Table 3A.

Clinical Activity of Patients Who Received the Concurrent 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]	Aggregate Clinical Activity Rate║ % [95% CI]	≥80% Tumor Reduction at 12 wk n (%)
1	0.3 mg/kg nivolumab + 3 mg/kg ipilimumab	14	1	2	0	2	2 (14)	0	21 [5-51]	50 [23-77]	4 (29)
2	1 mg/kg nivolumab + 3 mg/kg ipilimumab	17	3	6	0	0	0	2 (12)	53 [28-77]	65 [38-86]	7 (41)**
2a	3 mg/kg nivolumab + 1 mg/kg ipilimumab	15	1	5	2	1	2 (13)	0	40 [16-68]	73 [45-92]	5 (33)
3	3 mg/kg nivolumab + 3 mg/kg ipilimumab	6	0	3	0	1	0	1 (17)	50 [12-88]	83 [36-100]	0
All	Concurrent treatment	52	5	16	2	4	4 (8)	3 (6)	40 [27-55]	65 [51-78]	16 (31)

^*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.

^**Two additional patients in cohort 2 achieved ≥80% tumor reduction at their first scheduled assessment, which was conducted after week 12.