CALIBRATION

• Research type

  Research Study

• Full title

  “CALIBRATION”: An exploratory study in patients with advanced oesophageal malignancies receiving MEDI4736 (Durvalumab), investigating whether early changes in circulating tumour DNA can predict tumour response

• IRAS ID

  223016

• Contact name

  Simon Pacey

• Contact email

  simon.pacey@addenbrookes.nhs.uk

• Sponsor organisation

  Cambridge University Hospitals NHS Foundation Trust

• Eudract number

  2017-001719-35

• Duration of Study in the UK

  3 years, 6 months, 28 days

• Research summary

  Patients with cancer are increasingly being treated with drugs designed to modulate the response of their immune system, broadly to boost their body’s defences against cancer. Drugs have positive and negative effects, so in parallel with development of new treatment options other important questions arise such as who will benefit most and which patients are unlikely to benefit.
  
  Deciding on benefit from therapy uses standard imaging methods (e.g. CT scans), which can take time (months) for a conclusive answer. Cancers release small amounts of genetic code, or DNA, into the bloodstream which can be measured. The main aim of this study is to assess whether changes in the level of circulating tumour DNA (ctDNA) can quickly determine a patients response.

  For individual patients this would support access to the best possible drug(s) matched (personalised) for their condition or reducing exposure to ineffective drugs reducing side effects and allowing their treatment to move on to the next step with minimal delay.

  Patients with advanced Oesophageal cancer will be treated with MEDI4736 (durvalumab), a drug designed to alter the immune system response.We will recruit patients with advanced cancer known to be progressing after first line (platinum containing) chemotherapy.

  The study will run at a single centre (Addenbrookes Hospital, Cambridge).

  Nineteen, evaluable, patients will receive durvalumab until progression while detailed studies will assess their tumour and immune response.

• REC name

  North West - Haydock Research Ethics Committee

• REC reference

  18/NW/0409

• Date of REC Opinion

  4 Jul 2018

• REC opinion

  Further Information Favourable Opinion