AMG 319 in HPV negative HNSCC

• Research type

  Research Study

• Full title

  A Cancer Research UK randomised, double-blind, placebo-controlled Phase IIa trial of AMG 319 given orally as a neoadjuvant therapy in patients with human papillomavirus (HPV) positive and negative head and neck squamous cell carcinoma (HNSCC)

• IRAS ID

  180375

• Contact name

  Christian Ottensmeier

• Contact email

  c.h.ottensmeier@soton.ac.uk

• Sponsor organisation

  Cancer Research UK’s Centre for Drug Development

• Eudract number

  2014-004388-20

• Duration of Study in the UK

  4 years, 0 months, 0 days

• Research summary

  Cancers use ‘defence mechanisms’ to hide from the immune system and teach the immune system not to destroy cancer cells. AMG 319 works by blocking these defence mechanisms in the tumour. It targets and blocks an important protein called PI3K delta.

  In the laboratory this leads to removal of a group of inhibitory immune cells. Releasing the immune brakes leads to immune attack and destruction of cancer cells.
  AMG 319 looks promising in laboratory studies and in a very early study in a small number of patients with leukaemia and we now wish to find out if it will be useful in treating patients with head and neck cancer.

  The proposed study is a randomised, double­-blind, placebo-­controlled Phase II trial looking at the effects of giving AMG 319 to patients with the type of head and neck cancer squamous cell carcinoma (HNSCC) with the worst outcomes. These are the cancers that are not caused by human papilloma virus (HPV). We propose to treat patients prior to resection surgery so that we can study the effect of AMG 319 on the cancer in fine detail.

  The main aims of the study are to find out:
­
  - how the immune system responds to AMG 319 and what affect this has on a patient's cancer ­
  - more about the potential side effects of AMG 319 and how they can be managed
­
  - what happens to the drug inside the body

  Up to 54 patients with HPV negative HNSCC of the hypopharynx, oropharynx or oral cavity will be entered into the study. Patients will be randomly assigned to one of two treatment groups and will receive between 21 and 30 days of oral dosing with AMG 319 or placebo immediately before resection surgery.

• REC name

  South Central - Hampshire B Research Ethics Committee

• REC reference

  15/SC/0289

• Date of REC Opinion

  8 Jun 2015

• REC opinion

  Favourable Opinion