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

Merck KGaA (EMD Serono)

Status and phase

Completed

Phase 2

Conditions

Gallbladder Cancer

Biliary Tract Cancer

Cholangiocarcinoma

Treatments

Drug: M7824

Study type

Interventional

Funder types

Industry

Identifiers

NCT03833661

MS200647_0047

2018-003707-19 (EudraCT Number)

Details and patient eligibility

About

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.

Enrollment

159 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion 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 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