Introduction

The combination of the drugs ipilimumab (trade name: Yervoy) and nivolumab (trade name: Opdivo) has been approved in Germany since January 2019 for the treatment of advanced renal cell cancer (renal cell carcinoma). This combination is a treatment option for patients who are having treatment for advanced renal cell cancer for the first time and who have an intermediate or poor prognosis.

Renal cell cancer is the most common type of kidney cancer. It usually goes unnoticed for a long time because symptoms only occur in people with advanced, larger tumors. Symptoms include pain in the kidney area that may radiate into the back, as well as blood in urine. If renal cell cancer has already grown too much or spread to other organs (metastatic tumors), surgery to remove it may no longer be an effective treatment.

When deciding on the most suitable treatment, doctors estimate how fast the kidney tumor will probably progress. This prognosis is based on several risk factors, such as whether the patient has anemia, high levels of calcium or certain blood cells, and whether the cancer is already affecting their everyday life. The more risk factors the patient has, the poorer their chances of recovery (prognosis): People who have 1 to 2 risk factors are considered to have an intermediate prognosis, and those who have 3 or more risk factors are considered to have a poor prognosis.

Both treatment with ipilimumab and treatment with nivolumab aims to stimulate the immune system to fight the cancer.

Application

Ipilimumab and nivolumab are each given as an infusion (IV drip), entering the bloodstream directly through a vein.

The treatment involves two phases. In the first phase, nivolumab and ipilimumab are given together. In the second phase, only nivolumab is given.

  • During the first 3 months of treatment, the patient has an infusion every three weeks. Each session starts with a dose of nivolumab, immediately followed by a dose of ipilimumab. The infusions each take about 30 minutes. The exact doses of both drugs will depend on the patient's body weight: The recommended doses are 3 mg per kilogram of body weight for nivolumab and 1 mg per kilogram of body weight for ipilimumab.
  • Three weeks after the final combination treatment, nivolumab is given on its own every two weeks at a dose of 240 mg. The infusion takes about 30 minutes. Alternatively, 6 weeks after the final combination treatment, nivolumab can be given every four weeks at a dose of 480 mg. Then the infusion takes about 60 minutes.

The treatment is stopped if the cancer progresses or if very severe side effects arise.

Other treatments

The most suitable first-line treatment for advanced renal cell cancer depends on the patient's prognosis:

  • For people who have an intermediate prognosis, the standard treatment is a combination of bevacizumab and interferon alfa-2a or treatment with pazopanib or sunitinib.
  • For people who have a poor prognosis, sunitinib or temsirolimus are options.

Assessment

In 2019, the Institute for Quality and Efficiency in Health Care (IQWiG, Germany) looked into whether the combination of ipilimumab and nivolumab has any advantages or disadvantages compared with the standard treatments for people who have advanced renal cell cancer that has not been treated before and who have an intermediate or poor prognosis.

The results of the assessment of the combination of ipilimumab and nivolumab are different for people with an intermediate prognosis and people with a poor prognosis.

Learn more

More information

This information summarizes the main results of reviews produced by the Institute for Quality and Efficiency in Health Care (IQWiG, Germany). The reviews were commissioned by the German Federal Joint Committee (G-BA) as part of the “early benefit assessment of medications.” On the basis of the reviews and the hearings received, the G-BA passed a resolution on the added benefit of ipilimumab (trade name: Yervoy) and nivolumab (trade name: Opdivo).