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A recent phase 3 study called CheckMate 914 has shown no improvement in disease-free survival when the nivolumab plus ipilimumab combination is given to patients with localised kidney cancer to prevent the cancer from coming back after surgery (adjuvant therapy).
The trial included 816 people who were at high risk of their cancer coming back after surgery. They were randomly put into two groups: one group were treated with nivolumab every 2 weeks for 12 doses plus ipilimumab every 6 weeks for 4 doses, the other group were treated with a placebo infusion. They were treated for up to 36 weeks, allowing for treatment delays.
The average follow-up was 3.5 years. 110 patients in the combination group had disease-free survival and 118 in the placebo group. Average disease-free survival was not reached in the nivolumab/ipilimumab group compared to 50.7 months in the placebo group. Disease-free survival rates at 24 months were 76% versus 74%.
The investigators concluded, “Adjuvant therapy with nivolumab plus ipilimumab did not improve disease-free survival compared to placebo in patients with localised kidney cancer at high risk of returning after nephrectomy.”
The second part of this trial is looking at nivolumab on its own compared to placebo as an adjuvant therapy.