WO40242 Phase III Double Blind Head & Neck Cancer Study

• Research type

  Research Study

• Full title

  A PHASE III, MULTICENTER, RANDOMIZED,DOUBLE-BLIND, PLACEBO-CONTROLLED STUDY OF ATEZOLIZUMAB (ANTI-PD-L1 ANTIBODY) AS ADJUVANT THERAPY AFTER DEFINITIVE LOCAL THERAPY IN PATIENTS WITH HIGH-RISK LOCALLY ADVANCED SQUAMOUS CELL CARCINOMA OF THE HEAD AND NECK

• IRAS ID

  237783

• Contact name

  Kevin Harrington

• Contact email

  kevin.harrington@icr.ac.uk

• Sponsor organisation

  F Hoffmann-La Roche Ltd

• Eudract number

  2017-003302-40

• Clinicaltrials.gov Identifier

  NCT03452137

• Duration of Study in the UK

  6 years, 2 months, 24 days

• Research summary

  There is currently no specific treatment for patients with advanced head & neck cancer, after they complete their initial treatment which may consist of surgery followed by either radiotherapy or chemotherapy. Instead, these patients are observed until their disease returns or worsens.

  The purpose of this phase III research study is to compare the effects, good or bad, of atezolizumab versus placebo (an inactive substance that looks like atezolizumab) on patients with locally advanced cancer of the head and neck region, also called squamous cell carcinoma of the head and neck (SCCHN), following previous treatment.
  Atezolizumab is an experimental drug and has not been approved by the health authorities for the treatment of head and neck cancer.

  The study will enroll approximately 400 patients globally who will be randomly allocated to one of two treatment arms: Arm A – Atezolizumab or Arm B the placebo.
  Neither the patient or doctor will know which treatment has been allocated, this is known as a double blind study.

  Treatment allocation will only be revealed if there is a safety concern or if required to support your future treatment.

  Patients with head & neck cancer, whose disease is at high risk and has not worsened since their initial treatment may be eligible to participate in this research study.
  The study will consist of the following stages:
  • Screening Period
  • Double blind treatment
  • Treatment Discontinuation
  • Long Term Follow-up

  The total length of the study is expected to be approximately 84 months.

  The study is sponsored by F. Hoffman La Roche
  Summary of results
  The lay summary of results is available on the forpatients platform:
  https://gbr01.safelinks.protection.outlook.com/?url=https%3A%2F%2Fclick.pstmrk.it%2F3ts%2Fforpatients.roche.com%252Fen%252Ftrials%252Fcancer%252FHead_and_Neck_Cancer%252Fa-study-of-atezolizumab--antipd-l1-antibody--as-adjuvant-therapy.html%2FNBTI%2F8uy5AQ%2FAQ%2F652a2581-6ee6-4345-a991-de30c0b50892%2F1%2FsP_MPYhCui&data=05%7C02%7Cderby.rec%40hra.nhs.uk%7C5badb70f4b70407b1e8808dd1916e6b1%7C8e1f0acad87d4f20939e36243d574267%7C0%7C0%7C638694308333447628%7CUnknown%7CTWFpbGZsb3d8eyJFbXB0eU1hcGkiOnRydWUsIlYiOiIwLjAuMDAwMCIsIlAiOiJXaW4zMiIsIkFOIjoiTWFpbCIsIldUIjoyfQ%3D%3D%7C0%7C%7C%7C&sdata=5YpI4UVNnURI7ACnnGlXP4zJ3GaZMXCi%2FZpDBzEN4F8%3D&reserved=0

• REC name

  East Midlands - Derby Research Ethics Committee

• REC reference

  18/EM/0127

• Date of REC Opinion

  4 Jul 2018

• REC opinion

  Further Information Favourable Opinion