Status:
COMPLETED
M7824 Monotherapy in Locally Advanced or Metastatic Second Line (2L) Biliary Tract Cancer (Cholangiocarcinoma and Gallbladder Cancer)
Lead Sponsor:
EMD Serono Research & Development Institute, Inc.
Collaborating Sponsors:
Merck KGaA, Darmstadt, Germany
Conditions:
Biliary Tract Cancer
Cholangiocarcinoma
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief 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.
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
March 26 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 30 2022
Estimated Enrollment :
159 Patients enrolled
Trial Details
Trial ID
NCT03833661
Start Date
March 26 2019
End Date
September 30 2022
Last Update
October 25 2023
Active Locations (33)
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1
Mayo Clinic Arizona
Scottsdale, Arizona, United States, 85259
2
UCSF Mount Zion Medical Ctr
San Francisco, California, United States, 94158
3
Mayo Clinic in Florida - Department of Neurology
Jacksonville, Florida, United States, 32224
4
H. Lee Moffitt Cancer Center and Research Institute, Inc
Tampa, Florida, United States, 33612-9497