Ignite Creation Date:
2025-12-24 @ 3:25 PM
Ignite Modification Date:
2026-01-11 @ 9:40 PM
Study NCT ID:
NCT03070392
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2025-08-01
First Post:
2017-02-14
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Safety and Efficacy of IMCgp100 Versus Investigator Choice in Advanced Uveal 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': 'D003606', 'term': 'Dacarbazine'}, {'id': 'D000074324', 'term': 'Ipilimumab'}, {'id': 'C582435', 'term': 'pembrolizumab'}], 'ancestors': [{'id': 'D014226', 'term': 'Triazenes'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D007093', 'term': 'Imidazoles'}, {'id': 'D001393', 'term': 'Azoles'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'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': 'clinicaltrials@immunocore.com', 'phone': '1-844-IMMUNO-1', 'title': 'Study Director', 'organization': 'Immunocore, Ltd'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'Approximately 36 months.', 'description': "The Safety Analysis Set included all randomized participants who received at least 1 full or partial dose of tebentafusp or investigator's choice. Combining participants into a single group (Investigator's Choice) was pre-specified as part of the study design and data for each treatment in that arm were not analyzed separately. Adverse events were defined as events that were new or worsened during the on-treatment period.", 'eventGroups': [{'id': 'EG000', 'title': 'Tebentafusp', 'description': 'Tebentafusp administered at 20 mcg at Cycle 1 Day 1, 30 mcg at Cycle 1 Day 8, and 68 mcg at Cycle 1 Day 15 by IV infusion and weekly thereafter.', 'otherNumAtRisk': 245, 'deathsNumAtRisk': 245, 'otherNumAffected': 245, 'seriousNumAtRisk': 245, 'deathsNumAffected': 84, 'seriousNumAffected': 69}, {'id': 'EG001', 'title': "Investigator's Choice", 'description': "1 of 3 Investigator's Choice options: Systemic Dacarbazine, Ipilimumab or Pembrolizumab. Dacarbazine: administered at 1,000 mg/m2 of body surface area IV infusion every 3 weeks until disease progression or unacceptable toxicity; Ipilimumab: administered at 3 mg/kg IV infusion over 90 minutes every 3 weeks for a total of 4 treatments; Pembrolizumab: administered at 2 mg/kg IV infusion up to a maximum of 200 mg administered Intravenously over 30 minutes every 3 weeks or 200 mg fixed dose administered intravenously every 3 weeks where approved locally until confirmed disease progression or unacceptable toxicity.", 'otherNumAtRisk': 111, 'deathsNumAtRisk': 111, 'otherNumAffected': 102, 'seriousNumAtRisk': 111, 'deathsNumAffected': 57, 'seriousNumAffected': 26}], 'otherEvents': [{'term': 'Anemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 245, 'numEvents': 62, 'numAffected': 25}, {'groupId': 'EG001', 'numAtRisk': 111, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.1'}, {'term': 'Lymphopenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 245, 'numEvents': 51, 'numAffected': 24}, {'groupId': 'EG001', 'numAtRisk': 111, 'numEvents': 4, 'numAffected': 3}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.1'}, {'term': 'Thrombocytopenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 245, 'numEvents': 7, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 111, 'numEvents': 10, 'numAffected': 6}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.1'}, {'term': 'Tachycardia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 245, 'numEvents': 45, 'numAffected': 24}, {'groupId': 'EG001', 'numAtRisk': 111, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.1'}, {'term': 'Hyperthyroidism', 'stats': [{'groupId': 'EG000', 'numAtRisk': 245, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 111, 'numEvents': 16, 'numAffected': 13}], 'organSystem': 'Endocrine disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.1'}, {'term': 'Hypothyroidism', 'stats': [{'groupId': 'EG000', 'numAtRisk': 245, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 111, 'numEvents': 15, 'numAffected': 12}], 'organSystem': 'Endocrine disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.1'}, {'term': 'Periorbital edema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 245, 'numEvents': 51, 'numAffected': 26}, {'groupId': 'EG001', 'numAtRisk': 111, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.1'}, {'term': 'Abdominal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 245, 'numEvents': 92, 'numAffected': 59}, {'groupId': 'EG001', 'numAtRisk': 111, 'numEvents': 21, 'numAffected': 14}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.1'}, {'term': 'Abdominal pain upper', 'stats': [{'groupId': 'EG000', 'numAtRisk': 245, 'numEvents': 79, 'numAffected': 50}, {'groupId': 'EG001', 'numAtRisk': 111, 'numEvents': 21, 'numAffected': 14}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.1'}, {'term': 'Constipation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 245, 'numEvents': 65, 'numAffected': 44}, {'groupId': 'EG001', 'numAtRisk': 111, 'numEvents': 15, 'numAffected': 13}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.1'}, {'term': 'Diarrhea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 245, 'numEvents': 120, 'numAffected': 61}, {'groupId': 'EG001', 'numAtRisk': 111, 'numEvents': 45, 'numAffected': 22}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.1'}, {'term': 'Dry mouth', 'stats': [{'groupId': 'EG000', 'numAtRisk': 245, 'numEvents': 9, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 111, 'numEvents': 6, 'numAffected': 6}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.1'}, {'term': 'Dyspepsia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 245, 'numEvents': 28, 'numAffected': 20}, {'groupId': 'EG001', 'numAtRisk': 111, 'numEvents': 5, 'numAffected': 5}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.1'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 245, 'numEvents': 288, 'numAffected': 119}, {'groupId': 'EG001', 'numAtRisk': 111, 'numEvents': 44, 'numAffected': 28}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.1'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 245, 'numEvents': 163, 'numAffected': 73}, {'groupId': 'EG001', 'numAtRisk': 111, 'numEvents': 19, 'numAffected': 10}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.1'}, {'term': 'Asthenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 245, 'numEvents': 71, 'numAffected': 38}, {'groupId': 'EG001', 'numAtRisk': 111, 'numEvents': 11, 'numAffected': 9}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.1'}, {'term': 'Chills', 'stats': [{'groupId': 'EG000', 'numAtRisk': 245, 'numEvents': 378, 'numAffected': 117}, {'groupId': 'EG001', 'numAtRisk': 111, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.1'}, {'term': 'Face edema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 245, 'numEvents': 39, 'numAffected': 25}, {'groupId': 'EG001', 'numAtRisk': 111, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.1'}, {'term': 'Fatigue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 245, 'numEvents': 352, 'numAffected': 124}, {'groupId': 'EG001', 'numAtRisk': 111, 'numEvents': 53, 'numAffected': 39}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.1'}, {'term': 'Influenza like illness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 245, 'numEvents': 75, 'numAffected': 18}, {'groupId': 'EG001', 'numAtRisk': 111, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.1'}, {'term': 'Edema peripheral', 'stats': [{'groupId': 'EG000', 'numAtRisk': 245, 'numEvents': 119, 'numAffected': 66}, {'groupId': 'EG001', 'numAtRisk': 111, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.1'}, {'term': 'Pyrexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 245, 'numEvents': 682, 'numAffected': 186}, {'groupId': 'EG001', 'numAtRisk': 111, 'numEvents': 11, 'numAffected': 7}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.1'}, {'term': 'Hepatic pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 245, 'numEvents': 41, 'numAffected': 15}, {'groupId': 'EG001', 'numAtRisk': 111, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.1'}, {'term': 'Hyperbilirubinemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 245, 'numEvents': 56, 'numAffected': 26}, {'groupId': 'EG001', 'numAtRisk': 111, 'numEvents': 6, 'numAffected': 6}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.1'}, {'term': 'Cytokine release syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 245, 'numEvents': 91, 'numAffected': 34}, {'groupId': 'EG001', 'numAtRisk': 111, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Immune system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.1'}, {'term': 'Nasopharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 245, 'numEvents': 24, 'numAffected': 20}, {'groupId': 'EG001', 'numAtRisk': 111, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.1'}, {'term': 'Urinary tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 245, 'numEvents': 19, 'numAffected': 14}, {'groupId': 'EG001', 'numAtRisk': 111, 'numEvents': 5, 'numAffected': 5}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.1'}, {'term': 'Alanine aminotransferase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 245, 'numEvents': 127, 'numAffected': 50}, {'groupId': 'EG001', 'numAtRisk': 111, 'numEvents': 19, 'numAffected': 12}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.1'}, {'term': 'Aspartate aminotransferase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 245, 'numEvents': 134, 'numAffected': 55}, {'groupId': 'EG001', 'numAtRisk': 111, 'numEvents': 19, 'numAffected': 11}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.1'}, {'term': 'Blood alkaline phosphatase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 245, 'numEvents': 60, 'numAffected': 23}, {'groupId': 'EG001', 'numAtRisk': 111, 'numEvents': 4, 'numAffected': 3}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.1'}, {'term': 'Blood creatinine increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 245, 'numEvents': 26, 'numAffected': 13}, {'groupId': 'EG001', 'numAtRisk': 111, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.1'}, {'term': 'Blood lactate dehydrogenase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 245, 'numEvents': 20, 'numAffected': 13}, {'groupId': 'EG001', 'numAtRisk': 111, 'numEvents': 8, 'numAffected': 3}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.1'}, {'term': 'Lipase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 245, 'numEvents': 73, 'numAffected': 35}, {'groupId': 'EG001', 'numAtRisk': 111, 'numEvents': 12, 'numAffected': 7}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.1'}, {'term': 'Weight decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 245, 'numEvents': 16, 'numAffected': 16}, {'groupId': 'EG001', 'numAtRisk': 111, 'numEvents': 11, 'numAffected': 7}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.1'}, {'term': 'Decreased appetite', 'stats': [{'groupId': 'EG000', 'numAtRisk': 245, 'numEvents': 56, 'numAffected': 45}, {'groupId': 'EG001', 'numAtRisk': 111, 'numEvents': 17, 'numAffected': 15}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.1'}, {'term': 'Hypokalemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 245, 'numEvents': 24, 'numAffected': 18}, {'groupId': 'EG001', 'numAtRisk': 111, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.1'}, {'term': 'Hypomagnesemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 245, 'numEvents': 31, 'numAffected': 19}, {'groupId': 'EG001', 'numAtRisk': 111, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.1'}, {'term': 'Hypophosphatemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 245, 'numEvents': 52, 'numAffected': 27}, {'groupId': 'EG001', 'numAtRisk': 111, 'numEvents': 5, 'numAffected': 2}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.1'}, {'term': 'Arthralgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 245, 'numEvents': 97, 'numAffected': 53}, {'groupId': 'EG001', 'numAtRisk': 111, 'numEvents': 30, 'numAffected': 18}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.1'}, {'term': 'Back pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 245, 'numEvents': 56, 'numAffected': 45}, {'groupId': 'EG001', 'numAtRisk': 111, 'numEvents': 14, 'numAffected': 9}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.1'}, {'term': 'Muscle spasms', 'stats': [{'groupId': 'EG000', 'numAtRisk': 245, 'numEvents': 30, 'numAffected': 14}, {'groupId': 'EG001', 'numAtRisk': 111, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.1'}, {'term': 'Myalgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 245, 'numEvents': 40, 'numAffected': 24}, {'groupId': 'EG001', 'numAtRisk': 111, 'numEvents': 9, 'numAffected': 7}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.1'}, {'term': 'Pain in extremity', 'stats': [{'groupId': 'EG000', 'numAtRisk': 245, 'numEvents': 36, 'numAffected': 24}, {'groupId': 'EG001', 'numAtRisk': 111, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.1'}, {'term': 'Dizziness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 245, 'numEvents': 46, 'numAffected': 26}, {'groupId': 'EG001', 'numAtRisk': 111, 'numEvents': 12, 'numAffected': 9}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.1'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 245, 'numEvents': 135, 'numAffected': 75}, {'groupId': 'EG001', 'numAtRisk': 111, 'numEvents': 15, 'numAffected': 11}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.1'}, {'term': 'Parasthesia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 245, 'numEvents': 53, 'numAffected': 27}, {'groupId': 'EG001', 'numAtRisk': 111, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.1'}, {'term': 'Anxiety', 'stats': [{'groupId': 'EG000', 'numAtRisk': 245, 'numEvents': 14, 'numAffected': 13}, {'groupId': 'EG001', 'numAtRisk': 111, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.1'}, {'term': 'Insomnia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 245, 'numEvents': 24, 'numAffected': 22}, {'groupId': 'EG001', 'numAtRisk': 111, 'numEvents': 6, 'numAffected': 6}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.1'}, {'term': 'Cough', 'stats': [{'groupId': 'EG000', 'numAtRisk': 245, 'numEvents': 67, 'numAffected': 44}, {'groupId': 'EG001', 'numAtRisk': 111, 'numEvents': 12, 'numAffected': 11}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.1'}, {'term': 'Dyspnea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 245, 'numEvents': 42, 'numAffected': 31}, {'groupId': 'EG001', 'numAtRisk': 111, 'numEvents': 7, 'numAffected': 7}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.1'}, {'term': 'Oropharyngeal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 245, 'numEvents': 20, 'numAffected': 16}, {'groupId': 'EG001', 'numAtRisk': 111, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.1'}, {'term': 'Alopecia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 245, 'numEvents': 22, 'numAffected': 21}, {'groupId': 'EG001', 'numAtRisk': 111, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.1'}, {'term': 'Dry skin', 'stats': [{'groupId': 'EG000', 'numAtRisk': 245, 'numEvents': 106, 'numAffected': 77}, {'groupId': 'EG001', 'numAtRisk': 111, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.1'}, {'term': 'Erythema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 245, 'numEvents': 120, 'numAffected': 60}, {'groupId': 'EG001', 'numAtRisk': 111, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.1'}, {'term': 'Hair color changes', 'stats': [{'groupId': 'EG000', 'numAtRisk': 245, 'numEvents': 62, 'numAffected': 48}, {'groupId': 'EG001', 'numAtRisk': 111, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.1'}, {'term': 'Night sweats', 'stats': [{'groupId': 'EG000', 'numAtRisk': 245, 'numEvents': 17, 'numAffected': 13}, {'groupId': 'EG001', 'numAtRisk': 111, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.1'}, {'term': 'Pruritus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 245, 'numEvents': 536, 'numAffected': 168}, {'groupId': 'EG001', 'numAtRisk': 111, 'numEvents': 33, 'numAffected': 26}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.1'}, {'term': 'Rash', 'stats': [{'groupId': 'EG000', 'numAtRisk': 245, 'numEvents': 603, 'numAffected': 132}, {'groupId': 'EG001', 'numAtRisk': 111, 'numEvents': 25, 'numAffected': 18}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.1'}, {'term': 'Rash maculo-papular', 'stats': [{'groupId': 'EG000', 'numAtRisk': 245, 'numEvents': 343, 'numAffected': 75}, {'groupId': 'EG001', 'numAtRisk': 111, 'numEvents': 10, 'numAffected': 9}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.1'}, {'term': 'Skin exfoliation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 245, 'numEvents': 80, 'numAffected': 51}, {'groupId': 'EG001', 'numAtRisk': 111, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.1'}, {'term': 'Skin hyperpigmentation', 'stats': [{'groupId': 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'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.1'}, {'term': 'Intracranial mass', 'stats': [{'groupId': 'EG000', 'numAtRisk': 245, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 111, 'numEvents': 2, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.1'}, {'term': 'Lethargy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 245, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 111, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.1'}, {'term': 'Motor dysfunction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 245, 'numEvents': 2, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 111, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.1'}, {'term': 'Presyncope', 'stats': [{'groupId': 'EG000', 'numAtRisk': 245, 'numEvents': 2, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 111, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.1'}, {'term': 'Seizure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 245, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 111, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.1'}, {'term': 'Spinal cord compression', 'stats': [{'groupId': 'EG000', 'numAtRisk': 245, 'numEvents': 2, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 111, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.1'}, {'term': 'Mental status changes', 'stats': [{'groupId': 'EG000', 'numAtRisk': 245, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 111, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.1'}, {'term': 'Acute kidney injury', 'stats': [{'groupId': 'EG000', 'numAtRisk': 245, 'numEvents': 2, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 111, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.1'}, {'term': 'Renal failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 245, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 111, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.1'}, {'term': 'Scrotal inflammation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 245, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 111, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.1'}, {'term': 'Cough', 'stats': [{'groupId': 'EG000', 'numAtRisk': 245, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 111, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.1'}, {'term': 'Dyspnea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 245, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 111, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.1'}, {'term': 'Pleurisy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 245, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 111, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.1'}, {'term': 'Pneumonitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 245, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 111, 'numEvents': 2, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.1'}, {'term': 'Pulmonary embolism', 'stats': [{'groupId': 'EG000', 'numAtRisk': 245, 'numEvents': 2, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 111, 'numEvents': 4, 'numAffected': 3}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.1'}, {'term': 'Pulmonary edema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 245, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 111, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.1'}, {'term': 'Sleep apnea syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 245, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 111, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.1'}, {'term': 'Pruritus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 245, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 111, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.1'}, {'term': 'Rash', 'stats': [{'groupId': 'EG000', 'numAtRisk': 245, 'numEvents': 10, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 111, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.1'}, {'term': 'Rash maculo-papular', 'stats': [{'groupId': 'EG000', 'numAtRisk': 245, 'numEvents': 13, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 111, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.1'}, {'term': 'Rash papular', 'stats': [{'groupId': 'EG000', 'numAtRisk': 245, 'numEvents': 2, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 111, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.1'}, {'term': 'Skin reaction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 245, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 111, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.1'}, {'term': 'Urticaria', 'stats': [{'groupId': 'EG000', 'numAtRisk': 245, 'numEvents': 2, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 111, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.1'}, {'term': 'Hypotension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 245, 'numEvents': 6, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 111, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.1'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Efficacy: Overall Survival', 'denoms': [{'units': 'Participants', 'counts': [{'value': '252', 'groupId': 'OG000'}, {'value': '126', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Tebentafusp', 'description': 'Tebentafusp administered at 20 mcg at Cycle 1 Day 1, 30 mcg at Cycle 1 Day 8, and 68 mcg at Cycle 1 Day 15 by IV infusion and weekly thereafter.'}, {'id': 'OG001', 'title': "Investigator's Choice", 'description': "1 of 3 Investigator's Choice options: Systemic Dacarbazine, Ipilimumab or Pembrolizumab. Dacarbazine: administered at 1,000 mg/m2 of body surface area IV infusion every 3 weeks until disease progression or unacceptable toxicity; Ipilimumab: administered at 3 mg/kg IV infusion over 90 minutes every 3 weeks for a total of 4 treatments; Pembrolizumab: administered at 2 mg/kg IV infusion up to a maximum of 200 mg administered Intravenously over 30 minutes every 3 weeks or 200 mg fixed dose administered intravenously every 3 weeks where approved locally until confirmed disease progression or unacceptable toxicity."}], 'classes': [{'categories': [{'measurements': [{'value': '21.7', 'groupId': 'OG000', 'lowerLimit': '18.6', 'upperLimit': '28.6'}, {'value': '16.0', 'groupId': 'OG001', 'lowerLimit': '9.7', 'upperLimit': '18.4'}]}]}], 'analyses': [{'pValue': '<0.0001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.51', 'ciLowerLimit': '0.37', 'ciUpperLimit': '0.71', 'statisticalMethod': 'Log Rank', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEDIAN', 'timeFrame': 'From randomization to the data cut off date of 13-Oct-2020; median follow-up duration was 14.1 months.', 'description': 'Overall survival is defined as the time from randomization to date of death due to any cause.', 'unitOfMeasure': 'Months', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': "The Intent-to-treat (ITT) Analysis Set comprises all participants assigned to treatment analyzed by the treatment assignment whether or not the participant received the assigned treatment. Combining participants into a single group as part of the Investigator's Choice arm was pre-specified as part of the study design; therefore, data per different treatments were not analyzed."}, {'type': 'SECONDARY', 'title': 'Safety: Number of Participants With Treatment Emergent Adverse Events', 'denoms': [{'units': 'Participants', 'counts': [{'value': '245', 'groupId': 'OG000'}, {'value': '111', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Tebentafusp', 'description': 'Tebentafusp administered at 20 mcg at Cycle 1 Day 1, 30 mcg at Cycle 1 Day 8, and 68 mcg at Cycle 1 Day 15 by IV infusion and weekly thereafter.'}, {'id': 'OG001', 'title': "Investigator's Choice", 'description': "1 of 3 Investigator's Choice options: Systemic Dacarbazine, Ipilimumab or Pembrolizumab. Dacarbazine: administered at 1,000 mg/m2 of body surface area IV infusion every 3 weeks until disease progression or unacceptable toxicity; Ipilimumab: administered at 3 mg/kg IV infusion over 90 minutes every 3 weeks for a total of 4 treatments; Pembrolizumab: administered at 2 mg/kg IV infusion up to a maximum of 200 mg administered Intravenously over 30 minutes every 3 weeks or 200 mg fixed dose administered intravenously every 3 weeks where approved locally until confirmed disease progression or unacceptable toxicity."}], 'classes': [{'categories': [{'measurements': [{'value': '245', 'groupId': 'OG000'}, {'value': '105', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Safety was assessed from informed consent through 90 days after end of treatment, up to 36 months.', 'description': 'Safety was defined as the number of participants with treatment emergent adverse events, including laboratory abnormalities, ECG changes, and/or physical examination findings.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': "The Safety Analysis Set includes all randomized participants who received at least 1 full or partial dose of tebentafusp or investigator's choice. Combining participants into a single group as part of the Investigator's Choice arm was pre-specified as part of the study design; therefore, data per different treatments were not analyzed."}, {'type': 'SECONDARY', 'title': 'Efficacy: Progression Free Survival (PFS)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '252', 'groupId': 'OG000'}, {'value': '126', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Tebentafusp', 'description': 'Tebentafusp administered at 20 mcg at Cycle 1 Day 1, 30 mcg at Cycle 1 Day 8, and 68 mcg at Cycle 1 Day 15 by IV infusion and weekly thereafter.'}, {'id': 'OG001', 'title': "Investigator's Choice", 'description': "1 of 3 Investigator's Choice options: Systemic Dacarbazine, Ipilimumab or Pembrolizumab. Dacarbazine: administered at 1,000 mg/m2 of body surface area IV infusion every 3 weeks until disease progression or unacceptable toxicity; Ipilimumab: administered at 3 mg/kg IV infusion over 90 minutes every 3 weeks for a total of 4 treatments; Pembrolizumab: administered at 2 mg/kg IV infusion up to a maximum of 200 mg administered Intravenously over 30 minutes every 3 weeks or 200 mg fixed dose administered intravenously every 3 weeks where approved locally until confirmed disease progression or unacceptable toxicity."}], 'classes': [{'categories': [{'measurements': [{'value': '3.3', 'groupId': 'OG000', 'lowerLimit': '3.0', 'upperLimit': '5.0'}, {'value': '2.9', 'groupId': 'OG001', 'lowerLimit': '2.8', 'upperLimit': '3.0'}]}]}], 'analyses': [{'pValue': '0.0139', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.73', 'ciLowerLimit': '0.58', 'ciUpperLimit': '0.94', 'statisticalMethod': 'Log Rank', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEDIAN', 'timeFrame': 'PFS was assessed every 3 months from randomization until disease progression or death, up to 36 months.', 'description': 'Progression free survival (PFS) is defined as the time from randomization to the date of progression (RECIST v1.1) or death due to any cause.', 'unitOfMeasure': 'Months', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': "The Intent-to-treat (ITT) Analysis Set comprises all participants assigned to treatment analyzed by the treatment assignment whether or not the participant received the assigned treatment. Combining participants into a single group as part of the Investigator's Choice arm was pre-specified as part of the study design; therefore, data per different treatments were not analyzed."}, {'type': 'SECONDARY', 'title': 'Quality-of-Life: Change From Baseline in EQ-5D,5L Domain Scores', 'denoms': [{'units': 'Participants', 'counts': [{'value': '252', 'groupId': 'OG000'}, {'value': '126', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Tebentafusp', 'description': 'Tebentafusp administered at 20 mcg at Cycle 1 Day 1, 30 mcg at Cycle 1 Day 8, and 68 mcg at Cycle 1 Day 15 by IV infusion and weekly thereafter.'}, {'id': 'OG001', 'title': "Investigator's Choice", 'description': "1 of 3 Investigator's Choice options: Systemic Dacarbazine, Ipilimumab or Pembrolizumab. Dacarbazine: administered at 1,000 mg/m2 of body surface area IV infusion every 3 weeks until disease progression or unacceptable toxicity; Ipilimumab: administered at 3 mg/kg IV infusion over 90 minutes every 3 weeks for a total of 4 treatments; Pembrolizumab: administered at 2 mg/kg IV infusion up to a maximum of 200 mg administered Intravenously over 30 minutes every 3 weeks or 200 mg fixed dose administered intravenously every 3 weeks where approved locally until confirmed disease progression or unacceptable toxicity."}], 'classes': [{'title': 'Mobility - Baseline Cycle 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '194', 'groupId': 'OG000'}, {'value': '78', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1.2', 'spread': '0.62', 'groupId': 'OG000'}, {'value': '1.3', 'spread': '0.55', 'groupId': 'OG001'}]}]}, {'title': 'Mobility - Change at Cycle 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '136', 'groupId': 'OG000'}, {'value': '45', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-0.1', 'spread': '0.66', 'groupId': 'OG000'}, {'value': '0.1', 'spread': '0.47', 'groupId': 'OG001'}]}]}, {'title': 'Mobility - Change at Cycle 5', 'denoms': [{'units': 'Participants', 'counts': [{'value': '108', 'groupId': 'OG000'}, {'value': '28', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.0', 'spread': '0.73', 'groupId': 'OG000'}, {'value': '0.3', 'spread': '0.65', 'groupId': 'OG001'}]}]}, {'title': 'Mobility - Change at Cycle 9', 'denoms': [{'units': 'Participants', 'counts': [{'value': '71', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.0', 'spread': '0.91', 'groupId': 'OG000'}, {'value': '0.0', 'spread': '0.55', 'groupId': 'OG001'}]}]}, {'title': 'Mobility - Change at Cycle 13', 'denoms': [{'units': 'Participants', 'counts': [{'value': '47', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-0.1', 'spread': '0.60', 'groupId': 'OG000'}, {'value': '0.3', 'spread': '0.87', 'groupId': 'OG001'}]}]}, {'title': 'Mobility - Change at Cycle 17', 'denoms': [{'units': 'Participants', 'counts': [{'value': '22', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.3', 'spread': '0.57', 'groupId': 'OG000'}, {'value': '0.2', 'spread': '0.41', 'groupId': 'OG001'}]}]}, {'title': 'Mobility - Change at Cycle 21', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.0', 'spread': '0.58', 'groupId': 'OG000'}, {'value': '0.5', 'spread': '0.71', 'groupId': 'OG001'}]}]}, {'title': 'Mobility - Change at Cycle 25', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.1', 'spread': '0.64', 'groupId': 'OG000'}, {'value': '0.0', 'spread': '0.00', 'groupId': 'OG001'}]}]}, {'title': 'Mobility - Change at Cycle 29', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.0', 'spread': '0.50', 'groupId': 'OG000'}, {'value': '0.0', 'spread': '0.00', 'groupId': 'OG001'}]}]}, {'title': 'Mobility - Change at EOT', 'denoms': [{'units': 'Participants', 'counts': [{'value': '95', 'groupId': 'OG000'}, {'value': '45', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.3', 'spread': '0.73', 'groupId': 'OG000'}, {'value': '0.4', 'spread': '0.99', 'groupId': 'OG001'}]}]}, {'title': 'Self-care - Baseline Cycle 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '194', 'groupId': 'OG000'}, {'value': '78', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1.1', 'spread': '0.45', 'groupId': 'OG000'}, {'value': '1.1', 'spread': '0.29', 'groupId': 'OG001'}]}]}, {'title': 'Self-care - Change at Cycle 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '136', 'groupId': 'OG000'}, {'value': '45', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.0', 'spread': '0.49', 'groupId': 'OG000'}, {'value': '0.0', 'spread': '0.26', 'groupId': 'OG001'}]}]}, {'title': 'Self-care - Change at Cycle 5', 'denoms': [{'units': 'Participants', 'counts': [{'value': '108', 'groupId': 'OG000'}, {'value': '28', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.0', 'spread': '0.42', 'groupId': 'OG000'}, {'value': '0.0', 'spread': '0.00', 'groupId': 'OG001'}]}]}, {'title': 'Self-care - Change at Cycle 9', 'denoms': [{'units': 'Participants', 'counts': [{'value': '71', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.0', 'spread': '0.58', 'groupId': 'OG000'}, {'value': '0.0', 'spread': '0.00', 'groupId': 'OG001'}]}]}, {'title': 'Self-care - Change at Cycle 13', 'denoms': [{'units': 'Participants', 'counts': [{'value': '47', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.1', 'spread': '0.52', 'groupId': 'OG000'}, {'value': '0.1', 'spread': '0.33', 'groupId': 'OG001'}]}]}, {'title': 'Self-care - Change at Cycle 17', 'denoms': [{'units': 'Participants', 'counts': [{'value': '22', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.1', 'spread': '0.68', 'groupId': 'OG000'}, {'value': '0.0', 'spread': '0.00', 'groupId': 'OG001'}]}]}, {'title': 'Self-care - Change at Cycle 21', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.0', 'spread': '0.00', 'groupId': 'OG000'}, {'value': '0.0', 'spread': '0.00', 'groupId': 'OG001'}]}]}, {'title': 'Self-care - Change at Cycle 25', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.0', 'spread': '0.00', 'groupId': 'OG000'}, {'value': '0.0', 'spread': '0.00', 'groupId': 'OG001'}]}]}, {'title': 'Self-care - Change at Cycle 29', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.0', 'spread': '0.00', 'groupId': 'OG000'}, {'value': '0.0', 'spread': '0.00', 'groupId': 'OG001'}]}]}, {'title': 'Self-care - Change at EOT', 'denoms': [{'units': 'Participants', 'counts': [{'value': '95', 'groupId': 'OG000'}, {'value': '45', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.1', 'spread': '0.60', 'groupId': 'OG000'}, {'value': '0.1', 'spread': '0.56', 'groupId': 'OG001'}]}]}, {'title': 'Usual activities - Baseline Cycle 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '194', 'groupId': 'OG000'}, {'value': '78', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1.2', 'spread': '0.53', 'groupId': 'OG000'}, {'value': '1.3', 'spread': '0.55', 'groupId': 'OG001'}]}]}, {'title': 'Usual activities - Change at Cycle 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '136', 'groupId': 'OG000'}, {'value': '45', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.2', 'spread': '0.59', 'groupId': 'OG000'}, {'value': '0.1', 'spread': '0.73', 'groupId': 'OG001'}]}]}, {'title': 'Usual activities - Change at Cycle 5', 'denoms': [{'units': 'Participants', 'counts': [{'value': '108', 'groupId': 'OG000'}, {'value': '28', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.1', 'spread': '0.61', 'groupId': 'OG000'}, {'value': '0.2', 'spread': '0.61', 'groupId': 'OG001'}]}]}, {'title': 'Usual activities - Change at Cycle 9', 'denoms': [{'units': 'Participants', 'counts': [{'value': '71', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.2', 'spread': '0.87', 'groupId': 'OG000'}, {'value': '0.1', 'spread': '0.53', 'groupId': 'OG001'}]}]}, {'title': 'Usual activities - Change at Cycle 13', 'denoms': [{'units': 'Participants', 'counts': [{'value': '47', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.3', 'spread': '0.79', 'groupId': 'OG000'}, {'value': '0.1', 'spread': '0.60', 'groupId': 'OG001'}]}]}, {'title': 'Usual activities - Change at Cycle 17', 'denoms': [{'units': 'Participants', 'counts': [{'value': '22', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.5', 'spread': '0.80', 'groupId': 'OG000'}, {'value': '0.2', 'spread': '0.41', 'groupId': 'OG001'}]}]}, {'title': 'Usual activities - Change at Cycle 21', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.3', 'spread': '0.48', 'groupId': 'OG000'}, {'value': '0.0', 'spread': '0.00', 'groupId': 'OG001'}]}]}, {'title': 'Usual activities - Change at Cycle 25', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.3', 'spread': '0.46', 'groupId': 'OG000'}, {'value': '0.0', 'spread': '0.00', 'groupId': 'OG001'}]}]}, {'title': 'Usual activities - Change at Cycle 29', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.2', 'spread': '0.44', 'groupId': 'OG000'}, {'value': '0.0', 'spread': '0.00', 'groupId': 'OG001'}]}]}, {'title': 'Usual activities - Change at EOT', 'denoms': [{'units': 'Participants', 'counts': [{'value': '95', 'groupId': 'OG000'}, {'value': '45', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.4', 'spread': '0.77', 'groupId': 'OG000'}, {'value': '0.5', 'spread': '0.87', 'groupId': 'OG001'}]}]}, {'title': 'Pain/Discomfort - Baseline Cycle 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '194', 'groupId': 'OG000'}, {'value': '78', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1.5', 'spread': '0.71', 'groupId': 'OG000'}, {'value': '1.5', 'spread': '0.73', 'groupId': 'OG001'}]}]}, {'title': 'Pain/Discomfort - Change at Cycle 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '136', 'groupId': 'OG000'}, {'value': '45', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.0', 'spread': '0.75', 'groupId': 'OG000'}, {'value': '0.1', 'spread': '0.73', 'groupId': 'OG001'}]}]}, {'title': 'Pain/Discomfort - Change at Cycle 5', 'denoms': [{'units': 'Participants', 'counts': [{'value': '108', 'groupId': 'OG000'}, {'value': '28', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.0', 'spread': '0.65', 'groupId': 'OG000'}, {'value': '0.2', 'spread': '0.72', 'groupId': 'OG001'}]}]}, {'title': 'Pain/Discomfort - Change at Cycle 9', 'denoms': [{'units': 'Participants', 'counts': [{'value': '71', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.1', 'spread': '0.73', 'groupId': 'OG000'}, {'value': '-0.1', 'spread': '0.73', 'groupId': 'OG001'}]}]}, {'title': 'Pain/Discomfort - Change at Cycle 13', 'denoms': [{'units': 'Participants', 'counts': [{'value': '47', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.1', 'spread': '0.51', 'groupId': 'OG000'}, {'value': '0.1', 'spread': '0.93', 'groupId': 'OG001'}]}]}, {'title': 'Pain/Discomfort - Change at Cycle 17', 'denoms': [{'units': 'Participants', 'counts': [{'value': '22', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.4', 'spread': '0.85', 'groupId': 'OG000'}, {'value': '0.3', 'spread': '0.52', 'groupId': 'OG001'}]}]}, {'title': 'Pain/Discomfort - Change at Cycle 21', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.2', 'spread': '0.55', 'groupId': 'OG000'}, {'value': '0.0', 'spread': '0.00', 'groupId': 'OG001'}]}]}, {'title': 'Pain/Discomfort - Change at Cycle 25', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.0', 'spread': '0.53', 'groupId': 'OG000'}, {'value': '1.0', 'spread': 'NA', 'comment': 'Not calculable due to single participant.', 'groupId': 'OG001'}]}]}, {'title': 'Pain/Discomfort - Change at Cycle 29', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.1', 'spread': '0.60', 'groupId': 'OG000'}, {'value': '0.5', 'spread': '0.71', 'groupId': 'OG001'}]}]}, {'title': 'Pain/Discomfort - Change at EOT', 'denoms': [{'units': 'Participants', 'counts': [{'value': '95', 'groupId': 'OG000'}, {'value': '45', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.2', 'spread': '0.87', 'groupId': 'OG000'}, {'value': '0.4', 'spread': '1.10', 'groupId': 'OG001'}]}]}, {'title': 'Anxiety/Depression - Baseline Cycle 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '194', 'groupId': 'OG000'}, {'value': '78', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1.8', 'spread': '0.94', 'groupId': 'OG000'}, {'value': '1.7', 'spread': '0.89', 'groupId': 'OG001'}]}]}, {'title': 'Anxiety/Depression - Change at Cycle 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '136', 'groupId': 'OG000'}, {'value': '45', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-0.2', 'spread': '0.77', 'groupId': 'OG000'}, {'value': '-0.3', 'spread': '0.55', 'groupId': 'OG001'}]}]}, {'title': 'Anxiety/Depression - Change at Cycle 5', 'denoms': [{'units': 'Participants', 'counts': [{'value': '108', 'groupId': 'OG000'}, {'value': '28', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-0.2', 'spread': '0.74', 'groupId': 'OG000'}, {'value': '0.0', 'spread': '0.61', 'groupId': 'OG001'}]}]}, {'title': 'Anxiety/Depression - Change at Cycle 9', 'denoms': [{'units': 'Participants', 'counts': [{'value': '71', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-0.3', 'spread': '0.80', 'groupId': 'OG000'}, {'value': '0.1', 'spread': '0.77', 'groupId': 'OG001'}]}]}, {'title': 'Anxiety/Depression - Change at Cycle 13', 'denoms': [{'units': 'Participants', 'counts': [{'value': '47', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-0.4', 'spread': '0.77', 'groupId': 'OG000'}, {'value': '-0.1', 'spread': '0.60', 'groupId': 'OG001'}]}]}, {'title': 'Anxiety/Depression - Change at Cycle 17', 'denoms': [{'units': 'Participants', 'counts': [{'value': '22', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-0.4', 'spread': '0.85', 'groupId': 'OG000'}, {'value': '0.0', 'spread': '0.00', 'groupId': 'OG001'}]}]}, {'title': 'Anxiety/Depression - Change at Cycle 21', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-0.5', 'spread': '0.88', 'groupId': 'OG000'}, {'value': '0.0', 'spread': '0.00', 'groupId': 'OG001'}]}]}, {'title': 'Anxiety/Depression - Change at Cycle 25', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-0.4', 'spread': '0.74', 'groupId': 'OG000'}, {'value': '0.0', 'spread': 'NA', 'comment': 'Not calculable due to single participant.', 'groupId': 'OG001'}]}]}, {'title': 'Anxiety/Depression - Change at Cycle 29', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-0.6', 'spread': '0.88', 'groupId': 'OG000'}, {'value': '0.5', 'spread': '0.71', 'groupId': 'OG001'}]}]}, {'title': 'Anxiety/Depression - Change at EOT', 'denoms': [{'units': 'Participants', 'counts': [{'value': '95', 'groupId': 'OG000'}, {'value': '45', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.3', 'spread': '0.94', 'groupId': 'OG000'}, {'value': '0.2', 'spread': '1.07', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'EQ-5D,5L was assessed at baseline (Cycle 1 Day 1) and on Day 1 of every other cycle to Cycle 5 Day 1, every fourth cycle thereafter, beginning with Cycle 9 Day 1 and End of Treatment (EOT), up to 36 months. Each cycle is 21 days.', 'description': 'General health status was assessed using the EQ-5D,5L questionnaire, which includes five dimensions (5D): mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each dimension has 3 scoring levels, where 1 indicates a better health state (no problems) and 3 indicates a worse health state. A positive change indicates improvement.', 'unitOfMeasure': 'Units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': "The Intent-to-treat (ITT) Analysis Set comprises all participants assigned to treatment analyzed by the treatment assignment whether or not the participant received the assigned treatment. Combining participants into a single group as part of the Investigator's Choice arm was pre-specified as part of the study design; therefore, data per different treatments were not analyzed."}, {'type': 'SECONDARY', 'title': 'Quality-of-life: Change From Baseline in EQ-5D Visual Analogue Score (VAS)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '252', 'groupId': 'OG000'}, {'value': '126', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Tebentafusp', 'description': 'Tebentafusp administered at 20 mcg at Cycle 1 Day 1, 30 mcg at Cycle 1 Day 8, and 68 mcg at Cycle 1 Day 15 by IV infusion and weekly thereafter.'}, {'id': 'OG001', 'title': "Investigator's Choice", 'description': "1 of 3 Investigator's Choice options: Systemic Dacarbazine, Ipilimumab or Pembrolizumab. Dacarbazine: administered at 1,000 mg/m2 of body surface area IV infusion every 3 weeks until disease progression or unacceptable toxicity; Ipilimumab: administered at 3 mg/kg IV infusion over 90 minutes every 3 weeks for a total of 4 treatments; Pembrolizumab: administered at 2 mg/kg IV infusion up to a maximum of 200 mg administered Intravenously over 30 minutes every 3 weeks or 200 mg fixed dose administered intravenously every 3 weeks where approved locally until confirmed disease progression or unacceptable toxicity."}], 'classes': [{'title': 'Baseline Cycle 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '194', 'groupId': 'OG000'}, {'value': '78', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '81.0', 'spread': '16.36', 'groupId': 'OG000'}, {'value': '80.4', 'spread': '18.31', 'groupId': 'OG001'}]}]}, {'title': 'Change at Cycle 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '136', 'groupId': 'OG000'}, {'value': '45', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.4', 'spread': '14.69', 'groupId': 'OG000'}, {'value': '-0.8', 'spread': '14.28', 'groupId': 'OG001'}]}]}, {'title': 'Change at Cycle 5', 'denoms': [{'units': 'Participants', 'counts': [{'value': '108', 'groupId': 'OG000'}, {'value': '28', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.6', 'spread': '15.61', 'groupId': 'OG000'}, {'value': '-0.7', 'spread': '14.38', 'groupId': 'OG001'}]}]}, {'title': 'Change at Cycle 9', 'denoms': [{'units': 'Participants', 'counts': [{'value': '71', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-0.9', 'spread': '19.81', 'groupId': 'OG000'}, {'value': '-3.3', 'spread': '13.30', 'groupId': 'OG001'}]}]}, {'title': 'Change at Cycle 13', 'denoms': [{'units': 'Participants', 'counts': [{'value': '47', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-2.0', 'spread': '16.48', 'groupId': 'OG000'}, {'value': '-2.6', 'spread': '8.37', 'groupId': 'OG001'}]}]}, {'title': 'Change at Cycle 17', 'denoms': [{'units': 'Participants', 'counts': [{'value': '22', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-10.2', 'spread': '20.93', 'groupId': 'OG000'}, {'value': '-8.5', 'spread': '33.82', 'groupId': 'OG001'}]}]}, {'title': 'Change at Cycle 21', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-1.8', 'spread': '14.52', 'groupId': 'OG000'}, {'value': '-1.0', 'spread': '5.66', 'groupId': 'OG001'}]}]}, {'title': 'Change at Cycle 25', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-13.6', 'spread': '19.43', 'groupId': 'OG000'}, {'value': '-4.0', 'spread': 'NA', 'comment': 'Not calculable due to single participant', 'groupId': 'OG001'}]}]}, {'title': 'Change at Cycle 29', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.0', 'spread': '9.25', 'groupId': 'OG000'}, {'value': '-2.0', 'spread': '1.41', 'groupId': 'OG001'}]}]}, {'title': 'Change at EOT', 'denoms': [{'units': 'Participants', 'counts': [{'value': '95', 'groupId': 'OG000'}, {'value': '45', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-10.1', 'spread': '22.53', 'groupId': 'OG000'}, {'value': '-11.7', 'spread': '21.40', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'EQ-5D,5L VAS was assessed at baseline (Cycle 1 Day 1) and on Day 1 of every other cycle to Cycle 5 Day 1, every fourth cycle thereafter, beginning with Cycle 9 Day 1 and End of Treatment (EOT), up to 36 months. Each cycle is 21 days.', 'description': "The EQ-5D VAS score records the participant's self-rated health on a vertical visual analogue scale, with 0 being the worst imaginable health state and 100 being the best imaginable health state. A positive change indicates improvement.", 'unitOfMeasure': 'Units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': "The Intent-to-treat (ITT) Analysis Set comprises all participants assigned to treatment analyzed by the treatment assignment whether or not the participant received the assigned treatment. Combining participants into a single group as part of the Investigator's Choice arm was pre-specified as part of the study design; therefore, data per different treatments were not analyzed."}, {'type': 'SECONDARY', 'title': 'Quality-of-Life: Change From Baseline in EORTC QLQ-C30 Global Health Status', 'denoms': [{'units': 'Participants', 'counts': [{'value': '252', 'groupId': 'OG000'}, {'value': '126', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Tebentafusp', 'description': 'Tebentafusp administered at 20 mcg at Cycle 1 Day 1, 30 mcg at Cycle 1 Day 8, and 68 mcg at Cycle 1 Day 15 by IV infusion and weekly thereafter.'}, {'id': 'OG001', 'title': "Investigator's Choice", 'description': "1 of 3 Investigator's Choice options: Systemic Dacarbazine, Ipilimumab or Pembrolizumab. Dacarbazine: administered at 1,000 mg/m2 of body surface area IV infusion every 3 weeks until disease progression or unacceptable toxicity; Ipilimumab: administered at 3 mg/kg IV infusion over 90 minutes every 3 weeks for a total of 4 treatments; Pembrolizumab: administered at 2 mg/kg IV infusion up to a maximum of 200 mg administered Intravenously over 30 minutes every 3 weeks or 200 mg fixed dose administered intravenously every 3 weeks where approved locally until confirmed disease progression or unacceptable toxicity."}], 'classes': [{'title': 'Baseline Cycle 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '173', 'groupId': 'OG000'}, {'value': '65', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '76.108', 'spread': '20.233', 'groupId': 'OG000'}, {'value': '74.872', 'spread': '20.439', 'groupId': 'OG001'}]}]}, {'title': 'Change at Cycle 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '105', 'groupId': 'OG000'}, {'value': '35', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.952', 'spread': '16.274', 'groupId': 'OG000'}, {'value': '-0.238', 'spread': '14.919', 'groupId': 'OG001'}]}]}, {'title': 'Change at Cycle 5', 'denoms': [{'units': 'Participants', 'counts': [{'value': '94', 'groupId': 'OG000'}, {'value': '22', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-1.152', 'spread': '20.797', 'groupId': 'OG000'}, {'value': '-10.227', 'spread': '22.557', 'groupId': 'OG001'}]}]}, {'title': 'Change at Cycle 9', 'denoms': [{'units': 'Participants', 'counts': [{'value': '57', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-2.193', 'spread': '19.577', 'groupId': 'OG000'}, {'value': '-8.333', 'spread': '13.176', 'groupId': 'OG001'}]}]}, {'title': 'Change at Cycle 13', 'denoms': [{'units': 'Participants', 'counts': [{'value': '40', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-5.625', 'spread': '17.641', 'groupId': 'OG000'}, {'value': '-10.185', 'spread': '16.017', 'groupId': 'OG001'}]}]}, {'title': 'Change at Cycle 17', 'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-10.185', 'spread': '28.087', 'groupId': 'OG000'}, {'value': '-4.167', 'spread': '6.972', 'groupId': 'OG001'}]}]}, {'title': 'Change at Cycle 21', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.758', 'spread': '18.429', 'groupId': 'OG000'}, {'value': '-4.167', 'spread': '5.893', 'groupId': 'OG001'}]}]}, {'title': 'Change at Cycle 25', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-2.381', 'spread': '27.936', 'groupId': 'OG000'}, {'value': '0.00', 'spread': '0.00', 'groupId': 'OG001'}]}]}, {'title': 'Change at Cycle 29', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-8.333', 'spread': '19.720', 'groupId': 'OG000'}, {'value': '0.00', 'spread': '0.00', 'groupId': 'OG001'}]}]}, {'title': 'Change at EOT', 'denoms': [{'units': 'Participants', 'counts': [{'value': '76', 'groupId': 'OG000'}, {'value': '34', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-10.417', 'spread': '20.911', 'groupId': 'OG000'}, {'value': '-10.539', 'spread': '23.148', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'EORTC QLQ-C30 was assessed at baseline (Cycle 1 Day 1) and on Day 1 of every other cycle to Cycle 5 Day 1, every fourth cycle thereafter, beginning with Cycle 9 Day 1 and End of Treatment (EOT), up to 36 months. Each cycle is 21 days.', 'description': 'Global health status and quality of life was assessed using the EORTC QLQ-C30 questionnaire. The score range for the EORTC QLQ-C30 is from 0 to 100, with higher scores indicating better functioning and better global health status and health-related quality of life. A positive change indicates improvement.', 'unitOfMeasure': 'Units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': "The Intent-to-treat (ITT) Analysis Set comprises all participants assigned to treatment analyzed by the treatment assignment whether or not the participant received the assigned treatment. Combining participants into a single group as part of the Investigator's Choice arm was pre-specified as part of the study design; therefore, data per different treatments were not analyzed."}, {'type': 'SECONDARY', 'title': 'Pharmacokinetics (PK): Tebentafusp Concentration', 'denoms': [{'units': 'Participants', 'counts': [{'value': '231', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Tebentafusp', 'description': 'Tebentafusp administered at 20 mcg at Cycle 1 Day 1, 30 mcg at Cycle 1 Day 8, and 68 mcg at Cycle 1 Day 15 by IV infusion and weekly thereafter.'}], 'classes': [{'title': 'Cycle 1 Day 1 - End of Infusion', 'denoms': [{'units': 'Participants', 'counts': [{'value': '207', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '4201.929', 'spread': '0.6', 'groupId': 'OG000'}]}]}, {'title': 'Cycle 1 Day 1 - 12 to 24 hours post-infusion', 'denoms': [{'units': 'Participants', 'counts': [{'value': '212', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '505.100', 'spread': '0.7', 'groupId': 'OG000'}]}]}, {'title': 'Cycle 1 Day 8 - End of Infusion', 'denoms': [{'units': 'Participants', 'counts': [{'value': '200', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '5787.139', 'spread': '0.4', 'groupId': 'OG000'}]}]}, {'title': 'Cycle 1 Day 8 - 12 to 24 hours post-infusion', 'denoms': [{'units': 'Participants', 'counts': [{'value': '198', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '738.602', 'spread': '0.7', 'groupId': 'OG000'}]}]}, {'title': 'Cycle 1 Day 15 - End of Infusion', 'denoms': [{'units': 'Participants', 'counts': [{'value': '202', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '13715.914', 'spread': '0.5', 'groupId': 'OG000'}]}]}, {'title': 'Cycle 1 Day 15 - 12 to 24 hours post-infusion', 'denoms': [{'units': 'Participants', 'counts': [{'value': '205', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '1685.354', 'spread': '0.6', 'groupId': 'OG000'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'PK concentrations were assessed at pre-dose, end of infusion and anytime in the 12 to 24 hour window after completion of the infusion in Cycle 1 on Days 1, 8 and 15.', 'description': 'Serum PK concentrations of tebentafusp were collected over time.', 'unitOfMeasure': 'pg/mL', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'The PK Analysis Set included participants in the Safety Analysis Set who had at least 1 measurable PK concentration and who had relevant date, time, and dosing data for the sample.'}, {'type': 'SECONDARY', 'title': 'Efficacy: Objective Response Rate (ORR)', 'timeFrame': 'ORR will be assessed after every participant has had at least 3 assessments, conducted every 3 months, up to 5.5 years.', 'description': 'Objective response rate (ORR) is defined as the proportion of patients achieving an objective response (RECIST v1.1).', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants'}, {'type': 'SECONDARY', 'title': 'Efficacy: Duration of Response (DOR)', 'timeFrame': 'DOR will be assessed every 3 months from randomization until disease progression, assessed up to 5.5 years.', 'description': 'Duration of response (DOR) is defined as the time from first documented objective response (RECIST v1.1) until the date of documented disease progression.', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants'}, {'type': 'SECONDARY', 'title': 'Efficacy: Disease Control Rate (DCR)', 'timeFrame': 'DCR will be assessed every 3 months from randomization until disease progression, up to 5.5 years.', 'description': 'Disease control rate (DCR) is defined as the proportion of patients with either an objective response or stable disease (RECIST v1.1)', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants'}, {'type': 'SECONDARY', 'title': 'Pharmacokinetics: Frequency of Anti-IMCgp100 Antibody Formation', 'timeFrame': 'Approximately 5 assessments will be performed between first dose of IMCgp100 and end of treatment, assessed up to 5.5 years.', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Tebentafusp', 'description': 'Tebentafusp administered at 20 mcg at Cycle 1 Day 1, 30 mcg at Cycle 1 Day 8, and 68 mcg at Cycle 1 Day 15 by IV infusion and weekly thereafter.'}, {'id': 'FG001', 'title': "Investigator's Choice: Dacarbazine", 'description': 'Dacarbazine administered at 1,000 mg/m\\^2 of body surface area IV infusion every 3 weeks until confirmed disease progression or unacceptable toxicity.'}, {'id': 'FG002', 'title': "Investigator's Choice: Ipilimumab", 'description': 'Ipilimumab administered at 3 mg/kg IV infusion over 90 minutes every 3 weeks for a total of 4 treatments.'}, {'id': 'FG003', 'title': "Investigator's Choice: Pembrolizumab", 'description': 'Pembrolizumab administered at 2 mg/kg IV infusion over 30 minutes every 3 weeks or 200 mg fixed dose administered intravenously every 3 weeks where approved locally until confirmed disease progression or unacceptable toxicity.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '252'}, {'groupId': 'FG001', 'numSubjects': '7'}, {'groupId': 'FG002', 'numSubjects': '16'}, {'groupId': 'FG003', 'numSubjects': '103'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '10'}, {'groupId': 'FG003', 'numSubjects': '0'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '252'}, {'groupId': 'FG001', 'numSubjects': '7'}, {'groupId': 'FG002', 'numSubjects': '6'}, {'groupId': 'FG003', 'numSubjects': '103'}]}], 'dropWithdraws': [{'type': 'Not Treated', 'reasons': [{'groupId': 'FG000', 'numSubjects': '7'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '3'}, {'groupId': 'FG003', 'numSubjects': '12'}]}, {'type': 'Death', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '1'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '7'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '3'}]}, {'type': 'Physician Decision', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '2'}]}, {'type': 'Progressive Disease', 'reasons': [{'groupId': 'FG000', 'numSubjects': '154'}, {'groupId': 'FG001', 'numSubjects': '6'}, {'groupId': 'FG002', 'numSubjects': '2'}, {'groupId': 'FG003', 'numSubjects': '70'}]}, {'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '6'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '1'}, {'groupId': 'FG003', 'numSubjects': '3'}]}, {'type': 'Alternate anticancer treatment', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '1'}]}, {'type': 'Ongoing', 'reasons': [{'groupId': 'FG000', 'numSubjects': '73'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '11'}]}]}], 'recruitmentDetails': "A total of 378 patients were randomly assigned (2:1) to Tebentafusp (n=252) or Investigator's Choice (n=126) at 58 sites in 14 countries.", 'preAssignmentDetails': "The data cut-off date for this analysis was 13 October 2020. Combining participants into a single group as part of the Investigator's Choice arm was pre-specified as part of the study design."}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '252', 'groupId': 'BG000'}, {'value': '126', 'groupId': 'BG001'}, {'value': '378', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Tebentafusp', 'description': 'Tebentafusp administered at 20 mcg at Cycle 1 Day 1, 30 mcg at Cycle 1 Day 8, and 68 mcg at Cycle 1 Day 15 by IV infusion and weekly thereafter.'}, {'id': 'BG001', 'title': "Investigator's Choice", 'description': "1 of 3 Investigator's Choice options: Systemic Dacarbazine, Ipilimumab or Pembrolizumab. Dacarbazine: administered at 1,000 mg/m2 of body surface area IV infusion every 3 weeks until disease progression or unacceptable toxicity; Ipilimumab: administered at 3 mg/kg IV infusion over 90 minutes every 3 weeks for a total of 4 treatments; Pembrolizumab: administered at 2 mg/kg IV infusion up to a maximum of 200 mg administered Intravenously over 30 minutes every 3 weeks or 200 mg fixed dose administered intravenously every 3 weeks where approved locally until confirmed disease progression or unacceptable toxicity."}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '61.3', 'spread': '11.9', 'groupId': 'BG000'}, {'value': '63.6', 'spread': '10.7', 'groupId': 'BG001'}, {'value': '62.1', 'spread': '11.6', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'Years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '124', 'groupId': 'BG000'}, {'value': '64', 'groupId': 'BG001'}, {'value': '188', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '128', 'groupId': 'BG000'}, {'value': '62', 'groupId': 'BG001'}, {'value': '190', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}, {'title': 'Asian', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Black or African American', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'White', 'measurements': [{'value': '222', 'groupId': 'BG000'}, {'value': '107', 'groupId': 'BG001'}, {'value': '329', 'groupId': 'BG002'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '30', 'groupId': 'BG000'}, {'value': '18', 'groupId': 'BG001'}, {'value': '48', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}], 'populationDescription': "The Intent-to-treat (ITT) Analysis Set comprises all participants assigned to treatment analyzed by the treatment assignment whether or not the participant received the assigned treatment. Combining participants into a single group as part of the Investigator's Choice arm was pre-specified as part of the study design."}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2020-03-31', 'size': 14046734, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2021-08-08T15:34', 'hasProtocol': True}, {'date': '2020-10-28', 'size': 5748409, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_001.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2021-08-08T15:40', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 378}}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2017-10-16', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'nctId': 'NCT04960891', 'statusForNctId': 'AVAILABLE', 'hasExpandedAccess': True}, 'statusVerifiedDate': '2025-07', 'completionDateStruct': {'date': '2025-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-07-22', 'studyFirstSubmitDate': '2017-02-14', 'resultsFirstSubmitDate': '2021-08-17', 'studyFirstSubmitQcDate': '2017-02-28', 'lastUpdatePostDateStruct': {'date': '2025-08-01', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2021-08-17', 'studyFirstPostDateStruct': {'date': '2017-03-03', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2021-09-14', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-10-13', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Efficacy: Overall Survival', 'timeFrame': 'From randomization to the data cut off date of 13-Oct-2020; median follow-up duration was 14.1 months.', 'description': 'Overall survival is defined as the time from randomization to date of death due to any cause.'}], 'secondaryOutcomes': [{'measure': 'Safety: Number of Participants With Treatment Emergent Adverse Events', 'timeFrame': 'Safety was assessed from informed consent through 90 days after end of treatment, up to 36 months.', 'description': 'Safety was defined as the number of participants with treatment emergent adverse events, including laboratory abnormalities, ECG changes, and/or physical examination findings.'}, {'measure': 'Efficacy: Progression Free Survival (PFS)', 'timeFrame': 'PFS was assessed every 3 months from randomization until disease progression or death, up to 36 months.', 'description': 'Progression free survival (PFS) is defined as the time from randomization to the date of progression (RECIST v1.1) or death due to any cause.'}, {'measure': 'Quality-of-Life: Change From Baseline in EQ-5D,5L Domain Scores', 'timeFrame': 'EQ-5D,5L was assessed at baseline (Cycle 1 Day 1) and on Day 1 of every other cycle to Cycle 5 Day 1, every fourth cycle thereafter, beginning with Cycle 9 Day 1 and End of Treatment (EOT), up to 36 months. Each cycle is 21 days.', 'description': 'General health status was assessed using the EQ-5D,5L questionnaire, which includes five dimensions (5D): mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each dimension has 3 scoring levels, where 1 indicates a better health state (no problems) and 3 indicates a worse health state. A positive change indicates improvement.'}, {'measure': 'Quality-of-life: Change From Baseline in EQ-5D Visual Analogue Score (VAS)', 'timeFrame': 'EQ-5D,5L VAS was assessed at baseline (Cycle 1 Day 1) and on Day 1 of every other cycle to Cycle 5 Day 1, every fourth cycle thereafter, beginning with Cycle 9 Day 1 and End of Treatment (EOT), up to 36 months. Each cycle is 21 days.', 'description': "The EQ-5D VAS score records the participant's self-rated health on a vertical visual analogue scale, with 0 being the worst imaginable health state and 100 being the best imaginable health state. A positive change indicates improvement."}, {'measure': 'Quality-of-Life: Change From Baseline in EORTC QLQ-C30 Global Health Status', 'timeFrame': 'EORTC QLQ-C30 was assessed at baseline (Cycle 1 Day 1) and on Day 1 of every other cycle to Cycle 5 Day 1, every fourth cycle thereafter, beginning with Cycle 9 Day 1 and End of Treatment (EOT), up to 36 months. Each cycle is 21 days.', 'description': 'Global health status and quality of life was assessed using the EORTC QLQ-C30 questionnaire. The score range for the EORTC QLQ-C30 is from 0 to 100, with higher scores indicating better functioning and better global health status and health-related quality of life. A positive change indicates improvement.'}, {'measure': 'Pharmacokinetics (PK): Tebentafusp Concentration', 'timeFrame': 'PK concentrations were assessed at pre-dose, end of infusion and anytime in the 12 to 24 hour window after completion of the infusion in Cycle 1 on Days 1, 8 and 15.', 'description': 'Serum PK concentrations of tebentafusp were collected over time.'}, {'measure': 'Efficacy: Objective Response Rate (ORR)', 'timeFrame': 'ORR will be assessed after every participant has had at least 3 assessments, conducted every 3 months, up to 5.5 years.', 'description': 'Objective response rate (ORR) is defined as the proportion of patients achieving an objective response (RECIST v1.1).'}, {'measure': 'Efficacy: Duration of Response (DOR)', 'timeFrame': 'DOR will be assessed every 3 months from randomization until disease progression, assessed up to 5.5 years.', 'description': 'Duration of response (DOR) is defined as the time from first documented objective response (RECIST v1.1) until the date of documented disease progression.'}, {'measure': 'Efficacy: Disease Control Rate (DCR)', 'timeFrame': 'DCR will be assessed every 3 months from randomization until disease progression, up to 5.5 years.', 'description': 'Disease control rate (DCR) is defined as the proportion of patients with either an objective response or stable disease (RECIST v1.1)'}, {'measure': 'Pharmacokinetics: Frequency of Anti-IMCgp100 Antibody Formation', 'timeFrame': 'Approximately 5 assessments will be performed between first dose of IMCgp100 and end of treatment, assessed up to 5.5 years.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Melanoma', 'Uveal Cancer', 'IMCgp100', 'Immunotherapy', 'Tebentafusp', 'Ocular Melanoma', 'Eye Melanoma', 'Uveal Melanoma', 'Gp100', 'TCR', 'Dacarbazine', 'Ipilimumab', 'Pembrolizumab', 'Bispecific T cell receptor fusion protein', 'ImmTAC', 'Immune mobilizing monoclonal T cell receptor against cancer', 'Kimmtrak'], 'conditions': ['Uveal Melanoma']}, 'referencesModule': {'references': [{'pmid': '37870955', 'type': 'DERIVED', 'citation': 'Hassel JC, Piperno-Neumann S, Rutkowski P, Baurain JF, Schlaak M, Butler MO, Sullivan RJ, Dummer R, Kirkwood JM, Orloff M, Sacco JJ, Ochsenreither S, Joshua AM, Gastaud L, Curti B, Piulats JM, Salama AKS, Shoushtari AN, Demidov L, Milhem M, Chmielowski B, Kim KB, Carvajal RD, Hamid O, Collins L, Ranade K, Holland C, Pfeiffer C, Nathan P. Three-Year Overall Survival with Tebentafusp in Metastatic Uveal Melanoma. N Engl J Med. 2023 Dec 14;389(24):2256-2266. doi: 10.1056/NEJMoa2304753. Epub 2023 Oct 21.'}, {'pmid': '34551229', 'type': 'DERIVED', 'citation': 'Nathan P, Hassel JC, Rutkowski P, Baurain JF, Butler MO, Schlaak M, Sullivan RJ, Ochsenreither S, Dummer R, Kirkwood JM, Joshua AM, Sacco JJ, Shoushtari AN, Orloff M, Piulats JM, Milhem M, Salama AKS, Curti B, Demidov L, Gastaud L, Mauch C, Yushak M, Carvajal RD, Hamid O, Abdullah SE, Holland C, Goodall H, Piperno-Neumann S; IMCgp100-202 Investigators. Overall Survival Benefit with Tebentafusp in Metastatic Uveal Melanoma. N Engl J Med. 2021 Sep 23;385(13):1196-1206. doi: 10.1056/NEJMoa2103485.'}]}, 'descriptionModule': {'briefSummary': "To evaluate the overall survival of HLA-A\\*0201 positive adult patients with previously untreated advanced UM receiving IMCgp100 compared to Investigator's Choice of dacarbazine, ipilimumab, or pembrolizumab.", 'detailedDescription': "This Phase II study is designed to evaluate the safety and efficacy of IMCgp100 compared with Investigator's Choice (dacarbazine, ipilimumab or pembrolizumab) in HLA-A\\*0201 positive adult patients with advanced UM treated in the first line setting with no prior systemic or liver-directed chemo-, radio- or immune-therapy administered in the advanced setting (prior surgical resection of liver metastases and adjuvant systemic therapy are acceptable). Comparison of the IMCgp100 efficacy results in this Phase II study will be made with the concurrently randomized arm (Investigator's Choice) with a primary endpoint of overall survival (OS) and secondary efficacy endpoints of progression-free survival (PFS), objective response rate (ORR), duration of response (DOR), and disease control rate (DCR)."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '99 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria\n\n1. Male or female participants age ≥ 18 years of age at the time of informed consent\n2. Ability to provide and understand written informed consent prior to any study procedures\n3. Histologically or cytologically confirmed metastatic UM\n4. Must meet the following criteria related to prior treatment:\n\n * No prior systemic therapy in the metastatic or advanced setting including chemotherapy, immunotherapy, or targeted therapy\n * No prior regional, liver-directed therapy including chemotherapy, radiotherapy, or embolization\n * Prior surgical resection of oligometastatic disease is allowed\n * Prior neoadjuvant or adjuvant therapy is allowed provided administered in the curative setting in participants with localized disease. Participants may not be re-treated with an Investigator's Choice therapy that was administered as adjuvant or neoadjuvant treatment. Additionally, participants who have received nivolumab as prior adjuvant/neoadjuvant treatment should not receive pembrolizumab as Investigator's Choice therapy.\n5. HLA A\\*0201 positive by central assay\n6. Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1 at Screening\n7. Participants have measurable disease or non-measurable disease according to RECIST v1.1\n8. All other relevant medical conditions must be well-managed and stable, in the opinion of the investigator, for at least 28 days prior to first administration of study drug\n\nExclusion Criteria\n\n1. Out-of-range laboratory values\n2. History of severe hypersensitivity reactions (eg, anaphylaxis) to other biologic drugs or monoclonal antibodies\n3. Clinically significant cardiac disease or impaired cardiac function,\n4. Presence of symptomatic or untreated central nervous system (CNS) metastases, or CNS metastases that require doses of corticosteroids within the prior 3 weeks to study Day 1. Participants with brain metastases are eligible if lesions have been treated with localized therapy and there is no evidence of PD for at least 4 weeks by magnetic resonance imaging (MRI) prior to the first dose of study drug\n5. Active infection requiring systemic antibiotic therapy. Participants requiring systemic antibiotics for infection must have completed therapy at least 1 week prior to the first dose of study drug\n6. Known history of human immunodeficiency virus infection (HIV). Testing for HIV status is not necessary unless clinically indicated\n7. Active hepatitis B virus (HBV) or hepatitis C virus (HCV) infection per institutional protocol. Testing for HBV or HCV status is not necessary unless clinically indicated or the patient has a history of HBV or HCV infection\n8. Malignant disease, other than that being treated in this study. Exceptions to this exclusion include the following: malignancies that were treated curatively and have not recurred within 2 years prior to study treatment; completely resected basal cell and squamous cell skin cancers; any malignancy considered to be indolent and that has never required therapy; and completely resected carcinoma in situ of any type\n9. Any medical condition that would, in the investigator's or Sponsor's judgment, prevent the participants participation in the clinical study due to safety concerns, compliance with clinical study procedures or interpretation of study results\n10. Participants receiving systemic steroid therapy or any other systemic immunosuppressive medication at any dose level, as these may interfere with the mechanism of action of study treatment. Local steroid therapies (eg, otic, ophthalmic, intra-articular, or inhaled medications) are acceptable\n11. History of adrenal insufficiency\n12. History of interstitial lung disease\n13. History of pneumonitis that required corticosteroid treatment or current pneumonitis\n14. History of colitis or inflammatory bowel disease\n15. Major surgery within 2 weeks of the first dose of study drug (minimally invasive procedures such as bronchoscopy, tumor biopsy, insertion of a central venous access device, and insertion of a feeding tube are not considered major surgery and are not exclusionary)\n16. Radiotherapy within 2 weeks of the first dose of study drug, with the exception of palliative radiotherapy to a limited field, such as for the treatment of bone pain or a focally painful tumor mass\n17. Use of hematopoietic colony-stimulating growth factors (e.g., G-CSF, GM-CSF, M-CSF) ≤ 2 weeks prior to start of study drug. An erythroid-stimulating agent is allowed as long as it was initiated at least 2 weeks prior to the first dose of study treatment and the patient is not red blood cell transfusion dependent\n18. Pregnant, likely to become pregnant, or lactating women (where pregnancy is defined as the state of a female after conception and until the termination of gestation)\n19. Women of childbearing potential who are sexually active with a non-sterilized male partner, defined as all women physiologically capable of becoming pregnant, unless they are using highly effective contraception during study treatment (defined in Section 6.7), and must agree to continue using such precautions for 6 months after the final dose of investigational product; cessation of birth control after this point should be discussed with a responsible physician. Highly effective methods of contraception are described in Section 6.7\n20. Male participants must be surgically sterile or use double barrier contraception methods from enrollment through treatment and for 6 months following administration of the last dose of study drug\n21. Participant who are in an institution due to official or judicial order.\n22. Participant who are the investigator or any subinvestigator, research assistant, pharmacist, study coordinator, or other staff thereof, directly involved in the conduct of the study.\n23. Contraindication for treatment with Investigator's Choice alternatives (dacarbazine, ipilimumab and pembrolizumab) as per applicable labelling. Participant may have a contraindication to 1 or 2 of the choices if he/she is a candidate for dosing with at least 1 Investigator's Choice and meets all other study eligibility criteria."}, 'identificationModule': {'nctId': 'NCT03070392', 'briefTitle': 'Safety and Efficacy of IMCgp100 Versus Investigator Choice in Advanced Uveal Melanoma', 'organization': {'class': 'INDUSTRY', 'fullName': 'Immunocore Ltd'}, 'officialTitle': 'A Phase II Randomized, Open-label, Multi-center Study of the Safety and Efficacy of IMCgp100 Compared With Investigator Choice in HLA-A*0201 Positive Patients With Previously Untreated Advanced Uveal Melanoma', 'orgStudyIdInfo': {'id': 'IMCgp100-202'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'IMCgp100 (tebentafusp, Kimmtrak)', 'description': 'Biologic:IMCgp100 (Soluble gp 100-specific T cell receptor with anti - CD3 scFV: IMCgp100)', 'interventionNames': ['Biological: IMCgp100']}, {'type': 'ACTIVE_COMPARATOR', 'label': "Investigator's Choice", 'description': "1 of 3 Investigator's Choice options: Systemic Dacarbazine\n\n1 of 3 Investigator's Choice options: Systemic Ipilimumab\n\n1 of 3 Investigator's Choice options: Systemic Pembrolizumab", 'interventionNames': ['Drug: Dacarbazine', 'Biological: Ipilimumab', 'Biological: Pembrolizumab']}], 'interventions': [{'name': 'IMCgp100', 'type': 'BIOLOGICAL', 'description': 'IMCgp100 is to be administered at 20 mcg cycle 1 day1, then 30 mcg cycle 1 day 8, then 68 mcg cycle 1 day 15 and weekly thereafter by IV infusion over 15 minutes until confirmed disease progression or unacceptable toxicity', 'armGroupLabels': ['IMCgp100 (tebentafusp, Kimmtrak)']}, {'name': 'Dacarbazine', 'type': 'DRUG', 'otherNames': ['DTIC-Dome', 'DTIC', 'DIC', 'Imidazole Carboxamide'], 'description': 'Dacarbazine is to be administered at 1,000 mg/m2 of body surface area IV infusion every 3 weeks until disease progression or unacceptable toxicity', 'armGroupLabels': ["Investigator's Choice"]}, {'name': 'Ipilimumab', 'type': 'BIOLOGICAL', 'otherNames': ['Yervoy'], 'description': 'Ipilimumab is to be administered at 3 mg/kg IV infusion over 90 minutes every 3 weeks for a total of 4 treatments', 'armGroupLabels': ["Investigator's Choice"]}, {'name': 'Pembrolizumab', 'type': 'BIOLOGICAL', 'otherNames': ['Keytruda'], 'description': 'Pembrolizumab is to be administered at 2 mg/kg IV infusion up to a maximum of 200 mg administered Intravenously over 30 minutes every 3 weeks or 200 mg fixed dose administered intravenously every 3 weeks where approved locally until confirmed disease progression or unacceptable toxicity', 'armGroupLabels': ["Investigator's Choice"]}]}, 'contactsLocationsModule': {'locations': [{'zip': '90024', 'city': 'Los Angeles', 'state': 'California', 'country': 'United States', 'facility': 'UCLA Medical Center', 'geoPoint': {'lat': 34.05223, 'lon': -118.24368}}, {'zip': '90025', 'city': 'Los Angeles', 'state': 'California', 'country': 'United States', 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