Study to test Pexa-Vec and Sorafenib vs Sorafenib in Liver Cancer

• Research type

  Research Study

• Full title

  A Phase 3 Randomized, Open-Label Study Comparing Pexa Vec (Vaccinia GM CSF / Thymidine Kinase-Deactivated Virus) Followed by Sorafenib Versus Sorafenib in Patients with Advanced Hepatocellular Carcinoma (HCC) Without Prior Systemic Therapy

• IRAS ID

  200385

• Contact name

  Debashis Sarker

• Contact email

  debashis.sarker@kcl.ac.uk

• Sponsor organisation

  SillaJen Inc.

• Eudract number

  2014-001985-86

• Clinicaltrials.gov Identifier

  NCT02562755

• Clinicaltrials.gov Identifier

  BB-IND 6486, IND Number

• Duration of Study in the UK

  3 years, 3 months, 31 days

• Research summary

  Hepatocellular carcinoma (HCC) is a form of liver cancer which is estimated to be the third most common cause of cancer-related deaths worldwide.

  This study, sponsored by SillaJen Inc. is a phase 3, randomized, open-label study to test a drug called Pexa-Vec in HCC patients who are no longer able to receive local therapy or surgery. This patient population is usually treated with a chemotherapy drug called Sorafenib.

  Pexa-Vec is a virus (called vaccinia virus) that has been genetically modified in a laboratory to selectively infect and destroy cancer cells and release a protein called GM-CSF which plays a role in the immune system against cancer. As of January 2015, over 300 patients have been treated with Pexa-Vec.

  The main purpose of this study is to find out whether Pexa-Vec followed by standard Sorafenib treatment is better at treating HCC than standard Sorafenib treatment alone. The addition of Pexa-Vec to Sorafenib treatment may shrink the cancer and may stimulate the body’s own immune system to kill liver cancer cells, but it could also cause side effects.

  This study will allow researchers to know whether this different approach is better, the same or worse than the usual approach of Sorafenib treatment. To be better, the addition of the study drug will need to increase survival time compared to the standard approach.

  Approximately 600 patients will take part in this study worldwide.

  A computer will randomly assign participants to one of the following:
  • Arm A will get the study drug, Pexa-Vec (by intra-tumoural injection), followed by Sorafenib (oral tablet)
  • Arm B will get Sorafenib only

  On average, active treatment will last 14 to 18 weeks, plus a follow-up period.

  Study procedures include medical history, ECG, blood pressure, pulse, temperature, weight, bloods tests, urine tests, questionnaires, CT or MRI scans.

• REC name

  London - West London & GTAC Research Ethics Committee

• REC reference

  16/LO/1244

• Date of REC Opinion

  17 Oct 2016

• REC opinion

  Further Information Favourable Opinion