{"calculatePct":false,"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"0"},{"groupId":"OG001","value":"4"},{"groupId":"OG002","value":"1"}]}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"3"},{"groupId":"OG001","value":"26"},{"groupId":"OG002","value":"5"}],"units":"Participants"}],"description":"Overall response rate was assessed according to Immune-related Response Criteria (irRC) (Wolchok, Hoos et al. 2009). ORR is the number of participants with a best overall response of irCR or irPR.\n\nirCR is defined as complete disappearance of all lesions with no new lesions; irPR as a ≥50% decrease in tumor burden from baseline; both are confirmed ≥4 weeks after initial documentation.\n\nOnly participants with adequate irRC tumor assessments (baseline and ≥1 post-baseline) and without major protocol deviations, were included in the analysis.","groups":[{"description":"Participants received 0.2 or 0.25 mg dose of Pegilodecakin QD administered SC and FOLFOX treatment on Day 1 of each 14-day cycle for a maximum of 12 cycles. Participants received:\n\noxaliplatin 85 mg/m2 IV over 2 hours, and leucovorin 200 mg/m2 IV over 2 hours, followed by 5-FU 400 mg/m2 IV bolus over 2-4 minutes, 5-FU 600 mg/m2/day IV over 22 hours, and leucovorin 200 mg/m2 over 2 hours on Day 2 followed by 5-FU 400 mg/m2 IV bolus over 2-4 minutes, and 5-FU 600 mg/m2/day IV over 22 hours.\n\nStudy treatment continued until disease progression, death, unacceptable toxicity, or end of trial.","id":"OG000","title":"Part C: Pegilodecakin 0.2/0.25 mg + FOLFOX"},{"description":"Participants received 0.4 or 0.5 mg of Pegilodecakin QD administered SC and FOLFOX treatment on Day 1 of each 14-day cycle for a maximum of 12 cycles. Participants received:\n\noxaliplatin 85 mg/m2 IV over 2 hours, and leucovorin 200 mg/m2 IV over 2 hours, followed by 5-FU 400 mg/m2 IV bolus over 2-4 minutes, 5-FU 600 mg/m2/day IV over 22 hours, and leucovorin 200 mg/m2 over 2 hours on Day 2 followed by 5-FU 400 mg/m2 IV bolus over 2-4 minutes, and 5-FU 600 mg/m2/day IV over 22 hours.\n\nStudy treatment continued until disease progression, death, unacceptable toxicity, or end of trial.","id":"OG001","title":"Part C: Pegilodecakin 0.4/0.5 mg + FOLFOX"},{"description":"Participants received 0.8 or 1 mg dose of Pegilodecakin QD administered SC and FOLFOX treatment on Day 1 of each 14-day cycle for a maximum of 12 cycles. Participants received:\n\noxaliplatin 85 mg/m2 IV over 2 hours, and leucovorin 200 mg/m2 IV over 2 hours, followed by 5-FU 400 mg/m2 IV bolus over 2-4 minutes, 5-FU 600 mg/m2/day IV over 22 hours, and leucovorin 200 mg/m2 over 2 hours on Day 2 followed by 5-FU 400 mg/m2 IV bolus over 2-4 minutes, and 5-FU 600 mg/m2/day IV over 22 hours.\n\nStudy treatment continued until disease progression, death, unacceptable toxicity, or end of trial.","id":"OG002","title":"Part C: Pegilodecakin 0.8/1 mg + FOLFOX"}],"paramType":"COUNT_OF_PARTICIPANTS","populationDescription":"Participants who received at least one dose of study intervention(s) and had an adequate irRC tumor assessment were included in the analysis.","reportingStatus":"POSTED","timeFrame":"From Date of First Dose of Study drug until Disease Progression or Death (Upto 23 months)","title":"Part C: Number of Participants With Overall Response Rate (ORR)","type":"SECONDARY","unitOfMeasure":"Participants"}