Table 2.

Response to Treatment.

Response	Nivolumab alone (N=316)	Nivolumab plus Ipilimumab (N=314)	Ipilimumab alone (N=315)
Best overall response — no. (%)†
Complete response	28 (8.9)	36 (11.5)	7 (2.2)
Partial response	110 (34.8)	145 (46.2)	53 (16.8)
Stable disease	34 (10.8)	41 (13.1)	69 (21.9)
Progressive disease	119 (37.7)	71 (22.6)	154 (48.9)
Could not be determined	25 (7.9)	21 (6.7)	32 (10.2)
Objective response‡
No. of patients (% [95% CI])	138 (43.7 [38.1–49.3])	181 (57.6 [52.0–63.2])	60 (19.0 [14.9–23.8])
Estimated odds ratio (95% CI)§	3.40 (2.02–5.72)	6.11 (3.59–10.38)	—
Two-sided P value	<0.00001	<0.00001	—
Time to objective response — mo
No. of responders	138	181	60
Median	2.78	2.76	2.79
Range	2.3–12.5	1.1–11.6	2.5–12.4

^†Best overall response was assessed by the investigator with the use of RECIST v1.1.

^‡Data include patients with a complete response and those with a partial response. The calculation of the confidence interval was based on the Clopper–Pearson method. These analyses were conducted using a two-sided Cochran-Mantel-Haenszel test stratified by PD-L1 status, BRAF mutation status, and metastasis stage.

^§Relative to ipilimumab alone.