ElevatION HCC101

• Research type

  Research Study

• Full title

  A Phase 1b study of PDR001 in combination with sorafenib in patients with advanced hepatocellular carcinoma (HCC)

• IRAS ID

  224937

• Contact name

  Debashis Sarker

• Contact email

  debashis.sarker@kcl.ac.uk

• Sponsor organisation

  Novartis Pharmaceutical UK Limited

• Eudract number

  2016-004131-20

• Clinicaltrials.gov Identifier

  NCT02988440

• Duration of Study in the UK

  1 years, 9 months, 17 days

• Research summary

  This Phase Ib study tests the safety of a new immunotherapy drug called PDR001, in combination with the established drug sorafenib.

  This study will be open to participants who have advanced hepatocellular carcinoma (HCC). The HCC is described as advanced when it cannot be removed by surgery or has spread other parts of the body. The participants won’t have received previous anti-cancer drug treatment for their advanced HCC.
  The study will consist of 2 parts:
  Part 1: Dose escalation part
  Part 1 will determine the dose of sorafenib which can be given alongside PDR001 without causing intolerable side effects. This dose will be used for part 2. Approximately 12 patients will be treated in Part 1

  Part 2: Dose expansion part
  30 participants: In part 2 all participants will be given PDR001+sorafenib combination at the dose determined in Part 1.

  The dose of PDR001 is fixed in both part of the study which will be 400mg every 4 weeks as an intravenous infusion. The dose of sorafenib will be determined in Part 1.

• REC name

  East of England - Essex Research Ethics Committee

• REC reference

  17/EE/0363

• Date of REC Opinion

  23 Nov 2017

• REC opinion

  Further Information Favourable Opinion