A trial evaluating combination immunotherapy with nivolumab and ipilimumab in patients with advanced biliary tract cancers, showed a significant activity in a subset of patients, according to an article published in JAMA Oncology.
This prospective multicentre phase 2 nonrandomised clinical trial included patients with rare advanced cancers. Subgroup analysis included 39 patients with biliary tract cancers. The primary endpoint was disease control rate, assessed by complete remission, partial remission, or stable disease.
Patients received treatment with nivolumab at a dose of 3mg/kg and ipilimumab at 1mg/kg every three weeks for four doses, followed by nivolumab 3mg/kg every 2 weeks for up to 96 weeks.
In the subgroup analysis the objective response rate was 23 per cent with a disease control rate of 44 per cent. The median progression-free survival was 2.9 months, and overall survival was 5.7 months. Immune-related toxic events were reported in 49 per cent of patients. Responses were exclusively observed in patients with intrahepatic cholangiocarcinoma and gallbladder carcinoma.
Nivolumab and ipilimumab combination regimen was associated with significantly improved clinical outcomes and durable responses in patients with gallbladder carcinoma and intrahepatic cholangiocarcinoma, contrasting with the generally short-lived responses obtained with chemotherapy.