CO44668 - Tiragolumab in HCC

• Research type

  Research Study

• Full title

  A Phase III, Randomized, Double-Blind, Placebo-Controlled Study Evaluating Atezolizumab and Bevacizumab, with and without Tiragolumab, In Patients With Untreated Locally Advanced or Metastatic Hepatocellular Carcinoma

• IRAS ID

  1008257

• Contact name

  Nicole Oaten

• Contact email

  welwyn.uk_ethics@roche.com

• Sponsor organisation

  F. Hoffmann-La Roche Ltd

• Research summary

  Hepatocellular carcinoma (HCC) is the most common type of liver cancer. Most people are first diagnosed with HCC once it has spread to surrounding tissues or lymph nodes (known as ‘advanced HCC’) or to other parts of the body (known as ‘metastatic HCC’). The standard first-line therapy for advanced HCC is a combination of an immunotherapy drug called atezolizumab and an anti-tumour blood vessel drug called bevacizumab. However, only a minority of patients respond and there is currently no cure for patients with advanced disease.

  New treatment combinations are therefore needed for advanced or metastatic HCC.
  Tiragolumab is a type of immunotherapy that may boost anti-cancer activity when given with atezolizumab and bevacizumab. Tiragolumab is an experimental medicine, which means it has not been approved by health authorities for treating HCC. This clinical trial aims to compare the effects, good or bad, of tiragolumab plus atezolizumab and bevacizumab versus placebo plus atezolizumab and bevacizumab in people with HCC.

  Approximate planned number of patients globally is 650; there are 2 treatment arms - active treatment with tiragolumab and a placebo arm, 1:1 ratio.
  People can take part in this trial if they are at least 18 years old and have advanced or metastatic HCC, or HCC that cannot be removed with surgery. People may not be able to take part in this trial if they have previously received certain treatments, including those for advanced/metastatic HCC, or have certain medical conditions, such as problems with bleeding in the gut, other cancer types, auto-immune, lung or heart disease, certain infections, are pregnant or breastfeeding, or are planning to become pregnant shortly after the trial.

  The study will last 2.5 years. There will be approximately 27 patients recruited at 10 UK sites.
  Research Summary version 1.0 dated 30-Aug-2023
  The study is sponsored by F. Hoffmann- La Roche

• REC name

  Yorkshire & The Humber - Leeds East Research Ethics Committee

• REC reference

  23/YH/0225

• Date of REC Opinion

  16 Oct 2023

• REC opinion

  Further Information Favourable Opinion