M7824 Monotherapy in Locally Advanced or Metastatic Second Line (2L) Biliary Tract Cancer (Cholan… (NCT03833661) | Clinical Trial Compass
CompletedPhase 2
M7824 Monotherapy in Locally Advanced or Metastatic Second Line (2L) Biliary Tract Cancer (Cholangiocarcinoma and Gallbladder Cancer)
United States159 participantsStarted 2019-03-26
Plain-language 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.
Who can participate
Age range18 Years
SexALL
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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) deox…
What they're measuring
1
Percentage of Participants With Confirmed Objective Response According to Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1) as Assessed by Independent Review Committee (IRC)
Timeframe: Time from first treatment up to 555 days
Trial details
NCT IDNCT03833661
SponsorEMD Serono Research & Development Institute, Inc.