臨床研究等提出・公開システム

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

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

Merck Biopharma Co., Ltd. Japan

Merck Biopharma Co., Ltd. Japan

+81-120-870-088

completed

Mar. 26, 2019

Interventional

Nonrandomized, Single Group Assignment, Open Label

treatment purpose

2

- participants with histologically or cytologically confirmed locally advanced or metastatic BTC.
- Availability of tumor (primary or metastatic) archival material or fresh biopsies (collected within 28 days before first administration) of study intervention is mandatory
- Participants with BTC must have failed or be intolerant to 1L systemic platinum-based chemotherapy
- Disease must be measurable with at least 1 unidimensionally measurable lesion by RECIST 1.1
- Eastern Cooperative Oncology Group (ECOG) PS of 0 to 1
- Life expectancy more than 12 weeks as judged by the Investigator
- Adequate hematological function defined by white blood cell (WBC) count more than 3 X 10^9/L with absolute neutrophil count (ANC) more than 1.5 X 10^9/L, lymphocyte count more than 0.5 X 10^9/L, platelet count more than 75 X 10^9/L, and hemoglobin (Hgb) more than 9 g/dL
- Adequate hepatic function defined by a total bilirubin level less than 1.5 X upper limit of normal (ULN), an aspartate aminotransferase (AST) level less than 2.5 X ULN, and an alanine aminotransferase (ALT) level less than 2.5 X ULN. For participants with liver involvement in their tumor, AST less than 5.0 X ULN and ALT less than 5.0 X ULN is acceptable
- Adequate coagulation function defined as prothrombin time (PT) or international normalized ratio (INR) less than 1.5 X ULN unless the participant is receiving anticoagulant therapy
- Albumin more than 3.0 g/dL
- Hepatitis B virus (HBV) deoxyribonucleic acid (DNA) positive participants must be treated and on a stable dose of antivirals
- dequate renal function defined by either creatinine more than 1.5 X ULN or an estimated creatinine clearance (CCr) > 40 mL per min according to the Cockcroft-Gault formula or by measure of CCr from 24-hour urine collection
- Other protocol defined inclusion criteria could apply

- 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
- Other protocol defined exclusion criteria could apply

Both

Biliary Tract Cancer

investigational material(s)
Generic name etc : M7824
INN of investigational material : -
Therapeutic category code : 429 Other antitumor agents
Dosage and Administration for Investigational material : Participants will receive an intravenous infusion of 1200 milligrams (mg) M7824 once every 2 weeks until confirmed disease progression, death, unacceptable toxicity, study withdrawal, or up to 24 months

control material(s)
Generic name etc :
INN of investigational material : -
Therapeutic category code :
Dosage and Administration for Investigational material :

safety
efficacy
Confirmed Objective Response (OR) According to Response Evaluation Criteria in Solid Tumors (RECIST Version 1.1) as Evaluated by Independent Review Committee [ Time Frame: Time from first treatment to planned final assessment at approximately 2.5 years ]

safety
efficacy

+81-45-520-2222

Mar. 20, 2019