From the Guidelines
For advanced renal cell carcinoma (RCC), the recommended dosing regimen for the combination of ipilimumab and nivolumab is: nivolumab 3 mg/kg intravenously over 30 minutes, followed by ipilimumab 1 mg/kg intravenously over 30 minutes on the same day, every 3 weeks for a total of 4 doses, as supported by the most recent and highest quality study 1. This combination therapy has shown improved overall survival compared to single-agent tyrosine kinase inhibitors, particularly in intermediate and poor-risk patients. The regimen works by enhancing T-cell function through complementary mechanisms - ipilimumab blocks CTLA-4, preventing T-cell inhibition, while nivolumab blocks PD-1, restoring T-cell activity against tumor cells. Some key points to consider when using this combination include:
- The dosing schedule is derived from the CheckMate 214 trial, which demonstrated statistically significant improvements in OS and ORR for patients receiving the combination compared with those receiving sunitinib 1.
- Patients should be monitored for immune-related adverse events, which may require dose delays or discontinuation based on severity, as reported in the study 1.
- The combination of ipilimumab and nivolumab has been shown to improve health-related quality of life (HRQoL) compared to sunitinib, as measured by the FKSI-19 1.
- The most recent study 1 provides the strongest evidence for the recommended dosing regimen, with a minimum study follow-up of 42 months in the primary efficacy population of intermediate- and poor-risk patients.
From the FDA Drug Label
Indication Recommended YERVOY Dosage Duration of Therapy Advanced renal cell carcinoma 1 mg/kg every 3 weeks‡ with nivolumab 3 mg/kg‡ In combination with nivolumabfor a maximum of 4 doses. After completing 4 doses of combination therapy, administer nivolumab as single agent until disease progression or unacceptable toxicity.
The recommended dosage of ipilimumab (YERVOY) in combination with nivolumab for advanced renal cell carcinoma is 1 mg/kg every 3 weeks with nivolumab 3 mg/kg every 3 weeks for a maximum of 4 doses, followed by nivolumab as a single agent until disease progression or unacceptable toxicity 2.
From the Research
Ipilimumab and Nivolumab Dosing for Kidneys CC Carcinoma
- The dosing of ipilimumab and nivolumab for kidneys cc carcinoma is not explicitly stated in the provided studies, but the administration of these drugs in accordance with the CHECKMATE 214 trial is mentioned 3.
- The CHECKMATE 214 trial is a pivotal phase III trial that evaluated the combination of nivolumab and ipilimumab in patients with treatment-naive advanced or metastatic renal cell carcinoma (RCC) 4.
- In the CHECKMATE 214 trial, nivolumab was administered at a dose of 3 mg/kg every 2 weeks, and ipilimumab was administered at a dose of 1 mg/kg every 3 weeks for 4 doses, followed by nivolumab 3 mg/kg every 2 weeks 4.
- The combination of nivolumab and ipilimumab has been approved for the treatment of intermediate- and poor-risk metastatic RCC, and has demonstrated superior efficacy in treatment-naive patients with clear cell histology 4, 5.
- Real-world studies have also evaluated the clinical outcomes of patients with metastatic RCC receiving pembrolizumab + axitinib vs. ipilimumab + nivolumab, and have shown that the combination of ipilimumab and nivolumab is effective in this setting 6, 7.