{"classes":[{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"20.4","upperLimit":"28.3","value":"24.2"},{"groupId":"OG001","lowerLimit":"32.7","upperLimit":"41.6","value":"37.1"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"472"},{"groupId":"OG001","value":"475"}],"units":"Participants"}],"title":"All randomized participants"},{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"27.3","upperLimit":"41.4","value":"34.1"},{"groupId":"OG001","lowerLimit":"28.4","upperLimit":"42.9","value":"35.4"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"185"},{"groupId":"OG001","value":"178"}],"units":"Participants"}],"title":"Randomized PD-L1 CPS >= 20 participants"}],"denoms":[{"counts":[{"groupId":"OG000","value":"472"},{"groupId":"OG001","value":"475"}],"units":"Participants"}],"description":"Objective Response Rate (ORR) is defined as the number of participants with a best overall response (BOR) of complete response (CR) or partial response (PR). Based on Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 criteria by blinded independent central review (BICR) assessment.\n\nComplete Response (CR): Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \\< 10 mm.\n\nPartial Response (PR): At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters.","dispersionType":"95% Confidence Interval","groups":[{"description":"Nivolumab 3 mg/kg IV every 2 weeks + Ipilimumab 1 mg/kg IV every 6 weeks until progression, unacceptable toxicity, or a maximum of 24 months from first nivolumab treatment.","id":"OG000","title":"Nivolumab + Ipilimumab"},{"description":"Cetuximab 400 mg/m2 IV for the initial dose only, then 250 mg/m2 weekly + cisplatin (100mg/m2) or carboplatin (AUC of 5 mg per milliliter per minute) on Day 1 and fluorouracil (1000 mg/m2 per day for 4 days) every 3 weeks for maximum of 6 cycles followed by maintenance cetuximab at 250 mg/m2 weekly (or every 2 weeks, per local prescribing information) until disease progression or unacceptable toxicity; the choice of cisplatin or carboplatin is at the discretion of the investigator.","id":"OG001","title":"EXTREME Regimen"}],"paramType":"NUMBER","populationDescription":"All randomized participants and randomized PD-L1 CPS \\>= 20 participants","reportingStatus":"POSTED","timeFrame":"From randomization up to approximately 65 months","title":"Objective Response Rate (ORR)","type":"SECONDARY","unitOfMeasure":"Percent"}