Multicenter phase 2 trial of nivolumab plus ipilimumab for metastatic castration-resistant prostate cancer with an immunogenic signature

Efficacy of immune checkpoint inhibitors in unselected patients with metastatic castration-resistant prostate cancer (mCRPC) is limited. The multicenter phase 2 NEPTUNES trial in the UK evaluated the combination of nivolumab plus ipilimumab in pretreated mCRPC with an immunogenic signature (ImS: mismatch repair deficiency, DNA damage repair gene loss, and/or high inflammatory infiltrate). Patients received four doses of nivolumab 1 mg/kg plus ipilimumab 3 mg/kg (cohort 1) or nivolumab 3 mg/kg plus ipilimumab 1 mg/kg (cohort 2) followed by nivolumab 480 mg once every 4 weeks up to 10 cycles. The study found that nivolumab 1 mg/kg plus ipilimumab 3 mg/kg is an active treatment in pretreated mCRPC with ImS features.