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Nivolumab
Source: Renal Cell Cancer Treatment (PDQ®)–Health Professional Version, National Cancer Institute.
Source updated: May 13, 2025 · Captured 2026-09-09.
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Context: Treatment of Stage IV and Recurrent Renal Cell Cancer / Immunotherapy / Immune checkpoint inhibitors
Nivolumab is the only treatment that has shown prolonged OS in patients who have previously received antiangiogenic therapy. Nivolumab is a fully human antibody that blocks ligand activation of the PD-1 protein. By blocking the interaction between PD-1 and PD-1 ligands 1 and 2, nivolumab blocks a pathway that inhibits the cellular immune response and restores cellular immunity.
Evidence (nivolumab):
A phase II trial showed promising results and no dose response with nivolumab, which was given every 3 weeks at a dose of 0.3 mg/kg, 2 mg/kg, or 10 mg/kg.[22]
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A phase II trial showed promising results and no dose response with nivolumab, which was given every 3 weeks at a dose of 0.3 mg/kg, 2 mg/kg, or 10 mg/kg.[22]
The median survival was 25.5 months with a dose of 2 mg/kg given every 3 weeks and 24.7 months with a dose of 10 mg/kg given every 3 weeks.
A randomized controlled trial compared nivolumab at a dose of 3 mg/kg every 2 weeks with everolimus at a dose of 10 mg daily.[38] The trial randomly assigned 821 patients with metastatic renal cell cancer and a clear cell component who had previously received one or two antiangiogenic regimens. It is not clear whether the dose of 3 mg/kg every 2 weeks used in the phase III trial offers any advantage over the dose of 2 mg/kg every 3 weeks used in the phase II trial. However, the latter dose offers substantial cost savings.
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A randomized controlled trial compared nivolumab at a dose of 3 mg/kg every 2 weeks with everolimus at a dose of 10 mg daily.[38] The trial randomly assigned 821 patients with metastatic renal cell cancer and a clear cell component who had previously received one or two antiangiogenic regimens. It is not clear whether the dose of 3 mg/kg every 2 weeks used in the phase III trial offers any advantage over the dose of 2 mg/kg every 3 weeks used in the phase II trial. However, the latter dose offers substantial cost savings.
The objective response rate was 25% with nivolumab, compared with 5% with everolimus (P < .001).
A randomized controlled trial compared nivolumab at a dose of 3 mg/kg every 2 weeks with everolimus at a dose of 10 mg daily.[38] The trial randomly assigned 821 patients with metastatic renal cell cancer and a clear cell component who had previously received one or two antiangiogenic regimens. It is not clear whether the dose of 3 mg/kg every 2 weeks used in the phase III trial offers any advantage over the dose of 2 mg/kg every 3 weeks used in the phase II trial. However, the latter dose offers substantial cost savings.
The median duration of treatment was 5.5 months with nivolumab, compared with 3.7 months with everolimus, and there was no significant difference in PFS (median PFS, 4.6 months with nivolumab vs. 4.4 months with everolimus).
A randomized controlled trial compared nivolumab at a dose of 3 mg/kg every 2 weeks with everolimus at a dose of 10 mg daily.[38] The trial randomly assigned 821 patients with metastatic renal cell cancer and a clear cell component who had previously received one or two antiangiogenic regimens. It is not clear whether the dose of 3 mg/kg every 2 weeks used in the phase III trial offers any advantage over the dose of 2 mg/kg every 3 weeks used in the phase II trial. However, the latter dose offers substantial cost savings.
However, OS was significantly longer with nivolumab (median OS, 25.0 months vs. 19.6 months; HR, 0.73; 98.5% CI, 0.57–0.93).[38]
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Preserved source evidence · Not medical advice