{"analyses":[{"groupDescription":"In Phase II part 2 cohort A, statistical Test stratified by indication to compare the Overall Response Rate between TG4001+Avelumab versus Avelumab alone.","groupIds":["OG002","OG003"],"nonInferiorityType":"OTHER","pValue":"0.832","pValueComment":"At level 0.05 without adjustments for multiplicity testing, pvalue is calculated using Cochran-Mantel-Haenszel Chi-Square test.","statisticalMethod":"Cochran-Mantel-Haenszel"}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"0.0"},{"groupId":"OG001","value":"50.0"},{"groupId":"OG002","value":"15.2"},{"groupId":"OG003","value":"13.6"}]}],"title":"Overall Response Rate (ORR)"},{"categories":[{"measurements":[{"groupId":"OG000","value":"33.3"},{"groupId":"OG001","value":"83.3"},{"groupId":"OG002","value":"65.2"},{"groupId":"OG003","value":"68.2"}]}],"title":"Disease Control Rate (DCR)"},{"categories":[{"measurements":[{"groupId":"OG000","value":"0.0"},{"groupId":"OG001","value":"0.0"},{"groupId":"OG002","value":"8.7"},{"groupId":"OG003","value":"2.3"}]}],"title":"Complete Response (CR)"},{"categories":[{"measurements":[{"groupId":"OG000","value":"0.0"},{"groupId":"OG001","value":"50.0"},{"groupId":"OG002","value":"6.5"},{"groupId":"OG003","value":"11.4"}]}],"title":"Partial Response (PR)"},{"categories":[{"measurements":[{"groupId":"OG000","value":"33.3"},{"groupId":"OG001","value":"33.3"},{"groupId":"OG002","value":"50.0"},{"groupId":"OG003","value":"54.5"}]}],"title":"Stable Disease (SD)"},{"categories":[{"measurements":[{"groupId":"OG000","value":"66.7"},{"groupId":"OG001","value":"16.7"},{"groupId":"OG002","value":"34.8"},{"groupId":"OG003","value":"31.8"}]}],"title":"Progressive Disease (PD)"}],"denoms":[{"counts":[{"groupId":"OG000","value":"3"},{"groupId":"OG001","value":"6"},{"groupId":"OG002","value":"46"},{"groupId":"OG003","value":"44"}],"units":"Participants"}],"description":"Percentage of participants whose best overall response is either a Complete Response or a Partial Response according to Response Evaluation Criteria In Solid Tumors (RECIST v1.0) criteria over the the total number of evaluable participants.\n\nPer Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by CT/MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \\>=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.\", or similar definition that is accurate and appropriate.","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":"OG000","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":"OG001","title":"Phase I - 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":"OG002","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":"OG003","title":"Phase II Part 2 - Cohort A - Participants Without Liver Metastases - Avelumab"}],"paramType":"NUMBER","populationDescription":"For Phase Ib / Phase II part 2 Cohort A: All participants who received at least one dose of IMP(s) according to treatment allocation.\n\nPhase II part 1 and phase II part 2 Cohort B: the outcome measure ORR has not been defined as secondary endpoint.\n\nTherefore Phase II part 1 and phase II part 2 Cohort B are not included in the analysis population for ORR as secondary endpoint.","reportingStatus":"POSTED","timeFrame":"From treatment start (phase Ib) / randomization (phase II part 2) : Every 6 weeks for the first 9 months, then every 12 weeks up to 2 years.","title":"Overall Response Rate (ORR) by Using RECIST 1.1 : Phase Ib, Phase II Part 2 Cohort A","type":"SECONDARY","unitOfMeasure":"percentage of participants"}