Clinical Trials /

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

NCT03833661

Description:

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.

Related Conditions:
  • Biliary Tract Carcinoma
Recruiting Status:

Recruiting

Phase:

Phase 2

Trial Eligibility

Document

Title

  • Brief Title: M7824 Monotherapy in Locally Advanced or Metastatic Second Line (2L) Biliary Tract Cancer (Cholangiocarcinoma and Gallbladder Cancer)
  • Official Title: 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

Clinical Trial IDs

  • ORG STUDY ID: MS200647_0047
  • SECONDARY ID: 2018-003707-19
  • NCT ID: NCT03833661

Conditions

  • Biliary Tract Cancer
  • Cholangiocarcinoma
  • Gallbladder Cancer

Interventions

DrugSynonymsArms
M7824Bintrafusp alfaM7824

Purpose

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.

Trial Arms

NameTypeDescriptionInterventions
M7824Experimental
  • M7824

Eligibility 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
             (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 >= 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 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
      
Maximum Eligible Age:N/A
Minimum Eligible Age:18 Years
Eligible Gender:All
Healthy Volunteers:No

Primary Outcome Measures

Measure: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 Issue:
Description:

Secondary Outcome Measures

Measure:Duration of Response (DOR) Assessed by Independent Review Committee (IRC)
Time Frame:Time from first treatment to planned final assessment at approximately 2.5 years
Safety Issue:
Description:
Measure:Durable Response of at Least 6 Months According to Response Evaluation Criteria in Solid Tumors (RECIST Version 1.1) Assessed by Independent Review Committee (IRC)
Time Frame:Time from first treatment to planned final assessment at approximately 2.5 years
Safety Issue:
Description:
Measure:Occurrence of Treatment-Emergent Adverse Events (TEAEs) and Treatment-Related AEs, Including Adverse Events of Special Interest (AESIs)
Time Frame:Time from first treatment to planned final assessment at approximately 2.5 years
Safety Issue:
Description:
Measure:Progression-Free Survival (PFS) According to Response Evaluation Criteria in Solid Tumors (RECIST Version 1.1) Assessed by Independent Review Committee (IRC)
Time Frame:Time from first treatment to planned final assessment at approximately 2.5 years
Safety Issue:
Description:
Measure:Objective Response (OR) According to Response Evaluation Criteria in Solid Tumors (RECIST Version 1.1) Assessed by Investigator
Time Frame:Time from first treatment to planned final assessment at approximately 2.5 years
Safety Issue:
Description:
Measure:Duration of Response (DOR) According to Response Evaluation Criteria in Solid Tumors (RECIST Version 1.1) Assessed by Investigator
Time Frame:Time from first treatment to planned final assessment at approximately 2.5 years
Safety Issue:
Description:
Measure:Durable Response According to Response Evaluation Criteria in Solid Tumors (RECIST Version 1.1) Assessed by Investigator
Time Frame:Time from first treatment to planned final assessment at approximately 2.5 years
Safety Issue:
Description:
Measure:Progression-Free Survival (PFS) According to Response Evaluation Criteria in Solid Tumors (RECIST Version 1.1) Assessed by Investigator
Time Frame:Time from first treatment to planned final assessment at approximately 2.5 years
Safety Issue:
Description:
Measure:Overall Survival (OS)
Time Frame:Time from first treatment to planned final assessment at approximately 2.5 years
Safety Issue:
Description:
Measure:Concentration of M7284 at the end of Infusion (Ceoi)
Time Frame:Time from first treatment to planned final assessment at approximately 2.5 years
Safety Issue:
Description:
Measure:Concentration of M7284 at the end of the Dosing Interval (C trough)
Time Frame:Time from first treatment to planned final assessment at approximately 2.5 years
Safety Issue:
Description:
Measure:Immunogenicity as measured by Anti-drug Antibodies Concentration
Time Frame:Time from first treatment to planned final assessment at approximately 2.5 years
Safety Issue:
Description:
Measure:Confirmed Objective Response According to RECIST Version 1.1 Assessed by Independent Review Committee (IRC) According to Programmed Death Ligand 1 (PD-L1) Expression and Microsatellite instability (MSI) Status
Time Frame:Time from first treatment to planned final assessment at approximately 2.5 years
Safety Issue:
Description:
Measure:Duration of Response (DOR) According to (RECIST Version 1.1) Assessed by an Independent Review Committee (IRC) According to Programmed Death Ligand 1 (PD-L1) Expression and Microsatellite instability (MSI) Status
Time Frame:Time from first treatment to planned final assessment at approximately 2.5 years
Safety Issue:
Description:
Measure:Durable Response According to RECIST Version 1.1 Assessed by an Independent Review Committee (IRC) According to Programmed Death Ligand 1 (PD-L1) Expression and Microsatellite instability (MSI) Status
Time Frame:Time from first treatment to planned final assessment at approximately 2.5 years
Safety Issue:
Description:

Details

Phase:Phase 2
Primary Purpose:Interventional
Overall Status:Recruiting
Lead Sponsor:EMD Serono Research & Development Institute, Inc.

Trial Keywords

  • M7824
  • Bintrafusp alfa (proposed INN)
  • Transforming growth factor-beta
  • First-line Platinum-Based Chemotherapy
  • Programmed death-ligand 1
  • Metastatic Biliary Tract Cancer
  • Cholangiocarcinoma
  • Gallbladder cancer
  • INTR@PID BTC 047

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