There is a phase 2 trial by Klein et al. The study is prospective multicenter phase 2 nonrandomized clinical trial included patients with advanced rare cancers including patients with biliary tract cancers. This subgroup analysis evaluated 39 patients from CA209-538 with biliary tract cancers who were enrolled from December 2017 to December 2019. Most of the patients (n = 33) had experienced disease progression after 1 or more lines of therapy and had tumor tissue available for biomarker.research. UNfortunately, the exact type of biliary cancer was not provided. Results were not very encouraging. The median progression-free survival was 2.9 months (95% CI, 2.2-4.6 months), and overall survival was 5.7 months (95% CI, 2.7-11.9 months). Immune-related toxic events were reported in 49% of patients (n = 19), with 15% (n = 6) experiencing grade 3 or 4 events.
Oliver Klein, MD Damien Kee, MD; Adnan Nagrial, MD; et al, Ipilimumab Immunotherapy in Patients With Advanced Biliary Tract Cancers
Subgroup Analysis of a Phase 2 Nonrandomized Clinical Trial. AMA Oncol. 2020;6(9):1405-1409