{"denoms":[{"counts":[{"groupId":"BG000","value":"4"},{"groupId":"BG001","value":"5"},{"groupId":"BG002","value":"1"},{"groupId":"BG003","value":"15"},{"groupId":"BG004","value":"7"},{"groupId":"BG005","value":"4"},{"groupId":"BG006","value":"10"},{"groupId":"BG007","value":"3"},{"groupId":"BG008","value":"7"},{"groupId":"BG009","value":"56"}],"units":"Participants"}],"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":"BG000","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":"BG001","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":"BG002","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":"BG003","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":"BG004","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":"BG005","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":"BG006","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":"BG007","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":"BG008","title":"Cohort 1C + Phase 2; Solid Tumors With Accessible Masses"},{"description":"Total of all reporting groups","id":"BG009","title":"Total"}],"measures":[{"classes":[{"categories":[{"measurements":[{"groupId":"BG000","lowerLimit":"37","upperLimit":"70","value":"52.5"},{"groupId":"BG001","lowerLimit":"26","upperLimit":"69","value":"55"},{"groupId":"BG002","lowerLimit":"66","upperLimit":"66","value":"66"},{"groupId":"BG003","lowerLimit":"39","upperLimit":"71","value":"59"},{"groupId":"BG004","lowerLimit":"21","upperLimit":"68","value":"51"},{"groupId":"BG005","lowerLimit":"46","upperLimit":"71","value":"66"},{"groupId":"BG006","lowerLimit":"34","upperLimit":"84","value":"64"},{"groupId":"BG007","lowerLimit":"45","upperLimit":"55","value":"54"},{"groupId":"BG008","lowerLimit":"31","upperLimit":"80","value":"58"},{"groupId":"BG009","lowerLimit":"21","upperLimit":"84","value":"58"}]}]}],"dispersionType":"FULL_RANGE","paramType":"MEDIAN","title":"Age, Continuous","unitOfMeasure":"years"},{"classes":[{"categories":[{"measurements":[{"groupId":"BG000","value":"3"},{"groupId":"BG001","value":"5"},{"groupId":"BG002","value":"0"},{"groupId":"BG003","value":"15"},{"groupId":"BG004","value":"2"},{"groupId":"BG005","value":"1"},{"groupId":"BG006","value":"6"},{"groupId":"BG007","value":"0"},{"groupId":"BG008","value":"4"},{"groupId":"BG009","value":"36"}],"title":"Female"},{"measurements":[{"groupId":"BG000","value":"1"},{"groupId":"BG001","value":"0"},{"groupId":"BG002","value":"1"},{"groupId":"BG003","value":"0"},{"groupId":"BG004","value":"5"},{"groupId":"BG005","value":"3"},{"groupId":"BG006","value":"4"},{"groupId":"BG007","value":"3"},{"groupId":"BG008","value":"3"},{"groupId":"BG009","value":"20"}],"title":"Male"}]}],"paramType":"COUNT_OF_PARTICIPANTS","title":"Sex: Female, Male","unitOfMeasure":"Participants"},{"classes":[{"categories":[{"measurements":[{"groupId":"BG000","value":"0"},{"groupId":"BG001","value":"0"},{"groupId":"BG002","value":"0"},{"groupId":"BG003","value":"0"},{"groupId":"BG004","value":"0"},{"groupId":"BG005","value":"0"},{"groupId":"BG006","value":"0"},{"groupId":"BG007","value":"0"},{"groupId":"BG008","value":"1"},{"groupId":"BG009","value":"1"}],"title":"Hispanic or Latino"},{"measurements":[{"groupId":"BG000","value":"4"},{"groupId":"BG001","value":"5"},{"groupId":"BG002","value":"1"},{"groupId":"BG003","value":"14"},{"groupId":"BG004","value":"7"},{"groupId":"BG005","value":"4"},{"groupId":"BG006","value":"10"},{"groupId":"BG007","value":"3"},{"groupId":"BG008","value":"6"},{"groupId":"BG009","value":"54"}],"title":"Not Hispanic or Latino"},{"measurements":[{"groupId":"BG000","value":"0"},{"groupId":"BG001","value":"0"},{"groupId":"BG002","value":"0"},{"groupId":"BG003","value":"1"},{"groupId":"BG004","value":"0"},{"groupId":"BG005","value":"0"},{"groupId":"BG006","value":"0"},{"groupId":"BG007","value":"0"},{"groupId":"BG008","value":"0"},{"groupId":"BG009","value":"1"}],"title":"Unknown or Not Reported"}]}],"paramType":"COUNT_OF_PARTICIPANTS","title":"Ethnicity (NIH/OMB)","unitOfMeasure":"Participants"},{"classes":[{"categories":[{"measurements":[{"groupId":"BG000","value":"0"},{"groupId":"BG001","value":"0"},{"groupId":"BG002","value":"0"},{"groupId":"BG003","value":"0"},{"groupId":"BG004","value":"0"},{"groupId":"BG005","value":"0"},{"groupId":"BG006","value":"0"},{"groupId":"BG007","value":"0"},{"groupId":"BG008","value":"0"},{"groupId":"BG009","value":"0"}],"title":"American Indian or Alaska Native"},{"measurements":[{"groupId":"BG000","value":"0"},{"groupId":"BG001","value":"0"},{"groupId":"BG002","value":"0"},{"groupId":"BG003","value":"0"},{"groupId":"BG004","value":"0"},{"groupId":"BG005","value":"0"},{"groupId":"BG006","value":"0"},{"groupId":"BG007","value":"0"},{"groupId":"BG008","value":"1"},{"groupId":"BG009","value":"1"}],"title":"Asian"},{"measurements":[{"groupId":"BG000","value":"0"},{"groupId":"BG001","value":"0"},{"groupId":"BG002","value":"0"},{"groupId":"BG003","value":"0"},{"groupId":"BG004","value":"0"},{"groupId":"BG005","value":"0"},{"groupId":"BG006","value":"0"},{"groupId":"BG007","value":"0"},{"groupId":"BG008","value":"0"},{"groupId":"BG009","value":"0"}],"title":"Native Hawaiian or Other Pacific Islander"},{"measurements":[{"groupId":"BG000","value":"0"},{"groupId":"BG001","value":"0"},{"groupId":"BG002","value":"0"},{"groupId":"BG003","value":"2"},{"groupId":"BG004","value":"2"},{"groupId":"BG005","value":"1"},{"groupId":"BG006","value":"2"},{"groupId":"BG007","value":"0"},{"groupId":"BG008","value":"0"},{"groupId":"BG009","value":"7"}],"title":"Black or African American"},{"measurements":[{"groupId":"BG000","value":"4"},{"groupId":"BG001","value":"5"},{"groupId":"BG002","value":"1"},{"groupId":"BG003","value":"11"},{"groupId":"BG004","value":"5"},{"groupId":"BG005","value":"3"},{"groupId":"BG006","value":"7"},{"groupId":"BG007","value":"3"},{"groupId":"BG008","value":"6"},{"groupId":"BG009","value":"45"}],"title":"White"},{"measurements":[{"groupId":"BG000","value":"0"},{"groupId":"BG001","value":"0"},{"groupId":"BG002","value":"0"},{"groupId":"BG003","value":"0"},{"groupId":"BG004","value":"0"},{"groupId":"BG005","value":"0"},{"groupId":"BG006","value":"0"},{"groupId":"BG007","value":"0"},{"groupId":"BG008","value":"0"},{"groupId":"BG009","value":"0"}],"title":"More than one race"},{"measurements":[{"groupId":"BG000","value":"0"},{"groupId":"BG001","value":"0"},{"groupId":"BG002","value":"0"},{"groupId":"BG003","value":"2"},{"groupId":"BG004","value":"0"},{"groupId":"BG005","value":"0"},{"groupId":"BG006","value":"1"},{"groupId":"BG007","value":"0"},{"groupId":"BG008","value":"0"},{"groupId":"BG009","value":"3"}],"title":"Unknown or Not Reported"}]}],"paramType":"COUNT_OF_PARTICIPANTS","title":"Race (NIH/OMB)","unitOfMeasure":"Participants"},{"classes":[{"categories":[{"measurements":[{"groupId":"BG000","value":"4"},{"groupId":"BG001","value":"5"},{"groupId":"BG002","value":"1"},{"groupId":"BG003","value":"15"},{"groupId":"BG004","value":"7"},{"groupId":"BG005","value":"4"},{"groupId":"BG006","value":"10"},{"groupId":"BG007","value":"3"},{"groupId":"BG008","value":"7"},{"groupId":"BG009","value":"56"}]}],"title":"United States"}],"paramType":"NUMBER","title":"Region of Enrollment","unitOfMeasure":"participants"},{"classes":[{"categories":[{"measurements":[{"groupId":"BG000","value":"2"},{"groupId":"BG001","value":"0"},{"groupId":"BG002","value":"0"},{"groupId":"BG003","value":"6"},{"groupId":"BG004","value":"4"},{"groupId":"BG005","value":"2"},{"groupId":"BG006","value":"4"},{"groupId":"BG007","value":"1"},{"groupId":"BG008","value":"4"},{"groupId":"BG009","value":"23"}],"title":"ECOG PS 0"},{"measurements":[{"groupId":"BG000","value":"2"},{"groupId":"BG001","value":"5"},{"groupId":"BG002","value":"1"},{"groupId":"BG003","value":"9"},{"groupId":"BG004","value":"3"},{"groupId":"BG005","value":"2"},{"groupId":"BG006","value":"6"},{"groupId":"BG007","value":"2"},{"groupId":"BG008","value":"3"},{"groupId":"BG009","value":"33"}],"title":"ECOG PS 1"}]}],"description":"PS 0 = Fully active, able to carry on all pre-disease performance without restriction; PS 1 = Restricted in physically strenuous activity but ambulatory and able to carry out work of a light or sedentary nature, e.g., light house work, office work; PS 2 = Ambulatory and capable of all selfcare but unable to carry out any work activities; up and about more than 50% of waking hours; PS 3 = Capable of only limited selfcare; confined to bed or chair more than 50% of waking hours; PS 4 = Completely disabled; cannot carry on any selfcare; totally confined to bed or chair; PS 5 = Dead","paramType":"COUNT_OF_PARTICIPANTS","title":"Eastern Cooperative Oncology Group (ECOG) Performance Status (PS)","unitOfMeasure":"Participants"}],"populationDescription":"All subjects who received at least one dose of study medication."}