{"classes":[{"categories":[{"measurements":[{"comment":"The upper limit of the confidence interval was not estimable due to the small number of events.","groupId":"OG000","lowerLimit":"82","upperLimit":"NA","value":"157"},{"comment":"The upper limit of the confidence interval was not estimable due to the small number of events.","groupId":"OG001","lowerLimit":"21","upperLimit":"NA","value":"44"},{"comment":"The upper and lower limits of the confidence interval were not estimable due to the small number of events.","groupId":"OG002","lowerLimit":"NA","upperLimit":"NA","value":"85"},{"groupId":"OG003","lowerLimit":"42","upperLimit":"225","value":"85"},{"groupId":"OG004","lowerLimit":"9","upperLimit":"83","value":"44"},{"comment":"The upper limit of the confidence interval was not estimable due to the small number of events.","groupId":"OG005","lowerLimit":"37","upperLimit":"NA","value":"68"},{"groupId":"OG006","lowerLimit":"26","upperLimit":"127","value":"82"},{"comment":"The upper limit of the confidence interval was not estimable due to the small number of events.","groupId":"OG007","lowerLimit":"24","upperLimit":"NA","value":"43"},{"comment":"The upper limit of the confidence interval was not estimable due to the small number of events.","groupId":"OG008","lowerLimit":"37","upperLimit":"NA","value":"84"}]}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"4"},{"groupId":"OG001","value":"5"},{"groupId":"OG002","value":"1"},{"groupId":"OG003","value":"15"},{"groupId":"OG004","value":"7"},{"groupId":"OG005","value":"4"},{"groupId":"OG006","value":"10"},{"groupId":"OG007","value":"3"},{"groupId":"OG008","value":"7"}],"units":"Participants"}],"description":"Tumor responses were evaluated using appropriate imaging and categorized according to irRECIST at Screening (up to 21 days before the first dose of study treatment), and in Cycles 4, 7, 9 and 11, when a subject discontinued treatment prematurely and 28 days after the last dose of study treatment.\n\nPFS was measured from the date of the first dose of study treatment to the date of earliest disease progression according to irRECIST or to the date of death, if disease progression did not occur. Per irRECIST, Progressive Disease (irPD) was defined as a ≥ 20% increase from nadir in the Total Measured Tumor Burden (TMTB).","dispersionType":"95% Confidence Interval","groups":[{"description":"Subjects received durvalumab (1500 mg IV every 4 weeks \\[Q4W\\] for 12 cycles). Poly-ICLC (1 mg) was administered intratumorally on days 1, 3, 5, 8, 10 and 15 and intramuscularly on days 17, 22, and 24 of Cycle 1 as well as intramuscularly on days 1, 3, 8, 10, 15, 17, 22 and 24 of Cycle 2 and on days 1 and 4 of Cycle 3.\n\nDurvalumab\n\nPoly-ICLC","id":"OG000","title":"Phase 1, Cohort 1A"},{"description":"Subjects received durvalumab (1500 mg IV Q4W for 12 cycles) and tremelimumab (75 mg IV Q4W for the first 4 cycles).\n\nPoly-ICLC (1 mg) was administered intratumorally on days 1, 3, 5, 8, 10 and 15 and intramuscularly on days 17, 22, and 24 of Cycle 1 as well as intramuscularly on days 1, 3, 8, 10, 15, 17, 22 and 24 of Cycle 2 and on days 1 and 4 of Cycle 3.\n\nDurvalumab\n\nTremelimumab\n\nPoly-ICLC","id":"OG001","title":"Phase 1, Cohort 1B"},{"description":"Subjects received durvalumab (1500 mg IV Q4W for 12 cycles) and tremelimumab (10 mg) intratumorally on days 1, 8, and 15 of Cycle 1, days 1 and 15 of Cycle 2 and day 1 of Cycles 3 and 4.\n\nPoly-ICLC (1 mg) was administered intratumorally on days 1, 3, 5, 8, 10 and 15 and intramuscularly on days 17, 22, and 24 of Cycle 1 as well as intramuscularly on days 1, 3, 8, 10, 15, 17, 22 and 24 of Cycle 2 and on days 1 and 4 of Cycle 3.\n\nDurvalumab\n\nTremelimumab\n\nPoly-ICLC","id":"OG002","title":"Cohort 1C + Phase 2; Head + Neck Squamous Cell Carcinoma"},{"description":"Subjects received durvalumab (1500 mg IV Q4W for 12 cycles) and tremelimumab (10 mg) intratumorally on days 1, 8, and 15 of Cycle 1, days 1 and 15 of Cycle 2 and day 1 of Cycles 3 and 4.\n\nPoly-ICLC (1 mg) was administered intratumorally on days 1, 3, 5, 8, 10 and 15 and intramuscularly on days 17, 22, and 24 of Cycle 1 as well as intramuscularly on days 1, 3, 8, 10, 15, 17, 22 and 24 of Cycle 2 and on days 1 and 4 of Cycle 3.\n\nDurvalumab\n\nTremelimumab\n\nPoly-ICLC","id":"OG003","title":"Cohort 1C + Phase 2; Locally Recurrent or Metastatic Breast Cancer"},{"description":"Subjects received durvalumab (1500 mg IV Q4W for 12 cycles) and tremelimumab (10 mg) intratumorally on days 1, 8, and 15 of Cycle 1, days 1 and 15 of Cycle 2 and day 1 of Cycles 3 and 4.\n\nPoly-ICLC (1 mg) was administered intratumorally on days 1, 3, 5, 8, 10 and 15 and intramuscularly on days 17, 22, and 24 of Cycle 1 as well as intramuscularly on days 1, 3, 8, 10, 15, 17, 22 and 24 of Cycle 2 and on days 1 and 4 of Cycle 3.\n\nDurvalumab\n\nTremelimumab\n\nPoly-ICLC","id":"OG004","title":"Cohort 1C + Phase 2; Sarcoma"},{"description":"Subjects received durvalumab (1500 mg IV Q4W for 12 cycles) and tremelimumab (10 mg) intratumorally on days 1, 8, and 15 of Cycle 1, days 1 and 15 of Cycle 2 and day 1 of Cycles 3 and 4.\n\nPoly-ICLC (1 mg) was administered intratumorally on days 1, 3, 5, 8, 10 and 15 and intramuscularly on days 17, 22, and 24 of Cycle 1 as well as intramuscularly on days 1, 3, 8, 10, 15, 17, 22 and 24 of Cycle 2 and on days 1 and 4 of Cycle 3.\n\nDurvalumab\n\nTremelimumab\n\nPoly-ICLC","id":"OG005","title":"Cohort 1C + Phase 2; Merkel Cell Carcinoma"},{"description":"Subjects received durvalumab (1500 mg IV Q4W for 12 cycles) and tremelimumab (10 mg) intratumorally on days 1, 8, and 15 of Cycle 1, days 1 and 15 of Cycle 2 and day 1 of Cycles 3 and 4.\n\nPoly-ICLC (1 mg) was administered intratumorally on days 1, 3, 5, 8, 10 and 15 and intramuscularly on days 17, 22, and 24 of Cycle 1 as well as intramuscularly on days 1, 3, 8, 10, 15, 17, 22 and 24 of Cycle 2 and on days 1 and 4 of Cycle 3.\n\nDurvalumab\n\nTremelimumab\n\nPoly-ICLC","id":"OG006","title":"Cohort 1C + Phase 2; Melanoma After Failure of Available Therapies"},{"description":"Subjects received durvalumab (1500 mg IV Q4W for 12 cycles) and tremelimumab (10 mg) intratumorally on days 1, 8, and 15 of Cycle 1, days 1 and 15 of Cycle 2 and day 1 of Cycles 3 and 4.\n\nPoly-ICLC (1 mg) was administered intratumorally on days 1, 3, 5, 8, 10 and 15 and intramuscularly on days 17, 22, and 24 of Cycle 1 as well as intramuscularly on days 1, 3, 8, 10, 15, 17, 22 and 24 of Cycle 2 and on days 1 and 4 of Cycle 3.\n\nDurvalumab\n\nTremelimumab\n\nPoly-ICLC","id":"OG007","title":"Cohort 1C + Phase 2; Genitourinary Cancers With Accessible Metastases"},{"description":"Subjects received durvalumab (1500 mg IV Q4W for 12 cycles) and tremelimumab (10 mg) intratumorally on days 1, 8, and 15 of Cycle 1, days 1 and 15 of Cycle 2 and day 1 of Cycles 3 and 4.\n\nPoly-ICLC (1 mg) was administered intratumorally on days 1, 3, 5, 8, 10 and 15 and intramuscularly on days 17, 22, and 24 of Cycle 1 as well as intramuscularly on days 1, 3, 8, 10, 15, 17, 22 and 24 of Cycle 2 and on days 1 and 4 of Cycle 3.\n\nDurvalumab\n\nTremelimumab\n\nPoly-ICLC","id":"OG008","title":"Cohort 1C + Phase 2; Solid Tumors With Accessible Masses"}],"paramType":"MEDIAN","populationDescription":"All subjects who had at least one dose of study medication.","reportingStatus":"POSTED","timeFrame":"up to 15 months","title":"Median Progression-free Survival (PFS) by Immune-related Response Evaluation Criteria in Solid Tumors (irRECIST) as Estimated Using the Kaplan-Meier Method","type":"SECONDARY","unitOfMeasure":"days"}