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A phase II trial of intermittent nivolumab in patients with metastatic renal cell carcinoma (mRCC) who have received prior anti-angiogenic therapy

Journal for ImmunoTherapy of Cancer May 23, 2019

Ornstein MC, et al. - Among patients with metastatic renal cell carcinoma (mRCC) ≥18 years of age who previously received at least one antiangiogenic therapy, researchers assessed if intermittent nivolumab dosing was feasible in this phase 2 clinical trial. For 12 weeks, nivolumab was given to patients; those who had RECIST PD were excluded. In cases with a ≥ 10% tumor burden (TB) increase, nivolumab was restarted and was again held with TB reduction ≥10%. Until RECIST PD while on nivolumab, they continued this intermittent nivolumab dosing. Of 14 patients included, 5 (36%) eligible patients were included in the intermittent phase of the trial. Therapy was restarted in only one patient, followed-up for a median of 48 weeks. The sustained response was seen in four remaining patients for a median of 34 weeks off therapy. During off therapy, RECIST PD developed in none. Further inquiry of intermittent immunotherapy dosing strategies in RCC was supported.

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