{"classes":[{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"2.13","upperLimit":"66.7","value":"16"},{"comment":"Median is not estimable because a limited number of death events mean there is insufficient information to estimate the median OS with the Kaplan-Meier method.","groupId":"OG001","lowerLimit":"5.8","upperLimit":"21.6","value":"NA"}]}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"47"},{"groupId":"OG001","value":"3"}],"units":"Participants"}],"description":"OS will be evaluated using Kaplan-Meier methods and is defined as the time from the date of first treatment to the date of death (any cause). Participants who are alive at the end of follow up will be censored at the last known date alive.","dispersionType":"Full Range","groups":[{"description":"Cohort 1, Arm 1, Treatment Assignment Code (TAC) 1: Participants with HPV associated malignancies will receive human papillomavirus (HPV) vaccine every (q) 4 weeks x6, then q3 months (MO) x2 + NHS-IL12 q 4 weeks (wks) + M7824 q 2 wks.\n\nPDS0101 will be administered on Day (D)1, D15, D29 followed by booster vaccines every 4 weeks for up to a year. Subcutaneous 1.0mL (2.4mg of total peptide and 3 mg of R-DOTAP (Versamune) injection).\n\nM7824 will be administered at a flat dose of 1,200 mg intravenous (IV) (over 1 hour) once every 2 weeks.\n\nNHS-IL12 will be administered by subcutaneous (SC) injection every 4 weeks.","id":"OG000","title":"Cohort 1, Arm 1: Human Papillomavirus (HPV) Associated Malignancies"},{"description":"Cohort 2, Arm 2, Treatment Assignment Code (TAC) 1: Participants with cervical cancer with prior pelvic radiation and boost brachytherapy will receive human papillomavirus (HPV) vaccine + NHS-IL12 + M7824 (MSB0011359C) at reduced doses.\n\nPDS0101 will be administered on Day (D)1, D15, D29 followed by booster vaccines every 4 weeks for up to a year. Subcutaneous 1.0mL (2.4mg of total peptide and 3 mg of R-DOTAP (Versamune) injection).\n\nM7824 will be administered at a flat dose of 1,200 mg intravenous (IV) (over 1 hour) once every 2 weeks.\n\nNHS-IL12 will be administered by subcutaneous (SC) injection every 4 weeks.","id":"OG001","title":"Cohort 2, Arm 2: Cervical Cancer With Prior Pelvic Radiation and Boost Brachytherapy"}],"paramType":"MEDIAN","reportingStatus":"POSTED","timeFrame":"The time from the date of first treatment to the date of death (any cause), up to 67 months","title":"Overall Survival (OS)","type":"SECONDARY","unitOfMeasure":"Months"}