{"groups":[{"description":"Participants received 5x10e6 pfu TG4001 subcutaneously along with 10 mg/kg avelumab intravenously until disease progression, unacceptable toxicity, participant withdrawal from study for any reason.","id":"FG000","title":"Phase I - TG4001 5x10e6 Pfu + Avelumab"},{"description":"Participants received 5x10e7 pfu TG4001 subcutaneously along with 10 mg/kg avelumab intravenously until disease progression, unacceptable toxicity, participant withdrawal from study for any reason.","id":"FG001","title":"Phase I - TG4001 5x10e7 Pfu + Avelumab"},{"description":"Participants received 5x10e7 pfu TG4001 subcutaneously along with 10 mg/kg avelumab intravenously until disease progression, unacceptable toxicity, participant withdrawal from study for any reason.","id":"FG002","title":"Phase II Part 1 - TG4001 5x10e7 Pfu + Avelumab"},{"description":"Participants received 5x10e7 pfu TG4001 subcutaneously along with 800 mg avelumab intravenously until disease progression, unacceptable toxicity, participant withdrawal from study for any reason.","id":"FG003","title":"Phase II Part 2 - Cohort A - Participants Without Liver Metastases - TG4001 5x10e7 Pfu + Avelumab"},{"description":"Participants received 800 mg avelumab intravenously until disease progression, unacceptable toxicity, participant withdrawal from study for any reason.","id":"FG004","title":"Phase II Part 2 - Cohort A - Participants Without Liver Metastases - Avelumab"},{"description":"Participants received 5x10e7 pfu TG4001 subcutaneously along with 800 mg avelumab intravenously until disease progression, unacceptable toxicity, participant withdrawal from study for any reason.","id":"FG005","title":"Phase II Part 2 - Cohort B - Participants With Liver Metastases - TG4001 5x10e7 Pfu + Avelumab"},{"description":"Participants received 800 mg avelumab intravenously until disease progression, unacceptable toxicity, participant withdrawal from study for any reason.","id":"FG006","title":"Phase II Part 2 - Cohort B - Participants With Liver Metastases - Avelumab"}],"periods":[{"dropWithdraws":[{"reasons":[{"groupId":"FG000","numSubjects":"0"},{"groupId":"FG001","numSubjects":"0"},{"groupId":"FG002","numSubjects":"4"},{"groupId":"FG003","numSubjects":"4"},{"groupId":"FG004","numSubjects":"4"},{"groupId":"FG005","numSubjects":"1"},{"groupId":"FG006","numSubjects":"2"}],"type":"Adverse Event"},{"reasons":[{"groupId":"FG000","numSubjects":"0"},{"groupId":"FG001","numSubjects":"1"},{"groupId":"FG002","numSubjects":"3"},{"groupId":"FG003","numSubjects":"1"},{"groupId":"FG004","numSubjects":"0"},{"groupId":"FG005","numSubjects":"0"},{"groupId":"FG006","numSubjects":"0"}],"type":"Clinical Progression"},{"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":"0"}],"type":"Physician Decision"},{"reasons":[{"groupId":"FG000","numSubjects":"0"},{"groupId":"FG001","numSubjects":"0"},{"groupId":"FG002","numSubjects":"0"},{"groupId":"FG003","numSubjects":"0"},{"groupId":"FG004","numSubjects":"3"},{"groupId":"FG005","numSubjects":"0"},{"groupId":"FG006","numSubjects":"0"}],"type":"Withdrawal by Subject"},{"reasons":[{"groupId":"FG000","numSubjects":"0"},{"groupId":"FG001","numSubjects":"0"},{"groupId":"FG002","numSubjects":"2"},{"groupId":"FG003","numSubjects":"5"},{"groupId":"FG004","numSubjects":"3"},{"groupId":"FG005","numSubjects":"0"},{"groupId":"FG006","numSubjects":"0"}],"type":"Under trial intervention"}],"milestones":[{"achievements":[{"groupId":"FG000","numSubjects":"3"},{"groupId":"FG001","numSubjects":"6"},{"groupId":"FG002","numSubjects":"34"},{"groupId":"FG003","numSubjects":"46"},{"groupId":"FG004","numSubjects":"44"},{"groupId":"FG005","numSubjects":"5"},{"groupId":"FG006","numSubjects":"5"}],"type":"STARTED"},{"achievements":[{"groupId":"FG000","numSubjects":"3"},{"groupId":"FG001","numSubjects":"5"},{"groupId":"FG002","numSubjects":"25"},{"groupId":"FG003","numSubjects":"35"},{"groupId":"FG004","numSubjects":"33"},{"groupId":"FG005","numSubjects":"4"},{"groupId":"FG006","numSubjects":"3"}],"type":"COMPLETED"},{"achievements":[{"groupId":"FG000","numSubjects":"0"},{"groupId":"FG001","numSubjects":"1"},{"groupId":"FG002","numSubjects":"9"},{"groupId":"FG003","numSubjects":"11"},{"groupId":"FG004","numSubjects":"11"},{"groupId":"FG005","numSubjects":"1"},{"groupId":"FG006","numSubjects":"2"}],"type":"NOT COMPLETED"}],"title":"Overall Study"}],"preAssignmentDetails":"Out of 361 screened participants, 143 were included in the trial and 142 were administered with trial interventions. 218 participants were not included (main reasons: 48.6% inclusion criterion of having histologically or cytologically documented HPV-16+ cancer, 18.8% inclusion criterion of having adequate hematological, hepatic and renal function)","recruitmentDetails":"From 01 September 2017 through 27 March 2024, a total of 361 participants were screened.\n\nPhase Ib: 01 September 2017 until 11 April 2018 Phase II part 1: 04 October 2018 until 10 August 2020 Phase II part 2: 03 Jun 2021 until 27 March 2024"}