{"groups":[{"description":"Nivolumab 3 mg/kg combined with Ipilimumab 1 mg/kg solutions intravenously every 3 weeks for 4 doses then Nivolumab 3 mg/kg solutions intravenously every 2 weeks until documented disease progression, discontinuation due to toxicity, withdrawal of consent or the study ends","id":"FG000","title":"Nivolumab + Ipilimumab"},{"description":"Sunitinib 50 mg capsules by mouth once daily for 4 weeks then 2 weeks off, continuously until documented disease progression, discontinuation due to toxicity, withdrawal of consent or the study ends After completion of final analysis eligible participants may switch from receiving Sunitinib to receiving Nivolumab 3 mg/kg IV combined with Ipilimumab 1 mg/kg IV every 3 weeks for 4 doses then Nivolumab 240mg flat dose IV every 2 weeks","id":"FG001","title":"Sunitinib"}],"periods":[{"dropWithdraws":[{"reasons":[{"groupId":"FG000","numSubjects":"0"},{"groupId":"FG001","numSubjects":"1"}],"type":"Disease progression"},{"reasons":[{"groupId":"FG000","numSubjects":"1"},{"groupId":"FG001","numSubjects":"2"}],"type":"Participant request to discontinue study treatment"},{"reasons":[{"groupId":"FG000","numSubjects":"1"},{"groupId":"FG001","numSubjects":"6"}],"type":"Withdrawal by Subject"},{"reasons":[{"groupId":"FG000","numSubjects":"0"},{"groupId":"FG001","numSubjects":"2"}],"type":"Poor/Non-compliance"},{"reasons":[{"groupId":"FG000","numSubjects":"1"},{"groupId":"FG001","numSubjects":"0"}],"type":"Participant no longer meet study criteria"}],"milestones":[{"achievements":[{"groupId":"FG000","numSubjects":"550"},{"groupId":"FG001","numSubjects":"546"}],"comment":"Started = Randomized","type":"STARTED"},{"achievements":[{"groupId":"FG000","numSubjects":"547"},{"groupId":"FG001","numSubjects":"535"}],"type":"COMPLETED"},{"achievements":[{"groupId":"FG000","numSubjects":"3"},{"groupId":"FG001","numSubjects":"11"}],"type":"NOT COMPLETED"}],"title":"Pre-treatment Period"},{"dropWithdraws":[{"reasons":[{"groupId":"FG000","numSubjects":"269"},{"groupId":"FG001","numSubjects":"366"}],"type":"Disease Progression"},{"reasons":[{"groupId":"FG000","numSubjects":"152"},{"groupId":"FG001","numSubjects":"73"}],"type":"Study Drug Toxicity"},{"reasons":[{"groupId":"FG000","numSubjects":"2"},{"groupId":"FG001","numSubjects":"1"}],"type":"Death"},{"reasons":[{"groupId":"FG000","numSubjects":"45"},{"groupId":"FG001","numSubjects":"35"}],"type":"Adverse Event"},{"reasons":[{"groupId":"FG000","numSubjects":"19"},{"groupId":"FG001","numSubjects":"22"}],"type":"Participant Request to Discontinue Study Treatment"},{"reasons":[{"groupId":"FG000","numSubjects":"12"},{"groupId":"FG001","numSubjects":"9"}],"type":"Withdrawal by Subject"},{"reasons":[{"groupId":"FG000","numSubjects":"0"},{"groupId":"FG001","numSubjects":"2"}],"type":"Lost to Follow-up"},{"reasons":[{"groupId":"FG000","numSubjects":"20"},{"groupId":"FG001","numSubjects":"6"}],"type":"Maximum Clinical Benefit"},{"reasons":[{"groupId":"FG000","numSubjects":"1"},{"groupId":"FG001","numSubjects":"1"}],"type":"Poor/Non-compliance"},{"reasons":[{"groupId":"FG000","numSubjects":"1"},{"groupId":"FG001","numSubjects":"0"}],"type":"Pregnancy"},{"reasons":[{"groupId":"FG000","numSubjects":"1"},{"groupId":"FG001","numSubjects":"0"}],"type":"Participant No Longer Meet Study Criteria"},{"reasons":[{"groupId":"FG000","numSubjects":"1"},{"groupId":"FG001","numSubjects":"0"}],"type":"Administration Reason by Sponsor"},{"reasons":[{"groupId":"FG000","numSubjects":"24"},{"groupId":"FG001","numSubjects":"18"}],"type":"Other Reasons"}],"milestones":[{"achievements":[{"groupId":"FG000","numSubjects":"547"},{"groupId":"FG001","numSubjects":"535"}],"type":"STARTED"},{"achievements":[{"groupId":"FG000","numSubjects":"0"},{"comment":"Participants received Nivolumab combined with Ipilimumab followed by Nivolumab","groupId":"FG001","numSubjects":"25"}],"type":"Crossover Extension Phase (Arm B)"},{"achievements":[{"groupId":"FG000","numSubjects":"0"},{"groupId":"FG001","numSubjects":"2"}],"type":"COMPLETED"},{"achievements":[{"groupId":"FG000","numSubjects":"547"},{"groupId":"FG001","numSubjects":"533"}],"type":"NOT COMPLETED"}],"title":"Treatment Period"}],"preAssignmentDetails":"A total of 1096 participants were randomized, with 550 assigned to the Nivolumab + Ipilimumab group and 546 assigned to the Sunitinib group. Of these, 1082 participants received at least one dose of study treatment, including 547 in the Nivolumab + Ipilimumab group and 535 in the Sunitinib group."}