Table 1.

Reported studies of PD-1 pathway blocking antibodies in RCC

Trial (ref.)	Phase	N a	Patient population	Primary endpoint	RR	Median PFS	Median OS
Nivolumab monotherapy
Drake et al. (33) NCT00730639	I	34/35 RCC	Advanced solid  tumors	Safety Tolerability	29%	7.3 mo	22 mo
Choueiri et al. (36) NCT01358721	I	91	Metastatic ccRCC  with prior antiangiogenic  therapy or treatment  naïve	Immunomodulatory  activity	17%	36% at  24 wks	NR
Motzer et al. (34, 35) NCT01354431	II Dose  ranging	168	Metastatic ccRCC  with prior  antiangiogenic  therapy	PFS	20%–22%	2.7–4.2 mo	18.2–25.5 mo
Nivolumab plus sunitinib, pazopanib, or ipilimumab
Hammers et al. (46); Amin et al. (42) NCT01472081	I	44 Ipi 43 S/P	mRCC: prior  antiangiogenic  therapy or  treatment naive	Safety Tolerability
				N3/I1	43%	37 wks	NR
				N1/I3	48%	38 wks	NR
				N + S	52%	49 wks
				N + P	45%	31 wks
MPDL3280A
Cho et al. (15)	I	69 RCC	Advanced solid  tumors	DLT	15%	24 wks	NR
McDermott et al. (37) NCT01375842			aAllowed non–clear  cell RCC
MPDL3280A plus bevacizumab
McDermott et al. (37)	I	10 RCC	Treatment naïve	Safety	40%	NR	NR
BMS-936559 Brahmer et al. (11) NCT00729664	I	17 RCC	Advanced solid tumors	Safety, MTD, DLT	12%	53% at  24 wks	NR

Abbreviations: DLT, dose-limited toxicity; I, ipilimumab; N, nivolumab; NR, not reached; P, pazopanib; S, sunitinib.

^aN, number evaluable over total enrolled when presented in ratio.