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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

Trial Profile

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

Status: Completed
Phase of Trial: Phase II

Latest Information Update: 06 Feb 2024

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At a glance

  • Drugs Bintrafusp alfa (Primary)
  • Indications Biliary cancer; Cholangiocarcinoma; Gallbladder cancer
  • Focus Therapeutic Use
  • Acronyms INTR@PID BTC 047
  • Sponsors EMD Serono Research & Development Institute; Merck KGaA

Most Recent Events

  • 04 Feb 2024 This trial has been completed in Italy, according to European Clinical Trials Database record
  • 03 Apr 2023 Primary endpoint (Confirmed Objective Response (OR) According to Response Evaluation Criteria in Solid Tumors (RECIST Version 1.1) as Evaluated by Independent Review Committee) has not been met according to Results published in the Hepatology.
  • 03 Apr 2023 Results assessing safety and efficacy of bintrafusp alfa as second-line therapy for patients with locally advanced/metastatic biliary tract cancers published in the Hepatology

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