Table 1.
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.