Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
EMD Serono Research & Development Institute, Inc.
With
Merck KGaA, Darmstadt, Germany
Age
18–any
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
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 =\< 1.5 \* ULN or an estimated creatinine clearance (CCr) \> 40 milliliter (mL) per minute (min) according to the Cockcroft-Gault formula or by measure of CCr from 24-hour urine collection
You may not be if
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
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
Clareo Health | M7824 Monotherapy in Locally Advanced or Metastatic Second Line (2L) Biliary Tract Cancer (Cholangiocarcinoma and Gallbladder Cancer)
