{"analyses":[{"groupDescription":"A Simon's two-stage design will be used. The null hypothesis for response rate H0 is set at 10% corresponding to the response rate observed in second line participants, the alternate hypothesis of efficacy is set at HA=25%, the type I error α is set at 5% one sided, the type II error β is set at 20% (power=80%).","groupIds":["OG000"],"nonInferiorityComment":"Enough participants will be treated to obtain 22 evaluable as a first stage. If at least 3/22 participants are considered responders, the enrolment will be continued, otherwise it will be stopped. For the second stage of the trial, enough participants will be treated to obtain a total of 40 evaluable participants and consider the study positive if at least 8/40 of them are considered responders.","nonInferiorityType":"OTHER","otherAnalysisDescription":"With a hierarchical strategy on the final analysis, a subgroup analysis performed in oropharyngeal SCCHN patients and with a null hypothesis for response rate (H0) set at 10% and the alternative hypothesis of efficacy set at HA = 35%, 18 oropharyngeal SCCHN patients would have been needed to reach a power of 81% and actual alpha at 2.8%. This analysis would have been considered positive with at least 5 responders among the 18 SCCHN patients. The second stage of the Simon's design has not been done following the decision to exclude oropharyngeal SCCHN and to change to a randomized controlled two-arms study (phase II part 2)."}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"5.64","upperLimit":"34.72","value":"16.67"}]}],"title":"Overall Response Rate"},{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"28.34","upperLimit":"65.67","value":"46.67"}]}],"title":"Disease Control Rate (DCR)"},{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"0.08","upperLimit":"17.22","value":"3.33"}]}],"title":"Complete Response (CR)"},{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"3.76","upperLimit":"30.72","value":"13.33"}]}],"title":"Partial Response (PR)"},{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"14.73","upperLimit":"49.40","value":"30.0"}]}],"title":"Stable Disease (SD)"},{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"34.33","upperLimit":"71.66","value":"53.33"}]}],"title":"Progressive disease (PD)"}],"denoms":[{"counts":[{"groupId":"OG000","value":"30"}],"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.","dispersionType":"95% Confidence Interval","groups":[{"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":"OG000","title":"Phase II Part 1 - TG4001 5x10e7 Pfu + Avelumab"}],"paramType":"NUMBER","populationDescription":"Phase II part 1 (Evaluable per protocol): Participants dosed with both IMPs and with at least baseline and post-baseline evaluable CT-scan at week 6 according to RECIST 1.1 and no major inc/exc, dosing or protocol violation, except if participant progressed or died due to disease.\n\nPhase Ib and phase II part 2: the outcome measure ORR has not been defined as primary endpoint.\n\nTherefore Phase Ib and phase II part 2 are not included in the analysis population for ORR as primary endpoint.","reportingStatus":"POSTED","timeFrame":"From treatment start, every 6 weeks for the first 9 months, then every 12 weeks up to 2 years.","title":"Phase II Part 1: Overall Response Rate (ORR) by RECIST 1.1","type":"PRIMARY","unitOfMeasure":"percentage of participants"}