CA2099DX_Ph3 Double Blind Liver Cancer Study using Nivolumab

• Research type

  Research Study

• Full title

  A Phase 3, Randomized, Double-blind Study of Adjuvant Nivolumab versus Placebo for Participants with Hepatocellular Carcinoma Who Are at High Risk of Recurrence after Curative Hepatic Resection or Ablation

• IRAS ID

  240494

• Contact name

  Tim Meyer

• Contact email

  t.meyer@ucl.ac.uk

• Sponsor organisation

  Bristol-Myers Squibb International Corporation

• Eudract number

  2017-002755-29

• Duration of Study in the UK

  6 years, 0 months, 3 days

• Research summary

  The purpose of this study is to test the effectiveness (how well the drug works), safety, and tolerability of an investigational drug called nivolumab for participants with hepatocellular carcinoma who are at high risk of recurrence after curative hepatic resection (A surgical procedure performed on the liver) or ablation (a procedure that uses heat to destroy certain types of cells).

  Nivolumab is a human monoclonal anti-PD-1 antibody (a type of protein) that works by blocking the programmed death receptor 1 (PD-1), a cell receptor on immune cells that is involved in preventing immune cells from destroying other cells. Blocking the receptor is expected to help immune cells attack cancer cells.

  After completing an initial screening process to determine eligibility, the participant will be assigned to receive either nivolumab or placebo. The placebo looks like the real treatment, but contains no active study drug. Neither the participant nor the study team will know if they have been assigned the active drug treatment or the placebo.There is a 50 percent chance of receiving nivolumab and a 50 percent chance of receiving the placebo.

  The participant will receive Nivolumab or matching placebo every 4 weeks for up to 1 year. The study will take place in specialist Oncology centres under the care of an Oncology team.

  The first two follow up visits will be in these Oncology centres, the first one will be about a month after treatment is finished and the second will be about two months after the first follow-up visit (about 100 days after treatment is finished).

  Tests undertaken will include but are not limited to; physical exam, vital signs, height, weight, pregnancy test, body scanning, electrocardiogram, questionnaires, blood and tissue tests.

• REC name

  North East - Newcastle & North Tyneside 2 Research Ethics Committee

• REC reference

  18/NE/0136

• Date of REC Opinion

  29 May 2018

• REC opinion

  Further Information Favourable Opinion