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

• Status: Active, not recruiting
• Trial end date: 2024-03-03
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: EMD Serono Research & Development Institute, Inc.
• Collaborator: Merck KGaA, Darmstadt, Germany

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 =< 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