COMICE

• Research type

  Research Study

• Full title

  Randomised Phase II Trial of Cediranib and Olaparib Maintenance in Advanced/Recurrent Cervical Cancer (COMICE)

• IRAS ID

  209375

• Contact name

  Rosemary Lord

• Contact email

  Rosemary.Lord@clatterbridgecc.nhs.uk

• Sponsor organisation

  The Clatterbridge Cancer Centre NHS Foundation

• Eudract number

  2016-004215-13

• Duration of Study in the UK

  2 years, 4 months, 0 days

• Research summary

  This study is looking to test if adding Cediranib and Olaparib therapy to standard of care in patients with Advance/Recurrent Cervical Cancer increases survival. It is a blinded randomised phase II clinical trial.

  Why?
  There is a demand for active treatments in metastatic and recurrent cervical cancer patients. Patients who are receiving chemotherapy to treat recurrent or metastatic cancer tend to respond poorly, with a median survival rate of less than a year. Adding Cediranib and Olaparib as biological agents to standard chemotherapy may cause anti-angiogenic effects (stops growth of blood vessels) and less DNA repair in the tumour. Recent studies have shown that adding these drugs is active in cervical cancer.

  What?
  The primary purpose of this study is to compare median survival of patients with metastatic or recurrent cervical cancer when treated with Cediranib (antiangiogenic agent) and Olaparib (PARP inhibitor) compared with a placebo after having platinum based chemoradiotherapy. Secondary to this is to examine drug toxicity and tolerability to the combination of drugs.

  Who?
  We will recruit patients with Advanced/Recurrent Cervical Cancer who have a good performance status and have completed one line of platinum based chemotherapy. The participants will be treated until disease progression has been observed on their scans.

  Where?
  The study will be conducted in approximately 23 tertiary NHS sites across the UK with expertise in cervical cancer. A total of 108 participants will be recruited. Patients will be randomly placed equally into two arms.

  How?
  After Informed Consent patient will be randomised to either:
  a) Receive standard care with Active Cediranib OD and Olaparib BD
  b) Standard care with matching Cediranib OD and Olaparib BD placebos
  All laboratory and physical assessment performed will be in line standard care where possible. We will ask to collect retrospective tissue samples for research.

• REC name

  North West - Greater Manchester South Research Ethics Committee

• REC reference

  17/NW/0634

• Date of REC Opinion

  29 Dec 2017

• REC opinion

  Further Information Favourable Opinion