The purpose of this study is to determine the safety of peri-operative gemcitabine, cisplatin, and pembrolizumab in patients with BTC, as well as whether the combination of gemcitabine, cisplatin, and pembrolizumab (gem/cis/pembro) is feasible and lead to pathologic responses.
Must have a newly diagnosed, biopsy-proven biliary tract cancer (BTC) including gallbladder, intrahepatic, extrahepatic, and hilar cholangiocarcinoma.
Resectable BTC (biliary tract cancer)
Measurable disease per RECIST 1.1 as determined by the investigator.
Age ≥18 years.
Receiving, or previously received, any systemic chemotherapy, or investigational agent for BTC.
Has received prior radiotherapy within 2 weeks of start of study intervention.
Patients with a history of prior treatment with anti-PD-1 and anti-PD-L1.
Have been diagnosed with another cancer or myeloproliferative disorder whose natural history or treatment has the potential to interfere with safety or efficacy assessment of this study's investigational drugs.
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Lead sponsor
Merck Sharp & Dohme LLC
Collaborator