{"denoms":[{"counts":[{"groupId":"BG000","value":"48"},{"groupId":"BG001","value":"3"},{"groupId":"BG002","value":"51"}],"units":"Participants"}],"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":"BG000","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":"BG001","title":"Cohort 2, Arm 2: Cervical Cancer With Prior Pelvic Radiation and Boost Brachytherapy"},{"description":"Total of all reporting groups","id":"BG002","title":"Total"}],"measures":[{"classes":[{"categories":[{"measurements":[{"groupId":"BG000","value":"0"},{"groupId":"BG001","value":"0"},{"groupId":"BG002","value":"0"}],"title":"<=18 years"},{"measurements":[{"groupId":"BG000","value":"37"},{"groupId":"BG001","value":"3"},{"groupId":"BG002","value":"40"}],"title":"Between 18 and 65 years"},{"measurements":[{"groupId":"BG000","value":"11"},{"groupId":"BG001","value":"0"},{"groupId":"BG002","value":"11"}],"title":">=65 years"}]}],"paramType":"COUNT_OF_PARTICIPANTS","title":"Age, Categorical","unitOfMeasure":"Participants"},{"classes":[{"categories":[{"measurements":[{"groupId":"BG000","spread":"10.72","value":"57.54"},{"groupId":"BG001","spread":"19.55","value":"51.17"},{"groupId":"BG002","spread":"11.2","value":"57.16"}]}]}],"dispersionType":"STANDARD_DEVIATION","paramType":"MEAN","title":"Age, Continuous","unitOfMeasure":"years"},{"classes":[{"categories":[{"measurements":[{"groupId":"BG000","value":"21"},{"groupId":"BG001","value":"3"},{"groupId":"BG002","value":"24"}],"title":"Female"},{"measurements":[{"groupId":"BG000","value":"27"},{"groupId":"BG001","value":"0"},{"groupId":"BG002","value":"27"}],"title":"Male"}]}],"paramType":"COUNT_OF_PARTICIPANTS","title":"Sex: Female, Male","unitOfMeasure":"Participants"},{"classes":[{"categories":[{"measurements":[{"groupId":"BG000","value":"5"},{"groupId":"BG001","value":"0"},{"groupId":"BG002","value":"5"}],"title":"Hispanic or Latino"},{"measurements":[{"groupId":"BG000","value":"41"},{"groupId":"BG001","value":"2"},{"groupId":"BG002","value":"43"}],"title":"Not Hispanic or Latino"},{"measurements":[{"groupId":"BG000","value":"2"},{"groupId":"BG001","value":"1"},{"groupId":"BG002","value":"3"}],"title":"Unknown or Not Reported"}]}],"paramType":"COUNT_OF_PARTICIPANTS","title":"Ethnicity (NIH/OMB)","unitOfMeasure":"Participants"},{"classes":[{"categories":[{"measurements":[{"groupId":"BG000","value":"1"},{"groupId":"BG001","value":"0"},{"groupId":"BG002","value":"1"}],"title":"American Indian or Alaska Native"},{"measurements":[{"groupId":"BG000","value":"1"},{"groupId":"BG001","value":"0"},{"groupId":"BG002","value":"1"}],"title":"Asian"},{"measurements":[{"groupId":"BG000","value":"0"},{"groupId":"BG001","value":"0"},{"groupId":"BG002","value":"0"}],"title":"Native Hawaiian or Other Pacific Islander"},{"measurements":[{"groupId":"BG000","value":"6"},{"groupId":"BG001","value":"1"},{"groupId":"BG002","value":"7"}],"title":"Black or African American"},{"measurements":[{"groupId":"BG000","value":"37"},{"groupId":"BG001","value":"2"},{"groupId":"BG002","value":"39"}],"title":"White"},{"measurements":[{"groupId":"BG000","value":"0"},{"groupId":"BG001","value":"0"},{"groupId":"BG002","value":"0"}],"title":"More than one race"},{"measurements":[{"groupId":"BG000","value":"3"},{"groupId":"BG001","value":"0"},{"groupId":"BG002","value":"3"}],"title":"Unknown or Not Reported"}]}],"paramType":"COUNT_OF_PARTICIPANTS","title":"Race (NIH/OMB)","unitOfMeasure":"Participants"},{"classes":[{"categories":[{"measurements":[{"groupId":"BG000","value":"48"},{"groupId":"BG001","value":"3"},{"groupId":"BG002","value":"51"}]}],"title":"United States"}],"paramType":"NUMBER","title":"Region of Enrollment","unitOfMeasure":"participants"}],"populationDescription":"Data was collected and reported here for one participant in cohort 1 who was a screening fail."}