A Phase II, Multicenter, Open-label Study to Investigate the Clinical Efficacy of M7824 Monotherapy in Participants With Locally Advanced or Metastatic Biliary Tract Cancer Who Fail or Are Intolerant to First-line Platinum-Based Chemotherapy

MS200647_0047

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.

2019-03-26

2020-11-09

2022-09-30

Completed

Early phase I

159

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 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

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2023-10-25