MS200647_0047 - M7824 in patients with metastatic biliary tract cancer

• Research type

  Research Study

• Full 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

• IRAS ID

  259187

• Contact name

  John Bridgewater

• Contact email

  j.bridgewater@ucl.ac.uk

• Sponsor organisation

  Merck KGaA

• Eudract number

  2018-003707-19

• Duration of Study in the UK

  2 years, 7 months, 5 days

• Research summary

  Summary of Research

  The study is being done to evaluate an investigational drug called M7824 in participants with biliary tract cancer (BTC) that has not responded to chemotherapy with platinum based drugs. M7824 has been used in a previous study of people with BTC.
  This study will include people who have locally advanced or metastatic BTC, which means cancer that has spread locally or to another part of the body (metastatic).

  The study will mainly evaluate the potential effectiveness of M7824 in BTC on the basis of how tumours respond (react) to the drug and how long tumours respond for. It will also look at the safety of M7824 in these participants, amongst other objectives.

  The study will include up to 141 people living in the United States, Europe, and Asia.
  All participants will receive M7824 for up to 2 years or until the cancer progresses, they experience unacceptable side effects, or they withdraw from the study. The time spent in the study may be up to 3 years.

  The study drug is given every 2 weeks as an intravenous infusion (a drip into a vein).

  Enrolment timelines:
  Planned start date in UK; May 2019
  Last participants in UK: May 2020

  Summary of Results

  the lay summary of the results is published at https://eur03.safelinks.protection.outlook.com/?url=https%3A%2F%2Fu2790089.ct.sendgrid.net%2Fls%2Fclick%3Fupn%3DXv3JSvJ-2B3M71ppf7N9agbd1X5b3S0XYk-2BWuIMgP6daBItKEYMmeT87-2FYxIv-2F3hkKqKc9XzEbekGRWc1gdeIDNgtLs1HtNTl-2BttgwlfTPjaQ-3D3PQB_E1aO2-2BZlVOSJJV-2FajQqskegTd6IRomHYTi-2Fbt8SH3YIlV5LF1NYbqXh6bGUcSfq-2BDJWTSOdNZQsmN-2BIEAvKio9aAEp-2F0PXCSlOVUnYF5m22D7rgQ7666pYlcVKYJrJorVhqzqOEAg1DKvtHft1Ur7QkBPglQSeLzPuHz-2B4Tj0zS6C-2BTHvvEdnlREE2LmfrGnJw6AlruzjMycLiTwTFBXvw-3D-3D&data=05%7C01%7Capprovals%40hra.nhs.uk%7C3eba2132ca2d45c9bc4308daf3db307f%7C8e1f0acad87d4f20939e36243d574267%7C0%7C0%7C638090419982315204%7CUnknown%7CTWFpbGZsb3d8eyJWIjoiMC4wLjAwMDAiLCJQIjoiV2luMzIiLCJBTiI6Ik1haWwiLCJXVCI6Mn0%3D%7C3000%7C%7C%7C&sdata=dB03flbBkkkj%2BQ45LRm4i2Vvtq45%2F3b4MuN6vq1GRx0%3D&reserved=0

• REC name

  London - City & East Research Ethics Committee

• REC reference

  19/LO/0309

• Date of REC Opinion

  2 May 2019

• REC opinion

  Further Information Favourable Opinion