{"groups":[{"description":"Participants received epacadostat 25 mg, orally, twice daily (BID) in combination of nivolumab 3 mg/kg intravenously (IV), on Days 1, 15, 29, and 43 of each 8-week cycle.","id":"FG000","title":"Phase 1, Part 1: Epacadostat 25 mg + Nivolumab 3 mg"},{"description":"Participants received epacadostat 50 mg, orally, BID in combination of nivolumab 3 mg/kg, IV, once every 3 weeks (Q3W), on Days 1, 15, 29, and 43 of each 8-week cycle.","id":"FG001","title":"Phase 1, Part 1: Epacadostat 50 mg + Nivolumab 3 mg"},{"description":"Participants received epacadostat 100 mg, orally, BID in combination of nivolumab 3 mg/kg, IV, Q3W, on Days 1, 15, 29, and 43 of each 8-week cycle.","id":"FG002","title":"Phase 1, Part 1: Epacadostat 100 mg + Nivolumab 3 mg"},{"description":"Participants received epacadostat 300 mg, orally, BID in combination of nivolumab 3 mg/kg, IV, Q3W, on Days 1, 15, 29, and 43 of each 8-week cycle.","id":"FG003","title":"Phase 1, Part 1: Epacadostat 300 mg + Nivolumab 3 mg"},{"description":"Participants with select solid tumor types received epacadostat 100 mg BID in combination with nivolumab 360 mg, IV, once every 2 weeks (Q2W), on Day 1 of each 21-day cycle along with 5-FU/Platinum chemotherapy regimen IV. Participants were de-escalated to epacadostat 50 mg BID if 100 mg was not tolerated.","id":"FG004","title":"Phase 1, Part 2: Epacadostat 100 mg + Nivolumab 360 mg + 5-FU/Platinum"},{"description":"Participants with select solid tumor types received epacadostat 100 mg BID in combination with nivolumab 360 mg, IV, Q2W, on Day 1 of each 21-day cycle along with Pemetrexed /Platinum chemotherapy regimen IV. Participants were de-escalated to epacadostat 50 mg BID if 100 mg was not tolerated.","id":"FG005","title":"Phase 1, Part 2: Epacadostat 100 mg + Nivolumab 360 mg + Pemetrexed/ Platinum"},{"description":"Participants with select solid tumor types received epacadostat 100 mg BID in combination with nivolumab 360 mg, IV, Q2W, on Day 1 of each 21-day cycle along with Paclitaxel/Platinum chemotherapy regimen IV. Participants were de-escalated to epacadostat 50 mg BID if 100 mg was not tolerated.","id":"FG006","title":"Phase 1, Part 2: Epacadostat 100 mg + Nivolumab 360 mg + Paclitaxel/ Platinum"},{"description":"Participants with select solid tumor types received epacadostat 100 mg BID in combination with nivolumab 240 mg IV infusion Q2W on Days 1, 15, 29, and 43 and participants with melanoma I/O-relapsed and melanoma I/O-refractory enrolled in this arm received epacadostat 100 mg BID in combination with nivolumab 480 mg IV infusion once every 4 weeks (Q4W) on Days 1 and Day 29 of each 8-week cycle.","id":"FG007","title":"Phase 2: Epacadostat 100 mg + Nivolumab 240/480 mg"},{"description":"Participants with select solid tumor types received epacadostat 300 mg BID in combination with nivolumab 240 mg IV infusion Q2W on Days 1, 15, 29, and 43 of each 8-week cycle.","id":"FG008","title":"Phase 2: Epacadostat 300 mg + Nivolumab 240 mg"}],"periods":[{"dropWithdraws":[{"reasons":[{"groupId":"FG000","numSubjects":"0"},{"groupId":"FG001","numSubjects":"1"},{"groupId":"FG002","numSubjects":"2"},{"groupId":"FG003","numSubjects":"1"},{"groupId":"FG004","numSubjects":"1"},{"groupId":"FG005","numSubjects":"0"},{"groupId":"FG006","numSubjects":"0"},{"groupId":"FG007","numSubjects":"11"},{"groupId":"FG008","numSubjects":"25"}],"type":"Participants Decision: Consent Withdrawal from Study and Follow-up"},{"reasons":[{"groupId":"FG000","numSubjects":"2"},{"groupId":"FG001","numSubjects":"4"},{"groupId":"FG002","numSubjects":"10"},{"groupId":"FG003","numSubjects":"6"},{"groupId":"FG004","numSubjects":"4"},{"groupId":"FG005","numSubjects":"3"},{"groupId":"FG006","numSubjects":"2"},{"groupId":"FG007","numSubjects":"51"},{"groupId":"FG008","numSubjects":"97"}],"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":"2"},{"groupId":"FG008","numSubjects":"5"}],"type":"Lost to Follow-up"},{"reasons":[{"groupId":"FG000","numSubjects":"1"},{"groupId":"FG001","numSubjects":"0"},{"groupId":"FG002","numSubjects":"1"},{"groupId":"FG003","numSubjects":"4"},{"groupId":"FG004","numSubjects":"0"},{"groupId":"FG005","numSubjects":"0"},{"groupId":"FG006","numSubjects":"0"},{"groupId":"FG007","numSubjects":"11"},{"groupId":"FG008","numSubjects":"25"}],"type":"Site Terminated by Sponsor"},{"reasons":[{"groupId":"FG000","numSubjects":"0"},{"groupId":"FG001","numSubjects":"0"},{"groupId":"FG002","numSubjects":"0"},{"groupId":"FG003","numSubjects":"1"},{"groupId":"FG004","numSubjects":"0"},{"groupId":"FG005","numSubjects":"0"},{"groupId":"FG006","numSubjects":"0"},{"groupId":"FG007","numSubjects":"0"},{"groupId":"FG008","numSubjects":"1"}],"type":"Physician Decision"},{"reasons":[{"groupId":"FG000","numSubjects":"0"},{"groupId":"FG001","numSubjects":"0"},{"groupId":"FG002","numSubjects":"0"},{"groupId":"FG003","numSubjects":"1"},{"groupId":"FG004","numSubjects":"1"},{"groupId":"FG005","numSubjects":"0"},{"groupId":"FG006","numSubjects":"1"},{"groupId":"FG007","numSubjects":"3"},{"groupId":"FG008","numSubjects":"11"}],"type":"Completed 100 Day Safety Follow-up Period"},{"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":"5"},{"groupId":"FG008","numSubjects":"12"}],"type":"Reason not Specified"}],"milestones":[{"achievements":[{"groupId":"FG000","numSubjects":"3"},{"groupId":"FG001","numSubjects":"6"},{"groupId":"FG002","numSubjects":"14"},{"groupId":"FG003","numSubjects":"13"},{"groupId":"FG004","numSubjects":"6"},{"groupId":"FG005","numSubjects":"3"},{"groupId":"FG006","numSubjects":"3"},{"groupId":"FG007","numSubjects":"83"},{"groupId":"FG008","numSubjects":"176"}],"type":"STARTED"},{"achievements":[{"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"}],"type":"COMPLETED"},{"achievements":[{"groupId":"FG000","numSubjects":"3"},{"groupId":"FG001","numSubjects":"6"},{"groupId":"FG002","numSubjects":"14"},{"groupId":"FG003","numSubjects":"13"},{"groupId":"FG004","numSubjects":"6"},{"groupId":"FG005","numSubjects":"3"},{"groupId":"FG006","numSubjects":"3"},{"groupId":"FG007","numSubjects":"83"},{"groupId":"FG008","numSubjects":"176"}],"type":"NOT COMPLETED"}],"title":"Overall Study"}],"preAssignmentDetails":"A total of 307 participants were enrolled in this study, 48 participants were enrolled in Phase 1 and 259 participants were enrolled in Phase 2. Participants in Phase 1 Part 2 and Phase 2 received dose per select solid tumor types (Colorectal, Melanoma I/O Naïve, Melanoma I/O relapsed, Melanoma I/O refractory, Non-small cell lung cancer (NSCLC), Ovarian, Squamous cell carcinoma of the head and neck (SCCHN), Diffuse large B-cell lymphoma (DLBCL) and Glioblastoma).","recruitmentDetails":"Participants took part in 22 study sites in the United States and 2 study sites in the United Kingdom from 26 November 2014 to 16 June 2020."}