{"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"0"},{"groupId":"OG001","value":"0"}]}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"3"},{"groupId":"OG001","value":"6"}],"units":"Participants"}],"description":"Dose limiting toxicities (DLTs) includes the following:\n\n* Grade ≥ 3 drug related adverse event (AEs). However, fatigue, nausea/vomiting adequately treated with anti-emetics, endocrinopathies adequately controlled with one physiologic hormone replacement, skin toxicity and single laboratory values out of normal range without any clinical correlate, asymptomatic grade ≥3 lipase or amylase elevation, tumor flare defined as local pain, irritation, or rash localized at sites of known or suspected tumor or a transient Grade 3 infusion adverse event are excluded.\n* Liver function test abnormality:\n\n  * AST or ALT \\> 5 x ULN\n  * Total bilirubin \\> 3 x ULN\n  * Concurrent AST or ALT \\> 3 x ULN and total bilirubin \\> 2 x ULN\n* Drug related AE requiring treatment interruption for more than 2 weeks","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"}],"paramType":"NUMBER","populationDescription":"Phase Ib : All participants included and who received any amount of study treatment were included in the SAF. Any participant who was assigned a participant number, but did not receive any study treatment was not included in the SAF.\n\nPhase II part 1 and Phase II part 2: the outcome measure safety and tolerability has not been defined as primary endpoint.\n\nTherefore Phase II part 1 and Phase II part 2 are not included in the analysis population for safety and tolerability as primary endpoint.","reportingStatus":"POSTED","timeFrame":"From Day 1 to Day 28","title":"Phase Ib: To Evaluate the Safety and Tolerability of the Combination of TG4001 Plus Avelumab in Participants With Recurrent or Metastatic HPV-16 Positive Advanced Malignancies","type":"PRIMARY","unitOfMeasure":"DLT"}