited selfcare, confined to bed/chair \\> 50% of waking hours\n4. \\- Completely disabled, confined to bed/chair, no selfcare\n5. \\- Dead", 'unitOfMeasure': 'Participants'}, {'title': 'Prior Systemic Anti-cancer Treatment', 'classes': [{'title': 'PD-1 Inhibitor', 'categories': [{'measurements': [{'value': '242', 'groupId': 'BG000'}, {'value': '237', 'groupId': 'BG001'}, {'value': '479', 'groupId': 'BG002'}]}]}, {'title': 'BRAK Inhibitor', 'categories': [{'measurements': [{'value': '36', 'groupId': 'BG000'}, {'value': '35', 'groupId': 'BG001'}, {'value': '71', 'groupId': 'BG002'}]}]}, {'title': 'MEK Inhibitor', 'categories': [{'measurements': [{'value': '36', 'groupId': 'BG000'}, {'value': '33', 'groupId': 'BG001'}, {'value': '69', 'groupId': 'BG002'}]}]}, {'title': 'Other', 'categories': [{'measurements': [{'value': '27', 'groupId': 'BG000'}, {'value': '38', 'groupId': 'BG001'}, {'value': '65', 'groupId': 'BG002'}]}]}, {'title': 'Other Immunotherapy', 'categories': [{'measurements': [{'value': '14', 'groupId': 'BG000'}, {'value': '18', 'groupId': 'BG001'}, {'value': '32', 'groupId': 'BG002'}]}]}, {'title': 'Cytokine', 'categories': [{'measurements': [{'value': '14', 'groupId': 'BG000'}, {'value': '10', 'groupId': 'BG001'}, {'value': '24', 'groupId': 'BG002'}]}]}, {'title': 'Chemotherapy', 'categories': [{'measurements': [{'value': '8', 'groupId': 'BG000'}, {'value': '11', 'groupId': 'BG001'}, {'value': '19', 'groupId': 'BG002'}]}]}, {'title': 'CTLA-4 Inhibitor', 'categories': [{'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '11', 'groupId': 'BG002'}]}]}, {'title': 'Oncolytic Virus', 'categories': [{'measurements': [{'value': '6', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '11', 'groupId': 'BG002'}]}]}, {'title': 'Other Targeted Therapy', 'categories': [{'measurements': [{'value': '6', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '11', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'description': 'Indicates multiple, known treatments. Participants may be counted in more than one category based on the combination of prior treatments.', 'unitOfMeasure': 'Prior Treatments'}, {'title': 'Prior Systemic Anti-cancer Treatment Setting', 'classes': [{'title': 'Unresectable/Metastatic Disease', 'categories': [{'measurements': [{'value': '214', 'groupId': 'BG000'}, {'value': '200', 'groupId': 'BG001'}, {'value': '414', 'groupId': 'BG002'}]}]}, {'title': 'Adjuvant', 'categories': [{'measurements': [{'value': '58', 'groupId': 'BG000'}, {'value': '76', 'groupId': 'BG001'}, {'value': '134', 'groupId': 'BG002'}]}]}, {'title': 'Neoadjuvant', 'categories': [{'measurements': [{'value': '6', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '8', 'groupId': 'BG002'}]}]}, {'title': 'Other', 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '5', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'Prior Treatment Settings'}, {'title': 'Best Response from Last Prior Systemic Anti-cancer Treatment', 'classes': [{'title': 'Complete Response', 'categories': [{'measurements': [{'value': '6', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '9', 'groupId': 'BG002'}]}]}, {'title': 'Partial Response', 'categories': [{'measurements': [{'value': '26', 'groupId': 'BG000'}, {'value': '23', 'groupId': 'BG001'}, {'value': '49', 'groupId': 'BG002'}]}]}, {'title': 'Stable Disease', 'categories': [{'measurements': [{'value': '49', 'groupId': 'BG000'}, {'value': '49', 'groupId': 'BG001'}, {'value': '98', 'groupId': 'BG002'}]}]}, {'title': 'Progressive Disease', 'categories': [{'measurements': [{'value': '135', 'groupId': 'BG000'}, {'value': '125', 'groupId': 'BG001'}, {'value': '260', 'groupId': 'BG002'}]}]}, {'title': 'Unknown', 'categories': [{'measurements': [{'value': '27', 'groupId': 'BG000'}, {'value': '38', 'groupId': 'BG001'}, {'value': '65', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Duration of Prior Anti-PD-1 Therapy', 'classes': [{'categories': [{'title': 'Greater than or Equal to 12 Weeks', 'measurements': [{'value': '207', 'groupId': 'BG000'}, {'value': '204', 'groupId': 'BG001'}, {'value': '411', 'groupId': 'BG002'}]}, {'title': 'Less than 12 Weeks', 'measurements': [{'value': '36', 'groupId': 'BG000'}, {'value': '34', 'groupId': 'BG001'}, {'value': '70', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'BRAF Mutation Status and Prior Targeted Therapy', 'classes': [{'categories': [{'title': 'BRAF Wild Type', 'measurements': [{'value': '188', 'groupId': 'BG000'}, {'value': '186', 'groupId': 'BG001'}, {'value': '374', 'groupId': 'BG002'}]}, {'title': 'BRAF Mutation Positive with Prior Targeted Therapy', 'measurements': [{'value': '35', 'groupId': 'BG000'}, {'value': '34', 'groupId': 'BG001'}, {'value': '69', 'groupId': 'BG002'}]}, {'title': 'BRAF Mutation Positive with no Prior Targeted Therapy', 'measurements': [{'value': '20', 'groupId': 'BG000'}, {'value': '18', 'groupId': 'BG001'}, {'value': '38', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2020-06-04', 'size': 1330049, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2022-07-13T15:05', 'hasProtocol': True}, {'date': '2021-02-25', 'size': 845548, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_001.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2022-07-13T15:06', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 481}}, 'statusModule': {'whyStopped': 'Lack of Efficacy', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2018-05-30', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-10', 'completionDateStruct': {'date': '2021-06-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-10-17', 'studyFirstSubmitDate': '2018-02-13', 'resultsFirstSubmitDate': '2022-08-19', 'studyFirstSubmitQcDate': '2018-02-20', 'lastUpdatePostDateStruct': {'date': '2022-11-08', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2022-10-17', 'studyFirstPostDateStruct': {'date': '2018-02-26', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2022-11-08', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-06-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Summary of Independent Reviewer-Assessed Objective Response Rate (ORR) by RECIST v1.1', 'timeFrame': 'Response is measured from the date of randomization, until disease progression, death, or start of new anti-cancer therapy (up to 36 months).', 'description': "The ORR for evaluable participants was calculated using the participant's best overall response (BOR).\n\nPer Response Evaluation Criteria in Solid Tumors (RECIST v1.1) for target lesions as assessed by MRI, CT or X-ray: Complete Response (CR) - disappearance of all target lesions; Partial Response (PR) - \\>=30% decrease from baseline of the sum of diameters of all target lesions; Stable Disease (SD) - does not qualify for CR, PR or Progression; Progressive Disease (PD) - 20% increase in the sum of diameters of target lesions.\n\nThe calculation is derived from measuring the diameter (mm) of the target lesion at baseline and comparing target lesion diameter (mm) at intervals during treatment and/or post-treatment. Based on the percent of tumor decrease or increase, the appropriate category is assigned."}, {'measure': 'Summary of Overall Survival', 'timeFrame': 'OS is measured from the date of randomization to the date of death from any cause (up to 36 months).', 'description': 'Efficacy measured by overall survival (OS) was defined as the number of participants alive compared to the number of participants that died by treatment group.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Melanoma', 'PD1', 'PD-1', 'refractory', 'metastatic', 'IMO-2125', 'illuminate 301', 'TLR9 agonist', 'advanced melanoma', 'CTLA4', 'CTLA-4', 'immunotherapy', 'skin cancer', 'ILLUMINATE-301'], 'conditions': ['Metastatic Melanoma']}, 'referencesModule': {'references': [{'pmid': '40048691', 'type': 'DERIVED', 'citation': 'Diab A, Ascierto PA, Maio M, Abdel-Wahab R, Negrier S, Mortier L, Arenberger P, Dalle S, Krajsova I, de la Cruz L, Leccia MT, Guida M, Lebbe C, Grob JJ, Butler MO, In GK, Loquai C, Walker JWT, Atkinson V, Kapiteijn E, Haferkamp S, Chunduru S, Rahimian S, Guidoboni M, Robert C. Randomized, Open-Label, Phase III Study of Tilsotolimod in Combination With Ipilimumab Versus Ipilimumab Alone in Patients With Advanced Refractory Melanoma (ILLUMINATE-301). J Clin Oncol. 2025 May 20;43(15):1800-1809. doi: 10.1200/JCO.24.00727. Epub 2025 Mar 6.'}]}, 'descriptionModule': {'briefSummary': 'A Phase 3 comparison of ipilimumab with and without IMO-2125 in advanced melanoma', 'detailedDescription': 'A Phase 3 global, multi-center, open-label comparison of ipilimumab with and without intratumoral IMO-2125 in subjects with advanced melanoma who had confirmed disease progression while on anti-PD-1'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n1. Subjects must be willing and able to sign the informed consent and comply with the study protocol.\n2. Subjects must be ≥18 years of age.\n3. Subjects must have histologically confirmed metastatic melanoma with measurable (by RECIST v1.1), stage III (lymph node or in transit lesions) or stage IVA, IVB, or IVC disease that is accessible for injection.\n4. Patients must have confirmed progression during or after treatment with a PD-1 inhibitor (cannot be part of a bi-specific antibody) e.g. nivolumab or pembrolizumab. Confirmed progression is defined as:\n\n * Radiological progression (confirmed at least 4 weeks after the initial scan showing PD); or\n * (For progression based solely on worsening of non-target or new, non-measurable disease) confirmation by an additional scan at least 4 weeks after the initial scan unless it is accompanied by correlative symptoms.\n\n In addition, all the following must hold:\n 1. No intervening anti-cancer therapy between the last course of PD-1 inhibitor treatment and the first dose of study treatment is allowed except for local measures (e.g., surgical excision or biopsy, focal radiation therapy).\n 2. The interval between last PD-1 inhibitor and start of study treatment should be at least 21 days with no residual anti-PD-1-related immune toxicities in excess of Grade 1 severity.\n 3. If BRAF mutation status is unknown, before randomization the subject must have BRAF testing performed using an approved assay method.\n 4. Patients with BRAF-positive tumor(s) are eligible for the study if they received prior treatment with a BRAF inhibitor (alone of in combination with a MEK inhibitor) or declined targeted therapy.\n5. Patients must have Eastern Cooperative Oncology Group (ECOG) Performance Status ≤ 1.\n6. Patients must meet the following laboratory criteria:\n\n 1. Absolute neutrophil count (ANC) ≥ 1.5 x 10\\^9/L (1500/mm3)\n 2. Platelet count ≥ 75 x 10\\^9/L (75,000/mm3)\n 3. Hemoglobin ≥ 8.0 g/dL (4.96 mmol/L)\n 4. Serum creatinine ≤ 1.5 x upper limit of normal (ULN) or calculated creatinine clearance ≥ 60 mL/minute\n 5. Aspartate aminotransferase (AST) ≤ 2.5 x ULN; alanine aminotransferase (ALT) ≤ 2.5 x ULN; AST/ALT \\< 5 x ULN if liver involvement\n 6. Serum bilirubin ≤ 1.5 x ULN, except in subjects with Gilbert's Syndrome who must have a total bilirubin \\< 3 mg/dL\n7. Women of childbearing potential (WOCBP) and men must agree to use effective contraceptive methods from Screening throughout the study treatment period and until at least 90 days after the last dose of either ipilimumab or IMO-2125, whichever is later.\n8. WOCBP must have a negative pregnancy test (serum or urine).\n\nExclusion Criteria:\n\n1. Ocular melanoma.\n2. Prior therapy with a toll-like receptor (TLR) agonist, excluding topical agents.\n3. Prior ipilimumab treatment with the exception of adjuvant treatment completed ≥6 months prior to enrollment\n4. Systemic treatment with interferon (IFN)-α within the previous 6 months.\n5. Known hypersensitivity to any oligodeoxynucleotide.\n6. Active autoimmune disease requiring disease-modifying therapy at the time of Screening.\n7. Subjects requiring systemic steroid therapy receiving \\>10 mg/day of prednisone (or equivalent) for the 2 weeks preceding start of study.\n8. Subjects with another primary malignancy that has not been in remission for at least 3 years, with the exception of non-melanoma skin cancer, curatively treated localized prostate cancer with non-detectable prostate-specific antigen, cervical carcinoma in situ on biopsy or a squamous intraepithelial lesion on Papanicolaou (Pap) smear, and thyroid cancer (except anaplastic).\n9. Active systemic infections requiring antibiotics\n10. Active hepatitis A, B, or C infection.\n11. Known diagnosis of human immunodeficiency virus (HIV) infection.\n12. Women who are pregnant or breastfeeding.\n13. Prior severe reaction to treatment with a human antibody that cannot be managed with standard supportive measures.\n14. Presence of known central nervous system, meningeal, or epidural metastatic disease. However, subjects with known brain metastases are allowed if the brain metastases are stable for ≥4 weeks before the first dose of study treatment. Stable is defined as neurological symptoms not present or resolved to baseline, no radiologic evidence of progression, and steroid requirement of prednisone ≤10 mg/day or equivalent\n15. Impaired cardiac function or clinically significant cardiac disease."}, 'identificationModule': {'nctId': 'NCT03445533', 'briefTitle': 'A Study of Tilsotolimod in Combo With Ipilimumab vs Ipilimumab Alone in Subjects With Anti-PD-1 Refractory Melanoma', 'organization': {'class': 'INDUSTRY', 'fullName': 'Idera Pharmaceuticals, Inc.'}, 'officialTitle': 'A Randomized Phase 3 Comparison of IMO-2125 With Ipilimumab Versus Ipilimumab Alone in Subjects With Anti-PD-1 Refractory Melanoma (ILLUMINATE-301)', 'orgStudyIdInfo': {'id': '2125-MEL-301'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Arm A: ipilimumab', 'description': 'ipilimumab 3 mg/kg intravenous', 'interventionNames': ['Drug: Ipilimumab']}, {'type': 'EXPERIMENTAL', 'label': 'Arm B: IMO-2125 plus ipilimumab', 'description': 'IMO-2125 by intratumoral injection plus ipilimumab 3 mg/kg intravenous', 'interventionNames': ['Drug: Tilsotolimod with Ipilimumab']}], 'interventions': [{'name': 'Ipilimumab', 'type': 'DRUG', 'otherNames': ['Yervoy®'], 'description': 'Arm A: 4 doses administered intravenously at a dose of 3 mg/kg over 90 minutes on Weeks 1, 4, 7, and 10.', 'armGroupLabels': ['Arm A: ipilimumab']}, {'name': 'Tilsotolimod with Ipilimumab', 'type': 'DRUG', 'otherNames': ['IMO-2125 with Yervoy'], 'description': 'IMO-2125 intratumoral injection administered as 9 doses on Weeks 1, 2, 3, 5, 8, 11, 16, 20, and 24. WITH (Arm B): Ipilimumab administered as 4 doses on Weeks 2, 5, 8, and 11. in combination with tilsotolimod', 'armGroupLabels': ['Arm B: IMO-2125 plus ipilimumab']}]}, 'contactsLocationsModule': {'locations': [{'zip': '35294', 'city': 'Birmingham', 'state': 'Alabama', 'country': 'United States', 'facility': 'University of Alabama at Birmingham (UAB)', 'geoPoint': {'lat': 33.52066, 'lon': -86.80249}}, {'zip': '85234', 'city': 'Gilbert', 'state': 'Arizona', 'country': 'United States', 'facility': 'Banner MD Anderson Cancer Center', 'geoPoint': {'lat': 33.35283, 'lon': -111.78903}}, {'zip': '85338', 'city': 'Scottsdale', 'state': 'Arizona', 'country': 'United States', 'facility': 'Cancer Treatment Centers of America (CTCA) - Western Regional Medical Center', 'geoPoint': {'lat': 33.50921, 'lon': -111.89903}}, {'zip': '90033', 'city': 'Los Angeles', 'state': 'California', 'country': 'United States', 'facility': 'University of Southern California', 'geoPoint': {'lat': 34.05223, 'lon': -118.24368}}, {'zip': '90095', 'city': 'Los Angeles', 'state': 'California', 'country': 'United States', 'facility': 'University of California, Los Angeles (UCLA)', 'geoPoint': {'lat': 34.05223, 'lon': -118.24368}}, {'zip': '95816', 'city': 'Sacramento', 'state': 'California', 'country': 'United States', 'facility': 'Sutter Health Sacramento', 'geoPoint': {'lat': 38.58157, 'lon': -121.4944}}, {'zip': '92093', 'city': 'San Diego', 'state': 'California', 'country': 'United States', 'facility': 'University of California, San Diego (UCSD) - Moores Cancer Center', 'geoPoint': {'lat': 32.71571, 'lon': -117.16472}}, {'zip': '94305', 'city': 'Stanford', 'state': 'California', 'country': 'United States', 'facility': 'Stanford Cancer Center', 'geoPoint': {'lat': 37.42411, 'lon': -122.16608}}, {'zip': '33140', 'city': 'Miami Beach', 'state': 'Florida', 'country': 'United States', 'facility': 'Mount Sinai Medical Center of Florida, Inc.', 'geoPoint': {'lat': 25.79065, 'lon': -80.13005}}, {'zip': '32806', 'city': 'Orlando', 'state': 'Florida', 'country': 'United States', 'facility': 'University of Florida Health Cancer Center - Orlando Health', 'geoPoint': {'lat': 28.53834, 'lon': -81.37924}}, {'zip': '07450', 'city': 'Ridgewood', 'state': 'New Jersey', 'country': 'United States', 'facility': 'The Valley Hospital', 'geoPoint': {'lat': 40.97926, 'lon': -74.11653}}, {'zip': '45219', 'city': 'Cincinnati', 'state': 'Ohio', 'country': 'United States', 'facility': 'University of Cincinnati Health', 'geoPoint': {'lat': 39.12711, 'lon': -84.51439}}, {'zip': '44195', 'city': 'Cleveland', 'state': 'Ohio', 'country': 'United States', 'facility': 'The Cleveland Clinic Foundation', 'geoPoint': {'lat': 41.4995, 'lon': -81.69541}}, {'zip': '43221', 'city': 'Columbus', 'state': 'Ohio', 'country': 'United States', 'facility': 'The Ohio State University Comprehensive Cancer Center - Arthur G. 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