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

Trial Status: Active

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.

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 =< 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
  • Systemic anticancer treatment after failing 1L platinum-based chemotherapy
  • Other protocol defined exclusion criteria could apply


Mayo Clinic Hospital
Mayo Clinic in Arizona


San Francisco
UCSF Medical Center-Mount Zion
Contact: Helen Diller Family Comprehensive Cancer Center
Phone: 877-827-3222


Mayo Clinic in Florida
Moffitt Cancer Center
Status: ACTIVE


Johns Hopkins University / Sidney Kimmel Cancer Center
Status: ACTIVE


Mayo Clinic


M D Anderson Cancer Center
Status: ACTIVE

Trial Phase Phase II

Trial Type Treatment

Lead Organization
EMD Serono Research & Development Institute, Inc.

  • Primary ID MS200647_0047
  • Secondary IDs NCI-2019-04160, 2018-003707-19
  • ID NCT03833661