Table 1.

Response rate and survival of nivolumab trials in renal cell carcinoma.

Study	Phase	Population	Treatment	Primary endpoint	n	ORR	PFS	OS
CA209-003	Ib	Pretreated met RCC (⩾1 prior ttt)	Nivolumab (1 or 10 mg/kg) q2w	Safety and tolerability	34	29.4% across all doses	NA	NA
CA209-009	I	Untreated and pretreated met ccRCC (⩾1 prior antiangiogenic ttt, ⩽3 prior systemic ttts)	Nivolumab (0.3–2–10 mg/kg) q3w	Immunomodulatory activity	80	9–23% across all doses	NA	Untreated: NR pretreated: 16.4–NR–25.2 months for 0.3–2–10 mg/kg cohorts
CA209-010	II	Pretreated adv/met RCC (⩾ 1 prior antiangiogenic ttt, ⩽3 prior systemic ttts)	Nivolumab (0.3–2–10 mg/kg) q3w	PFS (dose relationship)	150	20–22% across all doses	2.7–4–4.2 months for 0.3–2–10 mg/kg cohorts	18.5–25.5–24.8 months for 0.3−2−10 mg/kg cohorts
CA209-016	I	Untreated and pretreated adv/met ccRCC	Arm I1, I3, IN3 : Ipilimumab + nivolumab Q3W then Nivolumab Q2W Arm S : Sunitinib + nivolumab q3w Arm P : Pazopanib + nivolumab q3w	Safety and tolerability	175	38.3% arm I1 40.4% arm I3	33 weeks arm I1 47.3 weeks arm I3	NR
CA209-025	III	Adv or met ccRCC	Nivolumab 3 mg/kg q2w	OS	822	25%	4.4 months	25 months

Met, metastatic; RCC, renal cell carcinoma; adv, advanced; ccRCC, clear cell renal cell carcinoma; ttt, treatment; Q2W, every 2 weeks; Q3W, every 3 weeks; I1, ipilimumab 1 mg/kg + nivolumab 3 mg/kg; I3, ipilimumab 3 mg/kg + nivolumab 1 mg/kg; IN3, ipilimumab 3 mg/kg + nivolumab 3 mg/kg; NA, not assessed; NR, not reached; PFS, progression-free survival; OS, overall survival, ORR, objective response rate.