{"classes":[{"categories":[{"measurements":[{"groupId":"OG001","lowerLimit":"2.004","upperLimit":"2.168","value":"2.1587"},{"comment":"with a single participant contributing data, the full range values equal the observed value.","groupId":"OG004","lowerLimit":"NA","upperLimit":"NA","value":"2.0698"}]}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"0"},{"groupId":"OG001","value":"2"},{"groupId":"OG002","value":"0"},{"groupId":"OG003","value":"0"},{"groupId":"OG004","value":"1"},{"groupId":"OG005","value":"0"}],"units":"Participants"}],"description":"Time to response was defined as the time from first dose of AMG 820 until first documented complete or partial response per irRECIST divided by 365.25 days/12.","dispersionType":"Full Range","groups":[{"description":"Part 1 Cohorts 1 + 2 combined. Participants with advanced solid tumors were treated with 1400 mg or 1100 mg AMG 820 plus 200 mg pembrolizumab (Pem) every three weeks (Q3W) to determine safety. Participants could be treated up to 24 months if treatment was tolerable and clinical benefit was observed.","id":"OG000","title":"Part 1: AMG 820 + Pem"},{"description":"Group 1 is comprised of participants with colorectal cancer (CRC) who are proficient in mismatch repair genes (MMR).\n\nAMG 820 was administered at the recommended dose of 1100 mg intravenously in combination with pembrolizumab 200 mg every 3 weeks (± 3 days). Each group in Part 2 was evaluated separately using a Simon 2-stage design. Treatment continued until confirmed disease progression per modified irRECIST, or intolerance of study treatment, or clinically significant deterioration of health status requiring discontinuation, whichever occurred first, or the subject withdrew consent.","id":"OG001","title":"Part 2, Group 1: CRC MMR-proficient"},{"description":"Group 2 is comprised of participants with advanced pancreatic cancer who are naïve to anti programmed-death 1 (PD-1), anti PD-ligand 1 (PD-L1), colony stimulating factor 1 (CSF-1) and colony stimulating factor 1 receptor (CSF-1R) therapies.\n\nAMG 820 was administered at the recommended dose of 1100 mg intravenously in combination with pembrolizumab 200 mg every 3 weeks (± 3 days). Each group in Part 2 was evaluated separately using a Simon 2-stage design. Treatment continued until confirmed disease progression per modified irRECIST, or intolerance of study treatment, or clinically significant deterioration of health status requiring discontinuation, whichever occurred first, or the subject withdrew consent.","id":"OG002","title":"Part 2, Group 2: Pancreatic Cancer"},{"description":"Group 3 is comprised of participants with non-small cell lung cancer (NSCLC) who have low (\\< 50%) tumor PD-L1- expression and are naïve to anti-PD-1/PD-L1/CSF-1/CSF-1R agents.\n\nAMG 820 was administered at the recommended dose of 1100 mg intravenously in combination with pembrolizumab 200 mg every 3 weeks (± 3 days). Each group in Part 2 was evaluated separately using a Simon 2-stage design. Treatment continued until confirmed disease progression per modified irRECIST, or intolerance of study treatment, or clinically significant deterioration of health status requiring discontinuation, whichever occurred first, or the subject withdrew consent.","id":"OG003","title":"Part 2, Group 3: NSCLC PD-L1 Low, Naïve"},{"description":"Group 4a is comprised of participants who did not respond to or who relapsed during monotherapy with anti-PD-1/PD-L1 agents and are anti-CSF-1/CSF-1R naïve. These participants have low PD-L1 tumor expression (\\<50%).\n\nAMG 820 was administered at the recommended dose of 1100 mg intravenously in combination with pembrolizumab 200 mg every 3 weeks (± 3 days). Each group in Part 2 was evaluated separately using a Simon 2-stage design. Treatment continued until confirmed disease progression per modified irRECIST, or intolerance of study treatment, or clinically significant deterioration of health status requiring discontinuation, whichever occurred first, or the subject withdrew consent.","id":"OG004","title":"Part 2, Group 4a: Refractory / Relapsing NSCLC PD-L1 Low"},{"description":"Group 4b is comprised of participants who did not respond to or who relapsed during monotherapy with anti-PD-1/PD-L1 agents and are anti-CSF-1/CSF-1R naïve. These participants have high PD-L1 tumor expression (\\>=50%).\n\nAMG 820 was administered at the recommended dose of 1100 mg intravenously in combination with pembrolizumab 200 mg every 3 weeks (± 3 days). Each group in Part 2 was evaluated separately using a Simon 2-stage design. Treatment continued until confirmed disease progression per modified irRECIST, or intolerance of study treatment, or clinically significant deterioration of health status requiring discontinuation, whichever occurred first, or the subject withdrew consent.","id":"OG005","title":"Part 2, Group 4b: Refractory/Relapsing NSCLC PD-L1 High"}],"paramType":"MEAN","populationDescription":"Safety Analysis Set","reportingStatus":"POSTED","timeFrame":"Day 1 up to Month 16 (max time to censoring)","title":"Time to Response (TTR) Per Immune-Related Response Evaluation Criteria in Solid Tumors (irRECIST) For Participants Who Responded","type":"SECONDARY","unitOfMeasure":"month"}