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

Overview

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.

Full Title of Study: “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”

Study Type

  • Study Type: Interventional
  • Study Design
    • Intervention Model: Single Group Assignment
    • Primary Purpose: Treatment
    • Masking: None (Open Label)
  • Study Primary Completion Date: March 3, 2021

Interventions

  • Drug: M7824
    • 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

Arms, Groups and Cohorts

  • Experimental: M7824

Clinical Trial Outcome Measures

Primary Measures

  • 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

Secondary Measures

  • 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
  • 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
  • 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
  • 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
  • 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
  • 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
  • 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
  • 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
  • Overall Survival (OS)
    • Time Frame: Time from first treatment to planned final assessment at approximately 2.5 years
  • Concentration of M7284 at the end of Infusion (Ceoi)
    • Time Frame: Time from first treatment to planned final assessment at approximately 2.5 years
  • 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
  • Immunogenicity as measured by Anti-drug Antibodies Concentration
    • Time Frame: Time from first treatment to planned final assessment at approximately 2.5 years
  • 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
  • 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
  • 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

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • EMD Serono Research & Development Institute, Inc.
  • Collaborator
    • Merck KGaA, Darmstadt, Germany
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Medical Responsible, Study Director, Merck KGaA, Darmstadt, Germany
  • Overall Contact(s)
    • US Medical Information, +888-275-7376, service@emdgroup.com

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