Table 3B.

Clinical Activity of Patients Who Received the Sequenced Regimen of Nivolumab and Ipilimumab^*

Cohort	Dose	Response-Evaluable Patients † n	CR n	PR n	uPR‡ n	irPR§ n	SD ≥24 wk n	irSD§ ≥24 wk n	Objective Response Rate¶ % [95% CI]	AggregateClinical Activity Rate║ % [95% CI]	≥80% Tumor Reduction at 8 wk n (%)
6	1 mg/kg nivolumab + prior ipilimumab	16	1	5	2	2	1 (6)	0	38 [15-65]	69 [41-89]	4 (25)
7	3 mg/kg nivolumab + prior ipilimumab	14	0	0	1	1	0	0	0	14 [2-43]	0
All	Sequenced treatment	30	1	5	3	3	1 (3)	0	20 [8-39]	43 [26-63]	4 (13)

^*CR denotes complete response, PR partial response, uPR unconfirmed partial response, irPR immune-related partial response, SD stable disease, irSD immune-related stable disease.

^†Response-evaluable patients were those who received at least one dose of study therapy, had measurable disease at baseline, and one of the following: 1) at least one on-treatment tumor evaluation, 2) clinical progression, or 3) death prior to the first on-treatment tumor evaluation.

^‡Patients who had a PR after one tumor assessment but did not have sufficient follow-up time for confirmation of the initial PR.

^§Patients who had target tumor-lesion reduction in the presence of new lesions, consistent with immune-related PR or SD.¹¹

^¶[(CR + PR) / no. response-evaluable patients] × 100. Confidence intervals were estimated by the Clopper-Pearson method.

^║[(CR + PR + uCR + uPR + irPR + SD ≥24 wk + irSD ≥24 wk) / no. response-evaluable patients] × 100.