Ignite Creation Date:
2025-12-24 @ 7:45 PM
Ignite Modification Date:
2025-12-29 @ 1:58 AM
Study NCT ID:
NCT01271803
Status:
COMPLETED
Last Update Posted:
2019-07-29
First Post:
2011-01-05
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
A Study of Vemurafenib and GDC-0973 (Cobimetinib) in Participants With BRAFV600E Mutation-Positive Metastatic Melanoma
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D008545', 'term': 'Melanoma'}], 'ancestors': [{'id': 'D018358', 'term': 'Neuroendocrine Tumors'}, {'id': 'D017599', 'term': 'Neuroectodermal Tumors'}, {'id': 'D009373', 'term': 'Neoplasms, Germ Cell and Embryonal'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D009380', 'term': 'Neoplasms, Nerve Tissue'}, {'id': 'D018326', 'term': 'Nevi and Melanomas'}, {'id': 'D012878', 'term': 'Skin Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C574276', 'term': 'cobimetinib'}, {'id': 'D000077484', 'term': 'Vemurafenib'}], 'ancestors': [{'id': 'D013449', 'term': 'Sulfonamides'}, {'id': 'D000577', 'term': 'Amides'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D013450', 'term': 'Sulfones'}, {'id': 'D013457', 'term': 'Sulfur Compounds'}, {'id': 'D007211', 'term': 'Indoles'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'genentech@druginfo.com', 'phone': '800-821-8590', 'title': 'Medical Communications', 'organization': 'Hoffmann-LaRoche'}, 'certainAgreement': {'otherDetails': "The Study being conducted under this Agreement is part of the Overall Study. Investigator is free to publish in reputable journals or to present at professional conferences the results of the Study, but only after the first publication or presentation that involves the Overall Study. The Sponsor may request that Confidential Information be deleted and/or the publication be postponed in order to protect the Sponsor's intellectual property rights.", 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'Up to 82 months', 'description': 'Safety data was not reported per dose/regimen cohort. Due to final analysis data for adverse events were reported collectively for both the reporting groups- Vemurafenib PD and BRAFi-naïve participants along with Cobimetinib Monotherapy. Data is presented based on the final CSR. As of 2017 per-cohort data were not collected.', 'eventGroups': [{'id': 'EG000', 'title': 'Vemurafenib PD Participants', 'description': 'All participants who progressed on vemurafenib monotherapy immediately prior to enrollment into this study were treated with vemurafenib in combination with cobimetinib at a particular dose combination and dosing schedule depending on the cohort in which they were enrolled until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.', 'otherNumAtRisk': 66, 'otherNumAffected': 64, 'seriousNumAtRisk': 66, 'seriousNumAffected': 21}, {'id': 'EG001', 'title': 'BRAFi-naïve Participants', 'description': 'All participants who were previously untreated or previously treated but naïve to BRAF or MEK inhibitor therapy were considered as BRAFi-naïve participants. These participants were treated with vemurafenib in combination with cobimetinib at a particular dose combination and dosing schedule depending on the cohort in which they were enrolled until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.', 'otherNumAtRisk': 63, 'otherNumAffected': 63, 'seriousNumAtRisk': 63, 'seriousNumAffected': 36}, {'id': 'EG002', 'title': 'Cobimetinib Monotherapy (100 mg or 60 mg)', 'description': 'Participants received oral 60 mg cobimetinib QD on 21/7 dosing schedule, or oral 100 mg cobimetinib QD on 14/14 dosing schedule of every cycle (1 Cycle=28 Days), until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.', 'otherNumAtRisk': 2, 'otherNumAffected': 2, 'seriousNumAtRisk': 2, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Photosensitivity reaction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 66, 'numAffected': 12}, {'groupId': 'EG001', 'numAtRisk': 63, 'numAffected': 44}, {'groupId': 'EG002', 'numAtRisk': 2, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Rash', 'stats': [{'groupId': 'EG000', 'numAtRisk': 66, 'numAffected': 18}, {'groupId': 'EG001', 'numAtRisk': 63, 'numAffected': 33}, {'groupId': 'EG002', 'numAtRisk': 2, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Pruritus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 66, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 63, 'numAffected': 19}, {'groupId': 'EG002', 'numAtRisk': 2, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Dermatitis acneiform', 'stats': [{'groupId': 'EG000', 'numAtRisk': 66, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 63, 'numAffected': 22}, {'groupId': 'EG002', 'numAtRisk': 2, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Dry skin', 'stats': [{'groupId': 'EG000', 'numAtRisk': 66, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 63, 'numAffected': 17}, {'groupId': 'EG002', 'numAtRisk': 2, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Erythema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 66, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 63, 'numAffected': 16}, {'groupId': 'EG002', 'numAtRisk': 2, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Alopecia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 66, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 63, 'numAffected': 9}, {'groupId': 'EG002', 'numAtRisk': 2, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Hyperkeratosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 66, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 63, 'numAffected': 10}, {'groupId': 'EG002', 'numAtRisk': 2, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Actinic keratosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 66, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 63, 'numAffected': 19}, {'groupId': 'EG002', 'numAtRisk': 2, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Rash maculo-papular', 'stats': [{'groupId': 'EG000', 'numAtRisk': 66, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 63, 'numAffected': 20}, {'groupId': 'EG002', 'numAtRisk': 2, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Rash macular', 'stats': [{'groupId': 'EG000', 'numAtRisk': 66, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 63, 'numAffected': 9}, {'groupId': 'EG002', 'numAtRisk': 2, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Skin lesion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 66, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 63, 'numAffected': 7}, {'groupId': 'EG002', 'numAtRisk': 2, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Rash erythematous', 'stats': [{'groupId': 'EG000', 'numAtRisk': 66, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 63, 'numAffected': 7}, {'groupId': 'EG002', 'numAtRisk': 2, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Vitiligo', 'stats': [{'groupId': 'EG000', 'numAtRisk': 66, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 63, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 2, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Acne', 'stats': [{'groupId': 'EG000', 'numAtRisk': 66, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 63, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 2, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Keratosis pilaris', 'stats': [{'groupId': 'EG000', 'numAtRisk': 66, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 63, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 2, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Dermatitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 66, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 63, 'numAffected': 6}, {'groupId': 'EG002', 'numAtRisk': 2, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Erythema nodosum', 'stats': [{'groupId': 'EG000', 'numAtRisk': 66, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 63, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 2, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Hyperhidrosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 66, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 63, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 2, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Pain of skin', 'stats': [{'groupId': 'EG000', 'numAtRisk': 66, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 63, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 2, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Panniculitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 66, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 63, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 2, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Rash generalised', 'stats': [{'groupId': 'EG000', 'numAtRisk': 66, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 63, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 2, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Rosacea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 66, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 63, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 2, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Rash papular', 'stats': [{'groupId': 'EG000', 'numAtRisk': 66, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 63, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 2, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Rash pruritic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 66, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 63, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 2, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 66, 'numAffected': 31}, {'groupId': 'EG001', 'numAtRisk': 63, 'numAffected': 52}, {'groupId': 'EG002', 'numAtRisk': 2, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 66, 'numAffected': 22}, {'groupId': 'EG001', 'numAtRisk': 63, 'numAffected': 37}, {'groupId': 'EG002', 'numAtRisk': 2, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 66, 'numAffected': 13}, {'groupId': 'EG001', 'numAtRisk': 63, 'numAffected': 30}, {'groupId': 'EG002', 'numAtRisk': 2, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Abdominal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 66, 'numAffected': 10}, {'groupId': 'EG001', 'numAtRisk': 63, 'numAffected': 13}, {'groupId': 'EG002', 'numAtRisk': 2, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Constipation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 66, 'numAffected': 10}, {'groupId': 'EG001', 'numAtRisk': 63, 'numAffected': 13}, {'groupId': 'EG002', 'numAtRisk': 2, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Abdominal distension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 66, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 63, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 2, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Dry mouth', 'stats': [{'groupId': 'EG000', 'numAtRisk': 66, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 63, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 2, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Stomatitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 66, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 63, 'numAffected': 8}, {'groupId': 'EG002', 'numAtRisk': 2, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Abdominal pain upper', 'stats': [{'groupId': 'EG000', 'numAtRisk': 66, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 63, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 2, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Ascites', 'stats': [{'groupId': 'EG000', 'numAtRisk': 66, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 63, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 2, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Gastrooesophageal reflux disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 66, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 63, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 2, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Rectal haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 66, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 63, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 2, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Dyspepsia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 66, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 63, 'numAffected': 9}, {'groupId': 'EG002', 'numAtRisk': 2, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Fatigue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 66, 'numAffected': 18}, {'groupId': 'EG001', 'numAtRisk': 63, 'numAffected': 46}, {'groupId': 'EG002', 'numAtRisk': 2, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Oedema peripheral', 'stats': [{'groupId': 'EG000', 'numAtRisk': 66, 'numAffected': 11}, {'groupId': 'EG001', 'numAtRisk': 63, 'numAffected': 27}, {'groupId': 'EG002', 'numAtRisk': 2, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Pyrexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 66, 'numAffected': 11}, {'groupId': 'EG001', 'numAtRisk': 63, 'numAffected': 27}, {'groupId': 'EG002', 'numAtRisk': 2, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Chills', 'stats': [{'groupId': 'EG000', 'numAtRisk': 66, 'numAffected': 10}, {'groupId': 'EG001', 'numAtRisk': 63, 'numAffected': 17}, {'groupId': 'EG002', 'numAtRisk': 2, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Mucosal inflammation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 66, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 63, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 2, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Asthenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 66, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 63, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 2, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Chest pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 66, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 63, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 2, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Malaise', 'stats': [{'groupId': 'EG000', 'numAtRisk': 66, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 63, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 2, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Influenza like illness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 66, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 63, 'numAffected': 6}, {'groupId': 'EG002', 'numAtRisk': 2, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Blood alkaline phophatase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 66, 'numAffected': 10}, {'groupId': 'EG001', 'numAtRisk': 63, 'numAffected': 22}, {'groupId': 'EG002', 'numAtRisk': 2, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Blood creatine phosphokinase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 66, 'numAffected': 10}, {'groupId': 'EG001', 'numAtRisk': 63, 'numAffected': 30}, {'groupId': 'EG002', 'numAtRisk': 2, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Aspartate aminotransferase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 66, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 63, 'numAffected': 22}, {'groupId': 'EG002', 'numAtRisk': 2, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Alanine aminotransferase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 66, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 63, 'numAffected': 25}, {'groupId': 'EG002', 'numAtRisk': 2, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Blood creatinine increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 66, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 63, 'numAffected': 21}, {'groupId': 'EG002', 'numAtRisk': 2, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Blood bilirubin increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 66, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 63, 'numAffected': 9}, {'groupId': 'EG002', 'numAtRisk': 2, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Electrocardiogram QT prolonged', 'stats': [{'groupId': 'EG000', 'numAtRisk': 66, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 63, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 2, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Weight decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 66, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 63, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 2, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Gamma-glutamyl transferase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 66, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 63, 'numAffected': 8}, {'groupId': 'EG002', 'numAtRisk': 2, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Lymphocyte count decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 66, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 63, 'numAffected': 7}, {'groupId': 'EG002', 'numAtRisk': 2, 'numAffected': 0}], 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'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Renal cell carcinoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 66, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 63, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 2, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Seizure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 66, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 63, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 2, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Brain oedema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 66, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 63, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 2, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Anxiety', 'stats': [{'groupId': 'EG000', 'numAtRisk': 66, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 63, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 2, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Acute kidney injury', 'stats': [{'groupId': 'EG000', 'numAtRisk': 66, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 63, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 2, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Tubulointerstitial nephritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 66, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 63, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 2, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Photosensitivity reaction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 66, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 63, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 2, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Dermatitis acneiform', 'stats': [{'groupId': 'EG000', 'numAtRisk': 66, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 63, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 2, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Salpingo-Oophorectomy unilateral', 'stats': [{'groupId': 'EG000', 'numAtRisk': 66, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 63, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 2, 'numAffected': 0}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Number of Participants With Dose-Limiting Toxicities (DLTs) During DES in Combination Cohorts', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '27', 'groupId': 'OG002'}, {'value': '3', 'groupId': 'OG003'}, {'value': '4', 'groupId': 'OG004'}, {'value': '4', 'groupId': 'OG005'}, {'value': '4', 'groupId': 'OG006'}, {'value': '3', 'groupId': 'OG007'}, {'value': '5', 'groupId': 'OG008'}]}], 'groups': [{'id': 'OG000', 'title': 'DES (Cohort 1): 60 mg Cobimetinib + 720 mg Vemurafenib', 'description': 'Participants received oral 60 mg cobimetinib QD on 14/14 dosing schedule and oral 720 mg vemurafenib BID on Days 1-28 of every cycle (1 Cycle=28 Days), until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.'}, {'id': 'OG001', 'title': 'DES (Cohort 1A): 60 mg Cobimetinib + 720 mg Vemurafenib', 'description': 'Participants received oral 60 mg cobimetinib QD on 21/7 dosing schedule and oral 720 mg vemurafenib BID on Days 1-28 of every cycle (1 Cycle=28 Days), until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.'}, {'id': 'OG002', 'title': 'DES (Cohort 1B): 60 mg Cobimetinib + 960 mg Vemurafenib', 'description': 'Participants received oral 60 mg cobimetinib QD on 21/7 dosing schedule and oral 960 mg vemurafenib BID on Days 1-28 of every cycle (1 Cycle=28 Days), until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.'}, {'id': 'OG003', 'title': 'DES (Cohort 1C): 60 mg Cobimetinib + 720 mg Vemurafenib', 'description': 'Participants received oral 60 mg cobimetinib QD on 28/0 dosing schedule and oral 720 mg vemurafenib BID on Days 1-28 of every cycle (1 Cycle=28 Days), until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.'}, {'id': 'OG004', 'title': 'DES (Cohort 1D): 60 mg Cobimetinib + 960 mg Vemurafenib', 'description': 'Participants received oral 60 mg cobimetinib QD on 28/0 dosing schedule and oral 960 mg vemurafenib BID on Days 1-28 of every cycle (1 Cycle=28 Days), until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.'}, {'id': 'OG005', 'title': 'DES (Cohort 2): 80 mg Cobimetinib + 720 mg Vemurafenib', 'description': 'Participants received oral 80 mg cobimetinib QD on 14/14 dosing schedule and oral 720 mg vemurafenib BID on Days 1-28 of every cycle (1 Cycle=28 Days), until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.'}, {'id': 'OG006', 'title': 'DES (Cohort 2A): 100 mg Cobimetinib + 720 mg Vemurafenib', 'description': 'Participants received oral 100 mg cobimetinib QD on 14/14 dosing schedule and oral 720 mg vemurafenib BID on Days 1-28 of every cycle (1 Cycle=28 Days), until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.'}, {'id': 'OG007', 'title': 'DES (Cohort 3): 60 mg Cobimetinib + 960 mg Vemurafenib', 'description': 'Participants received oral 60 mg cobimetinib QD on 14/14 dosing schedule and oral 960 mg vemurafenib BID on Days 1-28 of every cycle (1 Cycle=28 Days), until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.'}, {'id': 'OG008', 'title': 'DES (Cohort 4): 80 mg Cobimetinib + 960 mg Vemurafenib', 'description': 'Participants received oral 80 mg cobimetinib QD on 14/14 dosing schedule and oral 960 mg vemurafenib BID on Days 1-28 of every cycle (1 Cycle=28 Days), until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '2', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}, {'value': '0', 'groupId': 'OG007'}, {'value': '1', 'groupId': 'OG008'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '28 Days', 'description': 'DLT is defined as 1 of the following toxicities considered by the investigator to be related to study treatment: a) Grade 3 nausea, vomiting or diarrhea that resolved to Grade less than or equal to (≤) 1 within 7 days, b) Grade 3 rash or photosensitivity that resolved to Grade ≤2 within 7 days, c) Grade 3 cutaneous squamous cell carcinoma (cuSCC) that was subsequently resected, d) Grade greater than or equal to (≥) 3 fatigue or hyperuricemia that resolved to Grade ≤2 within 7 days, e) Grade 3 fever, f) Grade 3 or 4 elevation of serum creatine phosphokinase (CPK) levels, which is asymptomatic, deemed by the investigator to be clinically insignificant and that returned to Grade ≤2 during the 14-day cobimetinib treatment holiday, g) Grade ≥3 febrile neutropenia, h) Grade ≥4 neutropenia (absolute neutrophil count \\[ANC\\] less than \\<500/microliter \\[μL\\]), i) Grade ≥4 thrombocytopenia, j) Grade ≥4 anemia, k) Grade ≥3 elevation of total bilirubin, hepatic transaminase or alkaline phosphatase.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety-evaluable population (SEP) included all participants who received at least one dose of study drug. SEP participants who received combination study treatment (cobimetinib + Vemurafenib) were included in the analysis of this outcome. Here, number of participants analyzed = participants who were evaluable for this outcome.'}, {'type': 'PRIMARY', 'title': 'Maximum Tolerated Doses (MTD) of Vemurafenib and Cobimetinib When Administered in Combination in DES', 'denoms': [{'units': 'Participants', 'counts': [{'value': '63', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Dose Escalation Stage (Stage 1)', 'description': 'All participants who received vemurafenib and cobimetinib in any dose combination during DES, until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.'}], 'classes': [{'title': 'Cobimetinib dose (21/7 dosing schedule)', 'categories': [{'measurements': [{'value': '60', 'groupId': 'OG000'}]}]}, {'title': 'Vemurafenib dose (21/7 dosing schedule)', 'categories': [{'measurements': [{'value': '960', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '28 Days', 'description': 'The highest dose level(s) at which fewer than one-third of participants experienced a DLT was declared the MTD. DLT is defined as 1 of the following toxicities considered by the investigator to be related to study treatment: a) Grade 3 nausea, vomiting or diarrhea that resolved to Grade ≤1 within 7 days, b) Grade 3 rash/photosensitivity that resolved to Grade ≤2 within 7 days, c) Grade 3 cuSCC that was subsequently resected, d) Grade ≥3 fatigue/hyperuricemia that resolved to Grade ≤2 within 7 days, e) Grade 3 fever, f) Grade 3 or 4 elevation of serum CPK levels, which is asymptomatic, deemed to be clinically insignificant and returns to Grade ≤2 during the 14-day cobimetinib treatment holiday, g) Grade ≥3 febrile neutropenia, h) Grade ≥4 neutropenia (ANC \\<500/ μL), i) Grade ≥4 thrombocytopenia, j) Grade ≥4 anemia, k) Grade ≥3 elevation of total bilirubin, hepatic transaminase or alkaline phosphatase.', 'unitOfMeasure': 'mg', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety-evaluable population. Here, number of participants analyzed = participants who were evaluable for this outcome.'}, {'type': 'PRIMARY', 'title': 'Maximum Plasma Concentration (Cmax) of Cobimetinib on Day 1, Cycle 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '26', 'groupId': 'OG002'}, {'value': '3', 'groupId': 'OG003'}, {'value': '4', 'groupId': 'OG004'}, {'value': '4', 'groupId': 'OG005'}, {'value': '4', 'groupId': 'OG006'}, {'value': '5', 'groupId': 'OG007'}, {'value': '27', 'groupId': 'OG008'}, {'value': '38', 'groupId': 'OG009'}]}], 'groups': [{'id': 'OG000', 'title': 'DES (Cohort 1): 60 mg Cobimetinib + 720 mg Vemurafenib', 'description': 'Participants received oral 60 mg cobimetinib QD on 14/14 dosing schedule and oral 720 mg vemurafenib BID on Days 1-28 of every cycle (1 Cycle=28 Days), until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.'}, {'id': 'OG001', 'title': 'DES (Cohort 1A): 60 mg Cobimetinib + 720 mg Vemurafenib', 'description': 'Participants received oral 60 mg cobimetinib QD on 21/7 dosing schedule and oral 720 mg vemurafenib BID on Days 1-28 of every cycle (1 Cycle=28 Days), until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.'}, {'id': 'OG002', 'title': 'DES (Cohort 1B): 60 mg Cobimetinib + 960 mg Vemurafenib', 'description': 'Participants received oral 60 mg cobimetinib QD on 21/7 dosing schedule and oral 960 mg vemurafenib BID on Days 1-28 of every cycle (1 Cycle=28 Days), until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.'}, {'id': 'OG003', 'title': 'DES (Cohort 1C): 60 mg Cobimetinib + 720 mg Vemurafenib', 'description': 'Participants received oral 60 mg cobimetinib QD on 28/0 dosing schedule and oral 720 mg vemurafenib BID on Days 1-28 of every cycle (1 Cycle=28 Days), until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.'}, {'id': 'OG004', 'title': 'DES (Cohort 1D): 60 mg Cobimetinib + 960 mg Vemurafenib', 'description': 'Participants received oral 60 mg cobimetinib QD on 28/0 dosing schedule and oral 960 mg vemurafenib BID on Days 1-28 of every cycle (1 Cycle=28 Days), until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.'}, {'id': 'OG005', 'title': 'DES (Cohort 2): 80 mg Cobimetinib + 720 mg Vemurafenib', 'description': 'Participants received oral 80 mg cobimetinib QD on 14/14 dosing schedule and oral 720 mg vemurafenib BID on Days 1-28 of every cycle (1 Cycle=28 Days), until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.'}, {'id': 'OG006', 'title': 'DES (Cohort 2A): 100 mg Cobimetinib + 720 mg Vemurafenib', 'description': 'Participants received oral 100 mg cobimetinib QD on 14/14 dosing schedule and oral 720 mg vemurafenib BID on Days 1-28 of every cycle (1 Cycle=28 Days), until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.'}, {'id': 'OG007', 'title': 'DES (Cohort 4): 80 mg Cobimetinib + 960 mg Vemurafenib', 'description': 'Participants received oral 80 mg cobimetinib QD on 14/14 dosing schedule and oral 960 mg vemurafenib BID on Days 1-28 of every cycle (1 Cycle=28 Days), until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.'}, {'id': 'OG008', 'title': 'CES (Cohort 1A): 60 mg Cobimetinib + 720 mg Vemurafenib', 'description': 'Participants received oral 60 mg cobimetinib QD on 21/7 dosing schedule and oral 720 mg vemurafenib BID on Days 1-28 of every cycle (1 Cycle=28 Days), until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.'}, {'id': 'OG009', 'title': 'CES (Cohort 1B): 60 mg Cobimetinib + 960 mg Vemurafenib', 'description': 'Participants received oral 60 mg cobimetinib QD on 21/7 dosing schedule and oral 960 mg vemurafenib BID on Days 1-28 of every cycle (1 Cycle=28 Days), until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.'}], 'classes': [{'categories': [{'measurements': [{'value': '159', 'spread': '110', 'groupId': 'OG000'}, {'value': '146', 'spread': '100', 'groupId': 'OG001'}, {'value': '121', 'spread': '96', 'groupId': 'OG002'}, {'value': '136', 'spread': '81', 'groupId': 'OG003'}, {'value': '130', 'spread': '53', 'groupId': 'OG004'}, {'value': '133', 'spread': '37', 'groupId': 'OG005'}, {'value': '146', 'spread': '79', 'groupId': 'OG006'}, {'value': '93.6', 'spread': '26', 'groupId': 'OG007'}, {'value': '84.3', 'spread': '67', 'groupId': 'OG008'}, {'value': '105', 'spread': '64', 'groupId': 'OG009'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Cycle 1: predose (0 hours [hr]) on Days 1, 2; 0.5, 1, 2, 4, 6 hr postdose on Day 1', 'unitOfMeasure': 'nanograms per milliliter (ng/mL)', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'PK population included all participants who received study treatment and had at least one vemurafenib and cobimetinib plasma concentration available. Here, number of participants analyzed = participants who were evaluable for this outcome.'}, {'type': 'PRIMARY', 'title': 'Cmax of Cobimetinib on Day 1, Cycle 1 in Cohort 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'DES (Cohort 3): 60 mg Cobimetinib + 960 mg Vemurafenib', 'description': 'Participants received oral 60 mg cobimetinib QD on 14/14 dosing schedule and oral 960 mg vemurafenib BID on Days 1-28 of every cycle (1 Cycle=28 Days), until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.'}], 'classes': [{'categories': [{'measurements': [{'value': '51.6', 'spread': '50.1', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Cycle 1: predose (0 hr) on Days 1, 2; 0.5, 1, 2, 4, 6 hr postdose on Day 1', 'unitOfMeasure': 'ng/mL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'PK population. Here, number of participants analyzed = participants who were evaluable for this outcome.'}, {'type': 'PRIMARY', 'title': 'Time Taken to Reach Maximum Plasma Concentration (Tmax) of Cobimetinib on Day 1, Cycle 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '26', 'groupId': 'OG002'}, {'value': '3', 'groupId': 'OG003'}, {'value': '4', 'groupId': 'OG004'}, {'value': '4', 'groupId': 'OG005'}, {'value': '4', 'groupId': 'OG006'}, {'value': '2', 'groupId': 'OG007'}, {'value': '5', 'groupId': 'OG008'}, {'value': '27', 'groupId': 'OG009'}, {'value': '38', 'groupId': 'OG010'}]}], 'groups': [{'id': 'OG000', 'title': 'DES (Cohort 1): 60 mg Cobimetinib + 720 mg Vemurafenib', 'description': 'Participants received oral 60 mg cobimetinib QD on 14/14 dosing schedule and oral 720 mg vemurafenib BID on Days 1-28 of every cycle (1 Cycle=28 Days), until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.'}, {'id': 'OG001', 'title': 'DES (Cohort 1A): 60 mg Cobimetinib + 720 mg Vemurafenib', 'description': 'Participants received oral 60 mg cobimetinib QD on 21/7 dosing schedule and oral 720 mg vemurafenib BID on Days 1-28 of every cycle (1 Cycle=28 Days), until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.'}, {'id': 'OG002', 'title': 'DES (Cohort 1B): 60 mg Cobimetinib + 960 mg Vemurafenib', 'description': 'Participants received oral 60 mg cobimetinib QD on 21/7 dosing schedule and oral 960 mg vemurafenib BID on Days 1-28 of every cycle (1 Cycle=28 Days), until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.'}, {'id': 'OG003', 'title': 'DES (Cohort 1C): 60 mg Cobimetinib + 720 mg Vemurafenib', 'description': 'Participants received oral 60 mg cobimetinib QD on 28/0 dosing schedule and oral 720 mg vemurafenib BID on Days 1-28 of every cycle (1 Cycle=28 Days), until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.'}, {'id': 'OG004', 'title': 'DES (Cohort 1D): 60 mg Cobimetinib + 960 mg Vemurafenib', 'description': 'Participants received oral 60 mg cobimetinib QD on 28/0 dosing schedule and oral 960 mg vemurafenib BID on Days 1-28 of every cycle (1 Cycle=28 Days), until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.'}, {'id': 'OG005', 'title': 'DES (Cohort 2): 80 mg Cobimetinib + 720 mg Vemurafenib', 'description': 'Participants received oral 80 mg cobimetinib QD on 14/14 dosing schedule and oral 720 mg vemurafenib BID on Days 1-28 of every cycle (1 Cycle=28 Days), until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.'}, {'id': 'OG006', 'title': 'DES (Cohort 2A): 100 mg Cobimetinib + 720 mg Vemurafenib', 'description': 'Participants received oral 100 mg cobimetinib QD on 14/14 dosing schedule and oral 720 mg vemurafenib BID on Days 1-28 of every cycle (1 Cycle=28 Days), until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.'}, {'id': 'OG007', 'title': 'DES (Cohort 3): 60 mg Cobimetinib + 960 mg Vemurafenib', 'description': 'Participants received oral 60 mg cobimetinib QD on 14/14 dosing schedule and oral 960 mg vemurafenib BID on Days 1-28 of every cycle (1 Cycle=28 Days), until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.'}, {'id': 'OG008', 'title': 'DES (Cohort 4): 80 mg Cobimetinib + 960 mg Vemurafenib', 'description': 'Participants received oral 80 mg cobimetinib QD on 14/14 dosing schedule and oral 960 mg vemurafenib BID on Days 1-28 of every cycle (1 Cycle=28 Days), until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.'}, {'id': 'OG009', 'title': 'CES (Cohort 1A): 60 mg Cobimetinib + 720 mg Vemurafenib', 'description': 'Participants received oral 60 mg cobimetinib QD on 21/7 dosing schedule and oral 720 mg vemurafenib BID on Days 1-28 of every cycle (1 Cycle=28 Days), until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.'}, {'id': 'OG010', 'title': 'CES (Cohort 1B): 60 mg Cobimetinib + 960 mg Vemurafenib', 'description': 'Participants received oral 60 mg cobimetinib QD on 21/7 dosing schedule and oral 960 mg vemurafenib BID on Days 1-28 of every cycle (1 Cycle=28 Days), until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.'}], 'classes': [{'categories': [{'measurements': [{'value': '4.00', 'groupId': 'OG000', 'lowerLimit': '2.0', 'upperLimit': '5.5'}, {'value': '4.0', 'groupId': 'OG001', 'lowerLimit': '2.0', 'upperLimit': '27'}, {'value': '4.00', 'groupId': 'OG002', 'lowerLimit': '1.0', 'upperLimit': '25'}, {'value': '2.03', 'groupId': 'OG003', 'lowerLimit': '2.0', 'upperLimit': '24'}, {'value': '3.99', 'groupId': 'OG004', 'lowerLimit': '1.0', 'upperLimit': '6.2'}, {'value': '4.02', 'groupId': 'OG005', 'lowerLimit': '4.0', 'upperLimit': '4.1'}, {'value': '4.03', 'groupId': 'OG006', 'lowerLimit': '4.0', 'upperLimit': '4.3'}, {'value': '3.05', 'groupId': 'OG007', 'lowerLimit': '2.0', 'upperLimit': '4.1'}, {'value': '4.00', 'groupId': 'OG008', 'lowerLimit': '2.0', 'upperLimit': '6.0'}, {'value': '4.00', 'groupId': 'OG009', 'lowerLimit': '0.5', 'upperLimit': '6.0'}, {'value': '4.00', 'groupId': 'OG010', 'lowerLimit': '1.0', 'upperLimit': '24'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Cycle 1: predose (0 hr) on Days 1, 2; 0.5, 1, 2, 4, 6 hr postdose on Day 1', 'unitOfMeasure': 'hours', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'PK population. Here, number of participants analyzed = participants who were evaluable for this outcome.'}, {'type': 'PRIMARY', 'title': 'Area Under Concentration Versus Time Curve (AUC) Over a Period of 24 Hours (AUC0-24) of Cobimetinib on Day 1, Cycle 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '26', 'groupId': 'OG002'}, {'value': '3', 'groupId': 'OG003'}, {'value': '4', 'groupId': 'OG004'}, {'value': '4', 'groupId': 'OG005'}, {'value': '4', 'groupId': 'OG006'}, {'value': '5', 'groupId': 'OG007'}, {'value': '27', 'groupId': 'OG008'}, {'value': '38', 'groupId': 'OG009'}]}], 'groups': [{'id': 'OG000', 'title': 'DES (Cohort 1): 60 mg Cobimetinib + 720 mg Vemurafenib', 'description': 'Participants received oral 60 mg cobimetinib QD on 14/14 dosing schedule and oral 720 mg vemurafenib BID on Days 1-28 of every cycle (1 Cycle=28 Days), until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.'}, {'id': 'OG001', 'title': 'DES (Cohort 1A): 60 mg Cobimetinib + 720 mg Vemurafenib', 'description': 'Participants received oral 60 mg cobimetinib QD on 21/7 dosing schedule and oral 720 mg vemurafenib BID on Days 1-28 of every cycle (1 Cycle=28 Days), until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.'}, {'id': 'OG002', 'title': 'DES (Cohort 1B): 60 mg Cobimetinib + 960 mg Vemurafenib', 'description': 'Participants received oral 60 mg cobimetinib QD on 21/7 dosing schedule and oral 960 mg vemurafenib BID on Days 1-28 of every cycle (1 Cycle=28 Days), until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.'}, {'id': 'OG003', 'title': 'DES (Cohort 1C): 60 mg Cobimetinib + 720 mg Vemurafenib', 'description': 'Participants received oral 60 mg cobimetinib QD on 28/0 dosing schedule and oral 720 mg vemurafenib BID on Days 1-28 of every cycle (1 Cycle=28 Days), until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.'}, {'id': 'OG004', 'title': 'DES (Cohort 1D): 60 mg Cobimetinib + 960 mg Vemurafenib', 'description': 'Participants received oral 60 mg cobimetinib QD on 28/0 dosing schedule and oral 960 mg vemurafenib BID on Days 1-28 of every cycle (1 Cycle=28 Days), until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.'}, {'id': 'OG005', 'title': 'DES (Cohort 2): 80 mg Cobimetinib + 720 mg Vemurafenib', 'description': 'Participants received oral 80 mg cobimetinib QD on 14/14 dosing schedule and oral 720 mg vemurafenib BID on Days 1-28 of every cycle (1 Cycle=28 Days), until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.'}, {'id': 'OG006', 'title': 'DES (Cohort 2A): 100 mg Cobimetinib + 720 mg Vemurafenib', 'description': 'Participants received oral 100 mg cobimetinib QD on 14/14 dosing schedule and oral 720 mg vemurafenib BID on Days 1-28 of every cycle (1 Cycle=28 Days), until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.'}, {'id': 'OG007', 'title': 'DES (Cohort 4): 80 mg Cobimetinib + 960 mg Vemurafenib', 'description': 'Participants received oral 80 mg cobimetinib QD on 14/14 dosing schedule and oral 960 mg vemurafenib BID on Days 1-28 of every cycle (1 Cycle=28 Days), until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.'}, {'id': 'OG008', 'title': 'CES (Cohort 1A): 60 mg Cobimetinib + 720 mg Vemurafenib', 'description': 'Participants received oral 60 mg cobimetinib QD on 21/7 dosing schedule and oral 720 mg vemurafenib BID on Days 1-28 of every cycle (1 Cycle=28 Days), until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.'}, {'id': 'OG009', 'title': 'CES (Cohort 1B): 60 mg Cobimetinib + 960 mg Vemurafenib', 'description': 'Participants received oral 60 mg cobimetinib QD on 21/7 dosing schedule and oral 960 mg vemurafenib BID on Days 1-28 of every cycle (1 Cycle=28 Days), until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.'}], 'classes': [{'categories': [{'measurements': [{'value': '2280', 'spread': '90', 'groupId': 'OG000'}, {'value': '1990', 'spread': '99', 'groupId': 'OG001'}, {'value': '1790', 'spread': '88', 'groupId': 'OG002'}, {'value': '1300', 'spread': '35', 'groupId': 'OG003'}, {'value': '1850', 'spread': '35', 'groupId': 'OG004'}, {'value': '1600', 'spread': '29', 'groupId': 'OG005'}, {'value': '2300', 'spread': '100', 'groupId': 'OG006'}, {'value': '1410', 'spread': '29', 'groupId': 'OG007'}, {'value': '1220', 'spread': '63', 'groupId': 'OG008'}, {'value': '1530', 'spread': '65', 'groupId': 'OG009'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Cycle 1: predose (0 hr) on Days 1, 2; 0.5, 1, 2, 4, 6 hr postdose on Day 1', 'unitOfMeasure': 'nanograms*hours per milliliter (ng*h/mL)', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'PK population. Here, number of participants analyzed = participants who were evaluable for this outcome.'}, {'type': 'PRIMARY', 'title': 'AUC0-24 of Cobimetinib on Day 1, Cycle 1 of Cohort 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'DES (Cohort 3): 60 mg Cobimetinib + 960 mg Vemurafenib', 'description': 'Participants received oral 60 mg cobimetinib QD on 14/14 dosing schedule and oral 960 mg vemurafenib BID on Days 1-28 of every cycle (1 Cycle=28 Days), until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.'}], 'classes': [{'categories': [{'measurements': [{'value': '727', 'spread': '556', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Cycle 1: predose (0 hr) on Days 1, 2; 0.5, 1, 2, 4, 6 hr postdose on Day 1', 'unitOfMeasure': 'ng*h/mL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'PK population. Here, number of participants analyzed = participants who were evaluable for this outcome.'}, {'type': 'PRIMARY', 'title': 'Cmax of Cobimetinib on Day 14 (Steady State), Cycle 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '25', 'groupId': 'OG002'}, {'value': '3', 'groupId': 'OG003'}, {'value': '3', 'groupId': 'OG004'}, {'value': '3', 'groupId': 'OG005'}, {'value': '4', 'groupId': 'OG006'}, {'value': '3', 'groupId': 'OG007'}, {'value': '3', 'groupId': 'OG008'}, {'value': '25', 'groupId': 'OG009'}, {'value': '32', 'groupId': 'OG010'}]}], 'groups': [{'id': 'OG000', 'title': 'DES (Cohort 1): 60 mg Cobimetinib + 720 mg Vemurafenib', 'description': 'Participants received oral 60 mg cobimetinib QD on 14/14 dosing schedule and oral 720 mg vemurafenib BID on Days 1-28 of every cycle (1 Cycle=28 Days), until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.'}, {'id': 'OG001', 'title': 'DES (Cohort 1A): 60 mg Cobimetinib + 720 mg Vemurafenib', 'description': 'Participants received oral 60 mg cobimetinib QD on 21/7 dosing schedule and oral 720 mg vemurafenib BID on Days 1-28 of every cycle (1 Cycle=28 Days), until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.'}, {'id': 'OG002', 'title': 'DES (Cohort 1B): 60 mg Cobimetinib + 960 mg Vemurafenib', 'description': 'Participants received oral 60 mg cobimetinib QD on 21/7 dosing schedule and oral 960 mg vemurafenib BID on Days 1-28 of every cycle (1 Cycle=28 Days), until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.'}, {'id': 'OG003', 'title': 'DES (Cohort 1C): 60 mg Cobimetinib + 720 mg Vemurafenib', 'description': 'Participants received oral 60 mg cobimetinib QD on 28/0 dosing schedule and oral 720 mg vemurafenib BID on Days 1-28 of every cycle (1 Cycle=28 Days), until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.'}, {'id': 'OG004', 'title': 'DES (Cohort 1D): 60 mg Cobimetinib + 960 mg Vemurafenib', 'description': 'Participants received oral 60 mg cobimetinib QD on 28/0 dosing schedule and oral 960 mg vemurafenib BID on Days 1-28 of every cycle (1 Cycle=28 Days), until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.'}, {'id': 'OG005', 'title': 'DES (Cohort 2): 80 mg Cobimetinib + 720 mg Vemurafenib', 'description': 'Participants received oral 80 mg cobimetinib QD on 14/14 dosing schedule and oral 720 mg vemurafenib BID on Days 1-28 of every cycle (1 Cycle=28 Days), until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.'}, {'id': 'OG006', 'title': 'DES (Cohort 2A): 100 mg Cobimetinib + 720 mg Vemurafenib', 'description': 'Participants received oral 100 mg cobimetinib QD on 14/14 dosing schedule and oral 720 mg vemurafenib BID on Days 1-28 of every cycle (1 Cycle=28 Days), until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.'}, {'id': 'OG007', 'title': 'DES (Cohort 3): 60 mg Cobimetinib + 960 mg Vemurafenib', 'description': 'Participants received oral 60 mg cobimetinib QD on 14/14 dosing schedule and oral 960 mg vemurafenib BID on Days 1-28 of every cycle (1 Cycle=28 Days), until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.'}, {'id': 'OG008', 'title': 'DES (Cohort 4): 80 mg Cobimetinib + 960 mg Vemurafenib', 'description': 'Participants received oral 80 mg cobimetinib QD on 14/14 dosing schedule and oral 960 mg vemurafenib BID on Days 1-28 of every cycle (1 Cycle=28 Days), until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.'}, {'id': 'OG009', 'title': 'CES (Cohort 1A): 60 mg Cobimetinib + 720 mg Vemurafenib', 'description': 'Participants received oral 60 mg cobimetinib QD on 21/7 dosing schedule and oral 720 mg vemurafenib BID on Days 1-28 of every cycle (1 Cycle=28 Days), until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.'}, {'id': 'OG010', 'title': 'CES (Cohort 1B): 60 mg Cobimetinib + 960 mg Vemurafenib', 'description': 'Participants received oral 60 mg cobimetinib QD on 21/7 dosing schedule and oral 960 mg vemurafenib BID on Days 1-28 of every cycle (1 Cycle=28 Days), until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.'}], 'classes': [{'categories': [{'measurements': [{'value': '342', 'spread': '130', 'groupId': 'OG000'}, {'value': '307', 'spread': '75', 'groupId': 'OG001'}, {'value': '232', 'spread': '80', 'groupId': 'OG002'}, {'value': '239', 'spread': '14', 'groupId': 'OG003'}, {'value': '414', 'spread': '16', 'groupId': 'OG004'}, {'value': '195', 'spread': '48', 'groupId': 'OG005'}, {'value': '383', 'spread': '50', 'groupId': 'OG006'}, {'value': '215', 'spread': '19', 'groupId': 'OG007'}, {'value': '350', 'spread': '37', 'groupId': 'OG008'}, {'value': '177', 'spread': '74', 'groupId': 'OG009'}, {'value': '200', 'spread': '91', 'groupId': 'OG010'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Cycle 1: predose (0 hr) on Days 8, 14; 0.5, 1, 2, 4, 6 hr postdose on Day 14', 'unitOfMeasure': 'ng/mL', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'PK population. Here, number of participants analyzed = participants who were evaluable for this outcome.'}, {'type': 'PRIMARY', 'title': 'Tmax of Cobimetinib on Day 14 (Steady State), Cycle 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '25', 'groupId': 'OG002'}, {'value': '3', 'groupId': 'OG003'}, {'value': '3', 'groupId': 'OG004'}, {'value': '3', 'groupId': 'OG005'}, {'value': '4', 'groupId': 'OG006'}, {'value': '3', 'groupId': 'OG007'}, {'value': '3', 'groupId': 'OG008'}, {'value': '25', 'groupId': 'OG009'}, {'value': '32', 'groupId': 'OG010'}]}], 'groups': [{'id': 'OG000', 'title': 'DES (Cohort 1): 60 mg Cobimetinib + 720 mg Vemurafenib', 'description': 'Participants received oral 60 mg cobimetinib QD on 14/14 dosing schedule and oral 720 mg vemurafenib BID on Days 1-28 of every cycle (1 Cycle=28 Days), until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.'}, {'id': 'OG001', 'title': 'DES (Cohort 1A): 60 mg Cobimetinib + 720 mg Vemurafenib', 'description': 'Participants received oral 60 mg cobimetinib QD on 21/7 dosing schedule and oral 720 mg vemurafenib BID on Days 1-28 of every cycle (1 Cycle=28 Days), until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.'}, {'id': 'OG002', 'title': 'DES (Cohort 1B): 60 mg Cobimetinib + 960 mg Vemurafenib', 'description': 'Participants received oral 60 mg cobimetinib QD on 21/7 dosing schedule and oral 960 mg vemurafenib BID on Days 1-28 of every cycle (1 Cycle=28 Days), until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.'}, {'id': 'OG003', 'title': 'DES (Cohort 1C): 60 mg Cobimetinib + 720 mg Vemurafenib', 'description': 'Participants received oral 60 mg cobimetinib QD on 28/0 dosing schedule and oral 720 mg vemurafenib BID on Days 1-28 of every cycle (1 Cycle=28 Days), until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.'}, {'id': 'OG004', 'title': 'DES (Cohort 1D): 60 mg Cobimetinib + 960 mg Vemurafenib', 'description': 'Participants received oral 60 mg cobimetinib QD on 28/0 dosing schedule and oral 960 mg vemurafenib BID on Days 1-28 of every cycle (1 Cycle=28 Days), until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.'}, {'id': 'OG005', 'title': 'DES (Cohort 2): 80 mg Cobimetinib + 720 mg Vemurafenib', 'description': 'Participants received oral 80 mg cobimetinib QD on 14/14 dosing schedule and oral 720 mg vemurafenib BID on Days 1-28 of every cycle (1 Cycle=28 Days), until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.'}, {'id': 'OG006', 'title': 'DES (Cohort 2A): 100 mg Cobimetinib + 720 mg Vemurafenib', 'description': 'Participants received oral 100 mg cobimetinib QD on 14/14 dosing schedule and oral 720 mg vemurafenib BID on Days 1-28 of every cycle (1 Cycle=28 Days), until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.'}, {'id': 'OG007', 'title': 'DES (Cohort 3): 60 mg Cobimetinib + 960 mg Vemurafenib', 'description': 'Participants received oral 60 mg cobimetinib QD on 14/14 dosing schedule and oral 960 mg vemurafenib BID on Days 1-28 of every cycle (1 Cycle=28 Days), until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.'}, {'id': 'OG008', 'title': 'DES (Cohort 4): 80 mg Cobimetinib + 960 mg Vemurafenib', 'description': 'Participants received oral 80 mg cobimetinib QD on 14/14 dosing schedule and oral 960 mg vemurafenib BID on Days 1-28 of every cycle (1 Cycle=28 Days), until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.'}, {'id': 'OG009', 'title': 'CES (Cohort 1A): 60 mg Cobimetinib + 720 mg Vemurafenib', 'description': 'Participants received oral 60 mg cobimetinib QD on 21/7 dosing schedule and oral 720 mg vemurafenib BID on Days 1-28 of every cycle (1 Cycle=28 Days), until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.'}, {'id': 'OG010', 'title': 'CES (Cohort 1B): 60 mg Cobimetinib + 960 mg Vemurafenib', 'description': 'Participants received oral 60 mg cobimetinib QD on 21/7 dosing schedule and oral 960 mg vemurafenib BID on Days 1-28 of every cycle (1 Cycle=28 Days), until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.'}], 'classes': [{'categories': [{'measurements': [{'value': '2.0', 'groupId': 'OG000', 'lowerLimit': '0.98', 'upperLimit': '4.0'}, {'value': '3.98', 'groupId': 'OG001', 'lowerLimit': '2.0', 'upperLimit': '7.0'}, {'value': '4.02', 'groupId': 'OG002', 'lowerLimit': '0.5', 'upperLimit': '8.0'}, {'value': '4.00', 'groupId': 'OG003', 'lowerLimit': '4.0', 'upperLimit': '4.1'}, {'value': '6.00', 'groupId': 'OG004', 'lowerLimit': '4.9', 'upperLimit': '6.1'}, {'value': '6.0', 'groupId': 'OG005', 'lowerLimit': '2.0', 'upperLimit': '6.0'}, {'value': '4.03', 'groupId': 'OG006', 'lowerLimit': '2.2', 'upperLimit': '6.1'}, {'value': '4.08', 'groupId': 'OG007', 'lowerLimit': '4.0', 'upperLimit': '6.1'}, {'value': '4.00', 'groupId': 'OG008', 'lowerLimit': '3.9', 'upperLimit': '4.1'}, {'value': '4.04', 'groupId': 'OG009', 'lowerLimit': '2.0', 'upperLimit': '8.0'}, {'value': '4.00', 'groupId': 'OG010', 'lowerLimit': '0.0', 'upperLimit': '8.0'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Cycle 1: predose (0 hr) on Days 8, 14; 0.5, 1, 2, 4, 6 hr postdose on Day 14', 'unitOfMeasure': 'hours', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'PK population. Here, number of participants analyzed = participants who were evaluable for this outcome.'}, {'type': 'PRIMARY', 'title': 'AUC0-24 of Cobimetinib on Day 14, Cycle 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '25', 'groupId': 'OG002'}, {'value': '3', 'groupId': 'OG003'}, {'value': '3', 'groupId': 'OG004'}, {'value': '3', 'groupId': 'OG005'}, {'value': '4', 'groupId': 'OG006'}, {'value': '3', 'groupId': 'OG007'}, {'value': '3', 'groupId': 'OG008'}, {'value': '25', 'groupId': 'OG009'}, {'value': '32', 'groupId': 'OG010'}]}], 'groups': [{'id': 'OG000', 'title': 'DES (Cohort 1): 60 mg Cobimetinib + 720 mg Vemurafenib', 'description': 'Participants received oral 60 mg cobimetinib QD on 14/14 dosing schedule and oral 720 mg vemurafenib BID on Days 1-28 of every cycle (1 Cycle=28 Days), until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.'}, {'id': 'OG001', 'title': 'DES (Cohort 1A): 60 mg Cobimetinib + 720 mg Vemurafenib', 'description': 'Participants received oral 60 mg cobimetinib QD on 21/7 dosing schedule and oral 720 mg vemurafenib BID on Days 1-28 of every cycle (1 Cycle=28 Days), until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.'}, {'id': 'OG002', 'title': 'DES (Cohort 1B): 60 mg Cobimetinib + 960 mg Vemurafenib', 'description': 'Participants received oral 60 mg cobimetinib QD on 21/7 dosing schedule and oral 960 mg vemurafenib BID on Days 1-28 of every cycle (1 Cycle=28 Days), until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.'}, {'id': 'OG003', 'title': 'DES (Cohort 1C): 60 mg Cobimetinib + 720 mg Vemurafenib', 'description': 'Participants received oral 60 mg cobimetinib QD on 28/0 dosing schedule and oral 720 mg vemurafenib BID on Days 1-28 of every cycle (1 Cycle=28 Days), until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.'}, {'id': 'OG004', 'title': 'DES (Cohort 1D): 60 mg Cobimetinib + 960 mg Vemurafenib', 'description': 'Participants received oral 60 mg cobimetinib QD on 28/0 dosing schedule and oral 960 mg vemurafenib BID on Days 1-28 of every cycle (1 Cycle=28 Days), until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.'}, {'id': 'OG005', 'title': 'DES (Cohort 2): 80 mg Cobimetinib + 720 mg Vemurafenib', 'description': 'Participants received oral 80 mg cobimetinib QD on 14/14 dosing schedule and oral 720 mg vemurafenib BID on Days 1-28 of every cycle (1 Cycle=28 Days), until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.'}, {'id': 'OG006', 'title': 'DES (Cohort 2A): 100 mg Cobimetinib + 720 mg Vemurafenib', 'description': 'Participants received oral 100 mg cobimetinib QD on 14/14 dosing schedule and oral 720 mg vemurafenib BID on Days 1-28 of every cycle (1 Cycle=28 Days), until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.'}, {'id': 'OG007', 'title': 'DES (Cohort 3): 60 mg Cobimetinib + 960 mg Vemurafenib', 'description': 'Participants received oral 60 mg cobimetinib QD on 14/14 dosing schedule and oral 960 mg vemurafenib BID on Days 1-28 of every cycle (1 Cycle=28 Days), until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.'}, {'id': 'OG008', 'title': 'DES (Cohort 4): 80 mg Cobimetinib + 960 mg Vemurafenib', 'description': 'Participants received oral 80 mg cobimetinib QD on 14/14 dosing schedule and oral 960 mg vemurafenib BID on Days 1-28 of every cycle (1 Cycle=28 Days), until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.'}, {'id': 'OG009', 'title': 'CES (Cohort 1A): 60 mg Cobimetinib + 720 mg Vemurafenib', 'description': 'Participants received oral 60 mg cobimetinib QD on 21/7 dosing schedule and oral 720 mg vemurafenib BID on Days 1-28 of every cycle (1 Cycle=28 Days), until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.'}, {'id': 'OG010', 'title': 'CES (Cohort 1B): 60 mg Cobimetinib + 960 mg Vemurafenib', 'description': 'Participants received oral 60 mg cobimetinib QD on 21/7 dosing schedule and oral 960 mg vemurafenib BID on Days 1-28 of every cycle (1 Cycle=28 Days), until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.'}], 'classes': [{'categories': [{'measurements': [{'value': '5180', 'spread': '170', 'groupId': 'OG000'}, {'value': '4800', 'spread': '76', 'groupId': 'OG001'}, {'value': '3540', 'spread': '83', 'groupId': 'OG002'}, {'value': '4500', 'spread': '17', 'groupId': 'OG003'}, {'value': '7020', 'spread': '27', 'groupId': 'OG004'}, {'value': '3820', 'spread': '48', 'groupId': 'OG005'}, {'value': '6360', 'spread': '46', 'groupId': 'OG006'}, {'value': '3520', 'spread': '35', 'groupId': 'OG007'}, {'value': '5790', 'spread': '36', 'groupId': 'OG008'}, {'value': '2540', 'spread': '84', 'groupId': 'OG009'}, {'value': '3220', 'spread': '124', 'groupId': 'OG010'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Cycle 1: predose (0 hr) on Days 8, 14; 0.5, 1, 2, 4, 6 hr postdose on Day 14', 'unitOfMeasure': 'ng*h/mL', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'PK population. Here, number of participants analyzed = participants who were evaluable for this outcome.'}, {'type': 'PRIMARY', 'title': 'Clearance (CL) of Cobimetinib on Day 14 (Steady State), Cycle 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '25', 'groupId': 'OG002'}, {'value': '3', 'groupId': 'OG003'}, {'value': '3', 'groupId': 'OG004'}, {'value': '3', 'groupId': 'OG005'}, {'value': '4', 'groupId': 'OG006'}, {'value': '3', 'groupId': 'OG007'}, {'value': '3', 'groupId': 'OG008'}, {'value': '25', 'groupId': 'OG009'}, {'value': '32', 'groupId': 'OG010'}]}], 'groups': [{'id': 'OG000', 'title': 'DES (Cohort 1): 60 mg Cobimetinib + 720 mg Vemurafenib', 'description': 'Participants received oral 60 mg cobimetinib QD on 14/14 dosing schedule and oral 720 mg vemurafenib BID on Days 1-28 of every cycle (1 Cycle=28 Days), until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.'}, {'id': 'OG001', 'title': 'DES (Cohort 1A): 60 mg Cobimetinib + 720 mg Vemurafenib', 'description': 'Participants received oral 60 mg cobimetinib QD on 21/7 dosing schedule and oral 720 mg vemurafenib BID on Days 1-28 of every cycle (1 Cycle=28 Days), until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.'}, {'id': 'OG002', 'title': 'DES (Cohort 1B): 60 mg Cobimetinib + 960 mg Vemurafenib', 'description': 'Participants received oral 60 mg cobimetinib QD on 21/7 dosing schedule and oral 960 mg vemurafenib BID on Days 1-28 of every cycle (1 Cycle=28 Days), until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.'}, {'id': 'OG003', 'title': 'DES (Cohort 1C): 60 mg Cobimetinib + 720 mg Vemurafenib', 'description': 'Participants received oral 60 mg cobimetinib QD on 28/0 dosing schedule and oral 720 mg vemurafenib BID on Days 1-28 of every cycle (1 Cycle=28 Days), until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.'}, {'id': 'OG004', 'title': 'DES (Cohort 1D): 60 mg Cobimetinib + 960 mg Vemurafenib', 'description': 'Participants received oral 60 mg cobimetinib QD on 28/0 dosing schedule and oral 960 mg vemurafenib BID on Days 1-28 of every cycle (1 Cycle=28 Days), until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.'}, {'id': 'OG005', 'title': 'DES (Cohort 2): 80 mg Cobimetinib + 720 mg Vemurafenib', 'description': 'Participants received oral 80 mg cobimetinib QD on 14/14 dosing schedule and oral 720 mg vemurafenib BID on Days 1-28 of every cycle (1 Cycle=28 Days), until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.'}, {'id': 'OG006', 'title': 'DES (Cohort 2A): 100 mg Cobimetinib + 720 mg Vemurafenib', 'description': 'Participants received oral 100 mg cobimetinib QD on 14/14 dosing schedule and oral 720 mg vemurafenib BID on Days 1-28 of every cycle (1 Cycle=28 Days), until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.'}, {'id': 'OG007', 'title': 'DES (Cohort 3): 60 mg Cobimetinib + 960 mg Vemurafenib', 'description': 'Participants received oral 60 mg cobimetinib QD on 14/14 dosing schedule and oral 960 mg vemurafenib BID on Days 1-28 of every cycle (1 Cycle=28 Days), until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.'}, {'id': 'OG008', 'title': 'DES (Cohort 4): 80 mg Cobimetinib + 960 mg Vemurafenib', 'description': 'Participants received oral 80 mg cobimetinib QD on 14/14 dosing schedule and oral 960 mg vemurafenib BID on Days 1-28 of every cycle (1 Cycle=28 Days), until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.'}, {'id': 'OG009', 'title': 'CES (Cohort 1A): 60 mg Cobimetinib + 720 mg Vemurafenib', 'description': 'Participants received oral 60 mg cobimetinib QD on 21/7 dosing schedule and oral 720 mg vemurafenib BID on Days 1-28 of every cycle (1 Cycle=28 Days), until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.'}, {'id': 'OG010', 'title': 'CES (Cohort 1B): 60 mg Cobimetinib + 960 mg Vemurafenib', 'description': 'Participants received oral 60 mg cobimetinib QD on 21/7 dosing schedule and oral 960 mg vemurafenib BID on Days 1-28 of every cycle (1 Cycle=28 Days), until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.'}], 'classes': [{'categories': [{'measurements': [{'value': '11.6', 'spread': '170', 'groupId': 'OG000'}, {'value': '12.5', 'spread': '76', 'groupId': 'OG001'}, {'value': '17.0', 'spread': '83', 'groupId': 'OG002'}, {'value': '13.3', 'spread': '17', 'groupId': 'OG003'}, {'value': '8.55', 'spread': '27', 'groupId': 'OG004'}, {'value': '21.0', 'spread': '48', 'groupId': 'OG005'}, {'value': '15.7', 'spread': '46', 'groupId': 'OG006'}, {'value': '17.0', 'spread': '35', 'groupId': 'OG007'}, {'value': '13.8', 'spread': '36', 'groupId': 'OG008'}, {'value': '23.6', 'spread': '84', 'groupId': 'OG009'}, {'value': '18.6', 'spread': '124', 'groupId': 'OG010'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Cycle 1: predose (0 hr) on Days 8, 14; 0.5, 1, 2, 4, 6 hr postdose on Day 14', 'description': 'Clearance of a drug is a measure of the rate at which a drug is metabolized or eliminated by normal biological processes.', 'unitOfMeasure': 'Liters per hour (L/h)', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'PK population. Here, number of participants analyzed = participants who were evaluable for this outcome.'}, {'type': 'PRIMARY', 'title': 'Cmax of Vemurafenib on Day -1, Cycle 1 in Participants Previously Treated With Vemurafenib Prior to Enrollment Into This Study', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '8', 'groupId': 'OG002'}, {'value': '3', 'groupId': 'OG003'}, {'value': '3', 'groupId': 'OG004'}, {'value': '1', 'groupId': 'OG005'}, {'value': '15', 'groupId': 'OG006'}, {'value': '19', 'groupId': 'OG007'}]}], 'groups': [{'id': 'OG000', 'title': 'DES (Cohort 1): 60 mg Cobimetinib + 720 mg Vemurafenib', 'description': 'Participants received oral 60 mg cobimetinib QD on 14/14 dosing schedule and oral 720 mg vemurafenib BID on Days 1-28 of every cycle (1 Cycle=28 Days), until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.'}, {'id': 'OG001', 'title': 'DES (Cohort 1A): 60 mg Cobimetinib + 720 mg Vemurafenib', 'description': 'Participants received oral 60 mg cobimetinib QD on 21/7 dosing schedule and oral 720 mg vemurafenib BID on Days 1-28 of every cycle (1 Cycle=28 Days), until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.'}, {'id': 'OG002', 'title': 'DES (Cohort 1B): 60 mg Cobimetinib + 960 mg Vemurafenib', 'description': 'Participants received oral 60 mg cobimetinib QD on 21/7 dosing schedule and oral 960 mg vemurafenib BID on Days 1-28 of every cycle (1 Cycle=28 Days), until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.'}, {'id': 'OG003', 'title': 'DES (Cohort 2): 80 mg Cobimetinib + 720 mg Vemurafenib', 'description': 'Participants received oral 80 mg cobimetinib QD on 14/14 dosing schedule and oral 720 mg vemurafenib BID on Days 1-28 of every cycle (1 Cycle=28 Days), until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.'}, {'id': 'OG004', 'title': 'DES (Cohort 3): 60 mg Cobimetinib + 960 mg Vemurafenib', 'description': 'Participants received oral 60 mg cobimetinib QD on 14/14 dosing schedule and oral 960 mg vemurafenib BID on Days 1-28 of every cycle (1 Cycle=28 Days), until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.'}, {'id': 'OG005', 'title': 'DES (Cohort 4): 80 mg Cobimetinib + 960 mg Vemurafenib', 'description': 'Participants received oral 80 mg cobimetinib QD on 14/14 dosing schedule and oral 960 mg vemurafenib BID on Days 1-28 of every cycle (1 Cycle=28 Days), until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.'}, {'id': 'OG006', 'title': 'CES (Cohort 1A): 60 mg Cobimetinib + 720 mg Vemurafenib', 'description': 'Participants received oral 60 mg cobimetinib QD on 21/7 dosing schedule and oral 720 mg vemurafenib BID on Days 1-28 of every cycle (1 Cycle=28 Days), until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.'}, {'id': 'OG007', 'title': 'CES (Cohort 1B): 60 mg Cobimetinib + 960 mg Vemurafenib', 'description': 'Participants received oral 60 mg cobimetinib QD on 21/7 dosing schedule and oral 960 mg vemurafenib BID on Days 1-28 of every cycle (1 Cycle=28 Days), until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.'}], 'classes': [{'categories': [{'measurements': [{'value': '36.4', 'spread': '58', 'groupId': 'OG000'}, {'value': '34.3', 'spread': '34', 'groupId': 'OG001'}, {'value': '60.9', 'spread': '32', 'groupId': 'OG002'}, {'value': '56.0', 'spread': '16', 'groupId': 'OG003'}, {'value': '36.4', 'spread': '19', 'groupId': 'OG004'}, {'value': '48.2', 'spread': 'NA', 'comment': 'Geometric coefficient of variation is not applicable as only 1 participant had evaluable data.', 'groupId': 'OG005'}, {'value': '40.9', 'spread': '110', 'groupId': 'OG006'}, {'value': '48.6', 'spread': '37', 'groupId': 'OG007'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Predose (0 hr) on Days -1, 1; 2, 4, 6, 8 hr postdose on Day -1', 'unitOfMeasure': 'micrograms per milliliter (mcg/mL)', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'PK population. Here, number of participants analyzed = participants who were previously treated with vemurafenib prior to enrollment into this study.'}, {'type': 'PRIMARY', 'title': 'Cmax of Vemurafenib on Day -1, Cycle 1 of Cohorts 1C and 2A in Participants Previously Treated With Vemurafenib Prior to Enrollment Into This Study', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'DES (Cohort 1C): 60 mg Cobimetinib + 720 mg Vemurafenib', 'description': 'Participants received oral 60 mg cobimetinib QD on 28/0 dosing schedule and oral 720 mg vemurafenib BID on Days 1-28 of every cycle (1 Cycle=28 Days), until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.'}, {'id': 'OG001', 'title': 'DES (Cohort 2A): 100 mg Cobimetinib + 720 mg Vemurafenib', 'description': 'Participants received oral 100 mg cobimetinib QD on 14/14 dosing schedule and oral 720 mg vemurafenib BID on Days 1-28 of every cycle (1 Cycle=28 Days), until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.'}], 'classes': [{'categories': [{'measurements': [{'value': '38.8', 'spread': '9.61', 'groupId': 'OG000'}, {'value': '48.8', 'spread': '35.4', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Predose (0 hr) on Day -1, 1; 2, 4, 6, 8 hr postdose on Day -1', 'unitOfMeasure': 'mcg/mL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'PK population. Here, number of participants analyzed = participants who were previously treated with vemurafenib prior to enrollment into this study.'}, {'type': 'PRIMARY', 'title': 'Tmax of Vemurafenib on Day -1, Cycle 1 in Participants Previously Treated With Vemurafenib Prior to Enrollment Into This Study', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '8', 'groupId': 'OG002'}, {'value': '2', 'groupId': 'OG003'}, {'value': '3', 'groupId': 'OG004'}, {'value': '2', 'groupId': 'OG005'}, {'value': '3', 'groupId': 'OG006'}, {'value': '1', 'groupId': 'OG007'}, {'value': '15', 'groupId': 'OG008'}, {'value': '19', 'groupId': 'OG009'}]}], 'groups': [{'id': 'OG000', 'title': 'DES (Cohort 1): 60 mg Cobimetinib + 720 mg Vemurafenib', 'description': 'Participants received oral 60 mg cobimetinib QD on 14/14 dosing schedule and oral 720 mg vemurafenib BID on Days 1-28 of every cycle (1 Cycle=28 Days), until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.'}, {'id': 'OG001', 'title': 'DES (Cohort 1A): 60 mg Cobimetinib + 720 mg Vemurafenib', 'description': 'Participants received oral 60 mg cobimetinib QD on 21/7 dosing schedule and oral 720 mg vemurafenib BID on Days 1-28 of every cycle (1 Cycle=28 Days), until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.'}, {'id': 'OG002', 'title': 'DES (Cohort 1B): 60 mg Cobimetinib + 960 mg Vemurafenib', 'description': 'Participants received oral 60 mg cobimetinib QD on 21/7 dosing schedule and oral 960 mg vemurafenib BID on Days 1-28 of every cycle (1 Cycle=28 Days), until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.'}, {'id': 'OG003', 'title': 'DES (Cohort 1C): 60 mg Cobimetinib + 720 mg Vemurafenib', 'description': 'Participants received oral 60 mg cobimetinib QD on 28/0 dosing schedule and oral 720 mg vemurafenib BID on Days 1-28 of every cycle (1 Cycle=28 Days), until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.'}, {'id': 'OG004', 'title': 'DES (Cohort 2): 80 mg Cobimetinib + 720 mg Vemurafenib', 'description': 'Participants received oral 80 mg cobimetinib QD on 14/14 dosing schedule and oral 720 mg vemurafenib BID on Days 1-28 of every cycle (1 Cycle=28 Days), until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.'}, {'id': 'OG005', 'title': 'DES (Cohort 2A): 100 mg Cobimetinib + 720 mg Vemurafenib', 'description': 'Participants received oral 100 mg cobimetinib QD on 14/14 dosing schedule and oral 720 mg vemurafenib BID on Days 1-28 of every cycle (1 Cycle=28 Days), until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.'}, {'id': 'OG006', 'title': 'DES (Cohort 3): 60 mg Cobimetinib + 960 mg Vemurafenib', 'description': 'Participants received oral 60 mg cobimetinib QD on 14/14 dosing schedule and oral 960 mg vemurafenib BID on Days 1-28 of every cycle (1 Cycle=28 Days), until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.'}, {'id': 'OG007', 'title': 'DES (Cohort 4): 80 mg Cobimetinib + 960 mg Vemurafenib', 'description': 'Participants received oral 80 mg cobimetinib QD on 14/14 dosing schedule and oral 960 mg vemurafenib BID on Days 1-28 of every cycle (1 Cycle=28 Days), until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.'}, {'id': 'OG008', 'title': 'CES (Cohort 1A): 60 mg Cobimetinib + 720 mg Vemurafenib', 'description': 'Participants received oral 60 mg cobimetinib QD on 21/7 dosing schedule and oral 720 mg vemurafenib BID on Days 1-28 of every cycle (1 Cycle=28 Days), until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.'}, {'id': 'OG009', 'title': 'CES (Cohort 1B): 60 mg Cobimetinib + 960 mg Vemurafenib', 'description': 'Participants received oral 60 mg cobimetinib QD on 21/7 dosing schedule and oral 960 mg vemurafenib BID on Days 1-28 of every cycle (1 Cycle=28 Days), until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.'}], 'classes': [{'categories': [{'measurements': [{'value': '2.42', 'groupId': 'OG000', 'lowerLimit': '1.3', 'upperLimit': '4.5'}, {'value': '2.50', 'groupId': 'OG001', 'lowerLimit': '0.7', 'upperLimit': '7.5'}, {'value': '3.69', 'groupId': 'OG002', 'lowerLimit': '1.1', 'upperLimit': '11'}, {'value': '4.55', 'groupId': 'OG003', 'lowerLimit': '3.1', 'upperLimit': '6.0'}, {'value': '2.03', 'groupId': 'OG004', 'lowerLimit': '0.9', 'upperLimit': '2.5'}, {'value': '1.65', 'groupId': 'OG005', 'lowerLimit': '1.3', 'upperLimit': '2.0'}, {'value': '1.92', 'groupId': 'OG006', 'lowerLimit': '0.6', 'upperLimit': '4.8'}, {'value': '0.83', 'comment': 'Full range is not applicable as only 1 participant had evaluable data.', 'groupId': 'OG007', 'lowerLimit': 'NA', 'upperLimit': 'NA'}, {'value': '2.33', 'groupId': 'OG008', 'lowerLimit': '0.3', 'upperLimit': '8.1'}, {'value': '1.93', 'groupId': 'OG009', 'lowerLimit': '0.6', 'upperLimit': '7.5'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Predose (0 hr) on Day -1, 1; 2, 4, 6, 8 hr postdose on Day -1', 'unitOfMeasure': 'hours', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'PK population. Here, number of participants analyzed = participants who were previously treated with vemurafenib prior to enrollment into this study.'}, {'type': 'PRIMARY', 'title': 'Cmax of Vemurafenib on Day 1, Cycle 1 in BRAFi-naïve Participants', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}, {'value': '3', 'groupId': 'OG004'}, {'value': '11', 'groupId': 'OG005'}, {'value': '19', 'groupId': 'OG006'}]}], 'groups': [{'id': 'OG000', 'title': 'DES (Cohort 1B): 60 mg Cobimetinib + 960 mg Vemurafenib', 'description': 'Participants received oral 60 mg cobimetinib QD on 21/7 dosing schedule and oral 960 mg vemurafenib BID on Days 1-28 of every cycle (1 Cycle=28 Days), until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.'}, {'id': 'OG001', 'title': 'DES (Cohort 1C): 60 mg Cobimetinib + 720 mg Vemurafenib', 'description': 'Participants received oral 60 mg cobimetinib QD on 28/0 dosing schedule and oral 720 mg vemurafenib BID on Days 1-28 of every cycle (1 Cycle=28 Days), until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.'}, {'id': 'OG002', 'title': 'DES (Cohort 1D): 60 mg Cobimetinib + 960 mg Vemurafenib', 'description': 'Participants received oral 60 mg cobimetinib QD on 28/0 dosing schedule and oral 960 mg vemurafenib BID on Days 1-28 of every cycle (1 Cycle=28 Days), until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.'}, {'id': 'OG003', 'title': 'DES (Cohort 2A): 100 mg Cobimetinib + 720 mg Vemurafenib', 'description': 'Participants received oral 100 mg cobimetinib QD on 14/14 dosing schedule and oral 720 mg vemurafenib BID on Days 1-28 of every cycle (1 Cycle=28 Days), until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.'}, {'id': 'OG004', 'title': 'DES (Cohort 4): 80 mg Cobimetinib + 960 mg Vemurafenib', 'description': 'Participants received oral 80 mg cobimetinib QD on 14/14 dosing schedule and oral 960 mg vemurafenib BID on Days 1-28 of every cycle (1 Cycle=28 Days), until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.'}, {'id': 'OG005', 'title': 'CES (Cohort 1A): 60 mg Cobimetinib + 720 mg Vemurafenib', 'description': 'Participants received oral 60 mg cobimetinib QD on 21/7 dosing schedule and oral 720 mg vemurafenib BID on Days 1-28 of every cycle (1 Cycle=28 Days), until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.'}, {'id': 'OG006', 'title': 'CES (Cohort 1B): 60 mg Cobimetinib + 960 mg Vemurafenib', 'description': 'Participants received oral 60 mg cobimetinib QD on 21/7 dosing schedule and oral 960 mg vemurafenib BID on Days 1-28 of every cycle (1 Cycle=28 Days), until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.'}], 'classes': [{'categories': [{'measurements': [{'value': '3.99', 'spread': '73', 'groupId': 'OG000'}, {'value': '2.31', 'spread': 'NA', 'comment': 'Geometric coefficient of variation is not applicable as only 1 participant had evaluable data.', 'groupId': 'OG001'}, {'value': '4.16', 'spread': '78', 'groupId': 'OG002'}, {'value': '1.25', 'spread': 'NA', 'comment': 'Geometric coefficient of variation is not applicable as only 1 participant had evaluable data.', 'groupId': 'OG003'}, {'value': '2.55', 'spread': '170', 'groupId': 'OG004'}, {'value': '2.60', 'spread': '70', 'groupId': 'OG005'}, {'value': '2.78', 'spread': '57', 'groupId': 'OG006'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Predose (0 hr) on Day 1, 2; 0.5, 1, 2, 4, 6 hr postdose on Day 1', 'unitOfMeasure': 'mcg/mL', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'PK population.Here, number of participants analyzed = participants who were BRAFi-naïve participants.'}, {'type': 'PRIMARY', 'title': 'Cmax of Vemurafenib on Day 1, Cycle 1 in Cohort 1A in BRAFi-naïve Participants', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'DES (Cohort 1A): 60 mg Cobimetinib + 720 mg Vemurafenib', 'description': 'Participants received oral 60 mg cobimetinib QD on 21/7 dosing schedule and oral 720 mg vemurafenib BID on Days 1-28 of every cycle (1 Cycle=28 Days), until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.'}], 'classes': [{'categories': [{'measurements': [{'value': '2.08', 'spread': '1.64', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Predose (0 hr) on Day 1, 2; 0.5, 1, 2, 4, 6 hr postdose on Day 1', 'unitOfMeasure': 'mcg/mL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'PK population. Here, number of participants analyzed = participants who were BRAFi-naïve participants.'}, {'type': 'PRIMARY', 'title': 'Tmax of Vemurafenib on Day 1, Cycle 1 in BRAFi-naïve Participants', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '3', 'groupId': 'OG003'}, {'value': '1', 'groupId': 'OG004'}, {'value': '3', 'groupId': 'OG005'}, {'value': '11', 'groupId': 'OG006'}, {'value': '19', 'groupId': 'OG007'}]}], 'groups': [{'id': 'OG000', 'title': 'DES (Cohort 1A): 60 mg Cobimetinib + 720 mg Vemurafenib', 'description': 'Participants received oral 60 mg cobimetinib QD on 21/7 dosing schedule and oral 720 mg vemurafenib BID on Days 1-28 of every cycle (1 Cycle=28 Days), until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.'}, {'id': 'OG001', 'title': 'DES (Cohort 1B): 60 mg Cobimetinib + 960 mg Vemurafenib', 'description': 'Participants received oral 60 mg cobimetinib QD on 21/7 dosing schedule and oral 960 mg vemurafenib BID on Days 1-28 of every cycle (1 Cycle=28 Days), until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.'}, {'id': 'OG002', 'title': 'DES (Cohort 1C): 60 mg Cobimetinib + 720 mg Vemurafenib', 'description': 'Participants received oral 60 mg cobimetinib QD on 28/0 dosing schedule and oral 720 mg vemurafenib BID on Days 1-28 of every cycle (1 Cycle=28 Days), until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.'}, {'id': 'OG003', 'title': 'DES (Cohort 1D): 60 mg Cobimetinib + 960 mg Vemurafenib', 'description': 'Participants received oral 60 mg cobimetinib QD on 28/0 dosing schedule and oral 960 mg vemurafenib BID on Days 1-28 of every cycle (1 Cycle=28 Days), until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.'}, {'id': 'OG004', 'title': 'DES (Cohort 2A): 100 mg Cobimetinib + 720 mg Vemurafenib', 'description': 'Participants received oral 100 mg cobimetinib QD on 14/14 dosing schedule and oral 720 mg vemurafenib BID on Days 1-28 of every cycle (1 Cycle=28 Days), until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.'}, {'id': 'OG005', 'title': 'DES (Cohort 4): 80 mg Cobimetinib + 960 mg Vemurafenib', 'description': 'Participants received oral 80 mg cobimetinib QD on 14/14 dosing schedule and oral 960 mg vemurafenib BID on Days 1-28 of every cycle (1 Cycle=28 Days), until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.'}, {'id': 'OG006', 'title': 'CES (Cohort 1A): 60 mg Cobimetinib + 720 mg Vemurafenib', 'description': 'Participants received oral 60 mg cobimetinib QD on 21/7 dosing schedule and oral 720 mg vemurafenib BID on Days 1-28 of every cycle (1 Cycle=28 Days), until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.'}, {'id': 'OG007', 'title': 'CES (Cohort 1B): 60 mg Cobimetinib + 960 mg Vemurafenib', 'description': 'Participants received oral 60 mg cobimetinib QD on 21/7 dosing schedule and oral 960 mg vemurafenib BID on Days 1-28 of every cycle (1 Cycle=28 Days), until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.'}], 'classes': [{'categories': [{'measurements': [{'value': '5.2', 'groupId': 'OG000', 'lowerLimit': '4.4', 'upperLimit': '6.0'}, {'value': '4.15', 'groupId': 'OG001', 'lowerLimit': '1.0', 'upperLimit': '6.0'}, {'value': '5.17', 'comment': 'Full range is not applicable as only 1 participant had evaluable data.', 'groupId': 'OG002', 'lowerLimit': 'NA', 'upperLimit': 'NA'}, {'value': '5.33', 'groupId': 'OG003', 'lowerLimit': '2.0', 'upperLimit': '6.2'}, {'value': '2.08', 'comment': 'Full range is not applicable as only 1 participant had evaluable data.', 'groupId': 'OG004', 'lowerLimit': 'NA', 'upperLimit': 'NA'}, {'value': '4.00', 'groupId': 'OG005', 'lowerLimit': '2.0', 'upperLimit': '6.0'}, {'value': '4.00', 'groupId': 'OG006', 'lowerLimit': '2.0', 'upperLimit': '6.0'}, {'value': '4.00', 'groupId': 'OG007', 'lowerLimit': '1.0', 'upperLimit': '24'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Predose (0 hr) on Day 1, 2; 0.5, 1, 2, 4, 6 hr postdose on Day 1', 'unitOfMeasure': 'hours', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'PK population. Here, number of participants analyzed = participants who were BRAFi-naïve participants.'}, {'type': 'PRIMARY', 'title': 'Cmax of Vemurafenib on Day 14, Cycle 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '25', 'groupId': 'OG002'}, {'value': '3', 'groupId': 'OG003'}, {'value': '3', 'groupId': 'OG004'}, {'value': '3', 'groupId': 'OG005'}, {'value': '4', 'groupId': 'OG006'}, {'value': '3', 'groupId': 'OG007'}, {'value': '3', 'groupId': 'OG008'}, {'value': '25', 'groupId': 'OG009'}, {'value': '32', 'groupId': 'OG010'}]}], 'groups': [{'id': 'OG000', 'title': 'DES (Cohort 1): 60 mg Cobimetinib + 720 mg Vemurafenib', 'description': 'Participants received oral 60 mg cobimetinib QD on 14/14 dosing schedule and oral 720 mg vemurafenib BID on Days 1-28 of every cycle (1 Cycle=28 Days), until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.'}, {'id': 'OG001', 'title': 'DES (Cohort 1A): 60 mg Cobimetinib + 720 mg Vemurafenib', 'description': 'Participants received oral 60 mg cobimetinib QD on 21/7 dosing schedule and oral 720 mg vemurafenib BID on Days 1-28 of every cycle (1 Cycle=28 Days), until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.'}, {'id': 'OG002', 'title': 'DES (Cohort 1B): 60 mg Cobimetinib + 960 mg Vemurafenib', 'description': 'Participants received oral 60 mg cobimetinib QD on 21/7 dosing schedule and oral 960 mg vemurafenib BID on Days 1-28 of every cycle (1 Cycle=28 Days), until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.'}, {'id': 'OG003', 'title': 'DES (Cohort 1C): 60 mg Cobimetinib + 720 mg Vemurafenib', 'description': 'Participants received oral 60 mg cobimetinib QD on 28/0 dosing schedule and oral 720 mg vemurafenib BID on Days 1-28 of every cycle (1 Cycle=28 Days), until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.'}, {'id': 'OG004', 'title': 'DES (Cohort 1D): 60 mg Cobimetinib + 960 mg Vemurafenib', 'description': 'Participants received oral 60 mg cobimetinib QD on 28/0 dosing schedule and oral 960 mg vemurafenib BID on Days 1-28 of every cycle (1 Cycle=28 Days), until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.'}, {'id': 'OG005', 'title': 'DES (Cohort 2): 80 mg Cobimetinib + 720 mg Vemurafenib', 'description': 'Participants received oral 80 mg cobimetinib QD on 14/14 dosing schedule and oral 720 mg vemurafenib BID on Days 1-28 of every cycle (1 Cycle=28 Days), until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.'}, {'id': 'OG006', 'title': 'DES (Cohort 2A): 100 mg Cobimetinib + 720 mg Vemurafenib', 'description': 'Participants received oral 100 mg cobimetinib QD on 14/14 dosing schedule and oral 720 mg vemurafenib BID on Days 1-28 of every cycle (1 Cycle=28 Days), until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.'}, {'id': 'OG007', 'title': 'DES (Cohort 3): 60 mg Cobimetinib + 960 mg Vemurafenib', 'description': 'Participants received oral 60 mg cobimetinib QD on 14/14 dosing schedule and oral 960 mg vemurafenib BID on Days 1-28 of every cycle (1 Cycle=28 Days), until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.'}, {'id': 'OG008', 'title': 'DES (Cohort 4): 80 mg Cobimetinib + 960 mg Vemurafenib', 'description': 'Participants received oral 80 mg cobimetinib QD on 14/14 dosing schedule and oral 960 mg vemurafenib BID on Days 1-28 of every cycle (1 Cycle=28 Days), until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.'}, {'id': 'OG009', 'title': 'CES (Cohort 1A): 60 mg Cobimetinib + 720 mg Vemurafenib', 'description': 'Participants received oral 60 mg cobimetinib QD on 21/7 dosing schedule and oral 720 mg vemurafenib BID on Days 1-28 of every cycle (1 Cycle=28 Days), until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.'}, {'id': 'OG010', 'title': 'CES (Cohort 1B): 60 mg Cobimetinib + 960 mg Vemurafenib', 'description': 'Participants received oral 60 mg cobimetinib QD on 21/7 dosing schedule and oral 960 mg vemurafenib BID on Days 1-28 of every cycle (1 Cycle=28 Days), until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.'}], 'classes': [{'categories': [{'measurements': [{'value': '34.7', 'spread': '41', 'groupId': 'OG000'}, {'value': '29.4', 'spread': '25', 'groupId': 'OG001'}, {'value': '43.7', 'spread': '37', 'groupId': 'OG002'}, {'value': '31.7', 'spread': '42', 'groupId': 'OG003'}, {'value': '51.3', 'spread': '14', 'groupId': 'OG004'}, {'value': '43.6', 'spread': '45', 'groupId': 'OG005'}, {'value': '30.6', 'spread': '53', 'groupId': 'OG006'}, {'value': '40.9', 'spread': '20', 'groupId': 'OG007'}, {'value': '33.7', 'spread': '16', 'groupId': 'OG008'}, {'value': '33.3', 'spread': '58', 'groupId': 'OG009'}, {'value': '36.3', 'spread': '29', 'groupId': 'OG010'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Predose (0 hr) on Days 14, 15; 0.5, 1, 2, 4, 6, 8 hr postdose on Day 14', 'unitOfMeasure': 'mcg/mL', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'PK population. Here, number of participants analyzed = participants who were evaluable for this outcome.'}, {'type': 'PRIMARY', 'title': 'Tmax of Vemurafenib on Day 14, Cycle 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '25', 'groupId': 'OG002'}, {'value': '3', 'groupId': 'OG003'}, {'value': '3', 'groupId': 'OG004'}, {'value': '3', 'groupId': 'OG005'}, {'value': '4', 'groupId': 'OG006'}, {'value': '3', 'groupId': 'OG007'}, {'value': '3', 'groupId': 'OG008'}, {'value': '25', 'groupId': 'OG009'}, {'value': '32', 'groupId': 'OG010'}]}], 'groups': [{'id': 'OG000', 'title': 'DES (Cohort 1): 60 mg Cobimetinib + 720 mg Vemurafenib', 'description': 'Participants received oral 60 mg cobimetinib QD on 14/14 dosing schedule and oral 720 mg vemurafenib BID on Days 1-28 of every cycle (1 Cycle=28 Days), until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.'}, {'id': 'OG001', 'title': 'DES (Cohort 1A): 60 mg Cobimetinib + 720 mg Vemurafenib', 'description': 'Participants received oral 60 mg cobimetinib QD on 21/7 dosing schedule and oral 720 mg vemurafenib BID on Days 1-28 of every cycle (1 Cycle=28 Days), until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.'}, {'id': 'OG002', 'title': 'DES (Cohort 1B): 60 mg Cobimetinib + 960 mg Vemurafenib', 'description': 'Participants received oral 60 mg cobimetinib QD on 21/7 dosing schedule and oral 960 mg vemurafenib BID on Days 1-28 of every cycle (1 Cycle=28 Days), until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.'}, {'id': 'OG003', 'title': 'DES (Cohort 1C): 60 mg Cobimetinib + 720 mg Vemurafenib', 'description': 'Participants received oral 60 mg cobimetinib QD on 28/0 dosing schedule and oral 720 mg vemurafenib BID on Days 1-28 of every cycle (1 Cycle=28 Days), until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.'}, {'id': 'OG004', 'title': 'DES (Cohort 1D): 60 mg Cobimetinib + 960 mg Vemurafenib', 'description': 'Participants received oral 60 mg cobimetinib QD on 28/0 dosing schedule and oral 960 mg vemurafenib BID on Days 1-28 of every cycle (1 Cycle=28 Days), until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.'}, {'id': 'OG005', 'title': 'DES (Cohort 2): 80 mg Cobimetinib + 720 mg Vemurafenib', 'description': 'Participants received oral 80 mg cobimetinib QD on 14/14 dosing schedule and oral 720 mg vemurafenib BID on Days 1-28 of every cycle (1 Cycle=28 Days), until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.'}, {'id': 'OG006', 'title': 'DES (Cohort 2A): 100 mg Cobimetinib + 720 mg Vemurafenib', 'description': 'Participants received oral 100 mg cobimetinib QD on 14/14 dosing schedule and oral 720 mg vemurafenib BID on Days 1-28 of every cycle (1 Cycle=28 Days), until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.'}, {'id': 'OG007', 'title': 'DES (Cohort 3): 60 mg Cobimetinib + 960 mg Vemurafenib', 'description': 'Participants received oral 60 mg cobimetinib QD on 14/14 dosing schedule and oral 960 mg vemurafenib BID on Days 1-28 of every cycle (1 Cycle=28 Days), until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.'}, {'id': 'OG008', 'title': 'DES (Cohort 4): 80 mg Cobimetinib + 960 mg Vemurafenib', 'description': 'Participants received oral 80 mg cobimetinib QD on 14/14 dosing schedule and oral 960 mg vemurafenib BID on Days 1-28 of every cycle (1 Cycle=28 Days), until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.'}, {'id': 'OG009', 'title': 'CES (Cohort 1A): 60 mg Cobimetinib + 720 mg Vemurafenib', 'description': 'Participants received oral 60 mg cobimetinib QD on 21/7 dosing schedule and oral 720 mg vemurafenib BID on Days 1-28 of every cycle (1 Cycle=28 Days), until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.'}, {'id': 'OG010', 'title': 'CES (Cohort 1B): 60 mg Cobimetinib + 960 mg Vemurafenib', 'description': 'Participants received oral 60 mg cobimetinib QD on 21/7 dosing schedule and oral 960 mg vemurafenib BID on Days 1-28 of every cycle (1 Cycle=28 Days), until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.'}], 'classes': [{'categories': [{'measurements': [{'value': '1.98', 'groupId': 'OG000', 'lowerLimit': '0.0', 'upperLimit': '7.7'}, {'value': '2.15', 'groupId': 'OG001', 'lowerLimit': '0.0', 'upperLimit': '7.3'}, {'value': '1.95', 'groupId': 'OG002', 'lowerLimit': '0.0', 'upperLimit': '8.0'}, {'value': '1.98', 'groupId': 'OG003', 'lowerLimit': '0.3', 'upperLimit': '6.5'}, {'value': '0.33', 'groupId': 'OG004', 'lowerLimit': '0.2', 'upperLimit': '8.2'}, {'value': '5.6', 'groupId': 'OG005', 'lowerLimit': '1.7', 'upperLimit': '5.6'}, {'value': '1.05', 'groupId': 'OG006', 'lowerLimit': '0.0', 'upperLimit': '6.4'}, {'value': '1.83', 'groupId': 'OG007', 'lowerLimit': '0.8', 'upperLimit': '4.4'}, {'value': '1.85', 'groupId': 'OG008', 'lowerLimit': '0.1', 'upperLimit': '4.0'}, {'value': '1.17', 'groupId': 'OG009', 'lowerLimit': '0.0', 'upperLimit': '7.9'}, {'value': '1.90', 'groupId': 'OG010', 'lowerLimit': '0.0', 'upperLimit': '7.6'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Predose (0 hr) on Days 14, 15; 0.5, 1, 2, 4, 6, 8 hr postdose on Day 14', 'unitOfMeasure': 'hours', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'PK population. Here, number of participants analyzed = participants who were evaluable for this outcome.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With an Objective Response of Complete Response (CR) or Partial Response (PR) According to Response Evaluation Criteria in Solid Tumors (RECIST) Version (V) 1.1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '66', 'groupId': 'OG000'}, {'value': '63', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Vemurafenib PD Participants', 'description': 'All participants who progressed on vemurafenib monotherapy immediately prior to enrollment into this study were treated with vemurafenib in combination with cobimetinib at a particular dose combination and dosing schedule depending on the cohort in which they were enrolled until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.'}, {'id': 'OG001', 'title': 'BRAFi-naïve Participants', 'description': 'All participants who were previously untreated or previously treated but naïve to BRAF or MEK inhibitor therapy were considered as BRAFi-naïve participants. These participants were treated with vemurafenib in combination with cobimetinib at a particular dose combination and dosing schedule depending on the cohort in which they were enrolled until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.'}], 'classes': [{'categories': [{'measurements': [{'value': '15.2', 'groupId': 'OG000', 'lowerLimit': '7.5', 'upperLimit': '25.5'}, {'value': '87.3', 'groupId': 'OG001', 'lowerLimit': '76.7', 'upperLimit': '94.4'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Assessed at screening (within 28 days prior to initiation of Cycle 1), every 6 weeks thereafter until disease progression (up to 82 months)', 'description': 'Tumor response of CR or PR is considered as objective response. CR: disappearance of all target lesions, reduction in short axis \\<10 millimeters in pathological lymph nodes (target and non-target lesions); PR: at least a 30 percent (%) decrease in the sum of the longest diameter of target lesions, taking as reference the baseline sum longest diameter. Responses were confirmed by repeat assessments ≥4 weeks after initial documentation.', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Efficacy evaluable population who had measurable disease at baseline and had either a post-baseline tumour assessment or progressed before any tumour assessment was included in the analysis of this outcome.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With Disease Progression According to RECIST V 1.1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '66', 'groupId': 'OG000'}, {'value': '63', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Vemurafenib PD Participants', 'description': 'All participants who progressed on vemurafenib monotherapy immediately prior to enrollment into this study were treated with vemurafenib in combination with cobimetinib at a particular dose combination and dosing schedule depending on the cohort in which they were enrolled until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.'}, {'id': 'OG001', 'title': 'BRAFi-naïve Participants', 'description': 'All participants who were previously untreated or previously treated but naïve to BRAF or MEK inhibitor therapy were considered as BRAFi-naïve participants. These participants were treated with vemurafenib in combination with cobimetinib at a particular dose combination and dosing schedule depending on the cohort in which they were enrolled until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.'}], 'classes': [{'categories': [{'measurements': [{'value': '36.4', 'groupId': 'OG000'}, {'value': '3.2', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Assessed at screening (within 28 days prior to initiation of Cycle 1), every 6 weeks thereafter until disease progression or death (up to 82 months)', 'description': 'Progressive disease (PD) according to RECIST V 1.1: at least a 20% increase in the sum of the longest diameter of target lesions, taking as reference the smallest sum on study (nadir), including baseline; in addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm; appearance of 1 or more lesions is also considered as progression.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Efficacy evaluable population who had measurable disease at baseline and had either a post-baseline tumour assessment or progressed before any tumour assessment was included in the analysis of this outcome.'}, {'type': 'SECONDARY', 'title': 'Median Duration of Response (DOR)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '55', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Vemurafenib PD Participants', 'description': 'All participants who progressed on vemurafenib monotherapy immediately prior to enrollment into this study were treated with vemurafenib in combination with cobimetinib at a particular dose combination and dosing schedule depending on the cohort in which they were enrolled until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.'}, {'id': 'OG001', 'title': 'BRAFi-naïve Participants', 'description': 'All participants who were previously untreated or previously treated but naïve to BRAF or MEK inhibitor therapy were considered as BRAFi-naïve participants. These participants were treated with vemurafenib in combination with cobimetinib at a particular dose combination and dosing schedule depending on the cohort in which they were enrolled until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.'}], 'classes': [{'categories': [{'measurements': [{'value': '6.8', 'groupId': 'OG000', 'lowerLimit': '4.9', 'upperLimit': '10.4'}, {'value': '14.3', 'groupId': 'OG001', 'lowerLimit': '9.7', 'upperLimit': '23'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Time from first occurrence of objective response until the time of disease progression or death from any cause (up to 82 months)', 'description': 'Duration of response, defined as the time from first occurrence of a documented objective response until the time of disease progression, as determined by investigator review of tumor assessments using RECIST v 1.1, or death from any cause during the study (that is within 30 days after the last dose of study treatment).', 'unitOfMeasure': 'months', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Efficacy evaluable population who had measurable disease at baseline and had either a post-baseline tumour assessment or progressed before any tumour assessment was included in the analysis of this outcome. Number of participants analysed who were evaluated for this outcome measure.'}, {'type': 'SECONDARY', 'title': 'Overall Survival (OS)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '66', 'groupId': 'OG000'}, {'value': '63', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Vemurafenib PD Participants', 'description': 'All participants who progressed on vemurafenib monotherapy immediately prior to enrollment into this study were treated with vemurafenib in combination with cobimetinib at a particular dose combination and dosing schedule depending on the cohort in which they were enrolled until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.'}, {'id': 'OG001', 'title': 'BRAFi-naïve Participants', 'description': 'All participants who were previously untreated or previously treated but naïve to BRAF or MEK inhibitor therapy were considered as BRAFi-naïve participants. These participants were treated with vemurafenib in combination with cobimetinib at a particular dose combination and dosing schedule depending on the cohort in which they were enrolled until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.'}], 'classes': [{'categories': [{'measurements': [{'value': '8.5', 'groupId': 'OG000', 'lowerLimit': '1.6', 'upperLimit': '76.4'}, {'value': '31.8', 'groupId': 'OG001', 'lowerLimit': '2.7', 'upperLimit': '69.2'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Assessed at screening (within 28 days prior to initiation of Cycle 1), every 6 weeks thereafter until disease progression or death (up to 82 months)', 'description': 'OS was defined as the time from the date of randomization to the date of death due to any cause. Participants were censored at the last date of tumor measurement, the last date in the study drug log, or the date of last follow-up. OS analyzed using Kaplan-Meier estimate.', 'unitOfMeasure': 'months', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Efficacy evaluable population who had measurable disease at baseline and had either a post-baseline tumour assessment or progressed before any tumour assessment was included in the analysis of this outcome.'}, {'type': 'SECONDARY', 'title': 'Average Percent Change From Baseline in Fluorodeoxyglucose-positron Emission Tomography (FDG-PET) at Cycle 1 and Cycle 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '63', 'groupId': 'OG000'}, {'value': '63', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Vemurafenib PD Participants', 'description': 'All participants who progressed on vemurafenib monotherapy immediately prior to enrollment into this study were treated with vemurafenib in combination with cobimetinib at a particular dose combination and dosing schedule depending on the cohort in which they were enrolled until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.'}, {'id': 'OG001', 'title': 'BRAFi-naïve Participants', 'description': 'All participants who were previously untreated or previously treated but naïve to BRAF or MEK inhibitor therapy were considered as BRAFi-naïve participants. These participants were treated with vemurafenib in combination with cobimetinib at a particular dose combination and dosing schedule depending on the cohort in which they were enrolled until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.'}], 'classes': [{'title': 'Baseline (n=63,63)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '63', 'groupId': 'OG000'}, {'value': '63', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '8.75', 'spread': '5.55', 'groupId': 'OG000'}, {'value': '8.19', 'spread': '5.00', 'groupId': 'OG001'}]}]}, {'title': 'Percent Change at Cycle 1 (Days 10-14) (n=59,60)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '59', 'groupId': 'OG000'}, {'value': '60', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-43.33', 'spread': '26.00', 'groupId': 'OG000'}, {'value': '-65.74', 'spread': '14.82', 'groupId': 'OG001'}]}]}, {'title': 'Percent Change at Cycle 2 (Days 14+7) (n=50,56)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '50', 'groupId': 'OG000'}, {'value': '56', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-33.09', 'spread': '35.18', 'groupId': 'OG000'}, {'value': '-70.73', 'spread': '17.05', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Cycle 1 (Days 10 to 14), Cycle 2 (Days 14+7)', 'description': 'The pharmacodynamic effect of cobimetinib in combination with vemurafenib was assessed by measuring changes in FDG uptake as characterized by the lean body mass corrected (LBM) maximum standardized uptake value (SUV max) measurement using FDG-PET. Post-baseline timepoint Cycle 1 was averaged between Days 10 to 14 and Cycle 2 for Days 14+7.', 'unitOfMeasure': 'Percent change in FDG-PET', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety evaluable population who received combination study treatment (Cobimetinib + Vemurafenib) was included in the analysis of this outcome. Here, number of participants analyzed = participants who were evaluable for this outcome.'}, {'type': 'SECONDARY', 'title': 'Pharmacodynamics: Number of Participants With Mitogen-Activated Protein Kinase (MAPK) Inhibition, as Assessed by Immunohistochemistry (IHC)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Vemurafenib PD Participants', 'description': 'All participants who progressed on vemurafenib monotherapy immediately prior to enrollment into this study were treated with vemurafenib in combination with cobimetinib at a particular dose combination and dosing schedule depending on the cohort in which they were enrolled until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.'}, {'id': 'OG001', 'title': 'BRAFi-naïve Participants', 'description': 'All participants who were previously untreated or previously treated but naïve to BRAF or MEK inhibitor therapy were considered as BRAFi-naïve participants. These participants were treated with vemurafenib in combination with cobimetinib at a particular dose combination and dosing schedule depending on the cohort in which they were enrolled until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.'}], 'classes': [{'categories': [{'measurements': [{'value': '7', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'At baseline; Cycle 1: Day 14; at disease progression (Up to 32 months)', 'description': 'Changes in effector molecules of the MAPK pathway that are directly or indirectly affected by BRAF and MEK inhibition (including but not limited to ERK and phosphorylated ERK and MEK) by IHC using biopsies at baseline, between Days 10-14 of Cycle 1, and at disease progression. IHC is a staining process performed on fresh/frozen tumor tissue samples.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Number of participants analyzed=number of participants available for analysis of this outcome measure.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Vemurafenib PD Participants', 'description': 'All participants who progressed on vemurafenib monotherapy immediately prior to enrollment into this study were treated with vemurafenib in combination with cobimetinib at a particular dose combination and dosing schedule depending on the cohort in which they were enrolled until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.'}, {'id': 'FG001', 'title': 'BRAFi-naïve Participants', 'description': 'All participants who were previously untreated or previously treated but naïve to BRAF or MEK inhibitor therapy were considered as BRAFi-naïve participants. These participants were treated with vemurafenib in combination with cobimetinib at a particular dose combination and dosing schedule depending on the cohort in which they were enrolled until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.'}, {'id': 'FG002', 'title': 'Cobimetinib Monotherapy (100 mg or 60 mg)', 'description': 'Participants received oral 60 mg cobimetinib QD on 21/7 dosing schedule, or oral 100 mg cobimetinib QD on 14/14 dosing schedule of every cycle (1 Cycle=28 Days), until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '66'}, {'groupId': 'FG001', 'numSubjects': '63'}, {'groupId': 'FG002', 'numSubjects': '2'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '11'}, {'groupId': 'FG001', 'numSubjects': '24'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '55'}, {'groupId': 'FG001', 'numSubjects': '39'}, {'groupId': 'FG002', 'numSubjects': '2'}]}], 'dropWithdraws': [{'type': 'Progressive disease', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '2'}]}, {'type': 'Death', 'reasons': [{'groupId': 'FG000', 'numSubjects': '53'}, {'groupId': 'FG001', 'numSubjects': '34'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '5'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}]}]}], 'recruitmentDetails': 'Study included two stages. Stage 1: dose escalation stage (DES), consisted of 9 "Cobimetinib + Vemurafenib" combination arms and 1 Cobimetinib monotherapy. Stage 2: cohort expansion stage (CES), consisted of 2 "Cobimetinib + Vemurafenib" combination arms, treated with recommended phase 2 dose.', 'preAssignmentDetails': 'Participants data were pooled across dose/regimen cohorts from two stages and analyzed separately per final analysis for vemurafenib-PD and BRAFi-naive participants who received cobimetinib and vemurafenib. Data is presented based on the final CSR. As of 2017 per-cohort data were not collected'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '66', 'groupId': 'BG000'}, {'value': '63', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}, {'value': '131', 'groupId': 'BG003'}]}], 'groups': [{'id': 'BG000', 'title': 'Vemurafenib PD Participants', 'description': 'All participants who progressed on vemurafenib monotherapy immediately prior to enrollment into this study were treated with vemurafenib in combination with cobimetinib at a particular dose combination and dosing schedule depending on the cohort in which they were enrolled until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.'}, {'id': 'BG001', 'title': 'BRAFi-naïve Participants', 'description': 'All participants who were previously untreated or previously treated but naïve to BRAF or MEK inhibitor therapy were considered as BRAFi-naïve participants. These participants were treated with vemurafenib in combination with cobimetinib at a particular dose combination and dosing schedule depending on the cohort in which they were enrolled until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.'}, {'id': 'BG002', 'title': 'Cobimetinib Monotherapy (100 mg or 60 mg)', 'description': 'Participants received oral 60 mg cobimetinib QD on 21/7 dosing schedule, or oral 100 mg cobimetinib QD on 14/14 dosing schedule of every cycle (1 Cycle=28 Days), until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.'}, {'id': 'BG003', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '53.0', 'spread': '14.8', 'groupId': 'BG000'}, {'value': '54.0', 'spread': '13.0', 'groupId': 'BG001'}, {'value': '62.5', 'spread': '9.2', 'groupId': 'BG002'}, {'value': '53.6', 'spread': '13.9', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '24', 'groupId': 'BG000'}, {'value': '28', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '53', 'groupId': 'BG003'}]}, {'title': 'Male', 'measurements': [{'value': '42', 'groupId': 'BG000'}, {'value': '35', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '78', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}], 'populationDescription': 'Demographic data was not reported across dose/regimen cohort per final analysis, as it was pooled across separately for vemurafenib-PD and BRAFi-naive participants who received cobimetinib and vemurafenib. Data is presented based on the final CSR. As of 2017 per-cohort data were not collected'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2016-10-20', 'size': 2820198, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2019-03-19T10:21', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 131}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-02-17', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-07', 'completionDateStruct': {'date': '2017-12-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-07-26', 'studyFirstSubmitDate': '2011-01-05', 'resultsFirstSubmitDate': '2016-05-11', 'studyFirstSubmitQcDate': '2011-01-05', 'lastUpdatePostDateStruct': {'date': '2019-07-29', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2016-05-11', 'studyFirstPostDateStruct': {'date': '2011-01-07', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2016-06-17', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-10-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of Participants With Dose-Limiting Toxicities (DLTs) During DES in Combination Cohorts', 'timeFrame': '28 Days', 'description': 'DLT is defined as 1 of the following toxicities considered by the investigator to be related to study treatment: a) Grade 3 nausea, vomiting or diarrhea that resolved to Grade less than or equal to (≤) 1 within 7 days, b) Grade 3 rash or photosensitivity that resolved to Grade ≤2 within 7 days, c) Grade 3 cutaneous squamous cell carcinoma (cuSCC) that was subsequently resected, d) Grade greater than or equal to (≥) 3 fatigue or hyperuricemia that resolved to Grade ≤2 within 7 days, e) Grade 3 fever, f) Grade 3 or 4 elevation of serum creatine phosphokinase (CPK) levels, which is asymptomatic, deemed by the investigator to be clinically insignificant and that returned to Grade ≤2 during the 14-day cobimetinib treatment holiday, g) Grade ≥3 febrile neutropenia, h) Grade ≥4 neutropenia (absolute neutrophil count \\[ANC\\] less than \\<500/microliter \\[μL\\]), i) Grade ≥4 thrombocytopenia, j) Grade ≥4 anemia, k) Grade ≥3 elevation of total bilirubin, hepatic transaminase or alkaline phosphatase.'}, {'measure': 'Maximum Tolerated Doses (MTD) of Vemurafenib and Cobimetinib When Administered in Combination in DES', 'timeFrame': '28 Days', 'description': 'The highest dose level(s) at which fewer than one-third of participants experienced a DLT was declared the MTD. DLT is defined as 1 of the following toxicities considered by the investigator to be related to study treatment: a) Grade 3 nausea, vomiting or diarrhea that resolved to Grade ≤1 within 7 days, b) Grade 3 rash/photosensitivity that resolved to Grade ≤2 within 7 days, c) Grade 3 cuSCC that was subsequently resected, d) Grade ≥3 fatigue/hyperuricemia that resolved to Grade ≤2 within 7 days, e) Grade 3 fever, f) Grade 3 or 4 elevation of serum CPK levels, which is asymptomatic, deemed to be clinically insignificant and returns to Grade ≤2 during the 14-day cobimetinib treatment holiday, g) Grade ≥3 febrile neutropenia, h) Grade ≥4 neutropenia (ANC \\<500/ μL), i) Grade ≥4 thrombocytopenia, j) Grade ≥4 anemia, k) Grade ≥3 elevation of total bilirubin, hepatic transaminase or alkaline phosphatase.'}, {'measure': 'Maximum Plasma Concentration (Cmax) of Cobimetinib on Day 1, Cycle 1', 'timeFrame': 'Cycle 1: predose (0 hours [hr]) on Days 1, 2; 0.5, 1, 2, 4, 6 hr postdose on Day 1'}, {'measure': 'Cmax of Cobimetinib on Day 1, Cycle 1 in Cohort 3', 'timeFrame': 'Cycle 1: predose (0 hr) on Days 1, 2; 0.5, 1, 2, 4, 6 hr postdose on Day 1'}, {'measure': 'Time Taken to Reach Maximum Plasma Concentration (Tmax) of Cobimetinib on Day 1, Cycle 1', 'timeFrame': 'Cycle 1: predose (0 hr) on Days 1, 2; 0.5, 1, 2, 4, 6 hr postdose on Day 1'}, {'measure': 'Area Under Concentration Versus Time Curve (AUC) Over a Period of 24 Hours (AUC0-24) of Cobimetinib on Day 1, Cycle 1', 'timeFrame': 'Cycle 1: predose (0 hr) on Days 1, 2; 0.5, 1, 2, 4, 6 hr postdose on Day 1'}, {'measure': 'AUC0-24 of Cobimetinib on Day 1, Cycle 1 of Cohort 3', 'timeFrame': 'Cycle 1: predose (0 hr) on Days 1, 2; 0.5, 1, 2, 4, 6 hr postdose on Day 1'}, {'measure': 'Cmax of Cobimetinib on Day 14 (Steady State), Cycle 1', 'timeFrame': 'Cycle 1: predose (0 hr) on Days 8, 14; 0.5, 1, 2, 4, 6 hr postdose on Day 14'}, {'measure': 'Tmax of Cobimetinib on Day 14 (Steady State), Cycle 1', 'timeFrame': 'Cycle 1: predose (0 hr) on Days 8, 14; 0.5, 1, 2, 4, 6 hr postdose on Day 14'}, {'measure': 'AUC0-24 of Cobimetinib on Day 14, Cycle 1', 'timeFrame': 'Cycle 1: predose (0 hr) on Days 8, 14; 0.5, 1, 2, 4, 6 hr postdose on Day 14'}, {'measure': 'Clearance (CL) of Cobimetinib on Day 14 (Steady State), Cycle 1', 'timeFrame': 'Cycle 1: predose (0 hr) on Days 8, 14; 0.5, 1, 2, 4, 6 hr postdose on Day 14', 'description': 'Clearance of a drug is a measure of the rate at which a drug is metabolized or eliminated by normal biological processes.'}, {'measure': 'Cmax of Vemurafenib on Day -1, Cycle 1 in Participants Previously Treated With Vemurafenib Prior to Enrollment Into This Study', 'timeFrame': 'Predose (0 hr) on Days -1, 1; 2, 4, 6, 8 hr postdose on Day -1'}, {'measure': 'Cmax of Vemurafenib on Day -1, Cycle 1 of Cohorts 1C and 2A in Participants Previously Treated With Vemurafenib Prior to Enrollment Into This Study', 'timeFrame': 'Predose (0 hr) on Day -1, 1; 2, 4, 6, 8 hr postdose on Day -1'}, {'measure': 'Tmax of Vemurafenib on Day -1, Cycle 1 in Participants Previously Treated With Vemurafenib Prior to Enrollment Into This Study', 'timeFrame': 'Predose (0 hr) on Day -1, 1; 2, 4, 6, 8 hr postdose on Day -1'}, {'measure': 'Cmax of Vemurafenib on Day 1, Cycle 1 in BRAFi-naïve Participants', 'timeFrame': 'Predose (0 hr) on Day 1, 2; 0.5, 1, 2, 4, 6 hr postdose on Day 1'}, {'measure': 'Cmax of Vemurafenib on Day 1, Cycle 1 in Cohort 1A in BRAFi-naïve Participants', 'timeFrame': 'Predose (0 hr) on Day 1, 2; 0.5, 1, 2, 4, 6 hr postdose on Day 1'}, {'measure': 'Tmax of Vemurafenib on Day 1, Cycle 1 in BRAFi-naïve Participants', 'timeFrame': 'Predose (0 hr) on Day 1, 2; 0.5, 1, 2, 4, 6 hr postdose on Day 1'}, {'measure': 'Cmax of Vemurafenib on Day 14, Cycle 1', 'timeFrame': 'Predose (0 hr) on Days 14, 15; 0.5, 1, 2, 4, 6, 8 hr postdose on Day 14'}, {'measure': 'Tmax of Vemurafenib on Day 14, Cycle 1', 'timeFrame': 'Predose (0 hr) on Days 14, 15; 0.5, 1, 2, 4, 6, 8 hr postdose on Day 14'}], 'secondaryOutcomes': [{'measure': 'Percentage of Participants With an Objective Response of Complete Response (CR) or Partial Response (PR) According to Response Evaluation Criteria in Solid Tumors (RECIST) Version (V) 1.1', 'timeFrame': 'Assessed at screening (within 28 days prior to initiation of Cycle 1), every 6 weeks thereafter until disease progression (up to 82 months)', 'description': 'Tumor response of CR or PR is considered as objective response. CR: disappearance of all target lesions, reduction in short axis \\<10 millimeters in pathological lymph nodes (target and non-target lesions); PR: at least a 30 percent (%) decrease in the sum of the longest diameter of target lesions, taking as reference the baseline sum longest diameter. Responses were confirmed by repeat assessments ≥4 weeks after initial documentation.'}, {'measure': 'Percentage of Participants With Disease Progression According to RECIST V 1.1', 'timeFrame': 'Assessed at screening (within 28 days prior to initiation of Cycle 1), every 6 weeks thereafter until disease progression or death (up to 82 months)', 'description': 'Progressive disease (PD) according to RECIST V 1.1: at least a 20% increase in the sum of the longest diameter of target lesions, taking as reference the smallest sum on study (nadir), including baseline; in addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm; appearance of 1 or more lesions is also considered as progression.'}, {'measure': 'Median Duration of Response (DOR)', 'timeFrame': 'Time from first occurrence of objective response until the time of disease progression or death from any cause (up to 82 months)', 'description': 'Duration of response, defined as the time from first occurrence of a documented objective response until the time of disease progression, as determined by investigator review of tumor assessments using RECIST v 1.1, or death from any cause during the study (that is within 30 days after the last dose of study treatment).'}, {'measure': 'Overall Survival (OS)', 'timeFrame': 'Assessed at screening (within 28 days prior to initiation of Cycle 1), every 6 weeks thereafter until disease progression or death (up to 82 months)', 'description': 'OS was defined as the time from the date of randomization to the date of death due to any cause. Participants were censored at the last date of tumor measurement, the last date in the study drug log, or the date of last follow-up. OS analyzed using Kaplan-Meier estimate.'}, {'measure': 'Average Percent Change From Baseline in Fluorodeoxyglucose-positron Emission Tomography (FDG-PET) at Cycle 1 and Cycle 2', 'timeFrame': 'Cycle 1 (Days 10 to 14), Cycle 2 (Days 14+7)', 'description': 'The pharmacodynamic effect of cobimetinib in combination with vemurafenib was assessed by measuring changes in FDG uptake as characterized by the lean body mass corrected (LBM) maximum standardized uptake value (SUV max) measurement using FDG-PET. Post-baseline timepoint Cycle 1 was averaged between Days 10 to 14 and Cycle 2 for Days 14+7.'}, {'measure': 'Pharmacodynamics: Number of Participants With Mitogen-Activated Protein Kinase (MAPK) Inhibition, as Assessed by Immunohistochemistry (IHC)', 'timeFrame': 'At baseline; Cycle 1: Day 14; at disease progression (Up to 32 months)', 'description': 'Changes in effector molecules of the MAPK pathway that are directly or indirectly affected by BRAF and MEK inhibition (including but not limited to ERK and phosphorylated ERK and MEK) by IHC using biopsies at baseline, between Days 10-14 of Cycle 1, and at disease progression. IHC is a staining process performed on fresh/frozen tumor tissue samples.'}]}, 'conditionsModule': {'conditions': ['Malignant Melanoma']}, 'referencesModule': {'references': [{'pmid': '32746839', 'type': 'DERIVED', 'citation': 'Ascierto PA, Ribas A, Larkin J, McArthur GA, Lewis KD, Hauschild A, Flaherty KT, McKenna E, Zhu Q, Mun Y, Dreno B. Impact of initial treatment and prognostic factors on postprogression survival in BRAF-mutated metastatic melanoma treated with dacarbazine or vemurafenib +/- cobimetinib: a pooled analysis of four clinical trials. J Transl Med. 2020 Aug 3;18(1):294. doi: 10.1186/s12967-020-02458-x.'}, {'pmid': '25037139', 'type': 'DERIVED', 'citation': 'Ribas A, Gonzalez R, Pavlick A, Hamid O, Gajewski TF, Daud A, Flaherty L, Logan T, Chmielowski B, Lewis K, Kee D, Boasberg P, Yin M, Chan I, Musib L, Choong N, Puzanov I, McArthur GA. Combination of vemurafenib and cobimetinib in patients with advanced BRAF(V600)-mutated melanoma: a phase 1b study. Lancet Oncol. 2014 Aug;15(9):954-65. doi: 10.1016/S1470-2045(14)70301-8. Epub 2014 Jul 15.'}, {'pmid': '22651703', 'type': 'DERIVED', 'citation': 'Baudy AR, Dogan T, Flores-Mercado JE, Hoeflich KP, Su F, van Bruggen N, Williams SP. FDG-PET is a good biomarker of both early response and acquired resistance in BRAFV600 mutant melanomas treated with vemurafenib and the MEK inhibitor GDC-0973. EJNMMI Res. 2012 May 31;2(1):22. doi: 10.1186/2191-219X-2-22.'}]}, 'descriptionModule': {'briefSummary': 'This open-label, dose-escalation study of vemurafenib in combination with cobimetinib will evaluate the safety, tolerability and pharmacokinetics in participants with BRAFV600 mutation-positive metastatic melanoma. Participants with previously untreated, BRAFV600E mutation-positive, locally advanced/unresectable or metastatic melanoma or those who have progressed on vemurafenib monotherapy immediately prior to enrolling in this trial are eligible. Participants will be assigned to different cohorts with escalating oral doses of vemurafenib and cobimetinib. This study consists of 2 stages, Stage 1 (Dose Escalation Stage \\[DES\\] and Cohort Expansion Stage \\[CES\\]) and the anticipated time on study treatment is until disease progression, unacceptable toxicity or any other discontinuation criterion is met.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Participants with histologically confirmed melanoma (unresectable Stage IIIc and Stage IV metastatic melanoma, as defined by American Joint Committee on Cancer \\[AJCC\\])\n* Measurable disease per Response Evaluation Criteria in Solid Tumors (RECIST) Version (V) 1.1\n* Eastern Cooperative Oncology Group (ECOG) Performance Status of less than or equal to (\\</=) 1\n* Participants must\n\n 1. be previously untreated for locally advanced/unresectable or metastatic melanoma or\n 2. previously treated but without prior exposure to any BRAF or MEK inhibitor therapy or\n 3. progressed on vemurafenib while participating in a Phase I (including clinical pharmacology studies), II, or III clinical study or expanded access programs (EAP) immediately prior to enrollment in this study or\n 4. progressed on vemurafenib administered in a postmarketing setting immediately prior to enrollment in this study.\n* Life expectancy \\>/=12 weeks\n\nExclusion Criteria:\n\n* History of prior significant toxicity from another RAF or MEK pathway inhibitor requiring discontinuation of treatment\n* Palliative radiotherapy within 2 weeks prior to first dose of study drug treatment\n* Experimental therapy within 4 weeks prior to first dose of study drug treatment except vemurafenib\n* Major surgery within 4 weeks of first dose of study drug treatment or planning a major surgery during the study'}, 'identificationModule': {'nctId': 'NCT01271803', 'briefTitle': 'A Study of Vemurafenib and GDC-0973 (Cobimetinib) in Participants With BRAFV600E Mutation-Positive Metastatic Melanoma', 'organization': {'class': 'INDUSTRY', 'fullName': 'Hoffmann-La Roche'}, 'officialTitle': 'A Phase IB, Open-Label, Dose-Escalation Study Evaluating the Safety, Tolerability and Pharmacokinetics of Vemurafenib in Combination With GDC-0973 (Cobimetinib) When Administered in BRAFV600E Mutation-Positive Patients Previously Treated (But Without Prior Exposure to BRAF or MEK Inhibitor Therapy) or Previously Untreated for Locally Advanced/Unresectable or Metastatic Melanoma or Those Who Have Progressed After Treatment With Vemurafenib', 'orgStudyIdInfo': {'id': 'NO25395'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'DES (Cohort 1): 60 mg Cobimetinib + 720 mg Vemurafenib', 'description': 'Participants will receive oral 60 milligrams (mg) cobimetinib once daily (QD) on Days 1-14, followed by 14 days off on Days 15-28 (14/14 dosing schedule) and oral 720 mg vemurafenib twice daily (BID) on Days 1-28 of every cycle (1 Cycle=28 Days), until disease progression, unacceptable toxicity, or any other discontinuation criteria are met.', 'interventionNames': ['Drug: Cobimetinib', 'Drug: vemurafenib']}, {'type': 'EXPERIMENTAL', 'label': 'DES (Cohort 1A): 60 mg Cobimetinib + 720 mg Vemurafenib', 'description': 'Participants will receive oral 60 mg cobimetinib QD on Days 1-21, followed by 7 days off on Days 22-28 (21/7 dosing schedule) and oral 720 mg vemurafenib BID on Days 1-28 of every cycle (1 Cycle=28 Days), until disease progression, unacceptable toxicity, or any other discontinuation criteria are met.', 'interventionNames': ['Drug: Cobimetinib', 'Drug: vemurafenib']}, {'type': 'EXPERIMENTAL', 'label': 'DES (Cohort 1B): 60 mg Cobimetinib + 960 mg Vemurafenib', 'description': 'Participants will receive oral 60 mg cobimetinib QD on 21/7 dosing schedule and oral 960 mg vemurafenib BID on Days 1-28 of every cycle (1 Cycle=28 Days), until disease progression, unacceptable toxicity, or any other discontinuation criteria are met.', 'interventionNames': ['Drug: Cobimetinib', 'Drug: vemurafenib']}, {'type': 'EXPERIMENTAL', 'label': 'DES (Cohort 1C): 60 mg Cobimetinib + 720 mg Vemurafenib', 'description': 'Participants will receive oral 60 mg cobimetinib QD on Days 1-28 (28/0 dosing schedule) and oral 720 mg vemurafenib BID on Days 1-28 of every cycle (1 Cycle=28 Days), until disease progression, unacceptable toxicity, or any other discontinuation criteria are met.', 'interventionNames': ['Drug: Cobimetinib', 'Drug: vemurafenib']}, {'type': 'EXPERIMENTAL', 'label': 'DES (Cohort 1D): 60 mg Cobimetinib + 960 mg Vemurafenib', 'description': 'Participants will receive oral 60 mg cobimetinib QD on 28/0 dosing schedule and oral 960 mg vemurafenib BID on Days 1-28 of every cycle (1 Cycle=28 Days), until disease progression, unacceptable toxicity, or any other discontinuation criteria are met.', 'interventionNames': ['Drug: Cobimetinib', 'Drug: vemurafenib']}, {'type': 'EXPERIMENTAL', 'label': 'DES (Cohort 2): 80 mg Cobimetinib + 720 mg Vemurafenib', 'description': 'Participants will receive oral 80 mg cobimetinib QD on 14/14 dosing schedule and oral 720 mg vemurafenib BID on Days 1-28 of every cycle (1 Cycle=28 Days), until disease progression, unacceptable toxicity, or any other discontinuation criteria are met.', 'interventionNames': ['Drug: Cobimetinib', 'Drug: vemurafenib']}, {'type': 'EXPERIMENTAL', 'label': 'DES (Cohort 2A): 100 mg Cobimetinib + 720 mg Vemurafenib', 'description': 'Participants will receive oral 100 mg cobimetinib QD on 14/14 dosing schedule and oral 720 mg vemurafenib BID on Days 1-28 of every cycle (1 Cycle=28 Days), until disease progression, unacceptable toxicity, or any other discontinuation criteria are met.', 'interventionNames': ['Drug: Cobimetinib', 'Drug: vemurafenib']}, {'type': 'EXPERIMENTAL', 'label': 'DES (Cohort 3): 60 mg Cobimetinib + 960 mg Vemurafenib', 'description': 'Participants will receive oral 60 mg cobimetinib QD on 14/14 dosing schedule and oral 960 mg vemurafenib BID on Days 1-28 of every cycle (1 Cycle=28 Days), until disease progression, unacceptable toxicity, or any other discontinuation criteria are met.', 'interventionNames': ['Drug: Cobimetinib', 'Drug: vemurafenib']}, {'type': 'EXPERIMENTAL', 'label': 'DES (Cohort 4): 80 mg Cobimetinib + 960 mg Vemurafenib', 'description': 'Participants will receive oral 80 mg cobimetinib QD on 14/14 dosing schedule and oral 960 mg vemurafenib BID on Days 1-28 of every cycle (1 Cycle=28 Days), until disease progression, unacceptable toxicity, or any other discontinuation criteria are met.', 'interventionNames': ['Drug: Cobimetinib', 'Drug: vemurafenib']}, {'type': 'EXPERIMENTAL', 'label': 'Cobimetinib Monotherapy (100 mg or 60 mg)', 'description': 'Participants will receive oral 60 mg cobimetinib QD on 21/7 dosing schedule, or oral 100 mg cobimetinib QD on 14/14 dosing schedule of every cycle (1 Cycle=28 Days), until disease progression, unacceptable toxicity, or any other discontinuation criteria are met.', 'interventionNames': ['Drug: Cobimetinib']}, {'type': 'EXPERIMENTAL', 'label': 'CES (Cohort 1A): 60 mg Cobimetinib + 720 mg Vemurafenib', 'description': 'Participants will receive oral 60 mg cobimetinib QD on 21/7 dosing schedule and oral 720 mg vemurafenib BID on Days 1-28 of every cycle (1 Cycle=28 Days), until disease progression, unacceptable toxicity, or any other discontinuation criteria are met.', 'interventionNames': ['Drug: Cobimetinib', 'Drug: vemurafenib']}, {'type': 'EXPERIMENTAL', 'label': 'CES (Cohort 1B): 60 mg Cobimetinib + 960 mg Vemurafenib', 'description': 'Participants will receive oral 60 mg cobimetinib QD on 21/7 dosing schedule and oral 960 mg vemurafenib BID on Days 1-28 of every cycle (1 Cycle=28 Days), until disease progression, unacceptable toxicity, or any other discontinuation criteria are met.', 'interventionNames': ['Drug: Cobimetinib', 'Drug: vemurafenib']}], 'interventions': [{'name': 'Cobimetinib', 'type': 'DRUG', 'otherNames': ['GDC-0973'], 'description': 'Participants will receive cobimetinib 60 to 100 mg at any of the 3 dosing schedules with or without vemurafenib in cycles of 28 days each until disease progression, unacceptable toxicity, or any other discontinuation criteria are met.', 'armGroupLabels': ['CES (Cohort 1A): 60 mg Cobimetinib + 720 mg Vemurafenib', 'CES (Cohort 1B): 60 mg Cobimetinib + 960 mg Vemurafenib', 'Cobimetinib Monotherapy (100 mg or 60 mg)', 'DES (Cohort 1): 60 mg Cobimetinib + 720 mg Vemurafenib', 'DES (Cohort 1A): 60 mg Cobimetinib + 720 mg Vemurafenib', 'DES (Cohort 1B): 60 mg Cobimetinib + 960 mg Vemurafenib', 'DES (Cohort 1C): 60 mg Cobimetinib + 720 mg Vemurafenib', 'DES (Cohort 1D): 60 mg Cobimetinib + 960 mg Vemurafenib', 'DES (Cohort 2): 80 mg Cobimetinib + 720 mg Vemurafenib', 'DES (Cohort 2A): 100 mg Cobimetinib + 720 mg Vemurafenib', 'DES (Cohort 3): 60 mg Cobimetinib + 960 mg Vemurafenib', 'DES (Cohort 4): 80 mg Cobimetinib + 960 mg Vemurafenib']}, {'name': 'vemurafenib', 'type': 'DRUG', 'description': 'Participants will receive vemurafenib 720 or 960 mg along with cobimetinib in cycles of 28 days each until disease progression, unacceptable toxicity, or any other discontinuation criteria are met.', 'armGroupLabels': ['CES (Cohort 1A): 60 mg Cobimetinib + 720 mg Vemurafenib', 'CES (Cohort 1B): 60 mg Cobimetinib + 960 mg Vemurafenib', 'DES (Cohort 1): 60 mg Cobimetinib + 720 mg Vemurafenib', 'DES (Cohort 1A): 60 mg Cobimetinib + 720 mg Vemurafenib', 'DES (Cohort 1B): 60 mg Cobimetinib + 960 mg Vemurafenib', 'DES (Cohort 1C): 60 mg Cobimetinib + 720 mg Vemurafenib', 'DES (Cohort 1D): 60 mg Cobimetinib + 960 mg Vemurafenib', 'DES (Cohort 2): 80 mg Cobimetinib + 720 mg Vemurafenib', 'DES (Cohort 2A): 100 mg Cobimetinib + 720 mg Vemurafenib', 'DES (Cohort 3): 60 mg Cobimetinib + 960 mg Vemurafenib', 'DES (Cohort 4): 80 mg Cobimetinib + 960 mg Vemurafenib']}]}, 'contactsLocationsModule': {'locations': [{'zip': '90024', 'city': 'Los Angeles', 'state': 'California', 'country': 'United States', 'facility': 'UCLA Department of Medicine', 'geoPoint': {'lat': 34.05223, 'lon': -118.24368}}, {'zip': '94115', 'city': 'San Francisco', 'state': 'California', 'country': 'United States', 'facility': 'University of California at San Francisco', 'geoPoint': {'lat': 37.77493, 'lon': -122.41942}}, {'zip': '90025', 'city': 'Santa Monica', 'state': 'California', 'country': 'United States', 'facility': 'The Angeles Clinic and Research Institute, Santa Monica Office', 'geoPoint': {'lat': 34.01949, 'lon': -118.49138}}, {'zip': '80045', 'city': 'Aurora', 'state': 'Colorado', 'country': 'United States', 'facility': 'University of Colorado; Anschutz Cancer Pavilion', 'geoPoint': {'lat': 39.72943, 'lon': -104.83192}}, {'zip': '60637', 'city': 'Chicago', 'state': 'Illinois', 'country': 'United States', 'facility': 'University of Chicago', 'geoPoint': {'lat': 41.85003, 'lon': -87.65005}}, {'zip': '46202', 'city': 'Indianapolis', 'state': 'Indiana', 'country': 'United States', 'facility': 'Indiana University - Department of Medicine, Division of Gastroenterology/Hepatology', 'geoPoint': {'lat': 39.76838, 'lon': -86.15804}}, {'zip': '48201', 'city': 'Detroit', 'state': 'Michigan', 'country': 'United States', 'facility': 'Karmanos Cancer Inst. ; Hudson Webber; Cancer Research Building', 'geoPoint': {'lat': 42.33143, 'lon': -83.04575}}, {'zip': '10036', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': 'New York University Medical Center', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}, {'zip': '37232', 'city': 'Nashville', 'state': 'Tennessee', 'country': 'United States', 'facility': 'Vanderbilt University Medical Center', 'geoPoint': {'lat': 36.16589, 'lon': -86.78444}}, {'zip': '3000', 'city': 'Melbourne', 'state': 'Victoria', 'country': 'Australia', 'facility': 'Peter Maccallum Cancer Institute; Medical Oncology', 'geoPoint': {'lat': -37.814, 'lon': 144.96332}}], 'overallOfficials': [{'name': 'Clinical Trials', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Hoffmann-La Roche'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hoffmann-La Roche', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}