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)
Single group
Cemiplimab
Drugintravenous 300mg
Rate of conversion to resectable disease and subsequent surgical resection
Successful conversion to resectable disease must meet all of the following criteria: * Absence of extra-regional lymph node metastases, including retropancreatic or paraceliac lymph node involvement * Absence of invasion of the portal vein or main hepatic artery * Absence of extrahepatic organ tumor invasion, except for contiguous involvement of the diaphragm * Absence of bilobar liver involvement, including bilateral bile duct involvement to the secondary radicles * If right or left hepatic lobe atrophy, absence of contralateral secondary biliary radicle involvement * Absence of disseminated metastatic disease * Adequate estimated liver remnant after surgery (This may be achieved with portal vein embolization.) * Tumor resected.
Rate of R0 resection
Defined as surgical resection without any residual cancer
Time to resection
defined as time from start of treatment to surgical resection
Objective Response Rate (ORR)
ORR is defined as the rate of complete response or partial response, according to RECIST 1.1 criteria.
Median recurrence-free survival (mRFS) from the time of resection until histologic confirmation of recurrent BTC
mRFS is defined as the length of time after treatment during which 50% of patients remain free of disease recurrence or progression.
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Columbia University
Lead sponsor
Regeneron Pharmaceuticals
Collaborator
