{"groups":[{"description":"Within 17 days (preferably within 14 days) days after IV over 30 minutes on day 1. Treatment repeats every 3 weeks for 18 cycles in the absence of disease progression or unacceptable toxicity. Patients also undergo collection of blood throughout the study and MRI or CT on study.\n\nBiospecimen Collection: Undergo collection of blood\n\nComputed Tomography: Undergo CT\n\nMagnetic Resonance Imaging: Undergo MRI\n\nPembrolizumab: Given IV\n\nTherapeutic Conventional Surgery: Undergo surgery","id":"FG000","title":"Arm I (Adjuvant Pembrolizumab)"},{"description":"Patients receive pembrolizumab IV over 30 minutes on day 1 every 3 weeks for 3 cycles, then undergo surgery within 3 weeks. Within 84 days, patients receive pembrolizumab IV over 30 minutes every 3 weeks for 15 cycles in the absence of disease progression or unacceptable toxicity. Patients also undergo collection of blood throughout the study and MRI or CT on study.\n\nBiospecimen Collection: Undergo collection of blood\n\nComputed Tomography: Undergo CT\n\nMagnetic Resonance Imaging: Undergo MRI\n\nPembrolizumab: Given IV\n\nTherapeutic Conventional Surgery: Undergo surgery","id":"FG001","title":"Arm II (Adjuvant and Neoadjuvant Pembrolizumab)"}],"periods":[{"dropWithdraws":[{"reasons":[{"groupId":"FG000","numSubjects":"0"},{"groupId":"FG001","numSubjects":"10"}],"type":"Still receiving protocol therapy"},{"reasons":[{"groupId":"FG000","numSubjects":"7"},{"groupId":"FG001","numSubjects":"2"}],"type":"Withdrawal by Subject"},{"reasons":[{"groupId":"FG000","numSubjects":"0"},{"groupId":"FG001","numSubjects":"1"}],"type":"Toxicity"},{"reasons":[{"groupId":"FG000","numSubjects":"0"},{"groupId":"FG001","numSubjects":"12"}],"type":"Disease Progression"},{"reasons":[{"groupId":"FG000","numSubjects":"0"},{"groupId":"FG001","numSubjects":"1"}],"type":"Co-morbidities"},{"reasons":[{"groupId":"FG000","numSubjects":"1"},{"groupId":"FG001","numSubjects":"0"}],"type":"Scheduling Issues"},{"reasons":[{"groupId":"FG000","numSubjects":"0"},{"groupId":"FG001","numSubjects":"1"}],"type":"Participant Refusal"}],"milestones":[{"achievements":[{"groupId":"FG000","numSubjects":"159"},{"groupId":"FG001","numSubjects":"154"}],"type":"STARTED"},{"achievements":[{"groupId":"FG000","numSubjects":"151"},{"groupId":"FG001","numSubjects":"127"}],"type":"COMPLETED"},{"achievements":[{"groupId":"FG000","numSubjects":"8"},{"groupId":"FG001","numSubjects":"27"}],"type":"NOT COMPLETED"}],"title":"Step 1: Registration"},{"dropWithdraws":[{"reasons":[{"groupId":"FG000","numSubjects":"2"},{"groupId":"FG001","numSubjects":"1"}],"type":"Participant Refusal"},{"reasons":[{"groupId":"FG000","numSubjects":"0"},{"groupId":"FG001","numSubjects":"3"}],"type":"Neoadjuvant Toxicity"},{"reasons":[{"groupId":"FG000","numSubjects":"16"},{"groupId":"FG001","numSubjects":"9"}],"type":"Metastatic Disease"},{"reasons":[{"groupId":"FG000","numSubjects":"2"},{"groupId":"FG001","numSubjects":"1"}],"type":"Residual Disease"},{"reasons":[{"groupId":"FG000","numSubjects":"0"},{"groupId":"FG001","numSubjects":"1"}],"type":"Trial Closed due to Covid-19"},{"reasons":[{"groupId":"FG000","numSubjects":"0"},{"groupId":"FG001","numSubjects":"1"}],"type":"Concerns about Exposure to Covid-19"},{"reasons":[{"groupId":"FG000","numSubjects":"0"},{"groupId":"FG001","numSubjects":"2"}],"type":"Disease other than melanoma identified at surgery"},{"reasons":[{"groupId":"FG000","numSubjects":"1"},{"groupId":"FG001","numSubjects":"0"}],"type":"Radiotherapy-related Delays"}],"milestones":[{"achievements":[{"groupId":"FG000","numSubjects":"151"},{"groupId":"FG001","numSubjects":"127"}],"type":"STARTED"},{"achievements":[{"groupId":"FG000","numSubjects":"130"},{"groupId":"FG001","numSubjects":"109"}],"type":"COMPLETED"},{"achievements":[{"groupId":"FG000","numSubjects":"21"},{"groupId":"FG001","numSubjects":"18"}],"type":"NOT COMPLETED"}],"title":"Step 2: Surgery"},{"dropWithdraws":[{"reasons":[{"groupId":"FG000","numSubjects":"41"},{"groupId":"FG001","numSubjects":"33"}],"type":"Still receiving protocol therapy"},{"reasons":[{"groupId":"FG000","numSubjects":"41"},{"groupId":"FG001","numSubjects":"9"}],"type":"Disease Progression"},{"reasons":[{"groupId":"FG000","numSubjects":"4"},{"groupId":"FG001","numSubjects":"1"}],"type":"Death"},{"reasons":[{"groupId":"FG000","numSubjects":"6"},{"groupId":"FG001","numSubjects":"16"}],"type":"Other, unspecified reasons"}],"milestones":[{"achievements":[{"groupId":"FG000","numSubjects":"130"},{"groupId":"FG001","numSubjects":"109"}],"type":"STARTED"},{"achievements":[{"groupId":"FG000","numSubjects":"38"},{"groupId":"FG001","numSubjects":"50"}],"type":"COMPLETED"},{"achievements":[{"groupId":"FG000","numSubjects":"92"},{"groupId":"FG001","numSubjects":"59"}],"type":"NOT COMPLETED"}],"title":"Step 3: Adjuvant Pembrolizumab"}],"preAssignmentDetails":"Three hundred forty-five participants were assessed for eligibility. Thirty-two participants were deemed ineligible for either not having measurable disease, per RECIST criteria (27 participants), or having an ineligible disease stage (5). The remaining 313 eligible participants were randomized."}