{"groups":[{"description":"Participants received pembrolizumab 200 mg IV every 3 weeks in combination with PLX3397 at 400 mg/day (administered twice daily \\[BID\\] as a split dose of 200 mg in the morning and 200 mg in the evening).","id":"FG000","title":"Dose Escalation: 400 mg/Day"},{"description":"Participants received pembrolizumab 200 mg IV every 3 weeks in combination with PLX3397 at 600 mg/day (administered twice daily \\[BID\\] as a split dose of 200 mg in the morning and 400 mg in the evening).","id":"FG001","title":"Dose Escalation: 600 mg/Day"},{"description":"Participants with liver metastases received pembrolizumab 200 mg IV every 3 weeks in combination with PLX3397 at 600 mg/day (administered twice daily \\[BID\\] as a split dose of 200 mg in the morning and 400 mg in the evening).","id":"FG002","title":"Dose Escalation: 600 mg/Day (Liver Metastases"},{"description":"Participants with no liver metastases received pembrolizumab 200 mg IV every 3 weeks in combination with PLX3397 at 600 mg/day (administered twice daily \\[BID\\] as a split dose of 200 mg in the morning and 400 mg in the evening).","id":"FG003","title":"Dose Escalation: 600 mg/Day (no Liver Metastases)"},{"description":"Participants with liver metastases received pembrolizumab 200 mg IV every 3 weeks in combination with PLX3397 at 800 mg/day (administered twice daily \\[BID\\] as a split dose of 400 mg in the morning and 400 mg in the evening).","id":"FG004","title":"Dose Escalation: 800 mg/Day (Liver Metastases)"},{"description":"Participants with no liver metastases received pembrolizumab 200 mg IV every 3 weeks in combination with PLX3397 at 800 mg/day (administered twice daily \\[BID\\] as a split dose of 400 mg in the morning and 400 mg in the evening).","id":"FG005","title":"Dose Escalation: 800 mg/Day (no Liver Metastases)"},{"description":"Participants with melanoma received pembrolizumab 200 mg IV every 3 weeks in combination with PLX3397 at 600 mg/day (administered twice daily \\[BID\\] as a split dose of 200 mg in the morning and 400 mg in the evening).","id":"FG006","title":"Dose Expansion: Melanoma"},{"description":"Participants with NSCLC received pembrolizumab 200 mg IV every 3 weeks in combination with PLX3397 at 600 mg/day (administered twice daily \\[BID\\] as a split dose of 200 mg in the morning and 400 mg in the evening).","id":"FG007","title":"Dose Expansion: NSCLC"},{"description":"Participants with ovarian cancer received pembrolizumab 200 mg IV every 3 weeks in combination with PLX3397 at 600 mg/day (administered twice daily \\[BID\\] as a split dose of 200 mg in the morning and 400 mg in the evening).","id":"FG008","title":"Dose Expansion: Ovarian Cancer"},{"description":"Participants with SCCHN received pembrolizumab 200 mg IV every 3 weeks in combination with PLX3397 at 600 mg/day (administered twice daily \\[BID\\] as a split dose of 200 mg in the morning and 400 mg in the evening).","id":"FG009","title":"Dose Expansion: SCCHN"},{"description":"Participants with GIST received pembrolizumab 200 mg IV every 3 weeks in combination with PLX3397 at 600 mg/day (administered twice daily \\[BID\\] as a split dose of 200 mg in the morning and 400 mg in the evening).","id":"FG010","title":"Dose Expansion: GIST"}],"periods":[{"dropWithdraws":[{"reasons":[{"groupId":"FG000","numSubjects":"2"},{"groupId":"FG001","numSubjects":"2"},{"groupId":"FG002","numSubjects":"2"},{"groupId":"FG003","numSubjects":"6"},{"groupId":"FG004","numSubjects":"2"},{"groupId":"FG005","numSubjects":"0"},{"groupId":"FG006","numSubjects":"5"},{"groupId":"FG007","numSubjects":"1"},{"groupId":"FG008","numSubjects":"3"},{"groupId":"FG009","numSubjects":"1"},{"groupId":"FG010","numSubjects":"0"}],"type":"Death"},{"reasons":[{"groupId":"FG000","numSubjects":"0"},{"groupId":"FG001","numSubjects":"1"},{"groupId":"FG002","numSubjects":"1"},{"groupId":"FG003","numSubjects":"0"},{"groupId":"FG004","numSubjects":"0"},{"groupId":"FG005","numSubjects":"0"},{"groupId":"FG006","numSubjects":"0"},{"groupId":"FG007","numSubjects":"0"},{"groupId":"FG008","numSubjects":"0"},{"groupId":"FG009","numSubjects":"0"},{"groupId":"FG010","numSubjects":"0"}],"type":"Lost to Follow-up"},{"reasons":[{"groupId":"FG000","numSubjects":"0"},{"groupId":"FG001","numSubjects":"0"},{"groupId":"FG002","numSubjects":"3"},{"groupId":"FG003","numSubjects":"2"},{"groupId":"FG004","numSubjects":"0"},{"groupId":"FG005","numSubjects":"0"},{"groupId":"FG006","numSubjects":"1"},{"groupId":"FG007","numSubjects":"0"},{"groupId":"FG008","numSubjects":"1"},{"groupId":"FG009","numSubjects":"1"},{"groupId":"FG010","numSubjects":"0"}],"type":"Withdrawal by Subject"},{"reasons":[{"groupId":"FG000","numSubjects":"0"},{"groupId":"FG001","numSubjects":"0"},{"groupId":"FG002","numSubjects":"1"},{"groupId":"FG003","numSubjects":"0"},{"groupId":"FG004","numSubjects":"0"},{"groupId":"FG005","numSubjects":"1"},{"groupId":"FG006","numSubjects":"4"},{"groupId":"FG007","numSubjects":"3"},{"groupId":"FG008","numSubjects":"0"},{"groupId":"FG009","numSubjects":"0"},{"groupId":"FG010","numSubjects":"1"}],"type":"Other"},{"reasons":[{"groupId":"FG000","numSubjects":"0"},{"groupId":"FG001","numSubjects":"0"},{"groupId":"FG002","numSubjects":"0"},{"groupId":"FG003","numSubjects":"0"},{"groupId":"FG004","numSubjects":"0"},{"groupId":"FG005","numSubjects":"0"},{"groupId":"FG006","numSubjects":"0"},{"groupId":"FG007","numSubjects":"0"},{"groupId":"FG008","numSubjects":"2"},{"groupId":"FG009","numSubjects":"0"},{"groupId":"FG010","numSubjects":"0"}],"type":"Progressive disease (per RECIST)"},{"reasons":[{"groupId":"FG000","numSubjects":"0"},{"groupId":"FG001","numSubjects":"0"},{"groupId":"FG002","numSubjects":"0"},{"groupId":"FG003","numSubjects":"0"},{"groupId":"FG004","numSubjects":"0"},{"groupId":"FG005","numSubjects":"0"},{"groupId":"FG006","numSubjects":"0"},{"groupId":"FG007","numSubjects":"0"},{"groupId":"FG008","numSubjects":"0"},{"groupId":"FG009","numSubjects":"0"},{"groupId":"FG010","numSubjects":"1"}],"type":"Adverse Event"}],"milestones":[{"achievements":[{"groupId":"FG000","numSubjects":"4"},{"groupId":"FG001","numSubjects":"3"},{"groupId":"FG002","numSubjects":"7"},{"groupId":"FG003","numSubjects":"9"},{"groupId":"FG004","numSubjects":"4"},{"groupId":"FG005","numSubjects":"6"},{"groupId":"FG006","numSubjects":"13"},{"groupId":"FG007","numSubjects":"8"},{"groupId":"FG008","numSubjects":"15"},{"groupId":"FG009","numSubjects":"3"},{"groupId":"FG010","numSubjects":"6"}],"type":"STARTED"},{"achievements":[{"groupId":"FG000","numSubjects":"2"},{"groupId":"FG001","numSubjects":"0"},{"groupId":"FG002","numSubjects":"0"},{"groupId":"FG003","numSubjects":"1"},{"groupId":"FG004","numSubjects":"2"},{"groupId":"FG005","numSubjects":"5"},{"groupId":"FG006","numSubjects":"3"},{"groupId":"FG007","numSubjects":"4"},{"groupId":"FG008","numSubjects":"9"},{"groupId":"FG009","numSubjects":"1"},{"groupId":"FG010","numSubjects":"4"}],"type":"COMPLETED"},{"achievements":[{"groupId":"FG000","numSubjects":"2"},{"groupId":"FG001","numSubjects":"3"},{"groupId":"FG002","numSubjects":"7"},{"groupId":"FG003","numSubjects":"8"},{"groupId":"FG004","numSubjects":"2"},{"groupId":"FG005","numSubjects":"1"},{"groupId":"FG006","numSubjects":"10"},{"groupId":"FG007","numSubjects":"4"},{"groupId":"FG008","numSubjects":"6"},{"groupId":"FG009","numSubjects":"2"},{"groupId":"FG010","numSubjects":"2"}],"type":"NOT COMPLETED"}],"title":"Overall Study"}],"preAssignmentDetails":"Dose Escalation: Up to 42 participants with advanced solid tumors (any type) were to be enrolled sequentially in up to 7 cohorts (3+3 design).\n\nDose Expansion: Up to 483 participants were planned with the sample size for each tumor type based on a truncated sequential probability ratio test (max sample size 28 to 48 participants per tumor type).","recruitmentDetails":"Dose Escalation: 33 participants who met the inclusion and none of the exclusion criteria were enrolled and received study drug.\n\nDose Expansion: 45 participants with melanoma, non-small cell lung cancer (NSCLC), ovarian cancer, squamous cell carcinoma of the head and neck (SCCHN), and gastrointestinal stromal tumor (GIST) were enrolled."}