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The CheckMate-214 clinical trial was the first study to show the effectiveness of a combination of ipilimumab plus nivolumab (two immunotherapies) compared with standard treatment with sunitinib in patients with previously untreated kidney cancer. The results from this study resulted in the ipilimumab plus nivolumab combination becoming the new standard treatment for these patients.
However, the side effects of immunotherapy can be very bad. Serious or life-threatening side effects related to treatment with ipilimumab plus nivolumab were reported by nearly half of the patients (46%), and treatment with immunotherapy was stopped in nearly a quarter of patients (22%). The tolerability of combination immunotherapy led to the start of the PRISM study.
PRISM was a randomised, phase 2 study comparing the “standard” dosing schedule of ipilimumab/nivolumab given every 3 weeks for 12 weeks followed by maintenance nivolumab with the “modified” dosing schedule of ipilimumab/nivolumab given every 12 weeks.
The number of patients who reported a serious or life-threatening side effect during the first year of treatment with the “modified” immunotherapy dosing schedule was reduced compared to the “standard” dosing schedule: Just over a half of patients (52.1%) in the “standard” group reported a serious or life-threatening side effect compared to one third of patients (32.8%) in the “modified” group.
The proportion of patients who stopped treatment with immunotherapy was also lower with the “modified” immunotherapy dosing schedule, at 1 in 5 patients (22.7%) compared to 2 in 5 patients (39.1%) with the “standard” dosing schedule. Meanwhile, survival and response to treatment remained similar for both the “modified” and “standard” immunotherapy dosing schedules.
This study highlights the possibility of reducing the frequency of infusions with immunotherapy, while maintaining the effectiveness of the treatment for previously untreated advanced kidney cancer.
