In this phase 3 randomised study, presented at the European Society of Medical Oncology (ESMO) congress in Paris last weekend, the immune system was stimulated with nivolumab before surgery (neoadjuvant therapy) followed by nivolumab after surgery (adjuvant therapy) in patients with high risk localised kidney cancer. This was compared to surgery alone.
There were 819 patients in the study who were allocated to two treatment groups. In one group, patients were given one dose of nivolumab 4 weeks before surgery, followed by 9 doses after surgery. The control group had surgery followed by observation alone.
Recurrence-free survival was similar for both groups of patients and the study was stopped early because of lack of effectiveness. Average recurrence-free survival and overall survival times were not reached but were similar for both groups of patients. Serious of life-threatening side effects were reported by 20% of patients on nivolumab, compared to 6% in the control group.
This study showed that nivolumab given before and after surgery did not improve recurrence-free survival in kidney cancer patients who are at high risk of their cancer returning.
Read more in Urology Times here