From the Guidelines
For patients with renal cell carcinoma (RCC), the standard administration schedule for the ipilimumab and nivolumab combination consists of ipilimumab 1 mg/kg intravenously plus nivolumab 3 mg/kg intravenously every 3 weeks for 4 doses, followed by nivolumab monotherapy. This regimen is based on the most recent and highest quality study, which demonstrated improved overall survival and response rates compared to previous standard therapies 1. The combination of ipilimumab and nivolumab works by enhancing the immune response against cancer cells through complementary immune checkpoint inhibition mechanisms. Key points to consider when administering this combination include:
- Monitoring for immune-related adverse events, which may require dose delays or discontinuation based on severity
- Premedication is not routinely required but may be given if there's a history of infusion reactions
- The maintenance phase with nivolumab typically continues for up to 2 years or until disease progression or unacceptable toxicity occurs The evidence supporting this regimen comes from the CheckMate 214 trial, which compared combination ipilimumab/nivolumab followed by nivolumab monotherapy with sunitinib monotherapy in patients with advanced RCC 1. Overall, the ipilimumab and nivolumab combination has become a standard first-line treatment for intermediate and poor-risk advanced RCC patients based on its improved efficacy and safety profile compared to previous standard therapies.
From the FDA Drug Label
• Advanced Renal Cell Carcinoma: YERVOY 1 mg/kg immediately following nivolumab 3 mg/kg on the same day, every 3 weeks for 4 doses. After completing 4 doses of the combination, administer nivolumab as a single agent as recommended in Full Prescribing Information for nivolumab. (2. 2) The administration schedule for the ipilimumab and nivolumab combination in patients with Renal Cell Carcinoma (RCC) is:
- Ipilimumab: 1 mg/kg
- Nivolumab: 3 mg/kg
- Frequency: every 3 weeks for 4 doses
- Administration: ipilimumab immediately following nivolumab on the same day 2
From the Research
Administration Schedule for Ipilimumab and Nivolumab Combination in RCC
The administration schedule for the ipilimumab and nivolumab combination in patients with Renal Cell Carcinoma (RCC) is as follows:
- Ipilimumab 1 mg/kg in combination with Nivolumab 3 mg/kg every three weeks for four doses, followed by maintenance Nivolumab (240 or 480 mg flat dose every two or four weeks, respectively) until disease progression or unacceptable toxicity 3.
- Nivolumab 3 mg/kg plus ipilimumab 1 mg/kg every 3 weeks for four doses, followed by nivolumab 480 mg every 4 weeks for up to 2 years or until progression, toxicity, or protocol-specified discontinuation 4.
- Nivolumab (3 mg/kg) plus ipilimumab (1 mg/kg) every 3 weeks for 4 cycles, then either NIVO monotherapy 5.
Key Considerations
- The combination of ipilimumab and nivolumab has shown efficacy and safety in patients with advanced RCC, with a manageable safety profile 3, 4, 5.
- The administration schedule may vary depending on the specific clinical trial or study protocol 3, 4, 5.
- Patients with RCC may derive durable clinical benefit from the ipilimumab and nivolumab combination, with improved overall survival and progression-free survival rates 3, 4, 5.
Dosing and Administration
- The dosing and administration of ipilimumab and nivolumab may vary depending on the specific clinical context and patient population 3, 4, 5.
- Ipilimumab is typically administered at a dose of 1 mg/kg, while nivolumab is administered at a dose of 3 mg/kg or 240/480 mg flat dose 3, 4, 5.
Clinical Trials and Studies
- Several clinical trials and studies have investigated the efficacy and safety of the ipilimumab and nivolumab combination in patients with RCC, including CheckMate 214 and FRACTION-RCC 3, 4, 5.
- These studies have demonstrated the potential benefits of the ipilimumab and nivolumab combination in patients with RCC, with improved overall survival and progression-free survival rates 3, 4, 5.