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Kidney Cancer and Immunotherapy

Immunotherapy like nivolumab, ipilimumab, pembrolizumab and avelumab are drugs that have shown promise in the treatment of many cancers including the common form of kidney cancer, “clear cell” renal cell carcinoma. But studies have excluded people with other forms of kidney cancer, lumped together they are called “non-clear cell”, but are better thought of as rare kidney cancers. About one quarter of people with kidney cancer have the non-clear cell cancer type.  While it’s clear that older medicines for kidney cancer, VEGFR tyrosine kinase inhibitors, don’t work as well for rare kidney cancers, it made little scientific sense to exclude rare kidney cancers from immunotherapy treatment.

There is also an urgent unmet need for effective therapies for patients with rare kidney cancer, as people typically experience a more aggressive disease course, leading to a more limited prognosis compared to patients with the clear cell subtype.

So the UNISoN trial was designed to look at whether new immune treatments can help people with the rare type of kidney cancer called “non-clear cel” cancer. Kidney cancer trials have generally focussed on the more common clear cell cancer. As a result, we do not know whether immune treatments help treat non-clear cell kidney cancer.

The UNISoN study tested immune treatments in two stages. In the first part of the trial, one immune treatment called nivolumab was given by itself to 85 participants. If nivolumab was not helpful, participants had the option to move to the second part of the study. Forty-four participants entered the second part of the study, where another type of immune treatment called ipilimumab was added to nivolumab. Recruitment for the study ran 40% faster than expected and was effective at 19 sites across Australia.

The UNISoN trial will help us answer several important questions in this population of patients:

  • Does immunotherapy help people with rare kidney cancer?
  • Is nivolumab alone effective?
  • Is the combination of ipilimumab and nivolumab effective in people failed by nivolumab alone?

Both nivolumab and ipilimumab act by working with the immune system to fight cancer. These types of drugs are helpful in other types of cancer such as clear cell kidney cancer, melanoma and lung cancer. Based on experience in different cancer types, immune treatments are known to cause the immune system to attack normal cells. This can lead to side effects, but they are often easily controlled.

All the participants on the UNISoN trial have completed the first part of treatment with nivolumab. Outcomes such as how effective the treatment was and the frequency of side effects have been looked at in a ‘Part 1 analysis’ and will be reported soon. For everyone involved in the trial, it is exciting as the results will help us understand whether immune treatments work in non-clear cell kidney cancer.

In addition, there are profound real-world applications of the potential findings from UNISoN. Patients with rare kidney cancer generally experience only modest responses to treatment. In many settings, there are no reimbursed treatment options for patients with non-clear cell kidney cancer. UNISoN offers high quality, randomised evidence that will undoubtedly guide the management of patients with rare forms of kidney cancer. We are eagerly anticipating the results from UNISoN, which are expected in 2021.


  • Non-clear cell kidney cancer is rare and useful treatments are lacking
  • UNISoN tested two types of immune treatments – nivolumab and ipilimumab
  • Outcomes have been reviewed in ‘Part 1 analysis’
  • Results will be reported soon