M7824 Monotherapy in Locally Advanced or Metastatic Second Line (2L) Biliary Tract Cancer (Cholangiocarcinoma and Gallbladder Cancer)

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
(collected within 28 days before first administration) of study intervention is
mandatory

- Participants with BTC must have failed or be intolerant to 1L systemic platinum-based
chemotherapy

- Disease must be measurable with at least 1 unidimensionally measurable lesion by
RECIST 1.1

- Eastern Cooperative Oncology Group (ECOG) 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

- Other protocol defined inclusion criteria could apply

Exclusion Criteria:

- Ampullary cancer is 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 are 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

- Other protocol defined exclusion criteria could apply