GO42661 - Atezolizumab and Bevacizumab in patients with BTC

• Research type

  Research Study

• Full title

  A phase II, randomized, double-blind, placebo-controlled study of atezolizumab with or without bevacizumab in combination with Cisplatin plus Gemcitabine in patients with untreated, advanced biliary tract cancer

• IRAS ID

  1003497

• Contact name

  Trial Information Support Line-TISL

• Contact email

  global.rochegenentechtrials@roche.com

• Sponsor organisation

  F Hoffmann-La Roche Ltd

• Eudract number

  2020-003759-14

• Research summary

  Research Summary
  Biliary Tract Cancers (BTCs) are a group of different cancers which develop within the Biliary Tree. At the time of diagnosis,
  70-90% of patients with BTC present with unresectable locally advanced or metastatic disease.
  Currently, treatment for BTC is cisplatin & gemcitabine, however it highlights the need for more effective treatments to improve
  patient outcomes. Atezolizumab is an antibody (a protein similar to the ones produced by the body's immune system) that blocks
  the programmed death-ligand 1 (PD-L1) pathway. The PD L1 pathway is involved in regulating the body's natural immune
  response, but tumours can take advantage of this regulation to partially resist or evade the immune system. By blocking the PDL1
  pathway, Atezolizumab may help the immune system stop or reverse the growth of tumours. Bevacizumab is an antibody that
  slows the growth of new blood vessels and may help the body stop the growth of tumours. It has been approved for treating
  certain advanced cancers such as colorectal, non-small cell lung cancer in combination with chemotherapy.
  In this study, patients in both arms will receive this standard chemotherapy regimen in combination with either Atezolizumab plus
  Bevacizumab or Atezolizumab plus placebo, both arms are considered experimental. This randomized Phase II study aims to
  see the results of both experimental arms in order to inform the design of future studies in BTC.
  Treatment will consist of Treatment Arm A and B. Arm A will involve patients taking Atezolizumab + Bevacizumab and CIsGem
  and Arm B will involve taking Atezolizumab + placebo and CisGem. The study will enroll globally approximately 150 patients,
  who will be randomized in a 1:1 ratio to one of the two treatment arms. There will be 18 patients recruited at 6 UK sites
  The study is sponsored by F. Hoffman La Roche
  Research Summary; Version 1 and 24-NOV-20;

  Summary of Results
  https://gbr01.safelinks.protection.outlook.com/?url=https%3A%2F%2Fclick.pstmrk.it%2F3ts%2Fforpatients.roche.com%252Fen%252Ftrials%252Fcancer%252Fa-study-of-atezolizumab-with-or-without-bevacizumab-in--17170.html%2FNBTI%2FGv65AQ%2FAQ%2F9ae249fb-06f0-41f2-958b-f51693d74cab%2F1%2FQPmk9WMvgZ&data=05%7C02%7Cgmcentral.rec%40hra.nhs.uk%7C9bcfbd4022624dcb1bb608dd1b7c7c86%7C8e1f0acad87d4f20939e36243d574267%7C0%7C0%7C638696943650209489%7CUnknown%7CTWFpbGZsb3d8eyJFbXB0eU1hcGkiOnRydWUsIlYiOiIwLjAuMDAwMCIsIlAiOiJXaW4zMiIsIkFOIjoiTWFpbCIsIldUIjoyfQ%3D%3D%7C0%7C%7C%7C&sdata=%2FTg16pomXOeYyxLNwNXzYZ2mG3WcwPK3SFkPbDjXHcs%3D&reserved=0

• REC name

  North West - Greater Manchester Central Research Ethics Committee

• REC reference

  20/NW/0448

• Date of REC Opinion

  1 Feb 2021

• REC opinion

  Further Information Favourable Opinion