Ignite Creation Date:
2025-12-24 @ 3:23 PM
Ignite Modification Date:
2026-02-24 @ 12:14 AM
Study NCT ID:
NCT02967692
Status:
TERMINATED
Last Update Posted:
2025-09-18
First Post:
2016-11-16
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
A Study of the Anti-PD1 Antibody PDR001, in Combination With Dabrafenib and Trametinib in Advanced Melanoma
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D008545', 'term': 'Melanoma'}, {'id': 'D012878', 'term': 'Skin Neoplasms'}], 'ancestors': [{'id': 'D018358', 'term': 'Neuroendocrine Tumors'}, {'id': 'D017599', 'term': 'Neuroectodermal Tumors'}, {'id': 'D009373', 'term': 'Neoplasms, Germ Cell and Embryonal'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D009380', 'term': 'Neoplasms, Nerve Tissue'}, {'id': 'D018326', 'term': 'Nevi and Melanomas'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C000711728', 'term': 'spartalizumab'}, {'id': 'C561627', 'term': 'dabrafenib'}, {'id': 'C560077', 'term': 'trametinib'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'Novartis.email@Novartis.com', 'phone': '862 778 8300', 'title': 'Study Director', 'organization': 'Novartis Pharmaceuticals'}, 'certainAgreement': {'otherDetails': "The terms and conditions of Novartis' agreements with its investigators may vary. However, Novartis does not prohibit any investigator from publishing. Any publications from a single-site are postponed until the publication of the pooled data (i.e., data from all sites) in the clinical trial.", 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days safety follow-up, assessed up to approximately 86 months. Deaths were recorded from study start date until end of extended follow-up phase (end of study), assessed up to approximately 90 months.', 'description': 'Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events. The total number at risk in the extended follow-up included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.', 'eventGroups': [{'id': 'EG000', 'title': 'Part 1- Safety run-in: PDR001 400 mg Q4W + Dabrafenib 150 mg BID + Trametinib 2 mg QD', 'description': 'Part 1- Safety run-in: PDR001 400 mg Q4W + dabrafenib 150 mg BID + trametinib 2 mg QD - Events up to 30 days safety follow-up', 'otherNumAtRisk': 9, 'deathsNumAtRisk': 9, 'otherNumAffected': 9, 'seriousNumAtRisk': 9, 'deathsNumAffected': 2, 'seriousNumAffected': 7}, {'id': 'EG001', 'title': 'Part 2- Biomarker Cohort: PDR001 400 mg Q4W + Dabrafenib 150 mg BID + Trametinib 2 mg QD', 'description': 'Part 2- Biomarker cohort: PDR001 400 mg Q4W + dabrafenib 150 mg BID + trametinib 2 mg QD - Events up to 30 days safety follow-up', 'otherNumAtRisk': 27, 'deathsNumAtRisk': 27, 'otherNumAffected': 27, 'seriousNumAtRisk': 27, 'deathsNumAffected': 3, 'seriousNumAffected': 18}, {'id': 'EG002', 'title': 'Part 3- Arm 1: PDR001 400 mg Q4W + Dabrafenib 150 mg BID + Trametinib 2 mg QD', 'description': 'Part 3- Arm 1: PDR001 400 mg Q4W + dabrafenib 150 mg BID + trametinib 2 mg QD - Events up to 30 days safety follow-up', 'otherNumAtRisk': 267, 'deathsNumAtRisk': 267, 'otherNumAffected': 262, 'seriousNumAtRisk': 267, 'deathsNumAffected': 28, 'seriousNumAffected': 150}, {'id': 'EG003', 'title': 'Part 3- Arm 2: Placebo + Dabrafenib 150 mg BID + Trametinib 2 mg QD', 'description': 'Part 3- Arm 2: Placebo + dabrafenib 150 mg BID + trametinib 2 mg QD - Events up to 30 days safety follow-up', 'otherNumAtRisk': 264, 'deathsNumAtRisk': 265, 'otherNumAffected': 250, 'seriousNumAtRisk': 264, 'deathsNumAffected': 33, 'seriousNumAffected': 123}, {'id': 'EG004', 'title': 'Part 1- Safety run-in: PDR001 400 mg Q4W+Dabrafenib 150 mg BID+Trametinib 2 mg QD (Extended F/Up)', 'description': 'Part 1- Safety run-in: Spartalizumab (PDR001) 400 mg Q4W + dabrafenib 150 mg BID + trametinib 2 mg QD (Extended F/Up) - Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events.', 'otherNumAtRisk': 0, 'deathsNumAtRisk': 7, 'otherNumAffected': 0, 'seriousNumAtRisk': 0, 'deathsNumAffected': 1, 'seriousNumAffected': 0}, {'id': 'EG005', 'title': 'Part 2- Biomarker Cohort: PDR001 400 mg Q4W+Dabrafenib 150 mg BID+Trametinib 2 mg QD(Extended F/Up)', 'description': 'Part 2- Biomarker cohort: Spartalizumab (PDR001) 400 mg Q4W + dabrafenib 150 mg BID + trametinib 2 mg QD (Extended F/Up) - Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events.', 'otherNumAtRisk': 0, 'deathsNumAtRisk': 24, 'otherNumAffected': 0, 'seriousNumAtRisk': 0, 'deathsNumAffected': 15, 'seriousNumAffected': 0}, {'id': 'EG006', 'title': 'Part 3- Arm 1: PDR001 400 mg Q4W+Dabrafenib 150 mg BID+Trametinib 2 mg QD (Extended F/Up)', 'description': 'Part 3- Arm 1: Spartalizumab (PDR001) 400 mg Q4W + dabrafenib 150 mg BID + trametinib 2 mg QD (Extended F/Up) - Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events.', 'otherNumAtRisk': 0, 'deathsNumAtRisk': 239, 'otherNumAffected': 0, 'seriousNumAtRisk': 0, 'deathsNumAffected': 99, 'seriousNumAffected': 0}, {'id': 'EG007', 'title': 'Part 3- Arm 2: Placebo+Dabrafenib 150 mg BID+Trametinib 2 mg QD (Extended F/Up)', 'description': 'Part 3- Arm 2: Placebo + dabrafenib 150 mg BID + trametinib 2 mg QD (Extended F/Up) - Deaths in the extended follow-up (efficacy follow-up period or survival follow-up period) were not considered adverse events.', 'otherNumAtRisk': 0, 'deathsNumAtRisk': 232, 'otherNumAffected': 0, 'seriousNumAtRisk': 0, 'deathsNumAffected': 117, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 9, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 27, 'numAffected': 10}, {'groupId': 'EG002', 'numAtRisk': 267, 'numAffected': 49}, {'groupId': 'EG003', 'numAtRisk': 264, 'numAffected': 31}, {'groupId': 'EG004', 'numAtRisk': 0}, {'groupId': 'EG005', 'numAtRisk': 0}, {'groupId': 'EG006', 'numAtRisk': 0}, {'groupId': 'EG007', 'numAtRisk': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (27.0)'}, {'term': 'Leukopenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 9, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 27, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 267, 'numAffected': 23}, {'groupId': 'EG003', 'numAtRisk': 264, 'numAffected': 14}, {'groupId': 'EG004', 'numAtRisk': 0}, {'groupId': 'EG005', 'numAtRisk': 0}, {'groupId': 'EG006', 'numAtRisk': 0}, {'groupId': 'EG007', 'numAtRisk': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (27.0)'}, {'term': 'Lymphopenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 9, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 27, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 267, 'numAffected': 20}, {'groupId': 'EG003', 'numAtRisk': 264, 'numAffected': 11}, {'groupId': 'EG004', 'numAtRisk': 0}, {'groupId': 'EG005', 'numAtRisk': 0}, {'groupId': 'EG006', 'numAtRisk': 0}, {'groupId': 'EG007', 'numAtRisk': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (27.0)'}, {'term': 'Neutropenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 9, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 27, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 267, 'numAffected': 44}, {'groupId': 'EG003', 'numAtRisk': 264, 'numAffected': 37}, {'groupId': 'EG004', 'numAtRisk': 0}, {'groupId': 'EG005', 'numAtRisk': 0}, {'groupId': 'EG006', 'numAtRisk': 0}, {'groupId': 'EG007', 'numAtRisk': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (27.0)'}, {'term': 'Thrombocytopenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 9, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 27, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 267, 'numAffected': 24}, {'groupId': 'EG003', 'numAtRisk': 264, 'numAffected': 10}, {'groupId': 'EG004', 'numAtRisk': 0}, {'groupId': 'EG005', 'numAtRisk': 0}, {'groupId': 'EG006', 'numAtRisk': 0}, {'groupId': 'EG007', 'numAtRisk': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (27.0)'}, {'term': 'Thrombocytosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 9, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 27, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 267, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 264, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 0}, {'groupId': 'EG005', 'numAtRisk': 0}, {'groupId': 'EG006', 'numAtRisk': 0}, {'groupId': 'EG007', 'numAtRisk': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (27.0)'}, {'term': 'Ear congestion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 9, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 27, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 267, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 264, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 0}, {'groupId': 'EG005', 'numAtRisk': 0}, {'groupId': 'EG006', 'numAtRisk': 0}, {'groupId': 'EG007', 'numAtRisk': 0}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (27.0)'}, {'term': 'Ear pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 9, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 27, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 267, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 264, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 0}, {'groupId': 'EG005', 'numAtRisk': 0}, {'groupId': 'EG006', 'numAtRisk': 0}, {'groupId': 'EG007', 'numAtRisk': 0}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (27.0)'}, {'term': 'Motion sickness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 9, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 27, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 267, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 264, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 0}, {'groupId': 'EG005', 'numAtRisk': 0}, {'groupId': 'EG006', 'numAtRisk': 0}, {'groupId': 'EG007', 'numAtRisk': 0}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (27.0)'}, {'term': 'Hyperthyroidism', 'stats': [{'groupId': 'EG000', 'numAtRisk': 9, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 27, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 267, 'numAffected': 18}, {'groupId': 'EG003', 'numAtRisk': 264, 'numAffected': 5}, {'groupId': 'EG004', 'numAtRisk': 0}, {'groupId': 'EG005', 'numAtRisk': 0}, {'groupId': 'EG006', 'numAtRisk': 0}, {'groupId': 'EG007', 'numAtRisk': 0}], 'organSystem': 'Endocrine disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (27.0)'}, {'term': 'Hypophysitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 9, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 27, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 267, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 264, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 0}, {'groupId': 'EG005', 'numAtRisk': 0}, {'groupId': 'EG006', 'numAtRisk': 0}, {'groupId': 'EG007', 'numAtRisk': 0}], 'organSystem': 'Endocrine disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (27.0)'}, {'term': 'Hypothyroidism', 'stats': [{'groupId': 'EG000', 'numAtRisk': 9, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 27, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 267, 'numAffected': 20}, {'groupId': 'EG003', 'numAtRisk': 264, 'numAffected': 17}, {'groupId': 'EG004', 'numAtRisk': 0}, {'groupId': 'EG005', 'numAtRisk': 0}, {'groupId': 'EG006', 'numAtRisk': 0}, {'groupId': 'EG007', 'numAtRisk': 0}], 'organSystem': 'Endocrine disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (27.0)'}, {'term': 'Inappropriate antidiuretic hormone secretion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 9, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 27, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 267, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 264, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 0}, {'groupId': 'EG005', 'numAtRisk': 0}, {'groupId': 'EG006', 'numAtRisk': 0}, {'groupId': 'EG007', 'numAtRisk': 0}], 'organSystem': 'Endocrine disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (27.0)'}, {'term': 'Thyroiditis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 9, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 27, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 267, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 264, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 0}, {'groupId': 'EG005', 'numAtRisk': 0}, {'groupId': 'EG006', 'numAtRisk': 0}, {'groupId': 'EG007', 'numAtRisk': 0}], 'organSystem': 'Endocrine disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (27.0)'}, {'term': 'Dry eye', 'stats': [{'groupId': 'EG000', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 27, 'numAffected': 9}, {'groupId': 'EG002', 'numAtRisk': 267, 'numAffected': 5}, {'groupId': 'EG003', 'numAtRisk': 264, 'numAffected': 9}, {'groupId': 'EG004', 'numAtRisk': 0}, {'groupId': 'EG005', 'numAtRisk': 0}, {'groupId': 'EG006', 'numAtRisk': 0}, {'groupId': 'EG007', 'numAtRisk': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (27.0)'}, {'term': 'Iridocyclitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 9, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 27, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 267, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 264, 'numAffected': 3}, {'groupId': 'EG004', 'numAtRisk': 0}, {'groupId': 'EG005', 'numAtRisk': 0}, {'groupId': 'EG006', 'numAtRisk': 0}, {'groupId': 'EG007', 'numAtRisk': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (27.0)'}, {'term': 'Myopia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 9, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 27, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 267, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 264, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 0}, {'groupId': 'EG005', 'numAtRisk': 0}, {'groupId': 'EG006', 'numAtRisk': 0}, {'groupId': 'EG007', 'numAtRisk': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (27.0)'}, {'term': 'Ocular discomfort', 'stats': [{'groupId': 'EG000', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 27, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 267, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 264, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 0}, {'groupId': 'EG005', 'numAtRisk': 0}, {'groupId': 'EG006', 'numAtRisk': 0}, {'groupId': 'EG007', 'numAtRisk': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (27.0)'}, {'term': 'Papilloedema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 9, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 27, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 267, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 264, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 0}, {'groupId': 'EG005', 'numAtRisk': 0}, {'groupId': 'EG006', 'numAtRisk': 0}, {'groupId': 'EG007', 'numAtRisk': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (27.0)'}, {'term': 'Periorbital oedema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 9, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 27, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 267, 'numAffected': 4}, {'groupId': 'EG003', 'numAtRisk': 264, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 0}, {'groupId': 'EG005', 'numAtRisk': 0}, {'groupId': 'EG006', 'numAtRisk': 0}, {'groupId': 'EG007', 'numAtRisk': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (27.0)'}, {'term': 'Photophobia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 9, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 27, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 267, 'numAffected': 6}, {'groupId': 'EG003', 'numAtRisk': 264, 'numAffected': 3}, {'groupId': 'EG004', 'numAtRisk': 0}, {'groupId': 'EG005', 'numAtRisk': 0}, {'groupId': 'EG006', 'numAtRisk': 0}, {'groupId': 'EG007', 'numAtRisk': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (27.0)'}, {'term': 'Retinal haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 9, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 27, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 267, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 264, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 0}, {'groupId': 'EG005', 'numAtRisk': 0}, {'groupId': 'EG006', 'numAtRisk': 0}, {'groupId': 'EG007', 'numAtRisk': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (27.0)'}, {'term': 'Retinopathy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 9, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 27, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 267, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 264, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 0}, {'groupId': 'EG005', 'numAtRisk': 0}, {'groupId': 'EG006', 'numAtRisk': 0}, {'groupId': 'EG007', 'numAtRisk': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (27.0)'}, {'term': 'Uveitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 9, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 27, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 267, 'numAffected': 7}, {'groupId': 'EG003', 'numAtRisk': 264, 'numAffected': 4}, {'groupId': 'EG004', 'numAtRisk': 0}, {'groupId': 'EG005', 'numAtRisk': 0}, {'groupId': 'EG006', 'numAtRisk': 0}, {'groupId': 'EG007', 'numAtRisk': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (27.0)'}, {'term': 'Vision blurred', 'stats': [{'groupId': 'EG000', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 27, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 267, 'numAffected': 9}, {'groupId': 'EG003', 'numAtRisk': 264, 'numAffected': 13}, {'groupId': 'EG004', 'numAtRisk': 0}, {'groupId': 'EG005', 'numAtRisk': 0}, {'groupId': 'EG006', 'numAtRisk': 0}, {'groupId': 'EG007', 'numAtRisk': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (27.0)'}, {'term': 'Visual impairment', 'stats': [{'groupId': 'EG000', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 27, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 267, 'numAffected': 10}, {'groupId': 'EG003', 'numAtRisk': 264, 'numAffected': 6}, {'groupId': 'EG004', 'numAtRisk': 0}, {'groupId': 'EG005', 'numAtRisk': 0}, {'groupId': 'EG006', 'numAtRisk': 0}, {'groupId': 'EG007', 'numAtRisk': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (27.0)'}, {'term': 'Vitreal cells', 'stats': [{'groupId': 'EG000', 'numAtRisk': 9, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 27, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 267, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 264, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 0}, {'groupId': 'EG005', 'numAtRisk': 0}, {'groupId': 'EG006', 'numAtRisk': 0}, {'groupId': 'EG007', 'numAtRisk': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (27.0)'}, {'term': 'Abdominal distension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 9, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 27, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 267, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 264, 'numAffected': 5}, {'groupId': 'EG004', 'numAtRisk': 0}, {'groupId': 'EG005', 'numAtRisk': 0}, {'groupId': 'EG006', 'numAtRisk': 0}, {'groupId': 'EG007', 'numAtRisk': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (27.0)'}, {'term': 'Abdominal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 9, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 27, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 267, 'numAffected': 29}, {'groupId': 'EG003', 'numAtRisk': 264, 'numAffected': 26}, {'groupId': 'EG004', 'numAtRisk': 0}, {'groupId': 'EG005', 'numAtRisk': 0}, {'groupId': 'EG006', 'numAtRisk': 0}, {'groupId': 'EG007', 'numAtRisk': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (27.0)'}, {'term': 'Abdominal pain upper', 'stats': [{'groupId': 'EG000', 'numAtRisk': 9, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 27, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 267, 'numAffected': 26}, {'groupId': 'EG003', 'numAtRisk': 264, 'numAffected': 17}, {'groupId': 'EG004', 'numAtRisk': 0}, {'groupId': 'EG005', 'numAtRisk': 0}, {'groupId': 'EG006', 'numAtRisk': 0}, 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'EG007', 'numAtRisk': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (27.0)'}, {'term': 'Blood sodium decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 9, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 27, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 267, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 264, 'numAffected': 2}, {'groupId': 'EG004', 'numAtRisk': 0}, {'groupId': 'EG005', 'numAtRisk': 0}, {'groupId': 'EG006', 'numAtRisk': 0}, {'groupId': 'EG007', 'numAtRisk': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (27.0)'}, {'term': 'Blood testosterone decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 9, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 27, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 267, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 264, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 0}, 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{'term': 'Globulins increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 9, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 27, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 267, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 264, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 0}, {'groupId': 'EG005', 'numAtRisk': 0}, {'groupId': 'EG006', 'numAtRisk': 0}, {'groupId': 'EG007', 'numAtRisk': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (27.0)'}, {'term': 'Hepatic enzyme increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 27, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 267, 'numAffected': 5}, {'groupId': 'EG003', 'numAtRisk': 264, 'numAffected': 5}, {'groupId': 'EG004', 'numAtRisk': 0}, {'groupId': 'EG005', 'numAtRisk': 0}, {'groupId': 'EG006', 'numAtRisk': 0}, {'groupId': 'EG007', 'numAtRisk': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (27.0)'}, {'term': 'Lipase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 9, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 27, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 267, 'numAffected': 66}, {'groupId': 'EG003', 'numAtRisk': 264, 'numAffected': 38}, {'groupId': 'EG004', 'numAtRisk': 0}, {'groupId': 'EG005', 'numAtRisk': 0}, {'groupId': 'EG006', 'numAtRisk': 0}, {'groupId': 'EG007', 'numAtRisk': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (27.0)'}, {'term': 'Lymphocyte count decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 27, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 267, 'numAffected': 5}, {'groupId': 'EG003', 'numAtRisk': 264, 'numAffected': 5}, {'groupId': 'EG004', 'numAtRisk': 0}, {'groupId': 'EG005', 'numAtRisk': 0}, {'groupId': 'EG006', 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'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 267, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 264, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 0}, {'groupId': 'EG005', 'numAtRisk': 0}, {'groupId': 'EG006', 'numAtRisk': 0}, {'groupId': 'EG007', 'numAtRisk': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (27.0)'}, {'term': 'Embolism', 'stats': [{'groupId': 'EG000', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 27, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 267, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 264, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 0}, {'groupId': 'EG005', 'numAtRisk': 0}, {'groupId': 'EG006', 'numAtRisk': 0}, {'groupId': 'EG007', 'numAtRisk': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (27.0)'}, {'term': 'Haematoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 27, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 267, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 264, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 0}, {'groupId': 'EG005', 'numAtRisk': 0}, {'groupId': 'EG006', 'numAtRisk': 0}, {'groupId': 'EG007', 'numAtRisk': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (27.0)'}, {'term': 'Hypertension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 27, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 267, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 264, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 0}, {'groupId': 'EG005', 'numAtRisk': 0}, {'groupId': 'EG006', 'numAtRisk': 0}, {'groupId': 'EG007', 'numAtRisk': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (27.0)'}, {'term': 'Hypovolaemic shock', 'stats': [{'groupId': 'EG000', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 27, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 267, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 264, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 0}, {'groupId': 'EG005', 'numAtRisk': 0}, {'groupId': 'EG006', 'numAtRisk': 0}, {'groupId': 'EG007', 'numAtRisk': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (27.0)'}, {'term': 'Lymphoedema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 27, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 267, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 264, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 0}, {'groupId': 'EG005', 'numAtRisk': 0}, {'groupId': 'EG006', 'numAtRisk': 0}, {'groupId': 'EG007', 'numAtRisk': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (27.0)'}, {'term': 'Peripheral arterial occlusive disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 27, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 267, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 264, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 0}, {'groupId': 'EG005', 'numAtRisk': 0}, {'groupId': 'EG006', 'numAtRisk': 0}, {'groupId': 'EG007', 'numAtRisk': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (27.0)'}, {'term': 'Shock haemorrhagic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 27, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 267, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 264, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 0}, {'groupId': 'EG005', 'numAtRisk': 0}, {'groupId': 'EG006', 'numAtRisk': 0}, {'groupId': 'EG007', 'numAtRisk': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (27.0)'}, {'term': 'Vasculitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 27, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 267, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 264, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 0}, {'groupId': 'EG005', 'numAtRisk': 0}, {'groupId': 'EG006', 'numAtRisk': 0}, {'groupId': 'EG007', 'numAtRisk': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (27.0)'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Safety Run-In (Part 1): Number of Participants With Dose Limiting Toxicities (DLTs)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Part 1- Safety run-in: PDR001 400 mg Q4W + Dabrafenib 150 mg BID + Trametinib 2 mg QD', 'description': 'In Part 1, participants are treated with Spartalizumab (PDR001) 400 mg Q4W in combination with the approved dose of dabrafenib (150 mg BID) and trametinib (2 mg QD).'}], 'classes': [{'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Up to 8 weeks (Part 1)', 'description': 'DLT was defined as an adverse event or abnormal laboratory value that was unrelated to disease, disease progression, inter-current illness, or concomitant medications and occured within 8 weeks of treatment with spartalizumab in combination with dabrafenib and trametinib. The DLT criteria included Grade 4 hematological adverse events, Grade 4 bilirubin elevation, specific gastrointestinal adverse events, symptomatic serum amylase or lipase elevation, Grade 3 or higher hypertension, Grade 3 or higher cardiac events, Grade 2 or higher pneumonitis, Grade 3 or higher immune-related toxicities, infusion-related reactions, other clinically significant adverse events, and toxicities leading to a dosing delay of over 12 weeks. NCI CTCAE v4.03 was used for grading DLTs', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Dose-Determining Set (DDS) including all subjects in Part 1 who received at least one dose of study treatment who either 1) met the minimum exposure criterion and had sufficient safety evaluations, or 2) experienced a DLT during the first 8 weeks (56 days) of spartalizumab in combination with dabrafenib and trametinib dosing.'}, {'type': 'PRIMARY', 'title': 'Biomarker Cohort (Part 2): Change From Baseline in Programmed Cell Death-ligand 1 (PD-L1) Expression Upon Treatment With Spartalizumab in Combination With Dabrafenib and Trametinib', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Part 2- Biomarker Cohort: PDR001 400 mg Q4W + Dabrafenib 150 mg BID + Trametinib 2 mg QD', 'description': 'In Part 2, participants are treated with Spartalizumab (PDR001) 400 mg Q4W in combination with the approved dose of dabrafenib (150 mg BID) and trametinib (2 mg QD).'}], 'classes': [{'title': 'Cycle 1 Day 15', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '1.7', 'spread': '13.05', 'groupId': 'OG000'}]}]}, {'title': 'Cycle 3 Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '2.7', 'spread': '7.63', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Cycle 1 Day 15 and Cycle 3 Day 1 (Part 2). Each cycle is 28 days', 'description': 'Change from baseline in PD-L1 expression (as determined by immunohistochemistry in tissue samples) upon treatment with spartalizumab in combination with dabrafenib and trametinib in participants from Part 2', 'unitOfMeasure': 'Percentage of positive tumor cells', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants in Part 2 who received at least one dose of study treatment and with evaluable data at the pre-specified time points'}, {'type': 'PRIMARY', 'title': 'Biomarker Cohort (Part 2): Change From Baseline in CD8+ Cells Upon Treatment With Spartalizumab in Combination With Dabrafenib and Trametinib', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Part 2- Biomarker Cohort: PDR001 400 mg Q4W + Dabrafenib 150 mg BID + Trametinib 2 mg QD', 'description': 'In Part 2, participants are treated with Spartalizumab (PDR001) 400 mg Q4W in combination with the approved dose of dabrafenib (150 mg BID) and trametinib (2 mg QD).'}], 'classes': [{'title': 'Cycle 1 Day 15', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.4', 'spread': '3.22', 'groupId': 'OG000'}]}]}, {'title': 'Cycle 3 Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '1.2', 'spread': '2.43', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Cycle 1 Day 15 and Cycle 3 Day 1 (Part 2). Each cycle is 28 days', 'description': 'Change from baseline in CD8+ cells (as determined by flow cytometry in blood samples) upon treatment with spartalizumab in combination with dabrafenib and trametinib in participants from Part 2', 'unitOfMeasure': 'Percentage Marker Area', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants in Part 2 who received at least one dose of study treatment and with evaluable data at the pre-specified time points'}, {'type': 'PRIMARY', 'title': "Randomized (Part 3): Progression-Free Survival (PFS) as Per Investigator's Assessment by RECIST 1.1", 'denoms': [{'units': 'Participants', 'counts': [{'value': '267', 'groupId': 'OG000'}, {'value': '265', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Part 3- Arm 1: PDR001 400 mg Q4W + Dabrafenib 150 mg BID + Trametinib 2 mg QD', 'description': 'In Part 3, participants are randomized to receive Spartalizumab (PDR001) at the RP3R identified in Part 1 (400 mg Q4W) in combination with approved dose of dabrafenib (150 mg BID) and trametinib (2 mg QD)'}, {'id': 'OG001', 'title': 'Part 3- Arm 2: Placebo + Dabrafenib 150 mg BID + Trametinib 2 mg QD', 'description': 'In Part 3, participants are randomized to receive matching placebo in combination with the approved dose of dabrafenib (150 mg BID) and trametinib (2 mg QD)'}], 'classes': [{'categories': [{'measurements': [{'value': '16.2', 'groupId': 'OG000', 'lowerLimit': '12.7', 'upperLimit': '23.9'}, {'value': '12.0', 'groupId': 'OG001', 'lowerLimit': '10.2', 'upperLimit': '15.4'}]}]}], 'analyses': [{'pValue': '0.042', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.820', 'ciLowerLimit': '0.655', 'ciUpperLimit': '1.027', 'statisticalMethod': 'Log Rank', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEDIAN', 'timeFrame': 'Up to disease progression or death due to any cause, whichever occurs first, assessed up to 2.8 years (Part 3)', 'description': "Progression-free survival was defined as the time from the date of first dose to the date of the first documented radiological progression per investigator's assessment according to RECIST 1.1 or death due to any cause. The distribution of PFS was estimated using the Kaplan-Meier (KM) method. If a patient had not had an event at the time of data cut-off, progression-free survival was censored at the date of last adequate tumor assessment.", 'unitOfMeasure': 'Months', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants in Part 3 to whom study treatment was assigned by randomization regardless of whether or not treatment was administered.'}, {'type': 'SECONDARY', 'title': 'Overall Survival (OS)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}, {'value': '27', 'groupId': 'OG001'}, {'value': '267', 'groupId': 'OG002'}, {'value': '265', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Part 1- Safety run-in: PDR001 400 mg Q4W + Dabrafenib 150 mg BID + Trametinib 2 mg QD', 'description': 'In Part 1, participants are treated with Spartalizumab (PDR001) 400 mg Q4W in combination with the approved dose of dabrafenib (150 mg BID) and trametinib (2 mg QD).'}, {'id': 'OG001', 'title': 'Part 2- Biomarker Cohort: PDR001 400 mg Q4W + Dabrafenib 150 mg BID + Trametinib 2 mg QD', 'description': 'In Part 2, participants are treated with Spartalizumab (PDR001) 400 mg Q4W in combination with the approved dose of dabrafenib (150 mg BID) and trametinib (2 mg QD).'}, {'id': 'OG002', 'title': 'Part 3- Arm 1: PDR001 400 mg Q4W + Dabrafenib 150 mg BID + Trametinib 2 mg QD', 'description': 'In Part 3, participants are randomized to receive Spartalizumab (PDR001) at the RP3R identified in Part 1 (400 mg Q4W) in combination with approved dose of dabrafenib (150 mg BID) and trametinib (2 mg QD)'}, {'id': 'OG003', 'title': 'Part 3- Arm 2: Placebo + Dabrafenib 150 mg BID + Trametinib 2 mg QD', 'description': 'In Part 3, participants are randomized to receive matching placebo in combination with the approved dose of dabrafenib (150 mg BID) and trametinib (2 mg QD)'}], 'classes': [{'categories': [{'measurements': [{'value': 'NA', 'comment': 'Not estimable (NA) due to the insufficient number of participants with events', 'groupId': 'OG000', 'lowerLimit': '12.2', 'upperLimit': 'NA'}, {'value': '30.7', 'groupId': 'OG001', 'lowerLimit': '21.3', 'upperLimit': '67.4'}, {'value': '61.5', 'comment': 'Not estimable (NA) due to the insufficient number of participants with events', 'groupId': 'OG002', 'lowerLimit': '41.6', 'upperLimit': 'NA'}, {'value': '41.6', 'groupId': 'OG003', 'lowerLimit': '30.6', 'upperLimit': '56.9'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Up to death due to any cause, assessed up to approximately 7 years', 'description': 'Overall survival was defined as the time from date of randomization to date of death due to any cause', 'unitOfMeasure': 'Months', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants to whom study treatment was assigned by randomization regardless of whether or not treatment was administered.'}, {'type': 'SECONDARY', 'title': "Overall Response Rate (ORR) as Per Investigator's Assessment by RECIST 1.1", 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}, {'value': '27', 'groupId': 'OG001'}, {'value': '267', 'groupId': 'OG002'}, {'value': '265', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Part 1- Safety run-in: PDR001 400 mg Q4W + Dabrafenib 150 mg BID + Trametinib 2 mg QD', 'description': 'In Part 1, participants are treated with Spartalizumab (PDR001) 400 mg Q4W in combination with the approved dose of dabrafenib (150 mg BID) and trametinib (2 mg QD).'}, {'id': 'OG001', 'title': 'Part 2- Biomarker Cohort: PDR001 400 mg Q4W + Dabrafenib 150 mg BID + Trametinib 2 mg QD', 'description': 'In Part 2, participants are treated with Spartalizumab (PDR001) 400 mg Q4W in combination with the approved dose of dabrafenib (150 mg BID) and trametinib (2 mg QD).'}, {'id': 'OG002', 'title': 'Part 3- Arm 1: PDR001 400 mg Q4W + Dabrafenib 150 mg BID + Trametinib 2 mg QD', 'description': 'In Part 3, participants are randomized to receive Spartalizumab (PDR001) at the RP3R identified in Part 1 (400 mg Q4W) in combination with approved dose of dabrafenib (150 mg BID) and trametinib (2 mg QD)'}, {'id': 'OG003', 'title': 'Part 3- Arm 2: Placebo + Dabrafenib 150 mg BID + Trametinib 2 mg QD', 'description': 'In Part 3, participants are randomized to receive matching placebo in combination with the approved dose of dabrafenib (150 mg BID) and trametinib (2 mg QD)'}], 'classes': [{'categories': [{'measurements': [{'value': '100.0', 'groupId': 'OG000', 'lowerLimit': '66.4', 'upperLimit': '100.0'}, {'value': '70.4', 'groupId': 'OG001', 'lowerLimit': '49.8', 'upperLimit': '86.2'}, {'value': '68.5', 'groupId': 'OG002', 'lowerLimit': '62.6', 'upperLimit': '74.1'}, {'value': '64.2', 'groupId': 'OG003', 'lowerLimit': '58.1', 'upperLimit': '69.9'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Part 1: Up to 3.3 years. Part 2: Up to 3 years. Part 3: Up to 2.8 years', 'description': "ORR was defined as the percentage of subjects with confirmed best overall response of complete response (CR) or partial response (PR), as per investigator's assessment by RECIST 1.1. CR: Disappearance of all non-nodal target lesions. In addition, any pathological lymph nodes assigned as target lesions must have a reduction in short axis to \\<10 mm PR: At least a 30% decrease in the sum of diameter of all target lesions, taking as reference the baseline sum of diameters", 'unitOfMeasure': 'Percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'For Part 1 and 2: all subjects to whom study treatment was assigned and who received at least one dose of any study treatment. For Part 3: all subjects to whom study treatment was assigned by randomization, regardless of whether or not treatment was administered.'}, {'type': 'SECONDARY', 'title': "Duration of Response (DOR) as Per Investigator's Assessment by RECIST 1.1", 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}, {'value': '19', 'groupId': 'OG001'}, {'value': '183', 'groupId': 'OG002'}, {'value': '170', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Part 1- Safety run-in: PDR001 400 mg Q4W + Dabrafenib 150 mg BID + Trametinib 2 mg QD', 'description': 'In Part 1, participants are treated with Spartalizumab (PDR001) 400 mg Q4W in combination with the approved dose of dabrafenib (150 mg BID) and trametinib (2 mg QD).'}, {'id': 'OG001', 'title': 'Part 2- Biomarker Cohort: PDR001 400 mg Q4W + Dabrafenib 150 mg BID + Trametinib 2 mg QD', 'description': 'In Part 2, participants are treated with Spartalizumab (PDR001) 400 mg Q4W in combination with the approved dose of dabrafenib (150 mg BID) and trametinib (2 mg QD).'}, {'id': 'OG002', 'title': 'Part 3- Arm 1: PDR001 400 mg Q4W + Dabrafenib 150 mg BID + Trametinib 2 mg QD', 'description': 'In Part 3, participants are randomized to receive Spartalizumab (PDR001) at the RP3R identified in Part 1 (400 mg Q4W) in combination with approved dose of dabrafenib (150 mg BID) and trametinib (2 mg QD)'}, {'id': 'OG003', 'title': 'Part 3- Arm 2: Placebo + Dabrafenib 150 mg BID + Trametinib 2 mg QD', 'description': 'In Part 3, participants are randomized to receive matching placebo in combination with the approved dose of dabrafenib (150 mg BID) and trametinib (2 mg QD)'}], 'classes': [{'categories': [{'measurements': [{'value': 'NA', 'comment': 'Not estimable (NA) due to the insufficient number of participants with events', 'groupId': 'OG000', 'lowerLimit': '8.3', 'upperLimit': 'NA'}, {'value': '20.0', 'comment': 'Not estimable (NA) due to the insufficient number of participants with events', 'groupId': 'OG001', 'lowerLimit': '9.4', 'upperLimit': 'NA'}, {'value': 'NA', 'comment': 'Not estimable (NA) due to the insufficient number of participants with events', 'groupId': 'OG002', 'lowerLimit': '18.6', 'upperLimit': 'NA'}, {'value': '20.7', 'comment': 'Not estimable (NA) due to the insufficient number of participants with events', 'groupId': 'OG003', 'lowerLimit': '13.0', 'upperLimit': 'NA'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'From first documented response to date of first documented progression or death, up to 3.3 years (Part 1), 3 years (Part 2) and 2.8 years (Part 3)', 'description': 'DOR was defined as the time from first documented response of CR or PR to date of first documented progression or death, according to RECIST 1.1 criteria. The distribution of DOR was estimated using the KM method. CR: Disappearance of all non-nodal target lesions. In addition, any pathological lymph nodes assigned as target lesions must have a reduction in short axis to \\<10 mm PR: At least a 30% decrease in the sum of diameter of all target lesions, taking as reference the baseline sum of diameters', 'unitOfMeasure': 'Months', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'For Part 1 and 2: all subjects to whom study treatment was assigned and who received at least one dose of any study treatment for whom best overall response was CR or PR. For Part 3: all subjects to whom study treatment was assigned by randomization (regardless of whether or not treatment was administered) for whom best overall response was CR or PR.'}, {'type': 'SECONDARY', 'title': "Disease Control Rate (DCR) as Per Investigator's Assessment by RECIST 1.1", 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}, {'value': '27', 'groupId': 'OG001'}, {'value': '267', 'groupId': 'OG002'}, {'value': '265', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Part 1- Safety run-in: PDR001 400 mg Q4W + Dabrafenib 150 mg BID + Trametinib 2 mg QD', 'description': 'In Part 1, participants are treated with Spartalizumab (PDR001) 400 mg Q4W in combination with the approved dose of dabrafenib (150 mg BID) and trametinib (2 mg QD).'}, {'id': 'OG001', 'title': 'Part 2- Biomarker Cohort: PDR001 400 mg Q4W + Dabrafenib 150 mg BID + Trametinib 2 mg QD', 'description': 'In Part 2, participants are treated with Spartalizumab (PDR001) 400 mg Q4W in combination with the approved dose of dabrafenib (150 mg BID) and trametinib (2 mg QD).'}, {'id': 'OG002', 'title': 'Part 3- Arm 1: PDR001 400 mg Q4W + Dabrafenib 150 mg BID + Trametinib 2 mg QD', 'description': 'In Part 3, participants are randomized to receive Spartalizumab (PDR001) at the RP3R identified in Part 1 (400 mg Q4W) in combination with approved dose of dabrafenib (150 mg BID) and trametinib (2 mg QD)'}, {'id': 'OG003', 'title': 'Part 3- Arm 2: Placebo + Dabrafenib 150 mg BID + Trametinib 2 mg QD', 'description': 'In Part 3, participants are randomized to receive matching placebo in combination with the approved dose of dabrafenib (150 mg BID) and trametinib (2 mg QD)'}], 'classes': [{'categories': [{'measurements': [{'value': '100.0', 'groupId': 'OG000', 'lowerLimit': '66.4', 'upperLimit': '100.0'}, {'value': '92.6', 'groupId': 'OG001', 'lowerLimit': '75.7', 'upperLimit': '99.1'}, {'value': '84.3', 'groupId': 'OG002', 'lowerLimit': '79.3', 'upperLimit': '88.4'}, {'value': '86.4', 'groupId': 'OG003', 'lowerLimit': '81.7', 'upperLimit': '90.3'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Part 1: Up to 3.3 years. Part 2: Up to 3 years. Part 3: Up to 2.8 year', 'description': 'DCR was defined as the percentage of participants with CR or PR or subjects with stable disease (SD) lasting for a duration of at least 24 weeks as per local review according to RECIST 1.1 criteria. CR: Disappearance of all non-nodal target lesions. In addition, any pathological lymph nodes assigned as target lesions must have a reduction in short axis to \\<10 mm PR: At least a 30% decrease in the sum of diameter of all target lesions, taking as reference the baseline sum of diameters SD: Neither sufficient shrinkage to qualify for PR or CR nor an increase in lesions which would qualify for progressive disease.', 'unitOfMeasure': 'Percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'For Part 1 and 2: all subjects to whom study treatment was assigned and who received at least one dose of any study treatment. For Part 3: all subjects to whom study treatment was assigned by randomization, regardless of whether or not treatment was administered.'}, {'type': 'SECONDARY', 'title': 'Randomized (Part 3): Change From Baseline in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ) C30- Global Health Status Scores', 'denoms': [{'units': 'Participants', 'counts': [{'value': '175', 'groupId': 'OG000'}, {'value': '186', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Part 3- Arm 1: PDR001 400 mg Q4W + Dabrafenib 150 mg BID + Trametinib 2 mg QD', 'description': 'In Part 3, participants are randomized to receive Spartalizumab (PDR001) at the RP3R identified in Part 1 (400 mg Q4W) in combination with approved dose of dabrafenib (150 mg BID) and trametinib (2 mg QD)'}, {'id': 'OG001', 'title': 'Part 3- Arm 2: Placebo + Dabrafenib 150 mg BID + Trametinib 2 mg QD', 'description': 'In Part 3, participants are randomized to receive matching placebo in combination with the approved dose of dabrafenib (150 mg BID) and trametinib (2 mg QD)'}], 'classes': [{'title': 'Cycle 4 Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '175', 'groupId': 'OG000'}, {'value': '186', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.81', 'spread': '19.300', 'groupId': 'OG000'}, {'value': '2.20', 'spread': '24.918', 'groupId': 'OG001'}]}]}, {'title': 'Cycle 6 Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '157', 'groupId': 'OG000'}, {'value': '158', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1.22', 'spread': '25.050', 'groupId': 'OG000'}, {'value': '1.90', 'spread': '21.197', 'groupId': 'OG001'}]}]}, {'title': 'Cycle 8 Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '146', 'groupId': 'OG000'}, {'value': '151', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.00', 'spread': '24.526', 'groupId': 'OG000'}, {'value': '0.50', 'spread': '19.608', 'groupId': 'OG001'}]}]}, {'title': 'Cycle 10 Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '133', 'groupId': 'OG000'}, {'value': '125', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1.88', 'spread': '23.088', 'groupId': 'OG000'}, {'value': '0.27', 'spread': '18.752', 'groupId': 'OG001'}]}]}, {'title': 'Cycle 12 Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '110', 'groupId': 'OG000'}, {'value': '114', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.61', 'spread': '25.906', 'groupId': 'OG000'}, {'value': '0.00', 'spread': '24.541', 'groupId': 'OG001'}]}]}, {'title': 'Cycle 14 Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '103', 'groupId': 'OG000'}, {'value': '103', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.65', 'spread': '23.561', 'groupId': 'OG000'}, {'value': '-0.89', 'spread': '23.306', 'groupId': 'OG001'}]}]}, {'title': 'Cycle 16 Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '91', 'groupId': 'OG000'}, {'value': '90', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.82', 'spread': '25.186', 'groupId': 'OG000'}, {'value': '1.76', 'spread': '24.142', 'groupId': 'OG001'}]}]}, {'title': 'Cycle 18 Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '90', 'groupId': 'OG000'}, {'value': '83', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-0.46', 'spread': '24.106', 'groupId': 'OG000'}, {'value': '-0.10', 'spread': '19.193', 'groupId': 'OG001'}]}]}, {'title': 'Cycle 20 Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '82', 'groupId': 'OG000'}, {'value': '82', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1.93', 'spread': '21.766', 'groupId': 'OG000'}, {'value': '-1.02', 'spread': '23.144', 'groupId': 'OG001'}]}]}, {'title': 'Cycle 22 Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '79', 'groupId': 'OG000'}, {'value': '80', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.95', 'spread': '22.047', 'groupId': 'OG000'}, {'value': '2.29', 'spread': '21.947', 'groupId': 'OG001'}]}]}, {'title': 'Cycle 25 Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '63', 'groupId': 'OG000'}, {'value': '70', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '3.57', 'spread': '23.981', 'groupId': 'OG000'}, {'value': '-0.24', 'spread': '25.497', 'groupId': 'OG001'}]}]}, {'title': 'Cycle 28 Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '50', 'groupId': 'OG000'}, {'value': '55', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '4.50', 'spread': '19.793', 'groupId': 'OG000'}, {'value': '1.06', 'spread': '22.513', 'groupId': 'OG001'}]}]}, {'title': 'Cycle 31 Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '23', 'groupId': 'OG000'}, {'value': '26', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '11.59', 'spread': '24.967', 'groupId': 'OG000'}, {'value': '6.73', 'spread': '21.084', 'groupId': 'OG001'}]}]}, {'title': 'Cycle 34 Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '16.67', 'spread': '47.140', 'groupId': 'OG000'}, {'value': '13.89', 'spread': '20.184', 'groupId': 'OG001'}]}]}, {'title': '30 days post-progression', 'denoms': [{'units': 'Participants', 'counts': [{'value': '23', 'groupId': 'OG000'}, {'value': '30', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-11.59', 'spread': '24.967', 'groupId': 'OG000'}, {'value': '-7.78', 'spread': '29.274', 'groupId': 'OG001'}]}]}, {'title': '60 days post-progression', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-11.54', 'spread': '16.506', 'groupId': 'OG000'}, {'value': '-17.19', 'spread': '24.050', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'From baseline to 60 days post progression, assessed up to 2.8 years (Part 3)', 'description': "The EORTC QLQ-C30 was a 30-item questionnaire that patients complete, consisting of both multi-item scales and single-item measures. It included five functional scales, three symptom scales, six single items, and a Global Health Status/Quality of Life (GHS/QoL) scale. The GHS/QoL scale had seven possible response scores ranging from 1 (very poor) to 7 (excellent), which were averaged and transformed to a 0-100 scale. A higher score on this scale indicated a better quality of life. The change from baseline in GHS/QoL scores was calculated. A positive change from baseline indicated improvement in the patient's quality of life.", 'unitOfMeasure': 'Score on a Scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants in Part 3 to whom study treatment was assigned by randomization (regardless of whether or not treatment was administered) and with available data at the pre-specified time points'}, {'type': 'SECONDARY', 'title': 'Randomized (Part 3): Change From Baseline in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ) C30- Physical Functioning Scale Scores', 'denoms': [{'units': 'Participants', 'counts': [{'value': '175', 'groupId': 'OG000'}, {'value': '186', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Part 3- Arm 1: PDR001 400 mg Q4W + Dabrafenib 150 mg BID + Trametinib 2 mg QD', 'description': 'In Part 3, participants are randomized to receive Spartalizumab (PDR001) at the RP3R identified in Part 1 (400 mg Q4W) in combination with approved dose of dabrafenib (150 mg BID) and trametinib (2 mg QD)'}, {'id': 'OG001', 'title': 'Part 3- Arm 2: Placebo + Dabrafenib 150 mg BID + Trametinib 2 mg QD', 'description': 'In Part 3, participants are randomized to receive matching placebo in combination with the approved dose of dabrafenib (150 mg BID) and trametinib (2 mg QD)'}], 'classes': [{'title': 'Cycle 4 Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '175', 'groupId': 'OG000'}, {'value': '186', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-1.52', 'spread': '16.243', 'groupId': 'OG000'}, {'value': '-0.70', 'spread': '17.618', 'groupId': 'OG001'}]}]}, {'title': 'Cycle 6 Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '158', 'groupId': 'OG000'}, {'value': '158', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-2.38', 'spread': '16.121', 'groupId': 'OG000'}, {'value': '-0.60', 'spread': '14.824', 'groupId': 'OG001'}]}]}, {'title': 'Cycle 8 Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '146', 'groupId': 'OG000'}, {'value': '150', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-1.29', 'spread': '18.350', 'groupId': 'OG000'}, {'value': '-0.59', 'spread': '15.687', 'groupId': 'OG001'}]}]}, {'title': 'Cycle 10 Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '133', 'groupId': 'OG000'}, {'value': '126', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-0.18', 'spread': '17.985', 'groupId': 'OG000'}, {'value': '-1.11', 'spread': '13.736', 'groupId': 'OG001'}]}]}, {'title': 'Cycle 12 Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '110', 'groupId': 'OG000'}, {'value': '114', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-1.39', 'spread': '18.108', 'groupId': 'OG000'}, {'value': '-0.85', 'spread': '10.652', 'groupId': 'OG001'}]}]}, {'title': 'Cycle 14 Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '103', 'groupId': 'OG000'}, {'value': '103', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-2.42', 'spread': '16.720', 'groupId': 'OG000'}, {'value': '-2.61', 'spread': '12.320', 'groupId': 'OG001'}]}]}, {'title': 'Cycle 16 Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '91', 'groupId': 'OG000'}, {'value': '90', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-4.19', 'spread': '20.301', 'groupId': 'OG000'}, {'value': '-2.24', 'spread': '13.331', 'groupId': 'OG001'}]}]}, {'title': 'Cycle 18 Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '90', 'groupId': 'OG000'}, {'value': '83', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-3.48', 'spread': '18.862', 'groupId': 'OG000'}, {'value': '-3.55', 'spread': '13.474', 'groupId': 'OG001'}]}]}, {'title': 'Cycle 20 Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '82', 'groupId': 'OG000'}, {'value': '82', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-4.07', 'spread': '15.316', 'groupId': 'OG000'}, {'value': '-1.73', 'spread': '11.536', 'groupId': 'OG001'}]}]}, {'title': 'Cycle 22 Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '79', 'groupId': 'OG000'}, {'value': '80', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-3.21', 'spread': '15.538', 'groupId': 'OG000'}, {'value': '-0.85', 'spread': '11.157', 'groupId': 'OG001'}]}]}, {'title': 'Cycle 25 Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '64', 'groupId': 'OG000'}, {'value': '70', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-1.35', 'spread': '16.510', 'groupId': 'OG000'}, {'value': '-2.67', 'spread': '13.158', 'groupId': 'OG001'}]}]}, {'title': 'Cycle 28 Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '50', 'groupId': 'OG000'}, {'value': '55', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-0.80', 'spread': '13.843', 'groupId': 'OG000'}, {'value': '-2.67', 'spread': '15.953', 'groupId': 'OG001'}]}]}, {'title': 'Cycle 31 Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '23', 'groupId': 'OG000'}, {'value': '26', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-2.03', 'spread': '10.719', 'groupId': 'OG000'}, {'value': '-1.79', 'spread': '9.533', 'groupId': 'OG001'}]}]}, {'title': 'Cycle 34 Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.00', 'spread': '0.000', 'groupId': 'OG000'}, {'value': '-3.33', 'spread': '5.578', 'groupId': 'OG001'}]}]}, {'title': '30 days post-progression', 'denoms': [{'units': 'Participants', 'counts': [{'value': '23', 'groupId': 'OG000'}, {'value': '30', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-6.67', 'spread': '18.641', 'groupId': 'OG000'}, {'value': '-8.67', 'spread': '19.973', 'groupId': 'OG001'}]}]}, {'title': '60 days post-progression', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-13.85', 'spread': '15.977', 'groupId': 'OG000'}, {'value': '-21.25', 'spread': '27.991', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'From baseline to 60 days post progression, assessed up to 2.8 years (Part 3)', 'description': 'The EORTC QLQ-C30 was a patient completed 30 item questionnaire that was composed of both multi-item scales and single-item measures. These included five functional scales, three symptom scales, six single items and a global health status/QoL scale. The EORTC QLQ-C30 physical functioning scale measured a patient\'s ability to carry out daily activities and tasks requiring physical exertion. It consisted of five questions asking patients to rate their level of physical functioning, with response options ranging from 1="not at all" to 4="very much". The scores for each item were summed and transformed to a 0 to 100 scale, with higher scores indicating better physical functioning. The change from baseline in physical functioning scale scores was calculated. A positive change from baseline indicated improvement in physical functioning.', 'unitOfMeasure': 'Score on a Scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants in Part 3 to whom study treatment was assigned by randomization (regardless of whether or not treatment was administered) and with available data at the pre-specified time points'}, {'type': 'SECONDARY', 'title': 'Randomized (Part 3): Change From Baseline in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ) C30- Pain Symptom Scale Scores', 'denoms': [{'units': 'Participants', 'counts': [{'value': '175', 'groupId': 'OG000'}, {'value': '186', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Part 3- Arm 1: PDR001 400 mg Q4W + Dabrafenib 150 mg BID + Trametinib 2 mg QD', 'description': 'In Part 3, participants are randomized to receive Spartalizumab (PDR001) at the RP3R identified in Part 1 (400 mg Q4W) in combination with approved dose of dabrafenib (150 mg BID) and trametinib (2 mg QD)'}, {'id': 'OG001', 'title': 'Part 3- Arm 2: Placebo + Dabrafenib 150 mg BID + Trametinib 2 mg QD', 'description': 'In Part 3, participants are randomized to receive matching placebo in combination with the approved dose of dabrafenib (150 mg BID) and trametinib (2 mg QD)'}], 'classes': [{'title': 'Cycle 4 Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '175', 'groupId': 'OG000'}, {'value': '186', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-5.24', 'spread': '26.434', 'groupId': 'OG000'}, {'value': '-5.29', 'spread': '24.881', 'groupId': 'OG001'}]}]}, {'title': 'Cycle 6 Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '158', 'groupId': 'OG000'}, {'value': '158', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-6.43', 'spread': '28.820', 'groupId': 'OG000'}, {'value': '-7.49', 'spread': '23.611', 'groupId': 'OG001'}]}]}, {'title': 'Cycle 8 Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '146', 'groupId': 'OG000'}, {'value': '150', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-4.91', 'spread': '29.176', 'groupId': 'OG000'}, {'value': '-4.11', 'spread': '24.420', 'groupId': 'OG001'}]}]}, {'title': 'Cycle 10 Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '132', 'groupId': 'OG000'}, {'value': '126', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-7.95', 'spread': '28.346', 'groupId': 'OG000'}, {'value': '-4.76', 'spread': '23.557', 'groupId': 'OG001'}]}]}, {'title': 'Cycle 12 Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '110', 'groupId': 'OG000'}, {'value': '114', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-8.33', 'spread': '28.890', 'groupId': 'OG000'}, {'value': '-5.26', 'spread': '22.646', 'groupId': 'OG001'}]}]}, {'title': 'Cycle 14 Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '103', 'groupId': 'OG000'}, {'value': '103', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-5.50', 'spread': '28.140', 'groupId': 'OG000'}, {'value': '-3.56', 'spread': '23.062', 'groupId': 'OG001'}]}]}, {'title': 'Cycle 16 Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '91', 'groupId': 'OG000'}, {'value': '90', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-5.86', 'spread': '26.220', 'groupId': 'OG000'}, {'value': '-4.44', 'spread': '25.820', 'groupId': 'OG001'}]}]}, {'title': 'Cycle 18 Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '90', 'groupId': 'OG000'}, {'value': '83', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-3.15', 'spread': '30.178', 'groupId': 'OG000'}, {'value': '-3.21', 'spread': '20.898', 'groupId': 'OG001'}]}]}, {'title': 'Cycle 20 Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '82', 'groupId': 'OG000'}, {'value': '82', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-4.47', 'spread': '30.659', 'groupId': 'OG000'}, {'value': '-2.85', 'spread': '23.249', 'groupId': 'OG001'}]}]}, {'title': 'Cycle 22 Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '79', 'groupId': 'OG000'}, {'value': '80', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-5.49', 'spread': '27.049', 'groupId': 'OG000'}, {'value': '-3.54', 'spread': '23.969', 'groupId': 'OG001'}]}]}, {'title': 'Cycle 25 Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '64', 'groupId': 'OG000'}, {'value': '70', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-6.25', 'spread': '28.868', 'groupId': 'OG000'}, {'value': '-4.76', 'spread': '20.685', 'groupId': 'OG001'}]}]}, {'title': 'Cycle 28 Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '50', 'groupId': 'OG000'}, {'value': '55', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-3.00', 'spread': '26.872', 'groupId': 'OG000'}, {'value': '-3.03', 'spread': '22.701', 'groupId': 'OG001'}]}]}, {'title': 'Cycle 31 Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '23', 'groupId': 'OG000'}, {'value': '26', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-10.14', 'spread': '24.995', 'groupId': 'OG000'}, {'value': '-7.05', 'spread': '34.696', 'groupId': 'OG001'}]}]}, {'title': 'Cycle 34 Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-8.33', 'spread': '11.785', 'groupId': 'OG000'}, {'value': '-5.56', 'spread': '8.607', 'groupId': 'OG001'}]}]}, {'title': '30 days post-progression', 'denoms': [{'units': 'Participants', 'counts': [{'value': '23', 'groupId': 'OG000'}, {'value': '30', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '9.42', 'spread': '28.791', 'groupId': 'OG000'}, {'value': '0.56', 'spread': '28.190', 'groupId': 'OG001'}]}]}, {'title': '60 days post-progression', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '15.38', 'spread': '19.792', 'groupId': 'OG000'}, {'value': '11.46', 'spread': '24.884', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'From baseline to 60 days post progression, assessed up to 2.8 years (Part 3)', 'description': 'The EORTC QLQ-C30 was a patient completed 30 item questionnaire that was composed of both multi-item scales and single-item measures. These included five functional scales, three symptom scales, six single items and a global health status/QoL scale. The EORTC QLQ-C30 pain symptom scale was one of the symptom scales in the questionnaire, which measured the severity of pain experienced by the patient. The pain symptom scale consisted of two items, one measuring the severity of pain and the other measuring the use of painkillers. The items were rated on a 4-point scale ranging from 1="not at all" to 4="very much". The scores for each item were summed and transformed to a 0 to 100 scale, with higher scores indicating more severe pain. The change from baseline in pain symptom scale scores was calculated. A negative change from baseline indicated improvement.', 'unitOfMeasure': 'Score on a Scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants in Part 3 to whom study treatment was assigned by randomization (regardless of whether or not treatment was administered) and with available data at the pre-specified time points'}, {'type': 'SECONDARY', 'title': 'Randomized (Part 3): Time to 10 Point Definitive Deterioration in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ) C30- Global Health Status', 'denoms': [{'units': 'Participants', 'counts': [{'value': '267', 'groupId': 'OG000'}, {'value': '265', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Part 3- Arm 1: PDR001 400 mg Q4W + Dabrafenib 150 mg BID + Trametinib 2 mg QD', 'description': 'In Part 3, participants are randomized to receive Spartalizumab (PDR001) at the RP3R identified in Part 1 (400 mg Q4W) in combination with approved dose of dabrafenib (150 mg BID) and trametinib (2 mg QD)'}, {'id': 'OG001', 'title': 'Part 3- Arm 2: Placebo + Dabrafenib 150 mg BID + Trametinib 2 mg QD', 'description': 'In Part 3, participants are randomized to receive matching placebo in combination with the approved dose of dabrafenib (150 mg BID) and trametinib (2 mg QD)'}], 'classes': [{'categories': [{'measurements': [{'value': '19.4', 'groupId': 'OG000', 'lowerLimit': '15.7', 'upperLimit': '24.9'}, {'value': '22.1', 'comment': 'Not estimable (NA) due to the insufficient number of participants with events', 'groupId': 'OG001', 'lowerLimit': '17.5', 'upperLimit': 'NA'}]}]}], 'analyses': [{'pValue': '0.2975', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.183', 'ciLowerLimit': '0.865', 'ciUpperLimit': '1.619', 'statisticalMethod': 'Log Rank', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEDIAN', 'timeFrame': 'From baseline to date of at least 10 points relative to baseline worsening of the global health status score or death due to any cause, up to 2.8 years (Part 3)', 'description': 'The EORTC QLQ-C30 was a patient completed 30 item questionnaire that was composed of both multi-item scales and single-item measures. These included five functional scales, three symptom scales, six single items and a global health status/QoL scale. The GHS/QoL scale had seven possible response scores ranging from 1 (very poor) to 7 (excellent), which were averaged and transformed to a 0-100 scale. A higher score on this scale indicated a better quality of life. The time to definitive 10 point deterioration is defined as the time from the date of randomization to the date of event, which is defined as at least 10 points relative to baseline worsening of the GHS/QoL score or death due to any cause. If a subject had not had an event, the time to deterioration was censored at the date of the last adequate assessment. The distribution was estimated using KM method.', 'unitOfMeasure': 'Months', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants in Part 3 to whom study treatment was assigned by randomization regardless of whether or not treatment was administered.'}, {'type': 'SECONDARY', 'title': 'Randomized (Part 3): Change From Baseline in Function Assessment Cancer Therapy-melanoma (FACT-M) Melanoma Subscale Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '177', 'groupId': 'OG000'}, {'value': '190', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Part 3- Arm 1: PDR001 400 mg Q4W + Dabrafenib 150 mg BID + Trametinib 2 mg QD', 'description': 'In Part 3, participants are randomized to receive Spartalizumab (PDR001) at the RP3R identified in Part 1 (400 mg Q4W) in combination with approved dose of dabrafenib (150 mg BID) and trametinib (2 mg QD)'}, {'id': 'OG001', 'title': 'Part 3- Arm 2: Placebo + Dabrafenib 150 mg BID + Trametinib 2 mg QD', 'description': 'In Part 3, participants are randomized to receive matching placebo in combination with the approved dose of dabrafenib (150 mg BID) and trametinib (2 mg QD)'}], 'classes': [{'title': 'Cycle 4 Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '177', 'groupId': 'OG000'}, {'value': '190', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.83', 'spread': '6.600', 'groupId': 'OG000'}, {'value': '0.87', 'spread': '6.185', 'groupId': 'OG001'}]}]}, {'title': 'Cycle 6 Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '157', 'groupId': 'OG000'}, {'value': '159', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1.01', 'spread': '7.370', 'groupId': 'OG000'}, {'value': '1.18', 'spread': '6.219', 'groupId': 'OG001'}]}]}, {'title': 'Cycle 8 Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '145', 'groupId': 'OG000'}, {'value': '150', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1.14', 'spread': '7.284', 'groupId': 'OG000'}, {'value': '1.09', 'spread': '5.742', 'groupId': 'OG001'}]}]}, {'title': 'Cycle 10 Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '133', 'groupId': 'OG000'}, {'value': '125', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1.52', 'spread': '7.314', 'groupId': 'OG000'}, {'value': '0.54', 'spread': '6.492', 'groupId': 'OG001'}]}]}, {'title': 'Cycle 12 Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '110', 'groupId': 'OG000'}, {'value': '112', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1.21', 'spread': '7.515', 'groupId': 'OG000'}, {'value': '0.47', 'spread': '5.974', 'groupId': 'OG001'}]}]}, {'title': 'Cycle 14 Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '102', 'groupId': 'OG000'}, {'value': '106', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.77', 'spread': '7.071', 'groupId': 'OG000'}, {'value': '0.65', 'spread': '6.681', 'groupId': 'OG001'}]}]}, {'title': 'Cycle 16 Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '90', 'groupId': 'OG000'}, {'value': '92', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.93', 'spread': '6.451', 'groupId': 'OG000'}, {'value': '0.71', 'spread': '6.374', 'groupId': 'OG001'}]}]}, {'title': 'Cycle 18 Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '88', 'groupId': 'OG000'}, {'value': '86', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1.23', 'spread': '7.095', 'groupId': 'OG000'}, {'value': '0.47', 'spread': '6.152', 'groupId': 'OG001'}]}]}, {'title': 'Cycle 20 Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '82', 'groupId': 'OG000'}, {'value': '83', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1.28', 'spread': '6.634', 'groupId': 'OG000'}, {'value': '0.53', 'spread': '5.875', 'groupId': 'OG001'}]}]}, {'title': 'Cycle 22 Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '79', 'groupId': 'OG000'}, {'value': '80', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1.87', 'spread': '6.215', 'groupId': 'OG000'}, {'value': '0.79', 'spread': '5.970', 'groupId': 'OG001'}]}]}, {'title': 'Cycle 25 Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '64', 'groupId': 'OG000'}, {'value': '70', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '2.73', 'spread': '5.950', 'groupId': 'OG000'}, {'value': '0.74', 'spread': '6.792', 'groupId': 'OG001'}]}]}, {'title': 'Cycle 28 Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '50', 'groupId': 'OG000'}, {'value': '56', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '2.46', 'spread': '5.195', 'groupId': 'OG000'}, {'value': '0.61', 'spread': '8.020', 'groupId': 'OG001'}]}]}, {'title': 'Cycle 31 Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '21', 'groupId': 'OG000'}, {'value': '26', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '3.29', 'spread': '5.702', 'groupId': 'OG000'}, {'value': '1.88', 'spread': '6.154', 'groupId': 'OG001'}]}]}, {'title': 'Cycle 34 Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-0.50', 'spread': '2.121', 'groupId': 'OG000'}, {'value': '4.60', 'spread': '3.578', 'groupId': 'OG001'}]}]}, {'title': '30 days post-progression', 'denoms': [{'units': 'Participants', 'counts': [{'value': '24', 'groupId': 'OG000'}, {'value': '29', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.33', 'spread': '7.620', 'groupId': 'OG000'}, {'value': '-1.07', 'spread': '8.590', 'groupId': 'OG001'}]}]}, {'title': '60 days post-progression', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-2.60', 'spread': '5.734', 'groupId': 'OG000'}, {'value': '-3.06', 'spread': '8.948', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'From baseline to 60 days post progression, assessed up to 2.8 years (Part 3)', 'description': 'The Functional Assessment of Cancer Therapy-Melanoma (FACT-M) quality of life questionnaire was composed of the FACT-General (FACT-G) plus the Melanoma Subscale and the Melanoma Surgery Subscale, which complemented the general scale with items specific to quality of life (QoL) in melanoma. The Melanoma Subscale of FACT-M included 16 questions, with response options of 0= "Not at all", 1= "a little bit", 2= "somewhat", 3= "quite a bit" and 4= "very much". The FACT-M melanoma subscale score ranged from 0 to 64, with higher scores indicating a higher quality of life in relation to melanoma. The change from baseline in melanoma subscale scores was calculated. A positive change from baseline indicated improvement.', 'unitOfMeasure': 'Score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants in Part 3 to whom study treatment was assigned by randomization (regardless of whether or not treatment was administered) and with available data at the pre-specified time points'}, {'type': 'SECONDARY', 'title': 'Randomized (Part 3): Change From Baseline in EuroQoL 5-level Instrument (EQ-5D-5L)- Visual Analog Scale (VAS) Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '176', 'groupId': 'OG000'}, {'value': '190', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Part 3- Arm 1: PDR001 400 mg Q4W + Dabrafenib 150 mg BID + Trametinib 2 mg QD', 'description': 'In Part 3, participants are randomized to receive Spartalizumab (PDR001) at the RP3R identified in Part 1 (400 mg Q4W) in combination with approved dose of dabrafenib (150 mg BID) and trametinib (2 mg QD)'}, {'id': 'OG001', 'title': 'Part 3- Arm 2: Placebo + Dabrafenib 150 mg BID + Trametinib 2 mg QD', 'description': 'In Part 3, participants are randomized to receive matching placebo in combination with the approved dose of dabrafenib (150 mg BID) and trametinib (2 mg QD)'}], 'classes': [{'title': 'Cycle 4 Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '176', 'groupId': 'OG000'}, {'value': '190', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1.85', 'spread': '16.567', 'groupId': 'OG000'}, {'value': '2.16', 'spread': '19.733', 'groupId': 'OG001'}]}]}, {'title': 'Cycle 6 Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '156', 'groupId': 'OG000'}, {'value': '158', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1.55', 'spread': '20.751', 'groupId': 'OG000'}, {'value': '3.10', 'spread': '16.095', 'groupId': 'OG001'}]}]}, {'title': 'Cycle 8 Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '145', 'groupId': 'OG000'}, {'value': '149', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.39', 'spread': '20.246', 'groupId': 'OG000'}, {'value': '2.60', 'spread': '15.200', 'groupId': 'OG001'}]}]}, {'title': 'Cycle 10 Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '132', 'groupId': 'OG000'}, {'value': '124', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '2.45', 'spread': '19.050', 'groupId': 'OG000'}, {'value': '2.52', 'spread': '16.144', 'groupId': 'OG001'}]}]}, {'title': 'Cycle 12 Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '110', 'groupId': 'OG000'}, {'value': '113', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1.88', 'spread': '24.653', 'groupId': 'OG000'}, {'value': '1.42', 'spread': '15.695', 'groupId': 'OG001'}]}]}, {'title': 'Cycle 14 Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '102', 'groupId': 'OG000'}, {'value': '107', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '2.62', 'spread': '19.455', 'groupId': 'OG000'}, {'value': '1.71', 'spread': '14.337', 'groupId': 'OG001'}]}]}, {'title': 'Cycle 16 Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '89', 'groupId': 'OG000'}, {'value': '91', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1.30', 'spread': '18.640', 'groupId': 'OG000'}, {'value': '2.79', 'spread': '16.996', 'groupId': 'OG001'}]}]}, {'title': 'Cycle 18 Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '88', 'groupId': 'OG000'}, {'value': '86', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '2.16', 'spread': '20.762', 'groupId': 'OG000'}, {'value': '1.91', 'spread': '16.743', 'groupId': 'OG001'}]}]}, {'title': 'Cycle 20 Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '82', 'groupId': 'OG000'}, {'value': '83', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1.34', 'spread': '17.831', 'groupId': 'OG000'}, {'value': '1.28', 'spread': '16.108', 'groupId': 'OG001'}]}]}, {'title': 'Cycle 22 Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '79', 'groupId': 'OG000'}, {'value': '80', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '3.01', 'spread': '19.102', 'groupId': 'OG000'}, {'value': '1.55', 'spread': '14.973', 'groupId': 'OG001'}]}]}, {'title': 'Cycle 25 Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '64', 'groupId': 'OG000'}, {'value': '69', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '4.47', 'spread': '19.489', 'groupId': 'OG000'}, {'value': '0.26', 'spread': '14.784', 'groupId': 'OG001'}]}]}, {'title': 'Cycle 28 Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '49', 'groupId': 'OG000'}, {'value': '56', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '4.20', 'spread': '17.545', 'groupId': 'OG000'}, {'value': '-0.39', 'spread': '18.529', 'groupId': 'OG001'}]}]}, {'title': 'Cycle 31 Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '22', 'groupId': 'OG000'}, {'value': '26', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '6.45', 'spread': '19.561', 'groupId': 'OG000'}, {'value': '-0.08', 'spread': '16.747', 'groupId': 'OG001'}]}]}, {'title': 'Cycle 34 Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-9.50', 'spread': '14.849', 'groupId': 'OG000'}, {'value': '5.60', 'spread': '19.008', 'groupId': 'OG001'}]}]}, {'title': '30 days post-progression', 'denoms': [{'units': 'Participants', 'counts': [{'value': '24', 'groupId': 'OG000'}, {'value': '29', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-4.04', 'spread': '22.033', 'groupId': 'OG000'}, {'value': '-10.24', 'spread': '23.532', 'groupId': 'OG001'}]}]}, {'title': '60 days post-progression', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-19.25', 'spread': '19.923', 'groupId': 'OG000'}, {'value': '-8.19', 'spread': '21.192', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'From baseline to 60 days post progression, assessed up to 2.8 years (Part 3)', 'description': 'The EQ-5D-5L is a standardized questionnaire used to assess health-related quality of life, and it includes a Visual Analog Scale (VAS). The VAS score is obtained by asking the individual to rate their current health status on a scale from 0 to 100, where 0 represents the worst possible health state and 100 represents the best possible health state. The change from baseline in EQ-5D-5L VAS score was calculated. A positive change from baseline indicates improvement in the health status.', 'unitOfMeasure': 'Score on a Scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants in Part 3 to whom study treatment was assigned by randomization (regardless of whether or not treatment was administered) and with available data at the pre-specified time points'}, {'type': 'SECONDARY', 'title': "Randomized (Part 3): PFS as Per Investigator's Assessment by RECIST 1.1 by PD-L1 Expression", 'denoms': [{'units': 'Participants', 'counts': [{'value': '236', 'groupId': 'OG000'}, {'value': '241', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Part 3- Arm 1: PDR001 400 mg Q4W + Dabrafenib 150 mg BID + Trametinib 2 mg QD', 'description': 'In Part 3, participants are randomized to receive Spartalizumab (PDR001) at the RP3R identified in Part 1 (400 mg Q4W) in combination with approved dose of dabrafenib (150 mg BID) and trametinib (2 mg QD)'}, {'id': 'OG001', 'title': 'Part 3- Arm 2: Placebo + Dabrafenib 150 mg BID + Trametinib 2 mg QD', 'description': 'In Part 3, participants are randomized to receive matching placebo in combination with the approved dose of dabrafenib (150 mg BID) and trametinib (2 mg QD)'}], 'classes': [{'title': 'PD-L1 negative (<1%)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '98', 'groupId': 'OG000'}, {'value': '115', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '12.0', 'groupId': 'OG000', 'lowerLimit': '10.1', 'upperLimit': '15.7'}, {'value': '10.3', 'groupId': 'OG001', 'lowerLimit': '7.5', 'upperLimit': '13.0'}]}]}, {'title': 'PD-L1 positive (>=1%)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '138', 'groupId': 'OG000'}, {'value': '126', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '26.6', 'comment': 'Not estimable (NA) due to the insufficient number of participants with events', 'groupId': 'OG000', 'lowerLimit': '17.4', 'upperLimit': 'NA'}, {'value': '15.4', 'groupId': 'OG001', 'lowerLimit': '10.2', 'upperLimit': '25.3'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Up to disease progression or death due to any cause, up to 2.8 years (Part 3)', 'description': "PFS was defined as the time from the date of first dose to the date of the first documented radiological progression as per investigator's assessment using RECIST 1.1 response criteria or death due to any cause. The distribution of PFS was estimated using the KM method. If a patient had not had an event at the time of data cut-off, progression-free survival was censored at the date of last adequate tumor assessment. PFS analysis was performed by PD-L1 status (positive, negative) where a positive status was defined as having ≥ 1% expression and a negative status was defined as having \\< 1% expression.", 'unitOfMeasure': 'Months', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants in Part 3 to whom study treatment was assigned by randomization (regardless of whether or not treatment was administered) with an evaluable PD-L1 assessment.'}, {'type': 'SECONDARY', 'title': 'Randomized (Part 3): OS by PD-L1 Expression', 'denoms': [{'units': 'Participants', 'counts': [{'value': '112', 'groupId': 'OG000'}, {'value': '138', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Part 3- Arm 1: PDR001 400 mg Q4W + Dabrafenib 150 mg BID + Trametinib 2 mg QD', 'description': 'In Part 3, participants are randomized to receive Spartalizumab (PDR001) at the RP3R identified in Part 1 (400 mg Q4W) in combination with approved dose of dabrafenib (150 mg BID) and trametinib (2 mg QD)'}, {'id': 'OG001', 'title': 'Part 3- Arm 2: Placebo + Dabrafenib 150 mg BID + Trametinib 2 mg QD', 'description': 'In Part 3, participants are randomized to receive matching placebo in combination with the approved dose of dabrafenib (150 mg BID) and trametinib (2 mg QD)'}], 'classes': [{'title': 'PD-L1 negative (<1%)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '54', 'groupId': 'OG000'}, {'value': '74', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '41.6', 'comment': 'Not estimable (NA) due to the insufficient number of participants with events', 'groupId': 'OG000', 'lowerLimit': '27.6', 'upperLimit': 'NA'}, {'value': '21.0', 'groupId': 'OG001', 'lowerLimit': '16.9', 'upperLimit': '33.4'}]}]}, {'title': 'PD-L1 positive (>=1%)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '58', 'groupId': 'OG000'}, {'value': '64', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': 'NA', 'comment': 'Not estimable (NA) due to the insufficient number of participants with events', 'groupId': 'OG000', 'lowerLimit': '45.4', 'upperLimit': 'NA'}, {'value': '61.3', 'comment': 'Not estimable (NA) due to the insufficient number of participants with events', 'groupId': 'OG001', 'lowerLimit': '41.2', 'upperLimit': 'NA'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Up to death due to any cause, assessed up to approximately 7 years', 'description': 'Overall survival was defined as the time from date of randomization to date of death due to any cause. OS analysis was performed by PD-L1 subgroup (positive, negative) where a positive status was defined as having ≥ 1% expression and a negative status was defined as having \\< 1% expression.', 'unitOfMeasure': 'Months', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants in Part 3 to whom study treatment was assigned by randomization (regardless of whether or not treatment was administered) with an evaluable PD-L1 assessment.'}, {'type': 'SECONDARY', 'title': 'Spartalizumab Anti-drug Antibody (ADA) Prevalence at Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}, {'value': '26', 'groupId': 'OG001'}, {'value': '244', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Part 1- Safety run-in: PDR001 400 mg Q4W + Dabrafenib 150 mg BID + Trametinib 2 mg QD', 'description': 'In Part 1, participants are treated with Spartalizumab (PDR001) 400 mg Q4W in combination with the approved dose of dabrafenib (150 mg BID) and trametinib (2 mg QD).'}, {'id': 'OG001', 'title': 'Part 2- Biomarker Cohort: PDR001 400 mg Q4W + Dabrafenib 150 mg BID + Trametinib 2 mg QD', 'description': 'In Part 2, participants are treated with Spartalizumab (PDR001) 400 mg Q4W in combination with the approved dose of dabrafenib (150 mg BID) and trametinib (2 mg QD).'}, {'id': 'OG002', 'title': 'Part 3- Arm 1: PDR001 400 mg Q4W + Dabrafenib 150 mg BID + Trametinib 2 mg QD', 'description': 'In Part 3, participants are randomized to receive Spartalizumab (PDR001) at the RP3R identified in Part 1 (400 mg Q4W) in combination with approved dose of dabrafenib (150 mg BID) and trametinib (2 mg QD)'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '4', 'groupId': 'OG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Baseline', 'description': 'Spartalizumab ADA prevalence at baseline was calculated as the percentage of participants who had an spartalizumab ADA positive result at baseline.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Part 1 and 2: All subjects to whom study treatment was assigned and who received any study treatment with a determinant baseline immunogenicity sample and at least one determinant post-baseline immunogenicity sample. Part 3: All subjects randomized to spartalizumab with dabrafenib and trametinib with a determinant baseline immunogenicity sample and at least one determinant post-baseline immunogenicity sample. Determinant sample: sample that is neither ADA-inconclusive nor unevaluable'}, {'type': 'SECONDARY', 'title': 'Spartalizumab ADA Incidence', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}, {'value': '26', 'groupId': 'OG001'}, {'value': '244', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Part 1- Safety run-in: PDR001 400 mg Q4W + Dabrafenib 150 mg BID + Trametinib 2 mg QD', 'description': 'In Part 1, participants are treated with Spartalizumab (PDR001) 400 mg Q4W in combination with the approved dose of dabrafenib (150 mg BID) and trametinib (2 mg QD).'}, {'id': 'OG001', 'title': 'Part 2- Biomarker Cohort: PDR001 400 mg Q4W + Dabrafenib 150 mg BID + Trametinib 2 mg QD', 'description': 'In Part 2, participants are treated with Spartalizumab (PDR001) 400 mg Q4W in combination with the approved dose of dabrafenib (150 mg BID) and trametinib (2 mg QD).'}, {'id': 'OG002', 'title': 'Part 3- Arm 1: PDR001 400 mg Q4W + Dabrafenib 150 mg BID + Trametinib 2 mg QD', 'description': 'In Part 3, participants are randomized to receive Spartalizumab (PDR001) at the RP3R identified in Part 1 (400 mg Q4W) in combination with approved dose of dabrafenib (150 mg BID) and trametinib (2 mg QD)'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}, {'value': '55', 'groupId': 'OG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Throughout study until 150 days after the last dose of spartalizumab, up to 3.3 years (Part 1), 3 years (Part 2) and 2.8 years (Part 3).', 'description': 'Spartalizumab ADA incidence was calculated as the percentage of participants who were treatment-induced spartalizumab ADA positive (post-baseline ADA positive with ADA-negative sample at baseline) and treatment-boosted spartalizumab ADA positive (post-baseline ADA positive with titer that is at least the fold titer change greater than the ADA-positive baseline titer)', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Part 1 and 2: All subjects to whom study treatment was assigned and who received any study treatment with a determinant baseline immunogenicity sample and at least one determinant post-baseline immunogenicity sample. Part 3: All subjects randomized to spartalizumab with dabrafenib and trametinib with a determinant baseline immunogenicity sample and at least one determinant post-baseline immunogenicity sample. Determinant sample: sample that is neither ADA-inconclusive nor unevaluable'}, {'type': 'SECONDARY', 'title': 'Trough Concentration (Ctrough) for Spartalizumab', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}, {'value': '17', 'groupId': 'OG001'}, {'value': '138', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Part 1- Safety run-in: PDR001 400 mg Q4W + Dabrafenib 150 mg BID + Trametinib 2 mg QD', 'description': 'In Part 1, participants are treated with Spartalizumab (PDR001) 400 mg Q4W in combination with the approved dose of dabrafenib (150 mg BID) and trametinib (2 mg QD).'}, {'id': 'OG001', 'title': 'Part 2- Biomarker Cohort: PDR001 400 mg Q4W + Dabrafenib 150 mg BID + Trametinib 2 mg QD', 'description': 'In Part 2, participants are treated with Spartalizumab (PDR001) 400 mg Q4W in combination with the approved dose of dabrafenib (150 mg BID) and trametinib (2 mg QD).'}, {'id': 'OG002', 'title': 'Part 3- Arm 1: PDR001 400 mg Q4W + Dabrafenib 150 mg BID + Trametinib 2 mg QD', 'description': 'In Part 3, participants are randomized to receive Spartalizumab (PDR001) at the RP3R identified in Part 1 (400 mg Q4W) in combination with approved dose of dabrafenib (150 mg BID) and trametinib (2 mg QD)'}], 'classes': [{'title': 'Cycle 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}, {'value': '17', 'groupId': 'OG001'}, {'value': '138', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '31.9', 'spread': '4.59', 'groupId': 'OG000'}, {'value': '31.5', 'spread': '20.3', 'groupId': 'OG001'}, {'value': '28.4', 'spread': '13.4', 'groupId': 'OG002'}]}]}, {'title': 'Cycle 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}, {'value': '129', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '41.1', 'spread': '7.07', 'groupId': 'OG000'}, {'value': '56.1', 'spread': '34.2', 'groupId': 'OG001'}, {'value': '43.5', 'spread': '19.1', 'groupId': 'OG002'}]}]}, {'title': 'Cycle 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}, {'value': '121', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '47.8', 'groupId': 'OG000'}, {'value': '46.9', 'spread': '18.8', 'groupId': 'OG001'}, {'value': '50.5', 'spread': '24.2', 'groupId': 'OG002'}]}]}, {'title': 'Cycle 5', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}, {'value': '126', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '46.3', 'groupId': 'OG000'}, {'value': '56.7', 'spread': '19.5', 'groupId': 'OG001'}, {'value': '56.4', 'spread': '24.5', 'groupId': 'OG002'}]}]}, {'title': 'Cycle 6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}, {'value': '119', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '53.8', 'spread': '16.9', 'groupId': 'OG000'}, {'value': '60.9', 'spread': '23.6', 'groupId': 'OG001'}, {'value': '58.8', 'spread': '26.5', 'groupId': 'OG002'}]}]}, {'title': 'Cycle 7', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '119', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '56.1', 'spread': '12.1', 'groupId': 'OG000'}, {'value': '62.2', 'spread': '33.3', 'groupId': 'OG001'}, {'value': '63.7', 'spread': '29.6', 'groupId': 'OG002'}]}]}, {'title': 'Cycle 8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}, {'value': '104', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '57.9', 'spread': '12.7', 'groupId': 'OG000'}, {'value': '65.8', 'spread': '32.8', 'groupId': 'OG001'}, {'value': '64.1', 'spread': '29.9', 'groupId': 'OG002'}]}]}, {'title': 'Cycle 9', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '88', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '60.2', 'spread': '30.9', 'groupId': 'OG000'}, {'value': '69.5', 'spread': '25.2', 'groupId': 'OG001'}, {'value': '67.8', 'spread': '33.5', 'groupId': 'OG002'}]}]}, {'title': 'Cycle 10', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '87', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '62.1', 'spread': '22.5', 'groupId': 'OG000'}, {'value': '68.4', 'spread': '33.2', 'groupId': 'OG001'}, {'value': '63.8', 'spread': '28.4', 'groupId': 'OG002'}]}]}, {'title': 'Cycle 11', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}, {'value': '91', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '66.9', 'spread': '15.8', 'groupId': 'OG000'}, {'value': '63.2', 'spread': '35.8', 'groupId': 'OG001'}, {'value': '62.1', 'spread': '27.9', 'groupId': 'OG002'}]}]}, {'title': 'Cycle 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}, {'value': '85', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '67.0', 'spread': '16.5', 'groupId': 'OG000'}, {'value': '61.6', 'spread': '29.3', 'groupId': 'OG001'}, {'value': '60.7', 'spread': '27.2', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Pre-infusion on Day 1 of each Cycle starting from Cycle 2, up to 3.3 years (Part 1), 3 years (Part 2) and 2.8 years (Part 3). Cycle=28 days', 'description': 'Ctrough for spartalizumab refers to the serum concentration of spartalizumab immediately prior to the administration of a dose of spartalizumab on Day 1 of Cycle 2 and later cycles.', 'unitOfMeasure': 'microgram (μg)/miliLiter (mL)', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'All subjects who provided at least one evaluable spartalizumab PK concentration at the specified time points.'}, {'type': 'SECONDARY', 'title': 'Pre-dose Plasma Concentration for Dabrafenib', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '18', 'groupId': 'OG001'}, {'value': '127', 'groupId': 'OG002'}, {'value': '162', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Part 1- Safety run-in: PDR001 400 mg Q4W + Dabrafenib 150 mg BID + Trametinib 2 mg QD', 'description': 'In Part 1, participants are treated with Spartalizumab (PDR001) 400 mg Q4W in combination with the approved dose of dabrafenib (150 mg BID) and trametinib (2 mg QD).'}, {'id': 'OG001', 'title': 'Part 2- Biomarker Cohort: PDR001 400 mg Q4W + Dabrafenib 150 mg BID + Trametinib 2 mg QD', 'description': 'In Part 2, participants are treated with Spartalizumab (PDR001) 400 mg Q4W in combination with the approved dose of dabrafenib (150 mg BID) and trametinib (2 mg QD).'}, {'id': 'OG002', 'title': 'Part 3- Arm 1: PDR001 400 mg Q4W + Dabrafenib 150 mg BID + Trametinib 2 mg QD', 'description': 'In Part 3, participants are randomized to receive Spartalizumab (PDR001) at the RP3R identified in Part 1 (400 mg Q4W) in combination with approved dose of dabrafenib (150 mg BID) and trametinib (2 mg QD)'}, {'id': 'OG003', 'title': 'Part 3- Arm 2: Placebo + Dabrafenib 150 mg BID + Trametinib 2 mg QD', 'description': 'In Part 3, participants are randomized to receive matching placebo in combination with the approved dose of dabrafenib (150 mg BID) and trametinib (2 mg QD)'}], 'classes': [{'title': 'Cycle 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}, {'value': '18', 'groupId': 'OG001'}, {'value': '125', 'groupId': 'OG002'}, {'value': '162', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '33.7', 'spread': '27.4', 'groupId': 'OG000'}, {'value': '149', 'spread': '391', 'groupId': 'OG001'}, {'value': '208', 'spread': '473', 'groupId': 'OG002'}, {'value': '234', 'spread': '475', 'groupId': 'OG003'}]}]}, {'title': 'Cycle 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}, {'value': '127', 'groupId': 'OG002'}, {'value': '145', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '25.5', 'spread': '10.4', 'groupId': 'OG000'}, {'value': '183', 'spread': '469', 'groupId': 'OG001'}, {'value': '192', 'spread': '607', 'groupId': 'OG002'}, {'value': '135', 'spread': '266', 'groupId': 'OG003'}]}]}, {'title': 'Cycle 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}, {'value': '116', 'groupId': 'OG002'}, {'value': '131', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '23.0', 'spread': '15.8', 'groupId': 'OG000'}, {'value': '372', 'spread': '811', 'groupId': 'OG001'}, {'value': '169', 'spread': '404', 'groupId': 'OG002'}, {'value': '167', 'spread': '328', 'groupId': 'OG003'}]}]}, {'title': 'Cycle 5', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}, {'value': '110', 'groupId': 'OG002'}, {'value': '125', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '28.8', 'spread': '30.6', 'groupId': 'OG000'}, {'value': '152', 'spread': '293', 'groupId': 'OG001'}, {'value': '130', 'spread': '317', 'groupId': 'OG002'}, {'value': '152', 'spread': '363', 'groupId': 'OG003'}]}]}, {'title': 'Cycle 6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}, {'value': '110', 'groupId': 'OG002'}, {'value': '113', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '15.1', 'spread': '16.3', 'groupId': 'OG000'}, {'value': '73.7', 'spread': '131', 'groupId': 'OG001'}, {'value': '198', 'spread': '521', 'groupId': 'OG002'}, {'value': '94.6', 'spread': '186', 'groupId': 'OG003'}]}]}, {'title': 'Cycle 7', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '102', 'groupId': 'OG002'}, {'value': '111', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '20.9', 'spread': '13.9', 'groupId': 'OG000'}, {'value': '40.0', 'spread': '20.0', 'groupId': 'OG001'}, {'value': '180', 'spread': '510', 'groupId': 'OG002'}, {'value': '121', 'spread': '279', 'groupId': 'OG003'}]}]}, {'title': 'Cycle 8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}, {'value': '97', 'groupId': 'OG002'}, {'value': '96', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '22.9', 'spread': '16.8', 'groupId': 'OG000'}, {'value': '28.0', 'spread': '10.4', 'groupId': 'OG001'}, {'value': '173', 'spread': '532', 'groupId': 'OG002'}, {'value': '97.2', 'spread': '177', 'groupId': 'OG003'}]}]}, {'title': 'Cycle 9', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '91', 'groupId': 'OG002'}, {'value': '79', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '22.3', 'spread': '7.59', 'groupId': 'OG000'}, {'value': '43.3', 'spread': '40.6', 'groupId': 'OG001'}, {'value': '143', 'spread': '394', 'groupId': 'OG002'}, {'value': '133', 'spread': '259', 'groupId': 'OG003'}]}]}, {'title': 'Cycle 10', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '81', 'groupId': 'OG002'}, {'value': '85', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '24.5', 'spread': '9.19', 'groupId': 'OG000'}, {'value': '60.0', 'spread': '28.3', 'groupId': 'OG001'}, {'value': '167', 'spread': '472', 'groupId': 'OG002'}, {'value': '122', 'spread': '266', 'groupId': 'OG003'}]}]}, {'title': 'Cycle 11', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '79', 'groupId': 'OG002'}, {'value': '77', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '154', 'spread': '250', 'groupId': 'OG000'}, {'value': '33.8', 'spread': '22.6', 'groupId': 'OG001'}, {'value': '174', 'spread': '667', 'groupId': 'OG002'}, {'value': '119', 'spread': '238', 'groupId': 'OG003'}]}]}, {'title': 'Cycle 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '75', 'groupId': 'OG002'}, {'value': '67', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '10.9', 'spread': '10.3', 'groupId': 'OG000'}, {'value': '41.3', 'spread': '37.2', 'groupId': 'OG001'}, {'value': '148', 'spread': '396', 'groupId': 'OG002'}, {'value': '146', 'spread': '295', 'groupId': 'OG003'}]}]}, {'title': 'Cycle 18', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '24', 'groupId': 'OG002'}, {'value': '20', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '19.0', 'groupId': 'OG000'}, {'value': '50.6', 'spread': '49.7', 'groupId': 'OG001'}, {'value': '180', 'spread': '618', 'groupId': 'OG002'}, {'value': '167', 'spread': '385', 'groupId': 'OG003'}]}]}, {'title': 'Cycle 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '19', 'groupId': 'OG002'}, {'value': '15', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '91.5', 'spread': '98.3', 'groupId': 'OG001'}, {'value': '147', 'spread': '344', 'groupId': 'OG002'}, {'value': '60.2', 'spread': '67.9', 'groupId': 'OG003'}]}]}, {'title': 'Cycle 30', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '4', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '40.2', 'groupId': 'OG000'}, {'value': '226', 'spread': '488', 'groupId': 'OG002'}, {'value': '47.6', 'spread': '23.2', 'groupId': 'OG003'}]}]}, {'title': 'Cycle 36', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '47.6', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Pre-infusion on Day 1 of every cycle from Cycle 2 to 12, and then every 6 cycles from Cycle 18 to 36, up to 3.3 years (Part 1), 3 years (Part 2) and 2.8 years (Part 3). Cycle=28 days', 'description': 'Plasma concentration of dabrafenib immediately prior to the administration of a dose of dabrafenib.', 'unitOfMeasure': 'nanogram (ng)/ miliLiter (mL)', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'All subjects who provided at least one evaluable dabrafenib PK concentration at the specified time points.'}, {'type': 'SECONDARY', 'title': 'Pre-dose Plasma Concentration for Trametinib', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}, {'value': '103', 'groupId': 'OG002'}, {'value': '143', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Part 1- Safety run-in: PDR001 400 mg Q4W + Dabrafenib 150 mg BID + Trametinib 2 mg QD', 'description': 'In Part 1, participants are treated with Spartalizumab (PDR001) 400 mg Q4W in combination with the approved dose of dabrafenib (150 mg BID) and trametinib (2 mg QD).'}, {'id': 'OG001', 'title': 'Part 2- Biomarker Cohort: PDR001 400 mg Q4W + Dabrafenib 150 mg BID + Trametinib 2 mg QD', 'description': 'In Part 2, participants are treated with Spartalizumab (PDR001) 400 mg Q4W in combination with the approved dose of dabrafenib (150 mg BID) and trametinib (2 mg QD).'}, {'id': 'OG002', 'title': 'Part 3- Arm 1: PDR001 400 mg Q4W + Dabrafenib 150 mg BID + Trametinib 2 mg QD', 'description': 'In Part 3, participants are randomized to receive Spartalizumab (PDR001) at the RP3R identified in Part 1 (400 mg Q4W) in combination with approved dose of dabrafenib (150 mg BID) and trametinib (2 mg QD)'}, {'id': 'OG003', 'title': 'Part 3- Arm 2: Placebo + Dabrafenib 150 mg BID + Trametinib 2 mg QD', 'description': 'In Part 3, participants are randomized to receive matching placebo in combination with the approved dose of dabrafenib (150 mg BID) and trametinib (2 mg QD)'}], 'classes': [{'title': 'Cycle 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}, {'value': '103', 'groupId': 'OG002'}, {'value': '143', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '11.7', 'spread': '4.09', 'groupId': 'OG000'}, {'value': '11.2', 'spread': '3.4', 'groupId': 'OG001'}, {'value': '11.5', 'spread': '4.73', 'groupId': 'OG002'}, {'value': '13.9', 'spread': '9.36', 'groupId': 'OG003'}]}]}, {'title': 'Cycle 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}, {'value': '100', 'groupId': 'OG002'}, {'value': '131', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '8.34', 'spread': '0.354', 'groupId': 'OG000'}, {'value': '12.2', 'spread': '2.55', 'groupId': 'OG001'}, {'value': '11.4', 'spread': '5.98', 'groupId': 'OG002'}, {'value': '12.3', 'spread': '5.59', 'groupId': 'OG003'}]}]}, {'title': 'Cycle 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}, {'value': '102', 'groupId': 'OG002'}, {'value': '117', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '10.7', 'spread': '1.64', 'groupId': 'OG000'}, {'value': '12.5', 'spread': '4.84', 'groupId': 'OG001'}, {'value': '11.7', 'spread': '4.62', 'groupId': 'OG002'}, {'value': '11.9', 'spread': '5.04', 'groupId': 'OG003'}]}]}, {'title': 'Cycle 5', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}, {'value': '100', 'groupId': 'OG002'}, {'value': '114', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '10.1', 'groupId': 'OG000'}, {'value': '12.6', 'spread': '5.03', 'groupId': 'OG001'}, {'value': '11.3', 'spread': '4.91', 'groupId': 'OG002'}, {'value': '11.6', 'spread': '4.49', 'groupId': 'OG003'}]}]}, {'title': 'Cycle 6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '99', 'groupId': 'OG002'}, {'value': '103', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '10.0', 'spread': '1.38', 'groupId': 'OG000'}, {'value': '11.8', 'spread': '3.73', 'groupId': 'OG001'}, {'value': '11.6', 'spread': '5.12', 'groupId': 'OG002'}, {'value': '10.9', 'spread': '3.52', 'groupId': 'OG003'}]}]}, {'title': 'Cycle 7', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '95', 'groupId': 'OG002'}, {'value': '97', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '11.6', 'spread': '3.8', 'groupId': 'OG000'}, {'value': '11.8', 'spread': '5.24', 'groupId': 'OG001'}, {'value': '12.0', 'spread': '4.86', 'groupId': 'OG002'}, {'value': '11.0', 'spread': '4.26', 'groupId': 'OG003'}]}]}, {'title': 'Cycle 8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}, {'value': '87', 'groupId': 'OG002'}, {'value': '94', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '9.24', 'spread': '3.06', 'groupId': 'OG000'}, {'value': '10.2', 'spread': '4.13', 'groupId': 'OG001'}, {'value': '10.3', 'spread': '3.92', 'groupId': 'OG002'}, {'value': '11.3', 'spread': '4.08', 'groupId': 'OG003'}]}]}, {'title': 'Cycle 9', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '78', 'groupId': 'OG002'}, {'value': '75', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '8.73', 'spread': '3.35', 'groupId': 'OG000'}, {'value': '10.5', 'spread': '4.43', 'groupId': 'OG001'}, {'value': '10.9', 'spread': '4.57', 'groupId': 'OG002'}, {'value': '11.6', 'spread': '4.22', 'groupId': 'OG003'}]}]}, {'title': 'Cycle 10', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '71', 'groupId': 'OG002'}, {'value': '85', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '8.24', 'groupId': 'OG000'}, {'value': '10.5', 'spread': '4.02', 'groupId': 'OG001'}, {'value': '10.9', 'spread': '4.47', 'groupId': 'OG002'}, {'value': '11.8', 'spread': '4.26', 'groupId': 'OG003'}]}]}, {'title': 'Cycle 11', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}, {'value': '71', 'groupId': 'OG002'}, {'value': '71', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '10.7', 'groupId': 'OG000'}, {'value': '11.6', 'spread': '4.69', 'groupId': 'OG001'}, {'value': '10.3', 'spread': '3.67', 'groupId': 'OG002'}, {'value': '11.4', 'spread': '3.57', 'groupId': 'OG003'}]}]}, {'title': 'Cycle 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '65', 'groupId': 'OG002'}, {'value': '65', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '10.6', 'spread': '3.92', 'groupId': 'OG000'}, {'value': '11.0', 'spread': '4.53', 'groupId': 'OG001'}, {'value': '10.6', 'spread': '4.31', 'groupId': 'OG002'}, {'value': '11.2', 'spread': '3.82', 'groupId': 'OG003'}]}]}, {'title': 'Cycle 18', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '25', 'groupId': 'OG002'}, {'value': '21', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '10.1', 'groupId': 'OG000'}, {'value': '13.0', 'spread': '4.6', 'groupId': 'OG001'}, {'value': '9.66', 'spread': '3.49', 'groupId': 'OG002'}, {'value': '12.1', 'spread': '5.13', 'groupId': 'OG003'}]}]}, {'title': 'Cycle 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '17', 'groupId': 'OG002'}, {'value': '12', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '13.4', 'spread': '8.03', 'groupId': 'OG001'}, {'value': '10.7', 'spread': '4.89', 'groupId': 'OG002'}, {'value': '10.7', 'spread': '2.21', 'groupId': 'OG003'}]}]}, {'title': 'Cycle 30', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '5', 'groupId': 'OG002'}, {'value': '4', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '10.8', 'groupId': 'OG000'}, {'value': '9.34', 'spread': '7.56', 'groupId': 'OG002'}, {'value': '10.1', 'spread': '2.76', 'groupId': 'OG003'}]}]}, {'title': 'Cycle 36', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '8.97', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Pre-infusion on Day 1 of every cycle from Cycle 2 to 12, and then every 6 cycles from Cycle 18 to 36, up to 3.3 years (Part 1), 3 years (Part 2) and 2.8 years (Part 3). Cycle=28 days', 'description': 'Plasma concentration of trametinib immediately prior to the administration of a dose of trametinib.', 'unitOfMeasure': 'ng/mL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'All subjects who provided at least one evaluable trametinib PK concentration at the specified time points.'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Dose Interruptions', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}, {'value': '27', 'groupId': 'OG001'}, {'value': '267', 'groupId': 'OG002'}, {'value': '264', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Part 1- Safety run-in: PDR001 400 mg Q4W + Dabrafenib 150 mg BID + Trametinib 2 mg QD', 'description': 'In Part 1, participants are treated with Spartalizumab (PDR001) 400 mg Q4W in combination with the approved dose of dabrafenib (150 mg BID) and trametinib (2 mg QD).'}, {'id': 'OG001', 'title': 'Part 2- Biomarker Cohort: PDR001 400 mg Q4W + Dabrafenib 150 mg BID + Trametinib 2 mg QD', 'description': 'In Part 2, participants are treated with Spartalizumab (PDR001) 400 mg Q4W in combination with the approved dose of dabrafenib (150 mg BID) and trametinib (2 mg QD).'}, {'id': 'OG002', 'title': 'Part 3- Arm 1: PDR001 400 mg Q4W + Dabrafenib 150 mg BID + Trametinib 2 mg QD', 'description': 'In Part 3, participants are randomized to receive Spartalizumab (PDR001) at the RP3R identified in Part 1 (400 mg Q4W) in combination with approved dose of dabrafenib (150 mg BID) and trametinib (2 mg QD)'}, {'id': 'OG003', 'title': 'Part 3- Arm 2: Placebo + Dabrafenib 150 mg BID + Trametinib 2 mg QD', 'description': 'In Part 3, participants are randomized to receive matching placebo in combination with the approved dose of dabrafenib (150 mg BID) and trametinib (2 mg QD)'}], 'classes': [{'title': 'Spartalizumab (PDR001)', 'categories': [{'title': 'With no dose interruption', 'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}, {'value': '120', 'groupId': 'OG002'}, {'value': '170', 'groupId': 'OG003'}]}, {'title': 'With at least one dose interruption', 'measurements': [{'value': '5', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}, {'value': '147', 'groupId': 'OG002'}, {'value': '94', 'groupId': 'OG003'}]}]}, {'title': 'Dabrafenib', 'categories': [{'title': 'With no dose interruption', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '29', 'groupId': 'OG002'}, {'value': '74', 'groupId': 'OG003'}]}, {'title': 'With at least one dose interruption', 'measurements': [{'value': '9', 'groupId': 'OG000'}, {'value': '25', 'groupId': 'OG001'}, {'value': '238', 'groupId': 'OG002'}, {'value': '190', 'groupId': 'OG003'}]}]}, {'title': 'Trametinib', 'categories': [{'title': 'With no dose interruption', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '29', 'groupId': 'OG002'}, {'value': '64', 'groupId': 'OG003'}]}, {'title': 'With at least one dose interruption', 'measurements': [{'value': '9', 'groupId': 'OG000'}, {'value': '26', 'groupId': 'OG001'}, {'value': '238', 'groupId': 'OG002'}, {'value': '200', 'groupId': 'OG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'From baseline to end of treatment, assessed up to approximately 7 years', 'description': 'Number of participants with dose interruptions for spartalizumab, dabrafenib and trametinib', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants who received at least one dose of study treatment'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Dose Reductions', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}, {'value': '27', 'groupId': 'OG001'}, {'value': '267', 'groupId': 'OG002'}, {'value': '264', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Part 1- Safety run-in: PDR001 400 mg Q4W + Dabrafenib 150 mg BID + Trametinib 2 mg QD', 'description': 'In Part 1, participants are treated with Spartalizumab (PDR001) 400 mg Q4W in combination with the approved dose of dabrafenib (150 mg BID) and trametinib (2 mg QD).'}, {'id': 'OG001', 'title': 'Part 2- Biomarker Cohort: PDR001 400 mg Q4W + Dabrafenib 150 mg BID + Trametinib 2 mg QD', 'description': 'In Part 2, participants are treated with Spartalizumab (PDR001) 400 mg Q4W in combination with the approved dose of dabrafenib (150 mg BID) and trametinib (2 mg QD).'}, {'id': 'OG002', 'title': 'Part 3- Arm 1: PDR001 400 mg Q4W + Dabrafenib 150 mg BID + Trametinib 2 mg QD', 'description': 'In Part 3, participants are randomized to receive Spartalizumab (PDR001) at the RP3R identified in Part 1 (400 mg Q4W) in combination with approved dose of dabrafenib (150 mg BID) and trametinib (2 mg QD)'}, {'id': 'OG003', 'title': 'Part 3- Arm 2: Placebo + Dabrafenib 150 mg BID + Trametinib 2 mg QD', 'description': 'In Part 3, participants are randomized to receive matching placebo in combination with the approved dose of dabrafenib (150 mg BID) and trametinib (2 mg QD)'}], 'classes': [{'title': 'Dabrafenib', 'categories': [{'title': 'With neither dose reduction nor interruption', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '25', 'groupId': 'OG002'}, {'value': '68', 'groupId': 'OG003'}]}, {'title': 'With at least one dose reduction and/or interruption', 'measurements': [{'value': '9', 'groupId': 'OG000'}, {'value': '25', 'groupId': 'OG001'}, {'value': '242', 'groupId': 'OG002'}, {'value': '196', 'groupId': 'OG003'}]}]}, {'title': 'Trametinib', 'categories': [{'title': 'With neither dose reduction nor interruption', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '28', 'groupId': 'OG002'}, {'value': '63', 'groupId': 'OG003'}]}, {'title': 'With at least one dose reduction and/or interruption', 'measurements': [{'value': '9', 'groupId': 'OG000'}, {'value': '26', 'groupId': 'OG001'}, {'value': '239', 'groupId': 'OG002'}, {'value': '201', 'groupId': 'OG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'From baseline to end of treatment, assessed up to approximately 7 years', 'description': 'Number of patients with dose reductions for spartalizumab, dabrafenib and trametinib', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants who received at least one dose of study treatment'}, {'type': 'SECONDARY', 'title': 'Relative Dose Intensity', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}, {'value': '27', 'groupId': 'OG001'}, {'value': '267', 'groupId': 'OG002'}, {'value': '264', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Part 1- Safety run-in: PDR001 400 mg Q4W + Dabrafenib 150 mg BID + Trametinib 2 mg QD', 'description': 'In Part 1, participants are treated with Spartalizumab (PDR001) 400 mg Q4W in combination with the approved dose of dabrafenib (150 mg BID) and trametinib (2 mg QD).'}, {'id': 'OG001', 'title': 'Part 2- Biomarker Cohort: PDR001 400 mg Q4W + Dabrafenib 150 mg BID + Trametinib 2 mg QD', 'description': 'In Part 2, participants are treated with Spartalizumab (PDR001) 400 mg Q4W in combination with the approved dose of dabrafenib (150 mg BID) and trametinib (2 mg QD).'}, {'id': 'OG002', 'title': 'Part 3- Arm 1: PDR001 400 mg Q4W + Dabrafenib 150 mg BID + Trametinib 2 mg QD', 'description': 'In Part 3, participants are randomized to receive Spartalizumab (PDR001) at the RP3R identified in Part 1 (400 mg Q4W) in combination with approved dose of dabrafenib (150 mg BID) and trametinib (2 mg QD)'}, {'id': 'OG003', 'title': 'Part 3- Arm 2: Placebo + Dabrafenib 150 mg BID + Trametinib 2 mg QD', 'description': 'In Part 3, participants are randomized to receive matching placebo in combination with the approved dose of dabrafenib (150 mg BID) and trametinib (2 mg QD)'}], 'classes': [{'title': 'Spartalizumab (PDR001)', 'categories': [{'measurements': [{'value': '90.7', 'spread': '16.83', 'groupId': 'OG000'}, {'value': '91.7', 'spread': '10.41', 'groupId': 'OG001'}, {'value': '94.4', 'spread': '9.21', 'groupId': 'OG002'}, {'value': '97.5', 'spread': '5.33', 'groupId': 'OG003'}]}]}, {'title': 'Dabrafenib', 'categories': [{'measurements': [{'value': '62.2', 'spread': '26.36', 'groupId': 'OG000'}, {'value': '71.3', 'spread': '21.13', 'groupId': 'OG001'}, {'value': '78.1', 'spread': '21.21', 'groupId': 'OG002'}, {'value': '89.6', 'spread': '15.10', 'groupId': 'OG003'}]}]}, {'title': 'Trametinib', 'categories': [{'measurements': [{'value': '65.9', 'spread': '16.90', 'groupId': 'OG000'}, {'value': '76.2', 'spread': '17.19', 'groupId': 'OG001'}, {'value': '79.8', 'spread': '19.58', 'groupId': 'OG002'}, {'value': '89.5', 'spread': '14.86', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'From baseline to end of treatment, assessed up to approximately 7 years', 'description': 'Relative dose intensity for spartalizumab, dabrafenib and trametinib computed as the ratio (expressed as percentage) of dose intensity and planned dose intensity:\n\n* Spartalizumab (PDR001) = \\[Dose intensity (mg/4W) / planned dose intensity (mg/4W)\\]\\*100.\n* Trametinib and Dabrafenib = \\[Dose intensity (mg/day) / planned dose intensity (mg/day)\\]\\*100.', 'unitOfMeasure': 'Percentage of planned dose intensity', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants who received at least one dose of study treatment'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Part 1- Safety run-in: PDR001 400 mg Q4W + Dabrafenib 150 mg BID + Trametinib 2 mg QD', 'description': 'In Part 1, participants are treated with Spartalizumab (PDR001) 400 mg Q4W in combination with the approved dose of dabrafenib (150 mg BID) and trametinib (2 mg QD).'}, {'id': 'FG001', 'title': 'Part 2- Biomarker Cohort: PDR001 400 mg Q4W + Dabrafenib 150 mg BID + Trametinib 2 mg QD', 'description': 'In Part 2, participants are treated with Spartalizumab (PDR001) 400 mg Q4W in combination with the approved dose of dabrafenib (150 mg BID) and trametinib (2 mg QD).'}, {'id': 'FG002', 'title': 'Part 3- Arm 1: PDR001 400 mg Q4W + Dabrafenib 150 mg BID + Trametinib 2 mg QD', 'description': 'In Part 3, participants are randomized to receive Spartalizumab (PDR001) at the RP3R identified in Part 1 (400 mg Q4W) in combination with approved dose of dabrafenib (150 mg BID) and trametinib (2 mg QD)'}, {'id': 'FG003', 'title': 'Part 3- Arm 2: Placebo + Dabrafenib 150 mg BID + Trametinib 2 mg QD', 'description': 'In Part 3, participants are randomized to receive matching placebo in combination with the approved dose of dabrafenib (150 mg BID) and trametinib (2 mg QD)'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '9'}, {'groupId': 'FG001', 'numSubjects': '27'}, {'groupId': 'FG002', 'numSubjects': '267'}, {'groupId': 'FG003', 'numSubjects': '265'}]}, {'type': 'Treated', 'achievements': [{'groupId': 'FG000', 'numSubjects': '9'}, {'groupId': 'FG001', 'numSubjects': '27'}, {'groupId': 'FG002', 'numSubjects': '267'}, {'groupId': 'FG003', 'numSubjects': '264'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '9'}, {'groupId': 'FG001', 'numSubjects': '27'}, {'groupId': 'FG002', 'numSubjects': '267'}, {'groupId': 'FG003', 'numSubjects': '265'}]}], 'dropWithdraws': [{'type': 'Progressive disease', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '15'}, {'groupId': 'FG002', 'numSubjects': '114'}, {'groupId': 'FG003', 'numSubjects': '151'}]}, {'type': 'Subject/guardian decision', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '14'}, {'groupId': 'FG003', 'numSubjects': '22'}]}, {'type': 'Death', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '13'}, {'groupId': 'FG003', 'numSubjects': '13'}]}, {'type': 'Protocol deviation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '1'}, {'groupId': 'FG003', 'numSubjects': '1'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '1'}, {'groupId': 'FG003', 'numSubjects': '0'}]}, {'type': 'Physician Decision', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '22'}, {'groupId': 'FG003', 'numSubjects': '13'}]}, {'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '9'}, {'groupId': 'FG002', 'numSubjects': '60'}, {'groupId': 'FG003', 'numSubjects': '28'}]}, {'type': 'Study terminated by sponsor', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '42'}, {'groupId': 'FG003', 'numSubjects': '37'}]}]}], 'recruitmentDetails': 'Part 1 and 2 were conducted in 18 centers across 12 countries. Part 3 is conducted in 190 centers across 29 countries', 'preAssignmentDetails': 'The screening phase began once written informed consent was provided and ended after 28 days or when subject received the first dose (Part 1 and 2) or was randomized (Part 3), whichever came first.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'BG000'}, {'value': '27', 'groupId': 'BG001'}, {'value': '267', 'groupId': 'BG002'}, {'value': '265', 'groupId': 'BG003'}, {'value': '568', 'groupId': 'BG004'}]}], 'groups': [{'id': 'BG000', 'title': 'Part 1- Safety run-in: PDR001 400 mg Q4W + Dabrafenib 150 mg BID + Trametinib 2 mg QD', 'description': 'In Part 1, participants are treated with Spartalizumab (PDR001) 400 mg Q4W in combination with the approved dose of dabrafenib (150 mg BID) and trametinib (2 mg QD).'}, {'id': 'BG001', 'title': 'Part 2- Biomarker Cohort: PDR001 400 mg Q4W + Dabrafenib 150 mg BID + Trametinib 2 mg QD', 'description': 'In Part 2, participants are treated with Spartalizumab (PDR001) 400 mg Q4W in combination with the approved dose of dabrafenib (150 mg BID) and trametinib (2 mg QD).'}, {'id': 'BG002', 'title': 'Part 3- Arm 1: PDR001 400 mg Q4W + Dabrafenib 150 mg BID + Trametinib 2 mg QD', 'description': 'In Part 3, participants are randomized to receive Spartalizumab (PDR001) at the RP3R identified in Part 1 (400 mg Q4W) in combination with approved dose of dabrafenib (150 mg BID) and trametinib (2 mg QD)'}, {'id': 'BG003', 'title': 'Part 3- Arm 2: Placebo + Dabrafenib 150 mg BID + Trametinib 2 mg QD', 'description': 'In Part 3, participants are randomized to receive matching placebo in combination with the approved dose of dabrafenib (150 mg BID) and trametinib (2 mg QD)'}, {'id': 'BG004', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '7', 'groupId': 'BG000'}, {'value': '18', 'groupId': 'BG001'}, {'value': '189', 'groupId': 'BG002'}, {'value': '195', 'groupId': 'BG003'}, {'value': '409', 'groupId': 'BG004'}]}, {'title': '>=65 years', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '9', 'groupId': 'BG001'}, {'value': '78', 'groupId': 'BG002'}, {'value': '70', 'groupId': 'BG003'}, {'value': '159', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '12', 'groupId': 'BG001'}, {'value': '119', 'groupId': 'BG002'}, {'value': '106', 'groupId': 'BG003'}, {'value': '239', 'groupId': 'BG004'}]}, {'title': 'Male', 'measurements': [{'value': '7', 'groupId': 'BG000'}, {'value': '15', 'groupId': 'BG001'}, {'value': '148', 'groupId': 'BG002'}, {'value': '159', 'groupId': 'BG003'}, {'value': '329', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'categories': [{'title': 'White', 'measurements': [{'value': '9', 'groupId': 'BG000'}, {'value': '24', 'groupId': 'BG001'}, {'value': '225', 'groupId': 'BG002'}, {'value': '227', 'groupId': 'BG003'}, {'value': '485', 'groupId': 'BG004'}]}, {'title': 'Asian', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '5', 'groupId': 'BG002'}, {'value': '5', 'groupId': 'BG003'}, {'value': '12', 'groupId': 'BG004'}]}, {'title': 'Other', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '15', 'groupId': 'BG002'}, {'value': '14', 'groupId': 'BG003'}, {'value': '30', 'groupId': 'BG004'}]}, {'title': 'Unknown', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '22', 'groupId': 'BG002'}, {'value': '19', 'groupId': 'BG003'}, {'value': '41', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2023-01-27', 'size': 3908375, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2023-06-23T07:56', 'hasProtocol': True}, {'date': '2024-08-21', 'size': 293126, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_002.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2025-05-28T07:44', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR'], 'maskingDescription': 'Part 1 and Part 2 are open- label. Part 3 is double-blind and randomized.'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 568}}, 'statusModule': {'whyStopped': 'Sponsor decision', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2017-02-17', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-09', 'dispFirstSubmitDate': '2021-07-05', 'completionDateStruct': {'date': '2024-08-21', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-09-01', 'studyFirstSubmitDate': '2016-11-16', 'dispFirstSubmitQcDate': '2021-07-05', 'resultsFirstSubmitDate': '2023-06-26', 'studyFirstSubmitQcDate': '2016-11-16', 'dispFirstPostDateStruct': {'date': '2021-07-08', 'type': 'ACTUAL'}, 'lastUpdatePostDateStruct': {'date': '2025-09-18', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2023-06-26', 'studyFirstPostDateStruct': {'date': '2016-11-18', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2023-07-24', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-08-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Safety Run-In (Part 1): Number of Participants With Dose Limiting Toxicities (DLTs)', 'timeFrame': 'Up to 8 weeks (Part 1)', 'description': 'DLT was defined as an adverse event or abnormal laboratory value that was unrelated to disease, disease progression, inter-current illness, or concomitant medications and occured within 8 weeks of treatment with spartalizumab in combination with dabrafenib and trametinib. The DLT criteria included Grade 4 hematological adverse events, Grade 4 bilirubin elevation, specific gastrointestinal adverse events, symptomatic serum amylase or lipase elevation, Grade 3 or higher hypertension, Grade 3 or higher cardiac events, Grade 2 or higher pneumonitis, Grade 3 or higher immune-related toxicities, infusion-related reactions, other clinically significant adverse events, and toxicities leading to a dosing delay of over 12 weeks. NCI CTCAE v4.03 was used for grading DLTs'}, {'measure': 'Biomarker Cohort (Part 2): Change From Baseline in Programmed Cell Death-ligand 1 (PD-L1) Expression Upon Treatment With Spartalizumab in Combination With Dabrafenib and Trametinib', 'timeFrame': 'Baseline, Cycle 1 Day 15 and Cycle 3 Day 1 (Part 2). Each cycle is 28 days', 'description': 'Change from baseline in PD-L1 expression (as determined by immunohistochemistry in tissue samples) upon treatment with spartalizumab in combination with dabrafenib and trametinib in participants from Part 2'}, {'measure': 'Biomarker Cohort (Part 2): Change From Baseline in CD8+ Cells Upon Treatment With Spartalizumab in Combination With Dabrafenib and Trametinib', 'timeFrame': 'Baseline, Cycle 1 Day 15 and Cycle 3 Day 1 (Part 2). Each cycle is 28 days', 'description': 'Change from baseline in CD8+ cells (as determined by flow cytometry in blood samples) upon treatment with spartalizumab in combination with dabrafenib and trametinib in participants from Part 2'}, {'measure': "Randomized (Part 3): Progression-Free Survival (PFS) as Per Investigator's Assessment by RECIST 1.1", 'timeFrame': 'Up to disease progression or death due to any cause, whichever occurs first, assessed up to 2.8 years (Part 3)', 'description': "Progression-free survival was defined as the time from the date of first dose to the date of the first documented radiological progression per investigator's assessment according to RECIST 1.1 or death due to any cause. The distribution of PFS was estimated using the Kaplan-Meier (KM) method. If a patient had not had an event at the time of data cut-off, progression-free survival was censored at the date of last adequate tumor assessment."}], 'secondaryOutcomes': [{'measure': 'Overall Survival (OS)', 'timeFrame': 'Up to death due to any cause, assessed up to approximately 7 years', 'description': 'Overall survival was defined as the time from date of randomization to date of death due to any cause'}, {'measure': "Overall Response Rate (ORR) as Per Investigator's Assessment by RECIST 1.1", 'timeFrame': 'Part 1: Up to 3.3 years. Part 2: Up to 3 years. Part 3: Up to 2.8 years', 'description': "ORR was defined as the percentage of subjects with confirmed best overall response of complete response (CR) or partial response (PR), as per investigator's assessment by RECIST 1.1. CR: Disappearance of all non-nodal target lesions. In addition, any pathological lymph nodes assigned as target lesions must have a reduction in short axis to \\<10 mm PR: At least a 30% decrease in the sum of diameter of all target lesions, taking as reference the baseline sum of diameters"}, {'measure': "Duration of Response (DOR) as Per Investigator's Assessment by RECIST 1.1", 'timeFrame': 'From first documented response to date of first documented progression or death, up to 3.3 years (Part 1), 3 years (Part 2) and 2.8 years (Part 3)', 'description': 'DOR was defined as the time from first documented response of CR or PR to date of first documented progression or death, according to RECIST 1.1 criteria. The distribution of DOR was estimated using the KM method. CR: Disappearance of all non-nodal target lesions. In addition, any pathological lymph nodes assigned as target lesions must have a reduction in short axis to \\<10 mm PR: At least a 30% decrease in the sum of diameter of all target lesions, taking as reference the baseline sum of diameters'}, {'measure': "Disease Control Rate (DCR) as Per Investigator's Assessment by RECIST 1.1", 'timeFrame': 'Part 1: Up to 3.3 years. Part 2: Up to 3 years. Part 3: Up to 2.8 year', 'description': 'DCR was defined as the percentage of participants with CR or PR or subjects with stable disease (SD) lasting for a duration of at least 24 weeks as per local review according to RECIST 1.1 criteria. CR: Disappearance of all non-nodal target lesions. In addition, any pathological lymph nodes assigned as target lesions must have a reduction in short axis to \\<10 mm PR: At least a 30% decrease in the sum of diameter of all target lesions, taking as reference the baseline sum of diameters SD: Neither sufficient shrinkage to qualify for PR or CR nor an increase in lesions which would qualify for progressive disease.'}, {'measure': 'Randomized (Part 3): Change From Baseline in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ) C30- Global Health Status Scores', 'timeFrame': 'From baseline to 60 days post progression, assessed up to 2.8 years (Part 3)', 'description': "The EORTC QLQ-C30 was a 30-item questionnaire that patients complete, consisting of both multi-item scales and single-item measures. It included five functional scales, three symptom scales, six single items, and a Global Health Status/Quality of Life (GHS/QoL) scale. The GHS/QoL scale had seven possible response scores ranging from 1 (very poor) to 7 (excellent), which were averaged and transformed to a 0-100 scale. A higher score on this scale indicated a better quality of life. The change from baseline in GHS/QoL scores was calculated. A positive change from baseline indicated improvement in the patient's quality of life."}, {'measure': 'Randomized (Part 3): Change From Baseline in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ) C30- Physical Functioning Scale Scores', 'timeFrame': 'From baseline to 60 days post progression, assessed up to 2.8 years (Part 3)', 'description': 'The EORTC QLQ-C30 was a patient completed 30 item questionnaire that was composed of both multi-item scales and single-item measures. These included five functional scales, three symptom scales, six single items and a global health status/QoL scale. The EORTC QLQ-C30 physical functioning scale measured a patient\'s ability to carry out daily activities and tasks requiring physical exertion. It consisted of five questions asking patients to rate their level of physical functioning, with response options ranging from 1="not at all" to 4="very much". The scores for each item were summed and transformed to a 0 to 100 scale, with higher scores indicating better physical functioning. The change from baseline in physical functioning scale scores was calculated. A positive change from baseline indicated improvement in physical functioning.'}, {'measure': 'Randomized (Part 3): Change From Baseline in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ) C30- Pain Symptom Scale Scores', 'timeFrame': 'From baseline to 60 days post progression, assessed up to 2.8 years (Part 3)', 'description': 'The EORTC QLQ-C30 was a patient completed 30 item questionnaire that was composed of both multi-item scales and single-item measures. These included five functional scales, three symptom scales, six single items and a global health status/QoL scale. The EORTC QLQ-C30 pain symptom scale was one of the symptom scales in the questionnaire, which measured the severity of pain experienced by the patient. The pain symptom scale consisted of two items, one measuring the severity of pain and the other measuring the use of painkillers. The items were rated on a 4-point scale ranging from 1="not at all" to 4="very much". The scores for each item were summed and transformed to a 0 to 100 scale, with higher scores indicating more severe pain. The change from baseline in pain symptom scale scores was calculated. A negative change from baseline indicated improvement.'}, {'measure': 'Randomized (Part 3): Time to 10 Point Definitive Deterioration in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ) C30- Global Health Status', 'timeFrame': 'From baseline to date of at least 10 points relative to baseline worsening of the global health status score or death due to any cause, up to 2.8 years (Part 3)', 'description': 'The EORTC QLQ-C30 was a patient completed 30 item questionnaire that was composed of both multi-item scales and single-item measures. These included five functional scales, three symptom scales, six single items and a global health status/QoL scale. The GHS/QoL scale had seven possible response scores ranging from 1 (very poor) to 7 (excellent), which were averaged and transformed to a 0-100 scale. A higher score on this scale indicated a better quality of life. The time to definitive 10 point deterioration is defined as the time from the date of randomization to the date of event, which is defined as at least 10 points relative to baseline worsening of the GHS/QoL score or death due to any cause. If a subject had not had an event, the time to deterioration was censored at the date of the last adequate assessment. The distribution was estimated using KM method.'}, {'measure': 'Randomized (Part 3): Change From Baseline in Function Assessment Cancer Therapy-melanoma (FACT-M) Melanoma Subscale Score', 'timeFrame': 'From baseline to 60 days post progression, assessed up to 2.8 years (Part 3)', 'description': 'The Functional Assessment of Cancer Therapy-Melanoma (FACT-M) quality of life questionnaire was composed of the FACT-General (FACT-G) plus the Melanoma Subscale and the Melanoma Surgery Subscale, which complemented the general scale with items specific to quality of life (QoL) in melanoma. The Melanoma Subscale of FACT-M included 16 questions, with response options of 0= "Not at all", 1= "a little bit", 2= "somewhat", 3= "quite a bit" and 4= "very much". The FACT-M melanoma subscale score ranged from 0 to 64, with higher scores indicating a higher quality of life in relation to melanoma. The change from baseline in melanoma subscale scores was calculated. A positive change from baseline indicated improvement.'}, {'measure': 'Randomized (Part 3): Change From Baseline in EuroQoL 5-level Instrument (EQ-5D-5L)- Visual Analog Scale (VAS) Score', 'timeFrame': 'From baseline to 60 days post progression, assessed up to 2.8 years (Part 3)', 'description': 'The EQ-5D-5L is a standardized questionnaire used to assess health-related quality of life, and it includes a Visual Analog Scale (VAS). The VAS score is obtained by asking the individual to rate their current health status on a scale from 0 to 100, where 0 represents the worst possible health state and 100 represents the best possible health state. The change from baseline in EQ-5D-5L VAS score was calculated. A positive change from baseline indicates improvement in the health status.'}, {'measure': "Randomized (Part 3): PFS as Per Investigator's Assessment by RECIST 1.1 by PD-L1 Expression", 'timeFrame': 'Up to disease progression or death due to any cause, up to 2.8 years (Part 3)', 'description': "PFS was defined as the time from the date of first dose to the date of the first documented radiological progression as per investigator's assessment using RECIST 1.1 response criteria or death due to any cause. The distribution of PFS was estimated using the KM method. If a patient had not had an event at the time of data cut-off, progression-free survival was censored at the date of last adequate tumor assessment. PFS analysis was performed by PD-L1 status (positive, negative) where a positive status was defined as having ≥ 1% expression and a negative status was defined as having \\< 1% expression."}, {'measure': 'Randomized (Part 3): OS by PD-L1 Expression', 'timeFrame': 'Up to death due to any cause, assessed up to approximately 7 years', 'description': 'Overall survival was defined as the time from date of randomization to date of death due to any cause. OS analysis was performed by PD-L1 subgroup (positive, negative) where a positive status was defined as having ≥ 1% expression and a negative status was defined as having \\< 1% expression.'}, {'measure': 'Spartalizumab Anti-drug Antibody (ADA) Prevalence at Baseline', 'timeFrame': 'Baseline', 'description': 'Spartalizumab ADA prevalence at baseline was calculated as the percentage of participants who had an spartalizumab ADA positive result at baseline.'}, {'measure': 'Spartalizumab ADA Incidence', 'timeFrame': 'Throughout study until 150 days after the last dose of spartalizumab, up to 3.3 years (Part 1), 3 years (Part 2) and 2.8 years (Part 3).', 'description': 'Spartalizumab ADA incidence was calculated as the percentage of participants who were treatment-induced spartalizumab ADA positive (post-baseline ADA positive with ADA-negative sample at baseline) and treatment-boosted spartalizumab ADA positive (post-baseline ADA positive with titer that is at least the fold titer change greater than the ADA-positive baseline titer)'}, {'measure': 'Trough Concentration (Ctrough) for Spartalizumab', 'timeFrame': 'Pre-infusion on Day 1 of each Cycle starting from Cycle 2, up to 3.3 years (Part 1), 3 years (Part 2) and 2.8 years (Part 3). Cycle=28 days', 'description': 'Ctrough for spartalizumab refers to the serum concentration of spartalizumab immediately prior to the administration of a dose of spartalizumab on Day 1 of Cycle 2 and later cycles.'}, {'measure': 'Pre-dose Plasma Concentration for Dabrafenib', 'timeFrame': 'Pre-infusion on Day 1 of every cycle from Cycle 2 to 12, and then every 6 cycles from Cycle 18 to 36, up to 3.3 years (Part 1), 3 years (Part 2) and 2.8 years (Part 3). Cycle=28 days', 'description': 'Plasma concentration of dabrafenib immediately prior to the administration of a dose of dabrafenib.'}, {'measure': 'Pre-dose Plasma Concentration for Trametinib', 'timeFrame': 'Pre-infusion on Day 1 of every cycle from Cycle 2 to 12, and then every 6 cycles from Cycle 18 to 36, up to 3.3 years (Part 1), 3 years (Part 2) and 2.8 years (Part 3). Cycle=28 days', 'description': 'Plasma concentration of trametinib immediately prior to the administration of a dose of trametinib.'}, {'measure': 'Number of Participants With Dose Interruptions', 'timeFrame': 'From baseline to end of treatment, assessed up to approximately 7 years', 'description': 'Number of participants with dose interruptions for spartalizumab, dabrafenib and trametinib'}, {'measure': 'Number of Participants With Dose Reductions', 'timeFrame': 'From baseline to end of treatment, assessed up to approximately 7 years', 'description': 'Number of patients with dose reductions for spartalizumab, dabrafenib and trametinib'}, {'measure': 'Relative Dose Intensity', 'timeFrame': 'From baseline to end of treatment, assessed up to approximately 7 years', 'description': 'Relative dose intensity for spartalizumab, dabrafenib and trametinib computed as the ratio (expressed as percentage) of dose intensity and planned dose intensity:\n\n* Spartalizumab (PDR001) = \\[Dose intensity (mg/4W) / planned dose intensity (mg/4W)\\]\\*100.\n* Trametinib and Dabrafenib = \\[Dose intensity (mg/day) / planned dose intensity (mg/day)\\]\\*100.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Spartalizumab (PDR001)', 'dabrafenib', 'trametinib', 'melanoma', 'immunotherapy', 'PD 1 inhibitor', 'anti PD1', 'PD-1', 'anti-PD-1', 'combination treatment', 'malignant skin cancer', 'skin cancer', 'BRAF V600', 'unresectable BRAF V600 mutated melanoma', 'metastatic BRAF V600 mutated melanoma'], 'conditions': ['Melanoma']}, 'referencesModule': {'references': [{'pmid': '35728875', 'type': 'DERIVED', 'citation': 'Tawbi HA, Robert C, Brase JC, Gusenleitner D, Gasal E, Garrett J, Savchenko A, Gorgun G, Flaherty KT, Ribas A, Dummer R, Schadendorf D, Long GV, Nathan PD, Ascierto PA. Spartalizumab or placebo in combination with dabrafenib and trametinib in patients with BRAF V600-mutant melanoma: exploratory biomarker analyses from a randomized phase 3 trial (COMBI-i). J Immunother Cancer. 2022 Jun;10(6):e004226. doi: 10.1136/jitc-2021-004226.'}, {'pmid': '35030011', 'type': 'DERIVED', 'citation': 'Dummer R, Long GV, Robert C, Tawbi HA, Flaherty KT, Ascierto PA, Nathan PD, Rutkowski P, Leonov O, Dutriaux C, Mandala M, Lorigan P, Ferrucci PF, Grob JJ, Meyer N, Gogas H, Stroyakovskiy D, Arance A, Brase JC, Green S, Haas T, Masood A, Gasal E, Ribas A, Schadendorf D. Randomized Phase III Trial Evaluating Spartalizumab Plus Dabrafenib and Trametinib for BRAF V600-Mutant Unresectable or Metastatic Melanoma. J Clin Oncol. 2022 May 1;40(13):1428-1438. doi: 10.1200/JCO.21.01601. Epub 2022 Jan 14.'}, {'pmid': '33020648', 'type': 'DERIVED', 'citation': 'Dummer R, Lebbe C, Atkinson V, Mandala M, Nathan PD, Arance A, Richtig E, Yamazaki N, Robert C, Schadendorf D, Tawbi HA, Ascierto PA, Ribas A, Flaherty KT, Pakhle N, Campbell CD, Gusenleitner D, Masood A, Brase JC, Gasal E, Long GV. Combined PD-1, BRAF and MEK inhibition in advanced BRAF-mutant melanoma: safety run-in and biomarker cohorts of COMBI-i. Nat Med. 2020 Oct;26(10):1557-1563. doi: 10.1038/s41591-020-1082-2. Epub 2020 Oct 5.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study was to evaluate safety and efficacy of the combination of an anti-PD-1 antibody (PDR001), a BRAF inhibitor (dabrafenib) and a MEK inhibitor (trametinib) in patients with BRAF V600 mutant, unresectable and metastatic melanoma.', 'detailedDescription': "This study was designed as a phase III, multi-center study consisting of 3 parts:\n\n* Part 1: Safety run-in part The safety run-in part aimed to determine the recommended regimen of PDR001 in combination with dabrafenib and trametinib for previously untreated patients with BRAF V600 mutant unresectable or metastatic melanoma (stage IIIC/IV). Spartalizumab was administered at a starting dose level (DL1) of 400 mg every 4 weeks (Q4W), along with fixed doses of dabrafenib (150 mg twice daily) and trametinib (2 mg once daily). The RP3R for Part 3 was determined using the Bayesian Logistic Regression Model (BLRM) with escalation with overdose control (EWOC) criteria.\n* Part 2: Biomarker cohort Part 2 was run to explore changes in the immune microenvironment and biomarker modulations upon treatment with the combination of dabrafenib, trametinib and PDR001. Part 2 started when the fourth subject in dose level 1 (DL1) of Part 1 completed approximately 4 weeks of study treatment, and fewer than 3 dose-limiting toxicities (DLTs) were observed. Participants in Part 2 received PDR001 (spartalizumab) at a dosage of 400 mg Q4W, in combination with dabrafenib (150 mg BID) and trametinib (2 mg QD).\n* Part 3: Double-blind, randomized, placebo-controlled part Part 3 was comparing the efficacy and safety of spartalizumab in combination with dabrafenib and trametinib to placebo in combination with dabrafenib and trametinib. Part 3 was initiated after determining the RP3R for the combination of spartalizumab with dabrafenib and trametinib in Part 1. Subjects were randomized in a 1:1 ratio to receive either the RP3R dose of spartalizumab identified in Part 1 or placebo, along with dabrafenib (150 mg BID) and trametinib (2 mg QD).\n\nFor all parts of the study, the treatment continued until the subject experiences any of the following events: disease progression according to RECIST 1.1 as determined by the Investigator, unacceptable toxicity, initiation of a new anti-neoplastic therapy, pregnancy, withdrawal of consent, physician's decision, loss to follow-up, death, or termination of the study by the Sponsor. Safety evaluations are conducted for all subjects for up to 150 days after the last dose of spartalizumab/placebo (safety follow-up period).\n\nSubjects who discontinued study treatment without disease progression as per RECIST 1.1 continued with tumor assessments according to the protocol until documented disease progression, withdrawal of consent, loss to follow-up, or death, regardless of the initiation of new anti-neoplastic therapy (efficacy follow-up period).\n\nSubjects entered the survival follow-up period after completing the safety follow-up period or experiencing disease progression as per RECIST 1.1 or response criteria for immunotherapy, whichever period is longer (survival follow-up period)."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '100 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion criteria Part 1: Safety run-in\n\n* Histologically confirmed, unresectable or metastatic melanoma with BRAF V600 mutation\n* Aspartate transaminase (AST) \\< 2.5× ULN and Alanine transaminase (ALT) \\< 2.5× ULN\n* Measurable disease according to RECIST 1.1\n* ECOG performance status ≤ 1\n\nPart 2: Biomarker cohort\n\n* Histologically confirmed, unresectable or metastatic melanoma with BRAF V600 mutation\n* At least two cutaneous or subcutaneous or nodal lesions for tumor sample collection\n* Measurable disease according to RECIST 1.1\n* ECOG performance status ≤ 2\n\nPart 3: Double-blind, randomized, placebo-controlled part\n\n* Histologically confirmed, unresectable or metastatic melanoma with BRAF V600 mutation\n* ECOG performance status ≤ 2\n* Measurable disease according to RECIST 1.1\n\nExclusion Criteria:\n\nPart 1: Safety run-in\n\n* Subjects with uveal or mucosal melanoma\n* Any history of CNS metastases\n* Prior systemic anti-cancer treatment for unresectable or metastatic melanoma\n* Neoadjuvant and/or adjuvant therapy for melanoma completed less than 6 months prior to enrollmen\n* Radiation therapy within 4 weeks prior to start of study treatment\n* Active autoimmune disease, and/or history of autoimmune disease(s) that required treatment\n\nParts 2 \\& 3: Biomarker cohort \\& double-blind, randomized, placebo-controlled part\n\n* Subjects with uveal or mucosal melanoma\n* Prior systemic anti-cancer treatment for unresectable or metastatic melanoma\n* Neoadjuvant and/or adjuvant therapy for melanoma completed less than 6 months prior to enrollment\n* Radiation therapy within 4 weeks prior to start of study treatment\n* Clinically active cerebral melanoma metastasis.\n* Active autoimmune disease, and/or history of autoimmune disease(s) that required treatment\n\nOther protocol-defined Inclusion/Exclusion may apply.'}, 'identificationModule': {'nctId': 'NCT02967692', 'acronym': 'COMBI-i', 'briefTitle': 'A Study of the Anti-PD1 Antibody PDR001, in Combination With Dabrafenib and Trametinib in Advanced Melanoma', 'organization': {'class': 'INDUSTRY', 'fullName': 'Novartis'}, 'officialTitle': 'A Randomized, Double-blind, Placebo-controlled, Phase III Study Comparing the Combination of PDR001, Dabrafenib and Trametinib Versus Placebo, Dabrafenib and Trametinib in Previously Untreated Patients With Unresectable or Metastatic BRAF V600 Mutant Melanoma', 'orgStudyIdInfo': {'id': 'CPDR001F2301'}, 'secondaryIdInfos': [{'id': '2016-002794-35', 'type': 'EUDRACT_NUMBER'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Part 1: Safety run-in Cohort', 'description': 'In Part 1, participants are treated at different dose levels to determine the recommended Phase 3 regimen of spartalizumab in combination with dabrafenib and trametinib. The starting dose of spartalizumab is 400 mg Q4W in combination with the approved dose of dabrafenib (150 mg BID) and trametinib (2 mg QD).', 'interventionNames': ['Biological: Spartalizumab', 'Drug: Dabrafenib', 'Drug: Trametinib']}, {'type': 'EXPERIMENTAL', 'label': 'Part 2: Biomarker cohort', 'description': 'In Part 2, participants are treated with spartalizumab 400 mg Q4W in combination with the approved dose of dabrafenib (150 mg BID) and trametinib (2 mg QD).', 'interventionNames': ['Biological: Spartalizumab', 'Drug: Dabrafenib', 'Drug: Trametinib']}, {'type': 'EXPERIMENTAL', 'label': 'Part 3- Arm 1: Spartalizumab in combination with dabrafenib and trametinib', 'description': 'In Part 3, participants are randomized to receive spartalizumab at the RP3R identified in Part 1 (400 mg Q4W) in combination with approved dose of dabrafenib (150 mg BID) and trametinib (2 mg QD)', 'interventionNames': ['Biological: Spartalizumab', 'Drug: Dabrafenib', 'Drug: Trametinib']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Part 3- Arm 2: Placebo in combination with dabrafenib and trametinib', 'description': 'In Part 3, participants are randomized to receive matching placebo in combination with the approved dose of dabrafenib (150 mg BID) and trametinib (2 mg QD)', 'interventionNames': ['Other: Placebo', 'Drug: Dabrafenib', 'Drug: Trametinib']}], 'interventions': [{'name': 'Spartalizumab', 'type': 'BIOLOGICAL', 'otherNames': ['PDR001'], 'description': 'Spartalizumab powder for solution is used in Part 1 and Part 2, and as concentrate for solution for infusion for Part 3. 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