{"groups":[{"description":"IMMUNOTHERAPY INDUCTION (CYCLES 1-2): Patients receive nivolumab IV over 30-60 minutes and ipilimumab IV over 30-90 minutes on days 1 and 22. Treatment repeats every 6 weeks for 2 cycles in the absence of disease progression or unacceptable toxicity.\n\nIMMUNOTHERAPY MAINTENANCE (CYCLES 3-14): Patients receive nivolumab IV over 30-60 minutes on days 1, 15, and 29. Treatment repeats every 6 weeks for up to 12 cycles in the absence of disease progression or unacceptable toxicity. Upon disease progression (or before), patients re-register and cross over to Arm C.\n\nPatients also undergo CT, ECHO or MUGA, and collection of blood samples throughout the trial.\n\nBiospecimen Collection: Undergo collection of blood samples\n\nComputed Tomography: Undergo CT\n\nEchocardiography Test: Undergo ECHO\n\nIpilimumab: Given IV\n\nMultigated Acquisition Scan: Undergo MUGA scan\n\nNivolumab: Given IV\n\nQuality-of-Life Assessment: Ancillary studies","id":"FG000","title":"Arm A (Immunotherapy)"},{"description":"Patients receive dabrafenib mesylate PO BID and trametinib dimethyl sulfoxide PO daily on days 1-42. Cycles repeat every 6 weeks in the absence of disease progression or unacceptable toxicity. Upon disease progression (or before), patients re-register and cross over to Arm D.\n\nPatients also undergo CT, ECHO or MUGA, and collection of blood samples throughout the trial.\n\nBiospecimen Collection: Undergo collection of blood samples\n\nComputed Tomography: Undergo CT\n\nDabrafenib Mesylate: Given PO\n\nEchocardiography Test: Undergo ECHO\n\nMultigated Acquisition Scan: Undergo MUGA scan\n\nQuality-of-Life Assessment: Ancillary studies\n\nTrametinib Dimethyl Sulfoxide: Given PO","id":"FG001","title":"Arm B (BRAF Inhibitor Therapy)"}],"periods":[{"dropWithdraws":[{"reasons":[{"groupId":"FG000","numSubjects":"4"},{"groupId":"FG001","numSubjects":"0"}],"type":"Never start protocol therapy"},{"reasons":[{"groupId":"FG000","numSubjects":"42"},{"groupId":"FG001","numSubjects":"18"}],"type":"Adverse Event"},{"reasons":[{"groupId":"FG000","numSubjects":"33"},{"groupId":"FG001","numSubjects":"83"}],"type":"Disease progression"},{"reasons":[{"groupId":"FG000","numSubjects":"7"},{"groupId":"FG001","numSubjects":"4"}],"type":"Death"},{"reasons":[{"groupId":"FG000","numSubjects":"1"},{"groupId":"FG001","numSubjects":"7"}],"type":"Withdrawal by Subject"},{"reasons":[{"groupId":"FG000","numSubjects":"2"},{"groupId":"FG001","numSubjects":"1"}],"type":"Other complicating disease"},{"reasons":[{"groupId":"FG000","numSubjects":"7"},{"groupId":"FG001","numSubjects":"9"}],"type":"Other"},{"reasons":[{"groupId":"FG000","numSubjects":"0"},{"groupId":"FG001","numSubjects":"8"}],"type":"Reason unknown"},{"reasons":[{"groupId":"FG000","numSubjects":"0"},{"groupId":"FG001","numSubjects":"1"}],"type":"Alternative therapy"}],"milestones":[{"achievements":[{"groupId":"FG000","numSubjects":"135"},{"groupId":"FG001","numSubjects":"132"}],"type":"STARTED"},{"achievements":[{"groupId":"FG000","numSubjects":"131"},{"groupId":"FG001","numSubjects":"132"}],"type":"Treated"},{"achievements":[{"groupId":"FG000","numSubjects":"39"},{"groupId":"FG001","numSubjects":"1"}],"type":"COMPLETED"},{"achievements":[{"groupId":"FG000","numSubjects":"96"},{"groupId":"FG001","numSubjects":"131"}],"type":"NOT COMPLETED"}],"title":"Step 1"},{"dropWithdraws":[{"reasons":[{"groupId":"FG000","numSubjects":"4"},{"groupId":"FG001","numSubjects":"12"}],"type":"Adverse Event"},{"reasons":[{"groupId":"FG000","numSubjects":"16"},{"groupId":"FG001","numSubjects":"24"}],"type":"Disease progression"},{"reasons":[{"groupId":"FG000","numSubjects":"2"},{"groupId":"FG001","numSubjects":"3"}],"type":"Death"},{"reasons":[{"groupId":"FG000","numSubjects":"2"},{"groupId":"FG001","numSubjects":"0"}],"type":"Withdrawal by Subject"},{"reasons":[{"groupId":"FG000","numSubjects":"2"},{"groupId":"FG001","numSubjects":"3"}],"type":"Other reason"},{"reasons":[{"groupId":"FG000","numSubjects":"4"},{"groupId":"FG001","numSubjects":"0"}],"type":"On treatment"}],"milestones":[{"achievements":[{"comment":"61 patients progressed in step 1, 29 of them enrolled to step 2. In addition, one patient who had no progression also enrolled to step 2.","groupId":"FG000","numSubjects":"30"},{"comment":"98 patients progressed in step 1, and 49 of them enrolled in step 2. In addition, 3 patients who had no progression also enrolled in step 2.","groupId":"FG001","numSubjects":"52"}],"type":"STARTED"},{"achievements":[{"groupId":"FG000","numSubjects":"0"},{"groupId":"FG001","numSubjects":"10"}],"type":"COMPLETED"},{"achievements":[{"groupId":"FG000","numSubjects":"30"},{"groupId":"FG001","numSubjects":"42"}],"type":"NOT COMPLETED"}],"title":"Enrolled to Step 2"}],"recruitmentDetails":"The study was activated on July 13, 2015. The study was suspended between February 2 and April 11, 2016 due to a drug supply issue (acute shortage in the supply of Dabrafenib and Trametinib capsules) and closed to accrual on September 30, 2021 with a total accrual of 267 patients."}