m7824 monotherapy in locally advanced or metastatic second line (2l) biliary tract cancer (cholangiocarcinoma and gallbladder cancer)

Conditions: Biliary Tract Cancer; Cholangiocarcinoma; Gallbladder Cancer

Summary: the study to evaluate m7824 monotherapy in participants with advanced or metastatic biliary tract cancer (btc) who failed or were intolerant to first-line (1l) chemotherapy.


Eligibility criteria:
inclusion criteria * are participants with histologically or cytologically confirmed locally advanced or metastatic btc. * availability of tumor (primary or metastatic) archival material or fresh biopsies is mandatory * participants with btc must have failed or be intolerant to 1l systemic platinum-based chemotherapy administered for locally advanced or metastatic disease. only one prior treatment line is allowed * disease must be measurable with at least 1 unidimensionally measurable lesion by recist 1.1 * eastern cooperative oncology group (ecog) performance status (ps) of 0 to 1 * life expectancy \>= 12 weeks as judged by the investigator * adequate hematological function defined by white blood cell (wbc) count \>= 3 \* 10\^9/litre with absolute neutrophil count (anc) \>= 1.5 \* 109/litre, lymphocyte count \>= 0.5 \* 10\^9/litre, platelet count \>=75 \* 10\^9/litre, and hemoglobin (hgb) \>= 9 grams/decilitre * adequate hepatic function defined by a total bilirubin level =\< 1.5 \* upper limit of normal (uln), an aspartate aminotransferase (ast) level =\< 2.5 \* uln, and an alanine aminotransferase (alt) level =\<2.5 \* uln. for participants with liver involvement in their tumor, ast =\< 5.0 \* uln and alt =\< 5.0 \* uln is acceptable * adequate coagulation function defined as prothrombin time (pt) or international normalized ratio (inr) =\< 1.5 \* uln unless the participant is receiving anticoagulant therapy * albumin \>= 3.0 grams/decilitre * hepatitis b virus (hbv) deoxyribonucleic acid (dna) positive participants must be treated and on a stable dose of antivirals * adequate renal function defined by either creatinine =\ 40 milliliter (ml) per minute (min) according to the cockcroft-gault formula or by measure of ccr from 24-hour urine collection * other protocol defined inclusion criteria could apply exclusion criteria: * ampullary cancer was excluded * significant acute or chronic infections * active autoimmune disease that might deteriorate when receiving an immunostimulatory agent * interstitial lung disease or its history * participants who were not eligible for or have not been treated with 1l systemic chemotherapy * anticancer treatment within 21 days before the start of study intervention * concurrent treatment with nonpermitted drugs * prior participation in a m7824 clinical trial * prior therapy with other immunotherapy or checkpoint inhibitors, such as anti-pd 1, anti pd l1, anti- cytotoxic t-cell lymphocyte-4 (ctla-4) antibodies. * pregnancy or breast feeding * systemic anticancer treatment after failing 1l platinum-based chemotherapy * other protocol defined exclusion criteria could apply

Keywords: m7824 bintrafusp alfa (proposed inn) transforming growth factor-beta first-line platinum-based chemotherapy programmed death-ligand 1 metastatic biliary tract cancer cholangiocarcinoma gallbladder cancer