BO42533 - Phase 2 Study of Atezolizumab with Tiragolumab/Placebo in Metastatic Carcinoma

• Research type

  Research Study

• Full title

  A PHASE II, RANDOMIZED, DOUBLE-BLIND STUDY OF ATEZOLIZUMAB PLUS TIRAGOLUMAB AND ATEZOLIZUMAB PLUS PLACEBO AS FIRST-LINE TREATMENT IN PATIENTS WITH RECURRENT/METASTATIC PD-L1 POSITIVE SQUAMOUS CELL CARCINOMA OF THE HEAD AND NECK.

• IRAS ID

  1003525

• Contact name

  Kevin Harrington

• Contact email

  kevin.harrington@icr.ac.uk

• Sponsor organisation

  F.Hoffmann-La Roche AG

• Eudract number

  2020-002852-19

• Research summary

  The purpose of this study is to understand the effects, good or bad, of atezolizumab plus tiragolumab and atezolizumab plus
  placebo in patients with squamous cell carcinoma of the head and neck (SCCHN). Participants will get either atezolizumab plus
  tiragolumab or atezolizumab plus placebo. Which group they participate in will be random (50/50 chance) and neither the
  participant or doctor will know which group they are in.
  Tiragolumab is an antibody (a large Y-shaped protein used by your body's immune system to identify and neutralize foreign
  objects, such as tumour cells), and tiragolumab acts by blocking the TIGIT protein. TIGIT may allow tumour cells to escape the
  immune system; thus, by blocking the TIGIT protein, tiragolumab may help boost the immune system and stop or reverse the
  growth of tumours.
  Atezolizumab is an antibody that blocks the PD-L1 pathway. The PD-L1 pathway is involved in regulating the body's natural
  immune response, but tumours can take advantage of this regulation to partially resist or evade the immune system. By blocking
  the PD L1 pathway, atezolizumab may help the immune system stop or reverse the growth of tumours.
  Globally there will be 120 participants, with 10 UK participants at 5 UK sites.
  Male & Female adults with SCCHN can join the study if their cancer is recurrent (cancer has returned in the head and neck),
  cannot be cured with local treatments (such as surgery or radiation), or metastatic (cancer has spread to other organs), and have
  not received prior chemotherapy or immunotherapy to treat their cancer.
  The study will last approximately 43 months.
  This study has three parts; Screening (to see if they are eligible for the study), Treatment, Post-Treatment follow-up (to check on
  them after treatment is finished)
  The study is sponsored by F. Hoffman La Roche
  Research Summary; V1 24Nov2020

• REC name

  North West - Greater Manchester Central Research Ethics Committee

• REC reference

  21/NW/0003

• Date of REC Opinion

  18 Feb 2021

• REC opinion

  Further Information Favourable Opinion