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

Completed · Phase 2

Conditions studied: Biliary Tract Cancer, Cholangiocarcinoma, Gallbladder Cancer

In brief

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.

Key facts

Study ID

NCT03833661

Run by

EMD Serono Research & Development Institute, Inc.

People needed

159

Starts

2019-03-26

Expected to finish

2022-09-30

Last updated by the study team

2023-10-25

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Mayo Clinic Arizona — Scottsdale, Arizona, United States
• UCSF Mount Zion Medical Ctr — San Francisco, California, United States
• Mayo Clinic in Florida - Department of Neurology — Jacksonville, Florida, United States
• H. Lee Moffitt Cancer Center and Research Institute, Inc — Tampa, Florida, United States
• Sidney Kimmel Comprehensive Cancer Center at John Hopkins — Baltimore, Maryland, United States
• Mayo Clinic - Rochester — Rochester, Minnesota, United States
• MD Anderson Cancer Center - Unit — Houston, Texas, United States
• Peking University Cancer Hospital — Beijing, China
• Affiliated Tumor Hospital of Harbin Medical University — Harbin, China
• Groupe Hospitalier Sud - Hôpital Haut Lévêque - Service Hepato Gastroentérologie Oncologie Digest — Pessac, France
• ICO - Site René Gauducheau — Saint-Herblain, France
• Institut Gustave Roussy — Villejuif, France
• Istituto Clinico Humanitas — Rozzano, Milano, Italy
• Azienda Ospedaliera Universitaria Policlinico Sant'Orsola Malpighi - Unita' Operativa di Pediatria — Bologna, Italy
• Fondazione IRCCS Istituto Nazionale dei Tumori Milano — Milan, Italy
• Policlinico Universitario Agostino Gemelli - UOC Oncologia Medica — Roma, Italy
• National Cancer Center Hospital - Dept of Hepatobiliary and Pancreatic Oncology — Chūōku, Japan
• National Cancer Center Hospital East — Kashiwa-shi, Japan
• Kyorin University Hospital - Dept of Oncology — Mitaka-shi, Japan
• Kindai University Hospital - Dept of Gastroenterology — Osakasayama-shi, Japan
• Kanagawa Cancer Center — Yokohama, Japan
• Seoul National University Bundang Hospital — Seongnam-si, South Korea
• Seoul National University Hospital — Seoul, South Korea
• Severance Hospital, Yonsei University Health System — Seoul, South Korea
• Asan Medical Center — Seoul, South Korea

Full record on ClinicalTrials.gov

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