This study is being conducted to find out if treatment with gemcitabine, cisplatin, nab-paclitaxel, and cemiplimab can shrink previously inoperable tumors enough for surgery.
Histologically confirmed diagnosis of biliary tract adenocarcinoma (intra- or extra-hepatic, and gallbladder)
Tumor involvement of both hepatic lobes and/or vessels
Vascular invasion of the portal vein or main hepatic artery
For perihilar tumors: bilateral hepatic duct involvement up to secondary radicles
Histologies other than adenocarcinoma such as mixed hepatocellular carcinoma/cholangiocarcinoma, adenosquamous carcinoma or mixed adenocarcinoma/neuroendocrine carcinoma; ampullary carcinomas are also excluded.
Has initially resectable disease or distant metastasis, including distant lymph nodes.
Participants may not have had systemic chemotherapy, investigational therapy, or treatment with T-cell co-stimulating or immune check point blockade therapies (including anti-CTLA-4, anti PD-1, and anti PD-L1 therapeutic antibodies) prior to initiation of study treatment.
Participants receiving any other investigational agents concurrently or other anti-neoplastic agents (hormone therapy acceptable)
Columbia University
Lead sponsor
Regeneron Pharmaceuticals
Collaborator