This phase 2 study looked at the effect on survival of giving the combination of ipilimumab plus nivolumab after previous immunotherapy treatment has stopped working in patients with advanced kidney cancer.

Overall, 46 patients were included in the study. All had been treated with an immunotherapy, such as nivolumab, pembrolizumab, ipilimumab or atezolizumab. Patients previously treated with combinations of immunotherapies were not allowed in the trial. Patients were treated with nivolumab plus ipilimumab  every 3 weeks for four doses, followed by nivolumab every 4 weeks for up to 2 years or until the cancer got worse or they couldn’t tolerate the side effects.

Patients were followed up for nearly 3 years. The cancer shrank in 17.4% of patients and 41.3% of patients had stable disease. The cancer got worse in 30.4% of patients. The average duration of response to treatment with ipilimumab plus nivolumab was 16.4 months. After 24 weeks the combination was still working and the cancer had not got worse and median average overall survival time was 2 years.

Seven patients had serious or life-threatening side effects. There were no treatment-related deaths.

In conclusion, advanced kidney cancer patients who have previously been treated with immunotherapy which has stopped working may have improved survival from treatment with nivolumab plus ipilimumab.  The side effects from the combination were manageable and consistent with known side effects. The study contributes to the knowledge of optimal sequencing of immunotherapies for patients with advanced kidney cancer and high unmet needs.

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