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The combination of ipilimumab/nivolumab is approved for patients as a first-line treatment for metastatic kidney cancer. But duration of treatment and the safety or effectiveness of re-starting treatment when the cancer progresses is not known. This phase 2 clinical trial looks at the use of intermittent ipilimumab/nivolumab and re-starting treatment when the cancer progresses.
Patients with metastatic kidney cancer were treated in the first line with ipilimumab/nivolumab followed by up to 24 weeks of nivolumab. Patients who had a complete or partial response to treatment were able to enter a treatment-free observation period. Patients were assessed and staged every 12 weeks. Patients with no disease progression remained off treatment. When the cancer progressed, patients were treated with 2 doses of ipilimumab/nivolumab every 3 weeks. Recruitment of patients was slower than expected and the study was closed before the goal of 20 patients was reached.
Nine patients were included in the study. Response to ipilimumab/nivolumab followed by nivolumab was 33% complete response and 67% partial response. Most patients (7) have stayed off treatment, with an average treatment-free period of nearly 3 years. Two patients had progression of their cancer when they were off treatment and were given 2 cycles of ipilimumab and nivolumab. No serious side effects were reported when treatment was re-started.
This study shows that patients who respond to ipilimumab/nivolumab can have long treatment-free intervals. Further studies with more patients are needed.
